Novartis Pharmaceuticals Corporation announced today the successful completion of a cooperative research and development agreement (CRADA) with the Food and Drug Administration (FDA), one of the first projects conducted under the FDA's Critical Path Initiative.
The Critical Path Initiative was launched by FDA in 2004 to refine the science and processes through which FDA-regulated drugs, biologics, and devices are translated from a discovery or "proof of concept" to a medical product. The research produced under the CRADA led to a number of key achievements that will enhance the development and application of preclinical biomarkers to evaluate drug safety. "In working together with FDA, we have demonstrated the progress that can be achieved in the biomarker field, and in the science of drug development in general, through public-private partnerships," according to John Orloff, MD, Senior Vice President, US Medical and Drug Regulatory Affairs at Novartis Pharmaceuticals Corporation.
"We have developed both a process for defining biomarkers of safety and real-world data that can support regulatory decision making regarding renal safety." The FDA-Novartis CRADA had two primary objectives: 1) To define a process for qualifying preclinical safety biomarkers for regulatory decision making; and 2) to test this pilot process by submitting kidney-related safety biomarkers identified and characterized through preclinical studies to the FDA for qualification. Efforts conducted under the CRADA have resulted in the publication of the first pilot framework for a preclinical regulatory biomarker qualification process(1).
The development of this process will have a broad impact on the understanding of the qualification of safety biomarkers far beyond this partnership. In addition, the preclinical data identified thus far have demonstrated evidence for the superiority of new renal biomarkers over the current standards used to assess renal injury in drug testing, namely serum creatinine and blood urea nitrogen (BUN). Further efforts will focus on the extended clinical qualification of biomarkers that could allow clinicians to detect kidney injury in patients earlier than current clinical practice allows. Relevant safety biomarker data generated by Novartis as part of the CRADA has been shared with the Critical Path Institute's Predictive Safety Testing Consortium (PSTC).
The PSTC is a larger public/private partnership between industry, academia, and regulatory health authorities intended to serve as a neutral body for coordinating activities related to biomarker qualification in drug development. The CRADA data, together with data generated by other partners in the PSTC has been submitted to FDA and the European Medicines Agency (EMEA) as part of a Voluntary Exploratory Data Submission (VXDS). The two regulators are now considering whether to approve use of these biomarker data in support of particular aspects of regulatory decision making. As a result of this data submission,
FDA and EMEA have utilized appropriate internal boards and worked to refine the process to qualify such preclinical safety biomarker data. Further joint evaluation of additional data under the auspices of the PSTC is expected to lead to additional submissions of peripheral biomarkers representing additional renal pathologies. "The Biomarker CRADA is a significant step in bridging the gap between basic scientific research and the medical product development process," said Janet Woodcock, Director of the FDA's Center for Drug Evaluation and Research. "The FDA was pleased to work with Novartis to further the development of renal safety biomarkers that can be used to prevent drug-induced kidney damage." The data generated by Novartis under the CRADA will continue to have an impact despite the agreement's conclusion. Novartis intends to submit additional data on genomic- and proteomic-based renal safety biomarkers to FDA and EMEA in the summer of 2008.
Monday, March 31, 2008
Naglazyme Approved by Japanese Ministry of Health
BioMarin Pharmaceutical Inc. announced today that AnGes MG, Inc. (AnGes), BioMarin's marketing and distribution partner in Japan, has received approval for its Marketing Application for Naglazyme(R) (galsulfase) from the Japanese Ministry of Health, Labour and Welfare (MHLW) for the treatment of patients with Mucopolysaccharidosis VI ( MPS VI).
"We are proud to work with AnGes in bringing the first drug treatment option to MPS VI patients in Japan," said Stephen Aselage, Senior Vice President of Global Commercial Development at BioMarin. "We are dedicated to providing life-altering therapies to patients around the world and continue to expand our geographic footprint through our patient identification and commercialization efforts."
BioMarin established a marketing and distribution agreement with AnGes in December 2006, through which AnGes obtained exclusive rights to market Naglazyme in the Japanese market. AnGes submitted a marketing application to the MHLW in August 2007. Naglazyme was approved by the U.S. Food and Drug Administration (FDA) in May 2005 and by the European Commission (EC) in January 2006. As the first drug approved for MPS VI, the FDA and EC have both designated Naglazyme as an orphan drug, conferring seven years of market exclusivity in the United States and 10 years of market exclusivity in the European Union. In addition, Naglazyme obtained orphan designation in June 2007 from the MHLW in Japan.
"We are proud to work with AnGes in bringing the first drug treatment option to MPS VI patients in Japan," said Stephen Aselage, Senior Vice President of Global Commercial Development at BioMarin. "We are dedicated to providing life-altering therapies to patients around the world and continue to expand our geographic footprint through our patient identification and commercialization efforts."
BioMarin established a marketing and distribution agreement with AnGes in December 2006, through which AnGes obtained exclusive rights to market Naglazyme in the Japanese market. AnGes submitted a marketing application to the MHLW in August 2007. Naglazyme was approved by the U.S. Food and Drug Administration (FDA) in May 2005 and by the European Commission (EC) in January 2006. As the first drug approved for MPS VI, the FDA and EC have both designated Naglazyme as an orphan drug, conferring seven years of market exclusivity in the United States and 10 years of market exclusivity in the European Union. In addition, Naglazyme obtained orphan designation in June 2007 from the MHLW in Japan.
Suven Life Sciences gets Two product patents in Korea and Mexico
March 31, 2008 – Suven Life Sciences Ltd has announced that two product patents were granted in Mexico and Korea for two of their new chemical entities (NCEs) for the treatment of disorders associated with neurodegenerative diseases and these patents are valid until 2023.
These granted patents are exclusive intellectual property of Suven and are achieved through the exclusive internal discovery research efforts. Products out of these inventories, which are in pre-clinical development, may be out-licensed at the stage of clinical phase-I or phase-II stage.
"We are very pleased by the issuance of these patents to Suven for our drug candidates that are being developed for CNS disorders which targets an $18 billion potential market opportunity globally" says Venkat Jasti, CEO of Suven.
The granted claims of the patents include the class of selective 5-HT compounds discovered by Suven and are being developed as therapeutic agents and are useful in the treatment of cognitive impairment associated with neurodegenerative disorders like attention deficient hyperactivity, Alzheimer's, Parkinson, Schizophrenia and Huntington's.
These granted patents are exclusive intellectual property of Suven and are achieved through the exclusive internal discovery research efforts. Products out of these inventories, which are in pre-clinical development, may be out-licensed at the stage of clinical phase-I or phase-II stage.
"We are very pleased by the issuance of these patents to Suven for our drug candidates that are being developed for CNS disorders which targets an $18 billion potential market opportunity globally" says Venkat Jasti, CEO of Suven.
The granted claims of the patents include the class of selective 5-HT compounds discovered by Suven and are being developed as therapeutic agents and are useful in the treatment of cognitive impairment associated with neurodegenerative disorders like attention deficient hyperactivity, Alzheimer's, Parkinson, Schizophrenia and Huntington's.
Endo and Penwest File Lawsuit Against Actavis Relating to Opana ER
Endo Pharmaceuticals Inc., a subsidiary of Endo Pharmaceuticals Holdings Inc. (NASDAQ: ENDP), and Penwest Pharmaceuticals Co. (NASDAQ: PPCO) announced today that they have filed a lawsuit against Actavis South Atlantic LLC in the United States District Court for the District of New Jersey in connection with Actavis's Abbreviated New Drug Application (ANDA) for OPANA(R) ER (oxymorphone HCl) extended-release tablets CII.
The lawsuit is in response to Actavis's notice to Endo and Penwest, announced on February 15, 2008, advising of the filing by Actavis of an ANDA containing a Paragraph IV certification under 21 U.S.C. Section 355(j) for oxymorphone hydrochloride extended-release tablets CII. Actavis's Paragraph IV certification notice refers to four Penwest patents listed in the FDA's Orange Book, which patents cover the formulation of OPANA ER. The complaint filed today alleges infringement of U.S. Patent No. 5,958,456, which is one of these Orange Book-listed patents.
OPANA ER has been granted new dosage form regulatory exclusivity that prevents the FDA from approving any ANDA for a generic version of OPANA ER for launch prior to June 22, 2009, the date such regulatory exclusivity expires
The lawsuit is in response to Actavis's notice to Endo and Penwest, announced on February 15, 2008, advising of the filing by Actavis of an ANDA containing a Paragraph IV certification under 21 U.S.C. Section 355(j) for oxymorphone hydrochloride extended-release tablets CII. Actavis's Paragraph IV certification notice refers to four Penwest patents listed in the FDA's Orange Book, which patents cover the formulation of OPANA ER. The complaint filed today alleges infringement of U.S. Patent No. 5,958,456, which is one of these Orange Book-listed patents.
OPANA ER has been granted new dosage form regulatory exclusivity that prevents the FDA from approving any ANDA for a generic version of OPANA ER for launch prior to June 22, 2009, the date such regulatory exclusivity expires
Spanish Appellate Court Rules in Pfizer's Favor, Upholds Lipitor Patent
Mar 31, 2008 - Pfizer Inc said today that the Court of Appeal of Barcelona has upheld the company's enantiomer patent covering the calcium salt of atorvastatin, the active ingredient in Lipitor, reversing the lower court decision. The enantiomer patent expires in July 2010.
The patent was challenged jointly by generic companies Laboratorios Cinfa S.A., Kern Pharma S.L., Laboratorios Alter S.A. and Laboratorios Belmac S.A., and is one of four separate challenges to the enantiomer patent by generic companies in Spain. Lipitor is sold in Spain under the brand names Zarator and Cardyl. "This is a victory not only for Pfizer, but for all innovators pursuing high-risk medical discoveries and for the patients who benefit from those discoveries," said Pfizer Senior Vice President and Associate General Counsel Peter C. Richardson. Cinfa, Kern, Alter and Belmac can seek to appeal the decision to the Supreme Court of Spain
The patent was challenged jointly by generic companies Laboratorios Cinfa S.A., Kern Pharma S.L., Laboratorios Alter S.A. and Laboratorios Belmac S.A., and is one of four separate challenges to the enantiomer patent by generic companies in Spain. Lipitor is sold in Spain under the brand names Zarator and Cardyl. "This is a victory not only for Pfizer, but for all innovators pursuing high-risk medical discoveries and for the patients who benefit from those discoveries," said Pfizer Senior Vice President and Associate General Counsel Peter C. Richardson. Cinfa, Kern, Alter and Belmac can seek to appeal the decision to the Supreme Court of Spain
Actavis launches Bupropion Hydrochloride SR in the US; 29 products in Bulgaria in 1Quarter; dry skin range in Romania
31 March 2008 -- Actavis Group, the international generic pharmaceuticals company, today announced that it has received two separate approvals from the US Food & drug administration to market Bupropion Hydrochloride extended-release tablets (SR). Distribution of the products will commence immediately.
Bupropion Hydrochloride extended-release tablets (SR), available in 150mg strength, are the generic equivalent of Wellbutrin SR® and are indicated for the treatment of major depressive disorder. Annual sales of brand and generic Wellbutrin SR® were US$ 498 million for the 12 months ending December 2007 according to IMS Health data. Bupropion Hydrochloride extended-release tablets (SR), available in 150mg strength, are the generic equivalent of Zyban® and are indicated as an aid to smoking cessation treatment. Annual sales of brand and generic Zyban® were US$ 12 million for the 12 months ending December 2007 according to IMS Health data.
Actavis Bulgaria launches record 29 products in 1Q Actavis Bulgaria launched 29 new products during the first three months of the year. The company plans to launch a total of 43 new products in Bulgaria during 2008. The newly launched products include Fosinopril HCT (cardiovascular) and Lisinopril HCT (cardiovascular), both of which were first to market in Bulgaria; Irinotecan (oncology), which Actavis has also recently marketed in the United States; Sertraline (antidepressant) and Bicalutamide (oncology). Of the 29 products, 23 are nutritional supplements and products from the Decubal cosmetics line.
Actavis Romania says goodbye to dry skin Decubal, Actavis' complete range dedicated exclusively to dry skin, has been officially launched in Romania. The range comprises 17 products. The products, based on long-term research and clinic testing, are dedicated to cleaning and caring for the face, body, scalp and hair.
Bupropion Hydrochloride extended-release tablets (SR), available in 150mg strength, are the generic equivalent of Wellbutrin SR® and are indicated for the treatment of major depressive disorder. Annual sales of brand and generic Wellbutrin SR® were US$ 498 million for the 12 months ending December 2007 according to IMS Health data. Bupropion Hydrochloride extended-release tablets (SR), available in 150mg strength, are the generic equivalent of Zyban® and are indicated as an aid to smoking cessation treatment. Annual sales of brand and generic Zyban® were US$ 12 million for the 12 months ending December 2007 according to IMS Health data.
Actavis Bulgaria launches record 29 products in 1Q Actavis Bulgaria launched 29 new products during the first three months of the year. The company plans to launch a total of 43 new products in Bulgaria during 2008. The newly launched products include Fosinopril HCT (cardiovascular) and Lisinopril HCT (cardiovascular), both of which were first to market in Bulgaria; Irinotecan (oncology), which Actavis has also recently marketed in the United States; Sertraline (antidepressant) and Bicalutamide (oncology). Of the 29 products, 23 are nutritional supplements and products from the Decubal cosmetics line.
Actavis Romania says goodbye to dry skin Decubal, Actavis' complete range dedicated exclusively to dry skin, has been officially launched in Romania. The range comprises 17 products. The products, based on long-term research and clinic testing, are dedicated to cleaning and caring for the face, body, scalp and hair.
Caraco Pharmaceutical Laboratories Ltd. To Market Generic Ethyol
Caraco Pharmaceutical Laboratories, Ltd. announced today, that it has launched amifostine for injection 500mg on behalf of Sun Pharmaceutical Industries Ltd. (Sun Pharma). This product has been added to Caraco's Paragraph IV marketing agreement with Sun Pharma that was signed on January 29, 2008. Sun Pharma recently received approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for generic Ethyol(R), and being the first-to-file an ANDA with a Paragraph IV certification, has a 180-day marketing exclusivity. Sun Pharma is currently involved in patent litigation with MedImmune Oncology, Inc. concerning this product in the U.S. District Court for the District of Maryland.
Amifostine is indicated to reduce the cumulative renal toxicity associated with repeated administration of cisplatin in patients with ovarian cancer. This new product is bioequivalent to Ethyol(R), a registered trademark of MedImmune Oncology, Inc. Ethyol(R) had U.S. sales of approximately $80 million for the 12-month period ended December 31, 2007, according to IMS Data.
Amifostine is indicated to reduce the cumulative renal toxicity associated with repeated administration of cisplatin in patients with ovarian cancer. This new product is bioequivalent to Ethyol(R), a registered trademark of MedImmune Oncology, Inc. Ethyol(R) had U.S. sales of approximately $80 million for the 12-month period ended December 31, 2007, according to IMS Data.
Lannett Company Receives FDA Approval for Rifampin Capsules USP, 150 mg and 300 mg
Mar 31, 2008 - Lannett Company, Inc. (AMEX:LCI), a manufacturer of generic pharmaceuticals, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Rifampin Capsules in 150 mg and 300 mg, the generic equivalent of Rifadin(R) Capsules marketed by Sanofi Aventis US, LLC.
According to Wolters Kluwer, total sales of generic Rifampin Capsules were $38 million in 2007. Rifampin is indicated in the treatment of all forms of tuberculosis and for the treatment of asymptomatic carriers of Neisseria meningitidis to eliminate meningococci from the nasopharynx.
"This approval bolsters our growing portfolio of manufactured pharmaceutical products," said Arthur Bedrosian, president and chief executive officer of Lannett. "We expect to commence marketing both dosages of our Rifampin product in the near term."
According to Wolters Kluwer, total sales of generic Rifampin Capsules were $38 million in 2007. Rifampin is indicated in the treatment of all forms of tuberculosis and for the treatment of asymptomatic carriers of Neisseria meningitidis to eliminate meningococci from the nasopharynx.
"This approval bolsters our growing portfolio of manufactured pharmaceutical products," said Arthur Bedrosian, president and chief executive officer of Lannett. "We expect to commence marketing both dosages of our Rifampin product in the near term."
Judge Construes Claims In Carbatrol Patent Fight
March 28, 2008--A federal judge (STANLEY R. CHESLER) delivered a mixed ruling in Shire Laboratories Inc.'s patent lawsuit against generics maker Corepharma LLC over Shire's anti-seizure drug Carbatrol, accepting Corepharma's proposed construction of one disputed term and rejecting its constructions of three others.
Shire Laboratories, Inc. and Defendant Corepharma, LLC have filed an application for claim construction to resolve disputes over the construction of four claim terms in U.S. Patent No. 5,326,570 (“the ‘570 patent”).
Court Ordered that
(1) the term “unit” in claims 1 and 18 of the ‘570 patent shall be construed in all future proceedings, pursuant to Markman v. Westview Instruments, Inc., 52 F.3d 967 (Fed. Cir. 1995), as a single thing or entity that is a constituent or isolable member of a more inclusive whole, being the least part of the whole to have a clearly definable existence separate or different from other parts of the whole; and
(2) the term “immediate release unit” in claims 1 and 18 of the ‘570 patent shall be construed in all future proceedings, pursuant to Markman, 52 F.3d 967, as a unit, as defined above, which begins to release the carbamazepine upon ingestion; and
(3) the term “sustained release unit” in claims 1 and 18 of the ‘570 patent shall be construed in all future proceedings, pursuant to Markman, 52 F.3d 967, as a unit, as defined above, which provides for a gradual release of carbamazepine over time in the gastro-intestinal tract; and
(4) the term “enteric release unit” in claims 1 and 18 of the ‘570 patent shall be construed in all future proceedings, pursuant to Markman, 52 F.3d 967, as unit, as defined above, which provides for a delayed release of carbamazepine in the lower gastro-intestinal tract.
Shire Laboratories, Inc. and Defendant Corepharma, LLC have filed an application for claim construction to resolve disputes over the construction of four claim terms in U.S. Patent No. 5,326,570 (“the ‘570 patent”).
Court Ordered that
(1) the term “unit” in claims 1 and 18 of the ‘570 patent shall be construed in all future proceedings, pursuant to Markman v. Westview Instruments, Inc., 52 F.3d 967 (Fed. Cir. 1995), as a single thing or entity that is a constituent or isolable member of a more inclusive whole, being the least part of the whole to have a clearly definable existence separate or different from other parts of the whole; and
(2) the term “immediate release unit” in claims 1 and 18 of the ‘570 patent shall be construed in all future proceedings, pursuant to Markman, 52 F.3d 967, as a unit, as defined above, which begins to release the carbamazepine upon ingestion; and
(3) the term “sustained release unit” in claims 1 and 18 of the ‘570 patent shall be construed in all future proceedings, pursuant to Markman, 52 F.3d 967, as a unit, as defined above, which provides for a gradual release of carbamazepine over time in the gastro-intestinal tract; and
(4) the term “enteric release unit” in claims 1 and 18 of the ‘570 patent shall be construed in all future proceedings, pursuant to Markman, 52 F.3d 967, as unit, as defined above, which provides for a delayed release of carbamazepine in the lower gastro-intestinal tract.
Friday, March 28, 2008
Poniard signs agreement with Heraeus for Picoplatin
Poniard Pharmaceuticals, Inc, a biopharmaceutical company focused on oncology, signed an agreement with W. C. Heraeus GmbH for the commercial manufacture and supply of picoplatin active pharmaceutical ingredient (API). Financial terms were not disclosed.
Poniard is investigating picoplatin, the company's lead product candidate, in four clinical trials, including the ongoing pivotal phase III trial in small cell lung cancer, and is developing picoplatin as a potential new platform product for the treatment of solid tumours.
Heraeus is a global, family-owned company active in the businesses of precious metals, sensors, dental and medical products, quartz glass and specialty lighting sources.
"This agreement is a major step forward in the development of picoplatin as a commercial oncology product and to ensure that picoplatin is available to patients and oncologists once FDA approval is obtained," said Ronald Martell, president and chief operating officer of Poniard Pharmaceuticals. "Heraeus is a high-quality partner which will provide Poniard with access to large-scale production, and has the capacity to meet our production and quality goals. They are a leader in the manufacture of pharmaceuticals, precious metals and synthesis chemistry."
Under the agreement, Heraeus will manufacture picoplatin API to meet cGMP requirements, and would be ready to ship commercial quantities of picoplatin by 2009. Heraeus is the current manufacturer of picoplatin API for the company's four ongoing clinical trials.
Picoplatin is a chemotherapeutic agent with an improved safety profile compared to existing platinum-based chemotherapeutics. It was designed to overcome platinum resistance associated with the treatment of solid tumours. Picoplatin has been evaluated in more than 750 patients and has anti-tumour activity in multiple indications, with less severe kidney and nerve toxicity than is commonly observed with other platinum chemotherapy drugs.
Poniard is evaluating intravenous picoplatin in an ongoing pivotal phase III trial, known as SPEAR (Study of Picoplatin Efficacy After Relapse), in small cell lung cancer. This registrational trial is being conducted under a Special Protocol Assessment (SPA) from the US Food and Drug Administration (FDA) with overall survival as the primary endpoint. The company is also evaluating intravenous picoplatin in ongoing phase II clinical trials for the treatment of hormone refractory prostate cancer (HRPC) and metastatic colorectal cancer (mCRC). Oral picoplatin is being evaluated in a phase I clinical trial in solid tumours. Picoplatin has not been approved by any regulatory authority for use in humans.
Poniard is investigating picoplatin, the company's lead product candidate, in four clinical trials, including the ongoing pivotal phase III trial in small cell lung cancer, and is developing picoplatin as a potential new platform product for the treatment of solid tumours.
Heraeus is a global, family-owned company active in the businesses of precious metals, sensors, dental and medical products, quartz glass and specialty lighting sources.
"This agreement is a major step forward in the development of picoplatin as a commercial oncology product and to ensure that picoplatin is available to patients and oncologists once FDA approval is obtained," said Ronald Martell, president and chief operating officer of Poniard Pharmaceuticals. "Heraeus is a high-quality partner which will provide Poniard with access to large-scale production, and has the capacity to meet our production and quality goals. They are a leader in the manufacture of pharmaceuticals, precious metals and synthesis chemistry."
Under the agreement, Heraeus will manufacture picoplatin API to meet cGMP requirements, and would be ready to ship commercial quantities of picoplatin by 2009. Heraeus is the current manufacturer of picoplatin API for the company's four ongoing clinical trials.
Picoplatin is a chemotherapeutic agent with an improved safety profile compared to existing platinum-based chemotherapeutics. It was designed to overcome platinum resistance associated with the treatment of solid tumours. Picoplatin has been evaluated in more than 750 patients and has anti-tumour activity in multiple indications, with less severe kidney and nerve toxicity than is commonly observed with other platinum chemotherapy drugs.
Poniard is evaluating intravenous picoplatin in an ongoing pivotal phase III trial, known as SPEAR (Study of Picoplatin Efficacy After Relapse), in small cell lung cancer. This registrational trial is being conducted under a Special Protocol Assessment (SPA) from the US Food and Drug Administration (FDA) with overall survival as the primary endpoint. The company is also evaluating intravenous picoplatin in ongoing phase II clinical trials for the treatment of hormone refractory prostate cancer (HRPC) and metastatic colorectal cancer (mCRC). Oral picoplatin is being evaluated in a phase I clinical trial in solid tumours. Picoplatin has not been approved by any regulatory authority for use in humans.
US FDA approves Regeneron's Arcalyst for CAPS treatment
Regeneron Pharmaceuticals, Inc. has received marketing approval from the US Food and Drug Administration (FDA) for Arcalyst (rilonacept) injection for subcutaneous use, an interleukin-1 blocker, for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Auto-inflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS) in adults and children 12 and older.
Arcalyst is the only therapy approved for patients with CAPS, a group of rare, inherited, auto-inflammatory conditions characterized by life-long, recurrent symptoms of rash, fever/chills, joint pain, eye redness/pain, and fatigue. Intermittent, disruptive exacerbations or flares can be triggered at any time by exposure to cooling temperatures, stress, exercise, or other unknown stimuli.
Arcalyst is a targeted inhibitor of interleukin-1 (IL-1), the key driver of inflammation in CAPS. In the pivotal clinical development program, patients treated with Arcalyst experienced a greater improvement in overall symptom scores than patients treated with placebo. These improvements were sustained over time with continued Arcalyst treatment. The most commonly reported adverse reactions reported with Arcalyst were injection-site reaction and upper respiratory tract infection.
"The approval of Arcalyst represents a major advance in the treatment of CAPS patients," said Hal Hoffman, M.D., Associate Professor, University of California, San Diego and a leading expert on CAPS. "Much-needed treatment will now be available to patients suffering from debilitating CAPS symptoms. I hope that the approval of Arcalyst will also contribute to increased awareness of this rare disease which currently is frequently misdiagnosed and insufficiently treated."
Regeneron expects to launch Arcalyst, its first commercial product, within the next 30 days.
"This approval exemplifies Regeneron's commitment to discover, develop, and commercialize important medicines for patients suffering from serious diseases, such as CAPS. I would like to take this opportunity to thank the clinical investigators and CAPS patients participating in our studies, the FDA, and everyone at Regeneron for their collaborative effort in making Arcalyst available to patients who need it," said Leonard S. Schleifer, M.D., Ph.D., Regeneron's president and chief executive officer. "We recognize that Arcalyst may help address a significant unmet medical need that exists among CAPS patients and are therefore committed to helping these patients obtain access to this new treatment."
Arcalyst is the only therapy approved for patients with CAPS, a group of rare, inherited, auto-inflammatory conditions characterized by life-long, recurrent symptoms of rash, fever/chills, joint pain, eye redness/pain, and fatigue. Intermittent, disruptive exacerbations or flares can be triggered at any time by exposure to cooling temperatures, stress, exercise, or other unknown stimuli.
Arcalyst is a targeted inhibitor of interleukin-1 (IL-1), the key driver of inflammation in CAPS. In the pivotal clinical development program, patients treated with Arcalyst experienced a greater improvement in overall symptom scores than patients treated with placebo. These improvements were sustained over time with continued Arcalyst treatment. The most commonly reported adverse reactions reported with Arcalyst were injection-site reaction and upper respiratory tract infection.
"The approval of Arcalyst represents a major advance in the treatment of CAPS patients," said Hal Hoffman, M.D., Associate Professor, University of California, San Diego and a leading expert on CAPS. "Much-needed treatment will now be available to patients suffering from debilitating CAPS symptoms. I hope that the approval of Arcalyst will also contribute to increased awareness of this rare disease which currently is frequently misdiagnosed and insufficiently treated."
Regeneron expects to launch Arcalyst, its first commercial product, within the next 30 days.
"This approval exemplifies Regeneron's commitment to discover, develop, and commercialize important medicines for patients suffering from serious diseases, such as CAPS. I would like to take this opportunity to thank the clinical investigators and CAPS patients participating in our studies, the FDA, and everyone at Regeneron for their collaborative effort in making Arcalyst available to patients who need it," said Leonard S. Schleifer, M.D., Ph.D., Regeneron's president and chief executive officer. "We recognize that Arcalyst may help address a significant unmet medical need that exists among CAPS patients and are therefore committed to helping these patients obtain access to this new treatment."
Shire, TAP Pharma sign co-promotion agreement for Lialda
Shire plc, the global specialty biopharmaceutical company, announced a co-promotion agreement with TAP Pharmaceutical Products Inc. for Lialda (mesalamine) with MMX technology, indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis (UC).
This three year agreement is for the US only and will add more than 500 additional sales representatives from TAP to increase the reach and frequency of the Shire sales force, which consists of 120 representatives who are currently detailing Lialda primarily to gastroenterologists, a Shire press release stated.
"Aligning with TAP, one of the most successful and well-respected GI sales organizations in the industry, is a tremendous benefit for Shire as it will quadruple the Lialda sales force across the United States," said Mike Yasick, senior vice president of Shire's Gastrointestinal Business Unit. "With the added expertise of the TAP team, we'll be able to reach more GI specialists as well as primary care providers with messages about Lialda. Shire's GI team has made Lialda the fastest growing brand of mesalamine and with this collaboration we will bolster the frequency of sales calls to our existing base of specialist physicians."
lialda is the first and only FDA-approved once-daily oral formulation of mesalamine indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis. Mesalamines are a part of a drug class called aminosalicylates, which contain 5-aminosalicyclic acid (5-ASA), a well-established drug of choice and often a first-line treatment for patients with mild to moderate ulcerative colitis.
"Building on the successful introduction of Lialda, which Shire launched in the first quarter of last year, we are excited to work with the Shire team as together we take this medicine to the next level, increasing awareness among key physicians of the distinguishing benefits of this once-daily treatment for patients diagnosed with mild to moderate ulcerative colitis," said Tim Rudolphi, vice president of TAP's Gastroenterology Marketing Franchise. "This connection with Shire is a natural fit for our sales force, and is a win for all involved, especially the patient population who may benefit most."
Once-daily Lialda with MMX technology contains the highest mesalamine dose per tablet (1.2 g), so patients can take as few as two tablets once daily. Other currently available mesalamines require three to four times daily dosing and 6 to 16 pills a day.
The TAP sales force will begin detailing Lialda to specialists and targeted primary care physicians in April 2008. Shire shall compensate TAP based upon TAP's success under the co-promotion agreement. Upon dissolution of the TAP joint venture, Takeda will promote Lialda under the agreement.
Lialda is part of a drug class called aminosalicylates, which contain 5-aminosalicyclic acid (5-ASA). 5-ASA is a well-established drug of choice and often a first-line treatment for ulcerative colitis. LIALDA is indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis. The safety and efficacy of Lialda have been established for up to eight weeks. Lialda is the first new formulation in this class to be approved since 2000.
Shire has licensed from Giuliani SpA the exclusive rights to develop and commercialize Lialda in the US, Canada, Pacific Rim and Europe (excluding Italy). Lialda is known as Mezavant XL in the UK and Ireland, and Mezavant elsewhere outside of the US. Giuliani SpA retains the development and commercialization rights in Italy. Cosmo Pharmaceuticals SpA, Milan, developed the MMX technology.
This three year agreement is for the US only and will add more than 500 additional sales representatives from TAP to increase the reach and frequency of the Shire sales force, which consists of 120 representatives who are currently detailing Lialda primarily to gastroenterologists, a Shire press release stated.
"Aligning with TAP, one of the most successful and well-respected GI sales organizations in the industry, is a tremendous benefit for Shire as it will quadruple the Lialda sales force across the United States," said Mike Yasick, senior vice president of Shire's Gastrointestinal Business Unit. "With the added expertise of the TAP team, we'll be able to reach more GI specialists as well as primary care providers with messages about Lialda. Shire's GI team has made Lialda the fastest growing brand of mesalamine and with this collaboration we will bolster the frequency of sales calls to our existing base of specialist physicians."
lialda is the first and only FDA-approved once-daily oral formulation of mesalamine indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis. Mesalamines are a part of a drug class called aminosalicylates, which contain 5-aminosalicyclic acid (5-ASA), a well-established drug of choice and often a first-line treatment for patients with mild to moderate ulcerative colitis.
"Building on the successful introduction of Lialda, which Shire launched in the first quarter of last year, we are excited to work with the Shire team as together we take this medicine to the next level, increasing awareness among key physicians of the distinguishing benefits of this once-daily treatment for patients diagnosed with mild to moderate ulcerative colitis," said Tim Rudolphi, vice president of TAP's Gastroenterology Marketing Franchise. "This connection with Shire is a natural fit for our sales force, and is a win for all involved, especially the patient population who may benefit most."
Once-daily Lialda with MMX technology contains the highest mesalamine dose per tablet (1.2 g), so patients can take as few as two tablets once daily. Other currently available mesalamines require three to four times daily dosing and 6 to 16 pills a day.
The TAP sales force will begin detailing Lialda to specialists and targeted primary care physicians in April 2008. Shire shall compensate TAP based upon TAP's success under the co-promotion agreement. Upon dissolution of the TAP joint venture, Takeda will promote Lialda under the agreement.
Lialda is part of a drug class called aminosalicylates, which contain 5-aminosalicyclic acid (5-ASA). 5-ASA is a well-established drug of choice and often a first-line treatment for ulcerative colitis. LIALDA is indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis. The safety and efficacy of Lialda have been established for up to eight weeks. Lialda is the first new formulation in this class to be approved since 2000.
Shire has licensed from Giuliani SpA the exclusive rights to develop and commercialize Lialda in the US, Canada, Pacific Rim and Europe (excluding Italy). Lialda is known as Mezavant XL in the UK and Ireland, and Mezavant elsewhere outside of the US. Giuliani SpA retains the development and commercialization rights in Italy. Cosmo Pharmaceuticals SpA, Milan, developed the MMX technology.
FDA Issues a Communication about an Ongoing Safety Review Regranex (becaplermin)
March 28, 2008--FDA has received information regarding a study that was performed to investigate the possibility of an increased risk of cancer in patients with diabetes who applied the product Regranex (a topical medicine) directly to their foot and leg ulcers. This study was done using a health insurance plan database of patients with diabetes who were at least 19 years of age or older, with no history of cancer and either prescribed Regranex or not. In this study, among those who were prescribed Regranex three or more times, there was an increase in the number of patients who died as a result of cancer. There was not enough information to say whether there was an increase in the number of patients that developed new cancers.
At this time, FDA believes that there may be some evidence for an increased risk of death from cancer in patients who had repeated treatments with Regranex. Because there are known risks associated with diabetic foot and leg ulcers that do not heal, the potential risk of using Regranex should be weighed against the benefit for each individual patient.
What does FDA know now about these data?
Regranex is a medicine that is a recombinant form of human platelet-derived growth factor which is applied directly to diabetic foot and leg ulcers that are not healing. The recombinant form of platelet growth factor has a biologic activity that is much like that produced naturally by the body. Growth factors cause cells to divide more rapidly. It is for this reason that the manufacturer continued to monitor studies begun before Regranex was approved in December 1997 for any evidence of adverse effects such as increased numbers of cancers. In a long term safety study completed in 2001, there were more cancers in people who used Regranex than in those who did not use it.
Following the report of the study completed in 2001, an additional study was performed using a health insurance database that covered the period from January, 1998 through June, 2003. This study used the database to identify two groups of patients with similar diagnoses, drug use, and use of health services, one of which used Regranex and one group that did not. The results of this study showed that deaths from cancer were higher for patients who were given three or more prescriptions for treatment with Regranex than those who were not treated with Regranex. No single type of cancer was identified, but rather deaths from all types of cancer, combined were observed.
This communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs. FDA will communicate our conclusions, resulting recommendations and any regulatory actions to the public after the review of the data are completed.
(As per article published on pharmalive.com)
At this time, FDA believes that there may be some evidence for an increased risk of death from cancer in patients who had repeated treatments with Regranex. Because there are known risks associated with diabetic foot and leg ulcers that do not heal, the potential risk of using Regranex should be weighed against the benefit for each individual patient.
What does FDA know now about these data?
Regranex is a medicine that is a recombinant form of human platelet-derived growth factor which is applied directly to diabetic foot and leg ulcers that are not healing. The recombinant form of platelet growth factor has a biologic activity that is much like that produced naturally by the body. Growth factors cause cells to divide more rapidly. It is for this reason that the manufacturer continued to monitor studies begun before Regranex was approved in December 1997 for any evidence of adverse effects such as increased numbers of cancers. In a long term safety study completed in 2001, there were more cancers in people who used Regranex than in those who did not use it.
Following the report of the study completed in 2001, an additional study was performed using a health insurance database that covered the period from January, 1998 through June, 2003. This study used the database to identify two groups of patients with similar diagnoses, drug use, and use of health services, one of which used Regranex and one group that did not. The results of this study showed that deaths from cancer were higher for patients who were given three or more prescriptions for treatment with Regranex than those who were not treated with Regranex. No single type of cancer was identified, but rather deaths from all types of cancer, combined were observed.
This communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs. FDA will communicate our conclusions, resulting recommendations and any regulatory actions to the public after the review of the data are completed.
(As per article published on pharmalive.com)
Teva Provides Update on Generic Aricept Litigation
Mar 28, 2008 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. District Court for the District of New Jersey has granted Eisai's motion for a preliminary injunction related to Teva's tentatively approved Abbreviated New Drug Application (ANDA) to market its generic version of Eisai's Alzheimer's treatment Aricept(R) (Donepezil Hydrochloride) Tablets, 5 mg and 10 mg. The injunction is based on Eisai's enforcement of U.S. Patent No. 4,895,841 that Teva has asserted is unenforceable. A trial date has not been set.
Lannett Company Receives FDA Approval for Bethanechol Chloride Tablets USP, 5 mg, 10 mg, 25 mg, and 50 mg
Mar 28, 2008 - Lannett Company, Inc. (AMEX:LCI), a manufacturer of generic pharmaceuticals, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Bethanechol Chloride Tablets in 5 mg, 10 mg, 25 mg, and 50 mg, the generic equivalent of Urecholine(R) Tablets marketed by Odyssey Pharmaceuticals, Inc.
According to Wolters Kluwer, total sales of generic Bethanechol Chloride Tablets were $60 million in 2007. Bethanechol Chloride is indicated for the treatment of acute postoperative and postpartum nonobstructive (functional) urinary retention and for neurogenic atony of the urinary bladder with retention.
"This approval represents an important new addition to our product portfolio and is the result of the hard work and dedication of our employees," said Arthur Bedrosian, president and chief executive officer of Lannett. "We will commence marketing our Bethanechol Chloride product, in the 5 mg, 10 mg, 25 mg, and 50 mg tablets, immediately."
According to Wolters Kluwer, total sales of generic Bethanechol Chloride Tablets were $60 million in 2007. Bethanechol Chloride is indicated for the treatment of acute postoperative and postpartum nonobstructive (functional) urinary retention and for neurogenic atony of the urinary bladder with retention.
"This approval represents an important new addition to our product portfolio and is the result of the hard work and dedication of our employees," said Arthur Bedrosian, president and chief executive officer of Lannett. "We will commence marketing our Bethanechol Chloride product, in the 5 mg, 10 mg, 25 mg, and 50 mg tablets, immediately."
Actavis Receives Approval of Generic Wellbutrin SR and Zyban Tablets in the U.S.
Actavis Group, the international generic pharmaceuticals company, today announced that it has received two separate approvals from the U.S. Food & Drug Administration to market Bupropion Hydrochloride extended-release tablets (SR). Distribution of the products will commence immediately.
Bupropion Hydrochloride extended-release tablets (SR), available in 150mg strength, are the generic equivalent of Wellbutrin SR(R) and are indicated for the treatment of major depressive disorder. Annual sales of brand and generic Wellbutrin SR(R) were US$ 498 million for the 12 months ending December 2007 according to IMS Health data.
Bupropion Hydrochloride extended-release tablets (SR), available in 150mg strength, are the generic equivalent of Zyban(R) and are indicated as an aid to smoking cessation treatment. Annual sales of brand and generic Zyban(R) were US$ 12 million for the 12 months ending December 2007 according to IMS Health data.
Commenting on the new approvals, Terry Fullem, Vice President of Marketing and Portfolio in the U.S. said:
"These approvals further enhance our strength in the area of modified release products and provide valuable options to our customers and patients."
Bupropion Hydrochloride extended-release tablets (SR), available in 150mg strength, are the generic equivalent of Wellbutrin SR(R) and are indicated for the treatment of major depressive disorder. Annual sales of brand and generic Wellbutrin SR(R) were US$ 498 million for the 12 months ending December 2007 according to IMS Health data.
Bupropion Hydrochloride extended-release tablets (SR), available in 150mg strength, are the generic equivalent of Zyban(R) and are indicated as an aid to smoking cessation treatment. Annual sales of brand and generic Zyban(R) were US$ 12 million for the 12 months ending December 2007 according to IMS Health data.
Commenting on the new approvals, Terry Fullem, Vice President of Marketing and Portfolio in the U.S. said:
"These approvals further enhance our strength in the area of modified release products and provide valuable options to our customers and patients."
Thursday, March 27, 2008
Celgene's Amrubicin granted orphan drug designation by US FDA
Celgene Corporation's Amrubicin has been granted orphan drug designation by the US Food and Drug Administration (FDA) for the treatment of small cell lung cancer.
FDA's Orphan Drug Act was designed to encourage the development of products that demonstrate promise for the diagnosis, prevention and/or treatment of life-threatening or very serious conditions that are rare and affect 200,000 persons or less in the United States. Orphan drug designation provides an important economic incentive for the development of new products in the cancer field. US orphan drug designation provides for seven years of market exclusivity, reduction in regulatory fees, and additional regulatory support for R&D initiatives.
"The decision by the FDA to grant Amrubicin orphan drug designation in this critical area of oncology advances our efforts to deliver innovative therapies to patients in areas of unmet medical need and represents the first such milestone in the area of solid tumour cancers," said Graham Burton M.D., SVP, Global Regulatory Affairs and Pharmacovigilance for Celgene Corporation. "We will continue to work diligently with regulators as we advance this promising next generation anthracycline through clinical development."
Amrubicin is a third-generation, synthetic anthracycline analogue that has demonstrated substantial clinical efficacy in the treatment of small cell lung cancer. Amrubicin is a potent topoisomerase II inhibitor and is being studied as a single agent and in combination with anti-cancer therapies for a variety of solid tumours, including lung and breast cancers.
Amrubicin is currently approved and marketed in Japan for the treatment of small cell lung cancer by Nippon Kayaku, a Japanese pharmaceutical firm focused on oncology, which licensed Japanese marketing rights from Dainippon Sumitomo, the original developer of the therapy. Dainippon Sumitomo also licensed the US and European rights of Amrubicin to Pharmion Corporation, which was acquired by Celgene Corporation in 2008.
Patients diagnosed with SCLC each year in the US and EU, approximately 60 percent of patients have extensive disease at diagnosis, and the remaining 40 percent present with localized, or limited stage, disease.
FDA's Orphan Drug Act was designed to encourage the development of products that demonstrate promise for the diagnosis, prevention and/or treatment of life-threatening or very serious conditions that are rare and affect 200,000 persons or less in the United States. Orphan drug designation provides an important economic incentive for the development of new products in the cancer field. US orphan drug designation provides for seven years of market exclusivity, reduction in regulatory fees, and additional regulatory support for R&D initiatives.
"The decision by the FDA to grant Amrubicin orphan drug designation in this critical area of oncology advances our efforts to deliver innovative therapies to patients in areas of unmet medical need and represents the first such milestone in the area of solid tumour cancers," said Graham Burton M.D., SVP, Global Regulatory Affairs and Pharmacovigilance for Celgene Corporation. "We will continue to work diligently with regulators as we advance this promising next generation anthracycline through clinical development."
Amrubicin is a third-generation, synthetic anthracycline analogue that has demonstrated substantial clinical efficacy in the treatment of small cell lung cancer. Amrubicin is a potent topoisomerase II inhibitor and is being studied as a single agent and in combination with anti-cancer therapies for a variety of solid tumours, including lung and breast cancers.
Amrubicin is currently approved and marketed in Japan for the treatment of small cell lung cancer by Nippon Kayaku, a Japanese pharmaceutical firm focused on oncology, which licensed Japanese marketing rights from Dainippon Sumitomo, the original developer of the therapy. Dainippon Sumitomo also licensed the US and European rights of Amrubicin to Pharmion Corporation, which was acquired by Celgene Corporation in 2008.
Patients diagnosed with SCLC each year in the US and EU, approximately 60 percent of patients have extensive disease at diagnosis, and the remaining 40 percent present with localized, or limited stage, disease.
Singulair (montelukast)- Possible Association Between Use Of Singulair And Behavior/Mood Changes, Suicidality, And Suicide
March 27, 2008-FDA is investigating a possible association between the use of Singulair and behavior/mood changes, suicidality (suicidal thinking and behavior) and suicide. Singulair is a medicine in the drug class known as leukotriene receptor antagonists. Singulair is used to treat asthma and the symptoms of allergic rhinitis (sneezing, stuffy nose, runny nose, itching of the nose) and to prevent exercise-induced asthma.
Over the past year, the maker of Singulair, Merck & Co, Inc., has updated the prescribing information and patient information for Singulair to include the following post-marketing adverse events: tremor (March 2007), depression (April 2007), suicidality (suicidal thinking and behavior) (October 2007), and anxiousness (February 2008).
In February 2008, FDA and Merck discussed how best to communicate these labeling changes to prescribers and patients. Merck plans to highlight the recent changes in the prescribing information in face-to-face interactions with prescribers and provide prescribers with patient information leaflets about Singulair.
FDA is working with Merck to further evaluate a possible link between the use of Singulair and behavior/mood changes, suicidality and suicide in response to inquiries received by FDA. FDA has requested that Merck evaluate Singulair study data for more information about suicidality and suicide. FDA is reviewing the postmarketing reports it has received of behavior/mood changes, suicidality and suicide in patients who took Singulair.
Due to the complexity of the analyses, FDA anticipates that it may take up to 9 months to complete the ongoing evaluations. As soon as this review is complete, FDA will communicate the conclusions and recommendations to the public.
Singulair is an effective medicine that is indicated for the treatment of asthma and symptoms of allergic rhinitis. Patients should not stop taking Singulair before talking to their doctor if they have questions about this new information. Until further information is available, healthcare professionals and caregivers should monitor patients taking Singulair for suicidality (suicidal thinking and behavior) and changes in behavior and mood.
Other leukotriene modifying medications include zafirlukast (Accolate), which is also a leukotriene receptor antagonist and zileuton (Zyflo and Zyflo CR), which is a leukotriene synthesis inhibitor. FDA is reviewing postmarketing reports it has received of behavior/mood changes, suicidality and suicide in patients who took Accolate, Zyflo, and Zyflo CR and will assess whether further investigation is warranted.
Over the past year, the maker of Singulair, Merck & Co, Inc., has updated the prescribing information and patient information for Singulair to include the following post-marketing adverse events: tremor (March 2007), depression (April 2007), suicidality (suicidal thinking and behavior) (October 2007), and anxiousness (February 2008).
In February 2008, FDA and Merck discussed how best to communicate these labeling changes to prescribers and patients. Merck plans to highlight the recent changes in the prescribing information in face-to-face interactions with prescribers and provide prescribers with patient information leaflets about Singulair.
FDA is working with Merck to further evaluate a possible link between the use of Singulair and behavior/mood changes, suicidality and suicide in response to inquiries received by FDA. FDA has requested that Merck evaluate Singulair study data for more information about suicidality and suicide. FDA is reviewing the postmarketing reports it has received of behavior/mood changes, suicidality and suicide in patients who took Singulair.
Due to the complexity of the analyses, FDA anticipates that it may take up to 9 months to complete the ongoing evaluations. As soon as this review is complete, FDA will communicate the conclusions and recommendations to the public.
Singulair is an effective medicine that is indicated for the treatment of asthma and symptoms of allergic rhinitis. Patients should not stop taking Singulair before talking to their doctor if they have questions about this new information. Until further information is available, healthcare professionals and caregivers should monitor patients taking Singulair for suicidality (suicidal thinking and behavior) and changes in behavior and mood.
Other leukotriene modifying medications include zafirlukast (Accolate), which is also a leukotriene receptor antagonist and zileuton (Zyflo and Zyflo CR), which is a leukotriene synthesis inhibitor. FDA is reviewing postmarketing reports it has received of behavior/mood changes, suicidality and suicide in patients who took Accolate, Zyflo, and Zyflo CR and will assess whether further investigation is warranted.
Novel Oral Anticoagulant Pradaxa (dabigatran etexilate) Approved by the European Commission
27 March 2008 - Boehringer Ingelheim today announced that the European Commission has granted marketing authorisation of the novel, oral direct thrombin inhibitor, Pradaxa® (dabigatran etexilate) in all 27 EU member states. It is anticipated that Pradaxa® will be launched in Germany and the United Kingdom in the coming weeks.
Pradaxa® is approved for the prevention of venous thromboembolic events in adults who have undergone elective total hip or total knee replacement surgery.
Pradaxa® is approved for the prevention of venous thromboembolic events in adults who have undergone elective total hip or total knee replacement surgery.
Neptune Technologies Patent Granted for Novel Phospholipids in Multiple Diseases and Pharmaceutical Applications
Neptune Technologies & Bioressources Inc. ("Neptune") announces that the European Patent Office (EPO) granted on May 31st 2007 Neptune's composition of matter patent entitled "Natural Marine Source Phospholipids comprising flavonoids, polyunsaturated fatty acids and their applications" (EP01417211B1) and that this patent has now been issued and validated in twenty-four European countries.
This patent is directed to the use of Neptune marine phospholipid and flavonoid compositions as a medicament for the prevention and treatment of multiple chronic health conditions, including coronary artery disease caused by hypercholesterolemia, peripheral vascular disease, neurodegenerative and other cognitive disorders.
"This composition of matter patent is a critical achievement that constitutes a key component for our commercial pharmaceutical development program," said Dr. Tina Sampalis, Chief Scientific Officer of Neptune. "Neptune's mission has always been the development of innovative pharmaceutical ingredients, and this patent is viewed as a vital element towards Neptune's pharmaceutical initiatives. Its enforcement is a major accomplishment and a step forward," she added.
As part of the EPO procedure, within a nine-month period following the date of granting of the European patent, a notice of opposition can be filed in writing with the EPO. In the case of Neptune, oppositions were filed by Norway-based Aker BioMarine and Israel-based Enzymotec. The opposition proceedings are a multi-year (5-7 year) procedure with the potential outcome of maintaining the patent, amending it or, in certain cases, revoking it. According to EPO regulations, the opposed patent is considered and remains granted and enforceable in all countries in which it has been validated. The patent continues to preclude the competition from commercializing products as krill oil containing marine phospholipids in these European countries, providing only the patent holder with the benefit of exclusive commercialization.
This patent is directed to the use of Neptune marine phospholipid and flavonoid compositions as a medicament for the prevention and treatment of multiple chronic health conditions, including coronary artery disease caused by hypercholesterolemia, peripheral vascular disease, neurodegenerative and other cognitive disorders.
"This composition of matter patent is a critical achievement that constitutes a key component for our commercial pharmaceutical development program," said Dr. Tina Sampalis, Chief Scientific Officer of Neptune. "Neptune's mission has always been the development of innovative pharmaceutical ingredients, and this patent is viewed as a vital element towards Neptune's pharmaceutical initiatives. Its enforcement is a major accomplishment and a step forward," she added.
As part of the EPO procedure, within a nine-month period following the date of granting of the European patent, a notice of opposition can be filed in writing with the EPO. In the case of Neptune, oppositions were filed by Norway-based Aker BioMarine and Israel-based Enzymotec. The opposition proceedings are a multi-year (5-7 year) procedure with the potential outcome of maintaining the patent, amending it or, in certain cases, revoking it. According to EPO regulations, the opposed patent is considered and remains granted and enforceable in all countries in which it has been validated. The patent continues to preclude the competition from commercializing products as krill oil containing marine phospholipids in these European countries, providing only the patent holder with the benefit of exclusive commercialization.
Graceway Pharmaceuticals Files False Advertising and Unfair Competition Litigation Against River's Edge Pharmaceuticals
Mar 27, 2008 - Graceway Pharmaceuticals, LLC ("Graceway") today announced that it yesterday filed a lawsuit against River's Edge Pharmaceuticals, LLC ("River's Edge") in the United States District Court for the Northern District of Georgia based on River's Edge's improper sales and marketing practices.
The lawsuit alleges that River's Edge unlawfully promotes its benzoyl peroxide gel and wash products as generically equivalent to - or otherwise substitutable for - Graceway's Benziq(TM) family of products: Benziq LS Gel (benzoyl peroxide 2.75%); Benziq Gel 50 g Tube (benzoyl peroxide 5.25%); and Benziq Wash (benzoyl peroxide 5.25%) (collectively "Benziq"). The lawsuit sets forth claims for False Advertising and Unfair Competition in violation of the federal Lanham Act, as well as claims for common law Unfair Competition and Misappropriation.
Benziq is available by prescription only, and was created for patients with a preference for a hydrating benzoyl peroxide treatment that does not irritate the skin.
Indication:
Benziq is indicated for the topical treatment of acne vulgaris.
Safety Information:
Allergic contact dermatitis and dryness have been reported with topical benzoyl peroxide therapy. If severe irritation develops, discontinue use and institute appropriate therapy. After reaction clears, treatment may often be resumed with less frequent application.
The lawsuit alleges that River's Edge unlawfully promotes its benzoyl peroxide gel and wash products as generically equivalent to - or otherwise substitutable for - Graceway's Benziq(TM) family of products: Benziq LS Gel (benzoyl peroxide 2.75%); Benziq Gel 50 g Tube (benzoyl peroxide 5.25%); and Benziq Wash (benzoyl peroxide 5.25%) (collectively "Benziq"). The lawsuit sets forth claims for False Advertising and Unfair Competition in violation of the federal Lanham Act, as well as claims for common law Unfair Competition and Misappropriation.
Benziq is available by prescription only, and was created for patients with a preference for a hydrating benzoyl peroxide treatment that does not irritate the skin.
Indication:
Benziq is indicated for the topical treatment of acne vulgaris.
Safety Information:
Allergic contact dermatitis and dryness have been reported with topical benzoyl peroxide therapy. If severe irritation develops, discontinue use and institute appropriate therapy. After reaction clears, treatment may often be resumed with less frequent application.
Otsuka to Pay More Than $4 Million to Resolve Off-Label Marketing Allegations Involving Abilify
Otsuka American Pharmaceutical Inc., the U.S. subsidiary of Japanese pharmaceutical manufacturer Otsuka Pharmaceutical Co., Ltd., has agreed to pay more than $4 million to resolve allegations that it marketed Abilify, an atypical antipsychotic drug, for "off-label" uses, the Justice Department announced today.
Otsuka developed Abilify in Japan and then entered into an agreement with Bristol-Myers Squibb (BMS) to co-promote sales of the drug in the United States. Under the agreement, Otsuka sales representatives worked on sales teams led primarily by BMS sales managers. In September 2007, BMS and the government entered into an agreement resolving allegations that BMS had promoted Abilify for off-label uses.
The Food and Drug Administration (FDA) has approved Abilify to treat adult schizophrenia and bi-polar disorder but has not determined the drug to be safe and effective in the treatment of children and adolescents or in the treatment of geriatric patients suffering from dementia-related psychosis. The FDA has mandated that the package for Abilify carry a "black box" warning concerning its use in the treatment of dementia-related psychosis.
Today's settlement resolves government allegations that, from 2002 through the end of 2005, Otsuka knowingly promoted the sale and use of Abilify for pediatric use and to treat dementia-related psychosis. Otsuka is alleged to have participated in directing its sales force to call on child psychiatrists and other pediatric specialists, with the sales force then urging those physicians and others providers to prescribe Abilify for pediatric patients. Otsuka sales representatives also participated in a specialized long term care sales force that called almost exclusively on nursing homes, where dementia-related psychosis is far more prevalent than schizophrenia or bipolar disorder. Because of the potential market benefit, the long term care sales force promoted Abilify off-label for the treatment of dementia-related psychosis.
From the global civil settlement amount of $4 million, the federal recovery is approximately $2.3 million. Otsuka also will pay approximately $1.7 million to the Medicaid programs in the participating states. Also, as part of today's settlement, Otsuka entered into a Corporate Integrity Agreement with the Office of Inspector General of the Department of Health and Human Services.
This settlement resolves the remainder of the allegations made in a False Claims Act action entitled, Civil Action No. 05-10196-MLW (D. Mass.). The Department of Justice settled claims based on the same allegations with BMS in September 2007.
The False Claims Act allows for private persons to file a or whistleblower suit on behalf of the government. If the government is successful in resolving or litigating its claims, the whistleblower may receive a share of the recovery. The whistleblower, Joseph Piacentile, a physician, will receive a total of approximately $348,000 as his share of the federal recovery amount from today's settlement, and an additional share of the state settlement amount.
This matter was investigated by the Boston offices of the Office of Inspector General for the Department of Health and Human Services, the Federal Bureau of Investigation and the Food and Drug Administration's Office of Criminal Investigations, and was handled by United States Attorney's Office for the District of Massachusetts and the Department of Justice Civil Division.
Otsuka developed Abilify in Japan and then entered into an agreement with Bristol-Myers Squibb (BMS) to co-promote sales of the drug in the United States. Under the agreement, Otsuka sales representatives worked on sales teams led primarily by BMS sales managers. In September 2007, BMS and the government entered into an agreement resolving allegations that BMS had promoted Abilify for off-label uses.
The Food and Drug Administration (FDA) has approved Abilify to treat adult schizophrenia and bi-polar disorder but has not determined the drug to be safe and effective in the treatment of children and adolescents or in the treatment of geriatric patients suffering from dementia-related psychosis. The FDA has mandated that the package for Abilify carry a "black box" warning concerning its use in the treatment of dementia-related psychosis.
Today's settlement resolves government allegations that, from 2002 through the end of 2005, Otsuka knowingly promoted the sale and use of Abilify for pediatric use and to treat dementia-related psychosis. Otsuka is alleged to have participated in directing its sales force to call on child psychiatrists and other pediatric specialists, with the sales force then urging those physicians and others providers to prescribe Abilify for pediatric patients. Otsuka sales representatives also participated in a specialized long term care sales force that called almost exclusively on nursing homes, where dementia-related psychosis is far more prevalent than schizophrenia or bipolar disorder. Because of the potential market benefit, the long term care sales force promoted Abilify off-label for the treatment of dementia-related psychosis.
From the global civil settlement amount of $4 million, the federal recovery is approximately $2.3 million. Otsuka also will pay approximately $1.7 million to the Medicaid programs in the participating states. Also, as part of today's settlement, Otsuka entered into a Corporate Integrity Agreement with the Office of Inspector General of the Department of Health and Human Services.
This settlement resolves the remainder of the allegations made in a False Claims Act action entitled, Civil Action No. 05-10196-MLW (D. Mass.). The Department of Justice settled claims based on the same allegations with BMS in September 2007.
The False Claims Act allows for private persons to file a or whistleblower suit on behalf of the government. If the government is successful in resolving or litigating its claims, the whistleblower may receive a share of the recovery. The whistleblower, Joseph Piacentile, a physician, will receive a total of approximately $348,000 as his share of the federal recovery amount from today's settlement, and an additional share of the state settlement amount.
This matter was investigated by the Boston offices of the Office of Inspector General for the Department of Health and Human Services, the Federal Bureau of Investigation and the Food and Drug Administration's Office of Criminal Investigations, and was handled by United States Attorney's Office for the District of Massachusetts and the Department of Justice Civil Division.
Wednesday, March 26, 2008
FDA Announces New Pediatric Dosing Recommendations for Reyataz Capsules, Patients Ages 6 to 18 Years Old
March 26, 2008--The Reyataz (atazanavir) Capsule label has been updated to include the dosing recommendations for pediatric patients 6 to 18 years of age.
REYATAZ should not be administered to pediatric patients below the age of 3 months due to the risk of kernicterus (a type of brain damage caused by excessive levels of bilirubin).
REYATAZ should not be administered to pediatric patients below the age of 3 months due to the risk of kernicterus (a type of brain damage caused by excessive levels of bilirubin).
BioAlliance Pharma Receives Market Approval for Loramyc in Germany, Belgium and Luxemburg
BioAlliance Pharma SA (Paris:BIO) today announced that it has received three additional Marketing Authorizations under the European Mutual Recognition Procedure for Loramyc(R) in Germany, Belgium and Luxemburg (following on from the first authorizations granted in January in the United Kingdom and Denmark).
Market approval in Germany is another important milestone for BioAlliance Pharma in its Europe-wide commercialization strategy for Loramyc(R) via the dedicated SpeBio(R) subsidiary (a JV with SpePharm). Under the terms of the current licensing agreement, this marketing authorization will earn BioAlliance Pharma a EUR 2 million milestone payment from SpePharm. Milestone payments linked to marketing approval in Germany and the United Kingdom now amount to a total of EUR 4.5 million and will be fully counted in the turnover of Q1 2008. The terms of the agreement include up to EUR 17 million in sales-linked performance milestone payments.
"These new Marketing Authorizations mean that the internationalization of Loramyc(R) is continuing actively within Europe. We are working closely with the regulatory agencies in the remaining countries (Italy, Spain, Ireland, Sweden, Norway, Finland and The Netherlands), which should grant their approval in the very near future. The product availability for patients will depend on price negotiation and reimbursement constraints in each country but are scheduled for 2008 in the United Kingdom and Germany, in particular", commented Dominique Costantini, President and CEO.
Market approval in Germany is another important milestone for BioAlliance Pharma in its Europe-wide commercialization strategy for Loramyc(R) via the dedicated SpeBio(R) subsidiary (a JV with SpePharm). Under the terms of the current licensing agreement, this marketing authorization will earn BioAlliance Pharma a EUR 2 million milestone payment from SpePharm. Milestone payments linked to marketing approval in Germany and the United Kingdom now amount to a total of EUR 4.5 million and will be fully counted in the turnover of Q1 2008. The terms of the agreement include up to EUR 17 million in sales-linked performance milestone payments.
"These new Marketing Authorizations mean that the internationalization of Loramyc(R) is continuing actively within Europe. We are working closely with the regulatory agencies in the remaining countries (Italy, Spain, Ireland, Sweden, Norway, Finland and The Netherlands), which should grant their approval in the very near future. The product availability for patients will depend on price negotiation and reimbursement constraints in each country but are scheduled for 2008 in the United Kingdom and Germany, in particular", commented Dominique Costantini, President and CEO.
Shire and TAP Agree to Co-promote Lialda (mesalamine), the Oral Once-Daily Mesalamine For Patients With Active, Mild to Moderate Ulcerative Colitis
March 26, 2008 /PRNewswire-FirstCall/ -- Shire plc , the global specialty biopharmaceutical company, announced today a co-promotion agreement with TAP Pharmaceutical Products Inc. for LIALDA(TM) (mesalamine) with MMX(R) technology, indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis (UC). This three year agreement is for the U.S. only and will add more than 500 additional sales representatives from TAP to increase the reach and frequency of the Shire sales force, which consists of 120 representatives who are currently detailing LIALDA primarily to gastroenterologists.
"Aligning with TAP, one of the most successful and well-respected GI sales organizations in the industry, is a tremendous benefit for Shire as it will quadruple the Lialda sales force across the United States," said Mike Yasick, senior vice president of Shire's Gastrointestinal Business Unit. "With the added expertise of the TAP team, we'll be able to reach more GI specialists as well as primary care providers with messages about Lialda. Shire's GI team has made Lialda the fastest growing brand of mesalamine and with this collaboration we will bolster the frequency of sales calls to our existing base of specialist physicians."
LIALDA is the first and only FDA-approved once-daily oral formulation of mesalamine indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis. Mesalamines are a part of a drug class called aminosalicylates, which contain 5-aminosalicyclic acid (5-ASA), a well-established drug of choice and often a first-line treatment for patients with mild to moderate ulcerative colitis.
"Building on the successful introduction of Lialda, which Shire launched in the first quarter of last year, we are excited to work with the Shire team as together we take this medicine to the next level, increasing awareness among key physicians of the distinguishing benefits of this once-daily treatment for patients diagnosed with mild to moderate ulcerative colitis," said Tim Rudolphi, vice president of TAP's Gastroenterology Marketing Franchise. "This connection with Shire is a natural fit for our sales force, and is a win for all involved, especially the patient population who may benefit most."
Once-daily LIALDA with MMX technology contains the highest mesalamine dose per tablet (1.2 g), so patients can take as few as two tablets once daily. Other currently available mesalamines require three to four times daily dosing and 6 to 16 pills a day.
The TAP sales force will begin detailing LIALDA to specialists and targeted primary care physicians in April 2008. Shire shall compensate TAP based upon TAP's success under the co-promotion agreement. Upon dissolution of the TAP joint venture, Takeda will promote Lialda under the agreement.
"Aligning with TAP, one of the most successful and well-respected GI sales organizations in the industry, is a tremendous benefit for Shire as it will quadruple the Lialda sales force across the United States," said Mike Yasick, senior vice president of Shire's Gastrointestinal Business Unit. "With the added expertise of the TAP team, we'll be able to reach more GI specialists as well as primary care providers with messages about Lialda. Shire's GI team has made Lialda the fastest growing brand of mesalamine and with this collaboration we will bolster the frequency of sales calls to our existing base of specialist physicians."
LIALDA is the first and only FDA-approved once-daily oral formulation of mesalamine indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis. Mesalamines are a part of a drug class called aminosalicylates, which contain 5-aminosalicyclic acid (5-ASA), a well-established drug of choice and often a first-line treatment for patients with mild to moderate ulcerative colitis.
"Building on the successful introduction of Lialda, which Shire launched in the first quarter of last year, we are excited to work with the Shire team as together we take this medicine to the next level, increasing awareness among key physicians of the distinguishing benefits of this once-daily treatment for patients diagnosed with mild to moderate ulcerative colitis," said Tim Rudolphi, vice president of TAP's Gastroenterology Marketing Franchise. "This connection with Shire is a natural fit for our sales force, and is a win for all involved, especially the patient population who may benefit most."
Once-daily LIALDA with MMX technology contains the highest mesalamine dose per tablet (1.2 g), so patients can take as few as two tablets once daily. Other currently available mesalamines require three to four times daily dosing and 6 to 16 pills a day.
The TAP sales force will begin detailing LIALDA to specialists and targeted primary care physicians in April 2008. Shire shall compensate TAP based upon TAP's success under the co-promotion agreement. Upon dissolution of the TAP joint venture, Takeda will promote Lialda under the agreement.
State of Alaska and Eli Lilly and Company Reach Agreement to Settle Zyprexa Lawsuit
March 26, 2008 /PRNewswire-FirstCall/ -- Eli Lilly and Company and the State of Alaska have agreed on the following joint statement:
Alaska Attorney General Talis J. Colberg and Eli Lilly and Company today announced a settlement of the lawsuit filed by the State of Alaska over use of Zyprexa(R) (olanzapine) by the State's Medicaid program. The trial began March 3, 2008, in Superior Court in Anchorage.
The agreement resulted from ongoing mediation ordered by trial Judge Mark Rindner before the trial began. Presiding Judge Morgan Christen renewed mediation efforts with the parties last week.
The settlement will include payment by Lilly of $15 million plus a term that will ensure that Alaska is treated as favorably as any other state that may settle with Lilly in the future over similar claims.
"I am very pleased with the efforts by Assistant Attorney General Ed Sniffen and our team of trial attorneys," Colberg said. "We believe this is a good result for the State of Alaska and the Department of Health and Social Services," he added.
"We believe this settlement is in the best interest of the company, the State, and, importantly, of the patients, families and healthcare professionals for whom Zyprexa is an important treatment option," said Robert A. Armitage, Lilly's senior vice president and general counsel.
In addition, Lilly provided the following information:
"While we had a strong defense, we agreed with the State that the best result for everyone is an amicable resolution," Armitage said. "A trial always involves significant time and resources, especially a two-phase trial like this one that posed additional legal hurdles. A settlement helps us get back to what we want to focus on as a company: developing important new medications through research and partnerships with doctors and patients.
"We appreciate all the time and energy the jury invested over more than three weeks in such a complex case," Armitage added.
The agreement involves no admission of wrongdoing on Lilly's part.
The March, 2006 lawsuit claimed the State and healthcare providers were insufficiently warned about possible side effects relating to weight gain, high blood sugar and diabetes, causing harm to the State's Medicaid recipients and increased costs to the State. The lawsuit asked that Lilly pay the State for those costs and pay civil penalties under the Alaska Unfair Trade Practices and Consumer Protection Act (UTPCPA).
Prescribed for more than 23 million people since its initial approval by the FDA in 1996, Zyprexa is regularly prescribed in the U.S. and in more than 80 other countries. One of a class of medications called "atypical antipsychotics," it is approved to treat schizophrenia and bipolar disorder.
"Our decision to resolve this case does not change the fact that Zyprexa can continue to improve the lives of patients around the world who are suffering from schizophrenia and bipolar disorder," Armitage said.
Alaska Attorney General Talis J. Colberg and Eli Lilly and Company today announced a settlement of the lawsuit filed by the State of Alaska over use of Zyprexa(R) (olanzapine) by the State's Medicaid program. The trial began March 3, 2008, in Superior Court in Anchorage.
The agreement resulted from ongoing mediation ordered by trial Judge Mark Rindner before the trial began. Presiding Judge Morgan Christen renewed mediation efforts with the parties last week.
The settlement will include payment by Lilly of $15 million plus a term that will ensure that Alaska is treated as favorably as any other state that may settle with Lilly in the future over similar claims.
"I am very pleased with the efforts by Assistant Attorney General Ed Sniffen and our team of trial attorneys," Colberg said. "We believe this is a good result for the State of Alaska and the Department of Health and Social Services," he added.
"We believe this settlement is in the best interest of the company, the State, and, importantly, of the patients, families and healthcare professionals for whom Zyprexa is an important treatment option," said Robert A. Armitage, Lilly's senior vice president and general counsel.
In addition, Lilly provided the following information:
"While we had a strong defense, we agreed with the State that the best result for everyone is an amicable resolution," Armitage said. "A trial always involves significant time and resources, especially a two-phase trial like this one that posed additional legal hurdles. A settlement helps us get back to what we want to focus on as a company: developing important new medications through research and partnerships with doctors and patients.
"We appreciate all the time and energy the jury invested over more than three weeks in such a complex case," Armitage added.
The agreement involves no admission of wrongdoing on Lilly's part.
The March, 2006 lawsuit claimed the State and healthcare providers were insufficiently warned about possible side effects relating to weight gain, high blood sugar and diabetes, causing harm to the State's Medicaid recipients and increased costs to the State. The lawsuit asked that Lilly pay the State for those costs and pay civil penalties under the Alaska Unfair Trade Practices and Consumer Protection Act (UTPCPA).
Prescribed for more than 23 million people since its initial approval by the FDA in 1996, Zyprexa is regularly prescribed in the U.S. and in more than 80 other countries. One of a class of medications called "atypical antipsychotics," it is approved to treat schizophrenia and bipolar disorder.
"Our decision to resolve this case does not change the fact that Zyprexa can continue to improve the lives of patients around the world who are suffering from schizophrenia and bipolar disorder," Armitage said.
Pfizer Sues Ranbaxy To Block Generic Caduet Until 2016
Pfizer Inc. lodged a declaratory judgment suit on Monday claiming that Ranbaxy's proposed generic would infringe two patents related to atorvastatin, in a move that could stop Ranbaxy Laboratories Ltd. from marketing a generic version of the Caduet until 2016.
Pfizer filed its complaint in the U.S. District Court for the District of Delaware, seeking a judgment that Ranbaxy's copycat Caduet would infringe two patents Pfizer says are valid through July 16, 2016. The suit seeks injunctive relief barring Ranbaxy from making, selling or importing its generic until those patents expire.
Pfizer's suit centers on U.S. Patent Numbers 6,087,511 and 6,274,740 — which issued in 2000 and 2001, respectively. Both patents cover methods of making amorphous atorvastatin, Pfizer's complaint said.
The active ingredients of Caduet, which is a combination of the Pfizer drugs Lipitor and Norvasc, are atorvastatin calcium and amlopdipine besylate.
The atorvastatin calcium and amlodipine besylate product contemplated in Ranbaxy's abbreviated new drug application is made by a process that would infringe the '511 and '740 patents, and Ranbaxy's importation and/or future sales of the ANDA product will also infringe the patents at issue, according to Pfizer.
Ranbaxy is looking to market its generic Caduet as soon as it can get FDA approval, Pfizer said.
Ranbaxy notified Pfizer that it had filed an ANDA seeking approval for generic Caduet in January 2007, which led Pfizer to sue Ranbaxy in Delaware in March of that year.
In that suit, Pfizer asserted U.S. Patent Numbers 4,681,893 and 6,455,574. Ranbaxy also brought U.S. Patent Number 5,273,995 into the mix by filing counterclaims alleging that the '995 patent in invalid and unenforceable or not infringed.
In November 2007, the district court in Delaware granted Pfizer's bid for a judgment that Ranbaxy had infringed the '893 patent.
The complaint Pfizer filed Monday notes that the New York-based pharmaceutical giant already won a judgment that enjoined the effective date of approval of Ranbaxy's ANDA Number 78-747 — which seeks the U.S. Food and Drug Administration's permission to make and sell generic Caduet — until the expiration of the '893 patent.
Adding on six months of pediatric exclusivity, to which Pfizer claims to be entitled, extends the exclusivity afforded by the '893 patent through March 24, 2010, the plaintiff claims.
Pfizer filed its complaint in the U.S. District Court for the District of Delaware, seeking a judgment that Ranbaxy's copycat Caduet would infringe two patents Pfizer says are valid through July 16, 2016. The suit seeks injunctive relief barring Ranbaxy from making, selling or importing its generic until those patents expire.
Pfizer's suit centers on U.S. Patent Numbers 6,087,511 and 6,274,740 — which issued in 2000 and 2001, respectively. Both patents cover methods of making amorphous atorvastatin, Pfizer's complaint said.
The active ingredients of Caduet, which is a combination of the Pfizer drugs Lipitor and Norvasc, are atorvastatin calcium and amlopdipine besylate.
The atorvastatin calcium and amlodipine besylate product contemplated in Ranbaxy's abbreviated new drug application is made by a process that would infringe the '511 and '740 patents, and Ranbaxy's importation and/or future sales of the ANDA product will also infringe the patents at issue, according to Pfizer.
Ranbaxy is looking to market its generic Caduet as soon as it can get FDA approval, Pfizer said.
Ranbaxy notified Pfizer that it had filed an ANDA seeking approval for generic Caduet in January 2007, which led Pfizer to sue Ranbaxy in Delaware in March of that year.
In that suit, Pfizer asserted U.S. Patent Numbers 4,681,893 and 6,455,574. Ranbaxy also brought U.S. Patent Number 5,273,995 into the mix by filing counterclaims alleging that the '995 patent in invalid and unenforceable or not infringed.
In November 2007, the district court in Delaware granted Pfizer's bid for a judgment that Ranbaxy had infringed the '893 patent.
The complaint Pfizer filed Monday notes that the New York-based pharmaceutical giant already won a judgment that enjoined the effective date of approval of Ranbaxy's ANDA Number 78-747 — which seeks the U.S. Food and Drug Administration's permission to make and sell generic Caduet — until the expiration of the '893 patent.
Adding on six months of pediatric exclusivity, to which Pfizer claims to be entitled, extends the exclusivity afforded by the '893 patent through March 24, 2010, the plaintiff claims.
Tuesday, March 25, 2008
J&J gets approvable letter for Ceftobiprole from US FDA
Johnson and Johnson Pharmaceutical Research and Development, L.L.C. (J&JPRD), has received an approvable letter from the US Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for ceftobiprole for the treatment of complicated skin and skin structure infections, including diabetic foot infections.
J&JPRD, along with its co-development partner, Swiss-based Basilea Pharmaceutica Ltd., is reviewing the agency's letter and will work quickly to resolve any outstanding issues. The NDA for ceftobiprole was submitted to the FDA last May.
Dr. Anthony Man, CEO, Basilea said, "We are closely working together with our development partner Johnson & Johnson Pharmaceutical Research and Development, L.L.C., to quickly address the questions from the FDA."An application for the use of ceftobiprole in adults in the same indication is currently under regulatory review in Europe, Australia, Canada and in other countries.
The NDA submission of ceftobiprole for the treatment of complicated skin and skin structure infections includes the data from two pivotal phase III trials (STRAUSS 1 and STRAUSS 2). These trials comprise data from over 1600 patients including those with diabetic foot infections caused by Gram-negative and Gram-positive pathogens and with methicillin-resistant Staphylococcus aureus (MRSA) infections. In both of these large, multinational, double-blind, randomized phase III clinical studies, ceftobiprole was effective, demonstrated by achievement of the non-inferiority endpoint to single drug or two-drug combination comparators, respectively. Ceftobiprole was well tolerated with a safety profile consistent with the cephalosporin class of antibiotic.
J&JPRD, a part of Johnson & Johnson, has facilities throughout Asia, Europe and the United States. J&JPRD is leveraging drug discovery and drug development in a variety of therapeutic areas to address unmet medical needs worldwide.
J&JPRD, along with its co-development partner, Swiss-based Basilea Pharmaceutica Ltd., is reviewing the agency's letter and will work quickly to resolve any outstanding issues. The NDA for ceftobiprole was submitted to the FDA last May.
Dr. Anthony Man, CEO, Basilea said, "We are closely working together with our development partner Johnson & Johnson Pharmaceutical Research and Development, L.L.C., to quickly address the questions from the FDA."An application for the use of ceftobiprole in adults in the same indication is currently under regulatory review in Europe, Australia, Canada and in other countries.
The NDA submission of ceftobiprole for the treatment of complicated skin and skin structure infections includes the data from two pivotal phase III trials (STRAUSS 1 and STRAUSS 2). These trials comprise data from over 1600 patients including those with diabetic foot infections caused by Gram-negative and Gram-positive pathogens and with methicillin-resistant Staphylococcus aureus (MRSA) infections. In both of these large, multinational, double-blind, randomized phase III clinical studies, ceftobiprole was effective, demonstrated by achievement of the non-inferiority endpoint to single drug or two-drug combination comparators, respectively. Ceftobiprole was well tolerated with a safety profile consistent with the cephalosporin class of antibiotic.
J&JPRD, a part of Johnson & Johnson, has facilities throughout Asia, Europe and the United States. J&JPRD is leveraging drug discovery and drug development in a variety of therapeutic areas to address unmet medical needs worldwide.
Health Canada approved new treatment for heart failure
March 25, 2008 /CNW/ - Health Canada has approved a leading high blood pressure medicine Diovan* (valsartan) to treat chronic heart failure (HF) in patients who cannot tolerate angiotensin-converting-enzyme (ACE) inhibitors, a common type of heart failure therapy.
Characterized by a progressive weakening of the heart muscle until it no longer pumps blood effectively, HF is the most common cause for adult hospitalizations in Canada and carries a greater risk of death than most cancers.
"Quality of life remains compromised for many heart failure patients since 20% to 50% of these individuals can not tolerate standard therapy," says Dr. George Honos, a staff cardiologist and director of noninvasive cardiology at the Sir Mortimer B Davis Jewish General Hospital in Montreal, Quebec. "The approval of Diovan* is welcome news for this patient population who require additional options to improve survival."
Characterized by a progressive weakening of the heart muscle until it no longer pumps blood effectively, HF is the most common cause for adult hospitalizations in Canada and carries a greater risk of death than most cancers.
"Quality of life remains compromised for many heart failure patients since 20% to 50% of these individuals can not tolerate standard therapy," says Dr. George Honos, a staff cardiologist and director of noninvasive cardiology at the Sir Mortimer B Davis Jewish General Hospital in Montreal, Quebec. "The approval of Diovan* is welcome news for this patient population who require additional options to improve survival."
Obesity Drug Market Will Increase More Than Five-Fold, Reaching $2.7 Billion in 2016
March 25, -- Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that the obesity drug market in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan will experience more than five-fold growth, rising from $478 million in 2006 to more than $2.7 billion in 2016. The market will grow most rapidly in the United States, where sales will increase from $222 million in 2006 to nearly $2 billion in 2016.
The new Pharmacor report entitled Obesity finds that the significant market growth will be driven by a number of emerging therapies, including Arena Pharmaceuticals' lorcaserin and Amylin Pharmaceuticals' pramlintide/leptin combination, which are both expected to launch in the world's major pharmaceutical markets by 2011. Lorcaserin, pramlintide/leptin and other emerging novel therapies will capture 80% of the total obesity market in 2016 as physicians switch from the few currently available therapies to new treatments with novel mechanisms of action.
The report also finds that increasing concern of the Food and Drug Administration (FDA) regarding the long-term safety of drug treatments for chronic conditions such as obesity poses one of the most significant threats to companies developing anti-obesity drugs. For example, although Sanofi- Aventis's Acomplia (rimonabant) had been widely anticipated to become a key therapy for obesity, its blockbuster potential was eliminated after a negative opinion of the drug was issued by an FDA advisory panel last year. According to the report, similar safety concerns will plague Merck's taranabant and Pfizer's CP-945598, which belong to the same drug class as rimonabant.
"Given the high prevalence of obesity in the world's major pharmaceutical markets, the opportunity for agents that fulfill the need for safe, effective and well-tolerated weight-loss therapies is significant," said Donny Wong, Ph.D. principal analyst at Decision Resources. "Although the most efficacious emerging obesity drugs are combination therapies with multiple mechanisms of action, most of the late-stage therapies in development lack blockbuster potential because they are either associated with safety concerns or are available only in inconvenient injectable formulations."
The new Pharmacor report entitled Obesity finds that the significant market growth will be driven by a number of emerging therapies, including Arena Pharmaceuticals' lorcaserin and Amylin Pharmaceuticals' pramlintide/leptin combination, which are both expected to launch in the world's major pharmaceutical markets by 2011. Lorcaserin, pramlintide/leptin and other emerging novel therapies will capture 80% of the total obesity market in 2016 as physicians switch from the few currently available therapies to new treatments with novel mechanisms of action.
The report also finds that increasing concern of the Food and Drug Administration (FDA) regarding the long-term safety of drug treatments for chronic conditions such as obesity poses one of the most significant threats to companies developing anti-obesity drugs. For example, although Sanofi- Aventis's Acomplia (rimonabant) had been widely anticipated to become a key therapy for obesity, its blockbuster potential was eliminated after a negative opinion of the drug was issued by an FDA advisory panel last year. According to the report, similar safety concerns will plague Merck's taranabant and Pfizer's CP-945598, which belong to the same drug class as rimonabant.
"Given the high prevalence of obesity in the world's major pharmaceutical markets, the opportunity for agents that fulfill the need for safe, effective and well-tolerated weight-loss therapies is significant," said Donny Wong, Ph.D. principal analyst at Decision Resources. "Although the most efficacious emerging obesity drugs are combination therapies with multiple mechanisms of action, most of the late-stage therapies in development lack blockbuster potential because they are either associated with safety concerns or are available only in inconvenient injectable formulations."
Sagent Pharmaceuticals Launches Cefepime Injection
Sagent Pharmaceutical, today announced that it has launched Cefepime for injection, USP, a broad spectrum antibiotic used to treat bacterial infections. Sagent's Cefepime for injection will be available in 1g and 2g single dose vials. According to IMS data, sales of Cefepime in the US in 2006 were approximately $167 million. Sagent will begin marketing and shipping cefepime immediately.
"In the past week Sagent has launched two anti-infective products, each upon the expiration of innovator exclusivity. These launches illustrate both Sagent's capabilities and the depth of our unique worldwide partnerships in effectively developing, obtaining approval for, and marketing a broad range of injectable products," said Jeffrey M. Yordon, chief executive officer, founder, and chairman of the board of Sagent. "The addition of Cefepime to our product portfolio, underscores our commitment to rapidly provide our customers and patients with a strong portfolio of injectable antibiotic products."
The introduction of Cefepime for injection marks the fourth product launch from Sagent's pipeline of more than 200 products. This month, the Company has launched two essential antibiotic products: ciprofloxacin injection, USP, 5% dextrose premix bag, a synthetic broad spectrum antimicrobial agent for intravenous administration and Cefazolin for injection, USP.
(According to the article published on pharmalive.com)
"In the past week Sagent has launched two anti-infective products, each upon the expiration of innovator exclusivity. These launches illustrate both Sagent's capabilities and the depth of our unique worldwide partnerships in effectively developing, obtaining approval for, and marketing a broad range of injectable products," said Jeffrey M. Yordon, chief executive officer, founder, and chairman of the board of Sagent. "The addition of Cefepime to our product portfolio, underscores our commitment to rapidly provide our customers and patients with a strong portfolio of injectable antibiotic products."
The introduction of Cefepime for injection marks the fourth product launch from Sagent's pipeline of more than 200 products. This month, the Company has launched two essential antibiotic products: ciprofloxacin injection, USP, 5% dextrose premix bag, a synthetic broad spectrum antimicrobial agent for intravenous administration and Cefazolin for injection, USP.
(According to the article published on pharmalive.com)
APP Pharmaceuticals Launches Cefepime Hydrochloride for Injection
March 25, 2008--APP Pharmaceuticals, Inc. (Nasdaq:APPX), a leading manufacturer of multi-source and branded injectable pharmaceutical products, today announced that it has launched Cefepime Hydrochloride for Injection, the generic equivalent of Maxipime(R) marketed by Elan Corporation, plc. APP's cefepime is AP-rated, bar-coded and latex-free. According to IMS data, sales of Cefepime Hydrochloride in the United States were approximately $173 million in 2007.
Cefepime Hydrochloride for Injection is indicated in the treatment of the following infections: Pneumonia, Empiric Therapy for Febrile Neutropenic Patients, Urinary Tract Infections (including pyelonephritis), Skin and Skin Structure Infections, and Intra-abdominal Infections.
"The launch of Cefepime further bolsters our leadership position as a provider of the broadest portfolio of generic anti-infective injectable products," said Tom Silberg, President of APP. "APP is one of the only marketers of first, second, third and fourth generation cephalosporin in the U.S."
Cefepime Hydrochloride for Injection is indicated in the treatment of the following infections: Pneumonia, Empiric Therapy for Febrile Neutropenic Patients, Urinary Tract Infections (including pyelonephritis), Skin and Skin Structure Infections, and Intra-abdominal Infections.
"The launch of Cefepime further bolsters our leadership position as a provider of the broadest portfolio of generic anti-infective injectable products," said Tom Silberg, President of APP. "APP is one of the only marketers of first, second, third and fourth generation cephalosporin in the U.S."
Taro Receives FDA Approval for Ondansetron Hydrochloride Injection USP, 2 mg/mL ANDA
Mar 25, 2008 - Taro Pharmaceutical Industries Ltd. ("Taro," the "Company," Pink Sheets: TAROF) reported today that it has received approval from the U.S. Food and Drug Administration ("FDA") for its Abbreviated New Drug Application ("ANDA") for Ondansetron Hydrochloride Injection USP, 2 mg/mL ("Ondansetron Injection").
Taro's Ondansetron Injection is used for the prevention of nausea and vomiting associated with chemotherapy. This new Taro sterile injectable prescription product is bioequivalent to GlaxoSmithKline's Zofran(R) Injection, 2 mg/mL. Taro's Ondansetron Injection will be manufactured in the Company's sterile facility in Ireland. According to industry sources, branded and generic injectable ondansetron products had U.S. sales of more than $150 million in 2007.
Taro's Ondansetron Injection is used for the prevention of nausea and vomiting associated with chemotherapy. This new Taro sterile injectable prescription product is bioequivalent to GlaxoSmithKline's Zofran(R) Injection, 2 mg/mL. Taro's Ondansetron Injection will be manufactured in the Company's sterile facility in Ireland. According to industry sources, branded and generic injectable ondansetron products had U.S. sales of more than $150 million in 2007.
Monday, March 24, 2008
Aurobindo to enter Italian generic market
Aurobindo Pharma Ltd has recently concluded a strategic deal, for acquisition of intellectual property and marketing authorizations, with TAD Italy, a generic company registered in Italy.
This acquisition will give Aurobindo an access to more than 70 ready to market products which will fast track Aurobindo's entry into the Italian generic market. This strategic acquisition is expected to jump start the business for Aurobindo in Italy where the market and the regulatory procedures are considered as the one of the toughest in all EU.
"This deal will provide us with a ready local platform and will help us is immediately maximising the potential of our vast internal pipeline which is to follow in the next few months. Aurobindo has already flied 22 products for registration in Italy. During the integration process, we expect to derive maximum synergies from this acquisition by shifting the manufacturing of TAD's products to our own facilities", commented Ashish Menocha, Aurobindo's regional VP, Europe.
Aurobindo has also acquired high profile OTC brands Mapooro (www.mapooro.com) and Carmiooro from TAD as a part of this deal.
This is the company's third acquisition in Europe, after acquiring Milpharm Ltd in UK and Pharmacin International BV, in Netherlands. The company believes that such acquisitions reduce the time to market and enhance the relationships in the generic value chain in addition to building a broad and formidable product portfolio.
This acquisition will give Aurobindo an access to more than 70 ready to market products which will fast track Aurobindo's entry into the Italian generic market. This strategic acquisition is expected to jump start the business for Aurobindo in Italy where the market and the regulatory procedures are considered as the one of the toughest in all EU.
"This deal will provide us with a ready local platform and will help us is immediately maximising the potential of our vast internal pipeline which is to follow in the next few months. Aurobindo has already flied 22 products for registration in Italy. During the integration process, we expect to derive maximum synergies from this acquisition by shifting the manufacturing of TAD's products to our own facilities", commented Ashish Menocha, Aurobindo's regional VP, Europe.
Aurobindo has also acquired high profile OTC brands Mapooro (www.mapooro.com) and Carmiooro from TAD as a part of this deal.
This is the company's third acquisition in Europe, after acquiring Milpharm Ltd in UK and Pharmacin International BV, in Netherlands. The company believes that such acquisitions reduce the time to market and enhance the relationships in the generic value chain in addition to building a broad and formidable product portfolio.
MedWatch - B. Braun Heparin Sodium Injection Solutions - Recall due to heparin-like contaminant
March 24, 2008-B. Braun Medical Inc. was notified by its supplier, Scientific Protein Laboratories LLC (SPL) of a nationwide recall of Heparin Sodium USP active pharmaceutical ingredient (API). The voluntary recall affects 23 Finished Product lots manufactured and distributed by B. Braun Medical Inc. nationwide and to Canada. This product recall was initiated due to a notification received from SPL, disclosing that one lot of Heparin Sodium, USP API acquired by B. Braun has a heparin-like contaminant. FDA has received reports of serious injuries and/or deaths in patients who have been administered Heparin injectable products of other companies containing this contaminant.
SIGA Files Application Supporting Emergency Use Approval for ST-246
Mar 24, 2008 - SIGA Technologies, Inc. (NASDAQ: SIGA), a company specializing in the development of pharmaceutical agents to fight biowarfare pathogens, announced today that it has submitted to the FDA an application to support an Emergency Use Authorization (EUA) of its drug ST-246, an orally active, smallpox antiviral, to treat individuals exposed to the smallpox virus in the event of an outbreak.
The EUA mechanism was created by Congress to enable the FDA Commissioner to authorize the use of a drug that has not been approved, or has not been approved for a particular use, when the nation is in a state of declared emergency. EUA approval is given only to those drugs or products that may be effective in the prevention, diagnosis or treatment of serious or life-threatening diseases or conditions that can be caused by specified biological, chemical, radiological or nuclear agents.
Dr. Eric A. Rose, SIGA's Chief Executive Officer and Chairman, commented, "Opening a dialogue with the FDA regarding EUA status brings us closer to the opportunity for large-scale production and stockpiling of ST-246 to treat individuals with symptomatic smallpox infection. Based on the success to date of our product candidate in trials, we believe that we have the most advanced smallpox treatment in development, and that ST-246 represents the most effective treatment option should a smallpox threat ever arise."
Dr. Rose continued, "One year ago we were asked by the CDC to provide a formulation of ST-246 for treatment of a moribund child with eczema vaccinatum, an illness that mimics clinical smallpox. The FDA approved the compassionate emergency use of ST-246 within hours, and the child recovered after receiving ST-246 along with other medications. We believe that in the event of a smallpox outbreak responsible government agencies will also want to provide ST-246 to patients with clinical signs and symptoms, who otherwise would have an estimated mortality rate of 20 to 30%. Over the past year, we have completed additional animal effectiveness and human safety trials which, in the Company's view, have reasonably defined the adult dose of the drug for this purpose and a safety profile which, we believe, compares very favorably to the natural history of symptomatic smallpox. In addition, we have developed a manufacturing process to create substantial quantities of the drug for stockpiling."
"If the FDA determines that ST-246 is eligible for an Emergency Use Authorization, it will be a major milestone for our Company, facilitating government acquisition of the drug through Project BioShield. As we understand the BioShield requirements, ST-246 must demonstrate a path to FDA approval. Our EUA submission demonstrates, we believe, that ST-246 is progressing well on this path." Whether this or any drug receives Emergency Use Authorization is dependent on many factors, and the submission of an application to FDA provides no assurance that the application will be favorably acted upon by the agency.
The ST-246 project has, in part, been funded with Federal funds from the National Institute of Allergy and Infectious Disease and the Department of Defense's Threat Reduction Agency. The drug has previously shown significant antiviral activity in numerous animal models of orthopoxvirus disease, including the complete protection of primates from lethal doses of monkeypox and smallpox virus.
The EUA mechanism was created by Congress to enable the FDA Commissioner to authorize the use of a drug that has not been approved, or has not been approved for a particular use, when the nation is in a state of declared emergency. EUA approval is given only to those drugs or products that may be effective in the prevention, diagnosis or treatment of serious or life-threatening diseases or conditions that can be caused by specified biological, chemical, radiological or nuclear agents.
Dr. Eric A. Rose, SIGA's Chief Executive Officer and Chairman, commented, "Opening a dialogue with the FDA regarding EUA status brings us closer to the opportunity for large-scale production and stockpiling of ST-246 to treat individuals with symptomatic smallpox infection. Based on the success to date of our product candidate in trials, we believe that we have the most advanced smallpox treatment in development, and that ST-246 represents the most effective treatment option should a smallpox threat ever arise."
Dr. Rose continued, "One year ago we were asked by the CDC to provide a formulation of ST-246 for treatment of a moribund child with eczema vaccinatum, an illness that mimics clinical smallpox. The FDA approved the compassionate emergency use of ST-246 within hours, and the child recovered after receiving ST-246 along with other medications. We believe that in the event of a smallpox outbreak responsible government agencies will also want to provide ST-246 to patients with clinical signs and symptoms, who otherwise would have an estimated mortality rate of 20 to 30%. Over the past year, we have completed additional animal effectiveness and human safety trials which, in the Company's view, have reasonably defined the adult dose of the drug for this purpose and a safety profile which, we believe, compares very favorably to the natural history of symptomatic smallpox. In addition, we have developed a manufacturing process to create substantial quantities of the drug for stockpiling."
"If the FDA determines that ST-246 is eligible for an Emergency Use Authorization, it will be a major milestone for our Company, facilitating government acquisition of the drug through Project BioShield. As we understand the BioShield requirements, ST-246 must demonstrate a path to FDA approval. Our EUA submission demonstrates, we believe, that ST-246 is progressing well on this path." Whether this or any drug receives Emergency Use Authorization is dependent on many factors, and the submission of an application to FDA provides no assurance that the application will be favorably acted upon by the agency.
The ST-246 project has, in part, been funded with Federal funds from the National Institute of Allergy and Infectious Disease and the Department of Defense's Threat Reduction Agency. The drug has previously shown significant antiviral activity in numerous animal models of orthopoxvirus disease, including the complete protection of primates from lethal doses of monkeypox and smallpox virus.
Suven Life Sciences Secures Two Product Patents in all Russian Countries (Eurasia Region)
HYDERABAD, India, March 24, 2008 – Suven Life Sciences Ltd (Suven) announces today that two product patents were granted in Eurasia (009193 and 009367) for two of their New Chemical Entities (NCEs) for the treatment of disorders associated with Neurodegenerative diseases and these Patents are valid until 2023. The patents are valid in all contracting countries like Armenia, Azerbaijan, Belarus, Kyrgyzstan, Kazakhstan, Moldova, Russia, Tajikistan and Turkmenistan.
These granted patents are exclusive intellectual property of Suven and are achieved through the exclusive internal discovery research efforts. Products out of these inventions which are in pre-clinical development may be out-licensed at the stage of clinical Phase-I or Phase-II stage.
“We are very pleased by the issuance of these patents to Suven for our drug candidates that are being developed for CNS disorders which targets an $18 billion potential market opportunity globally “says Venkat Jasti, CEO of Suven.
The granted claims of the patents include the class of selective 5-HT compounds discovered by Suven and are being developed as therapeutic agents and are useful in the treatment of cognitive impairment associated with neuro-degenarative disorders like Attention deficient hyperactivity, Alzheimer’s, Parkinson, Schizophrenia and Huntington’s.
These granted patents are exclusive intellectual property of Suven and are achieved through the exclusive internal discovery research efforts. Products out of these inventions which are in pre-clinical development may be out-licensed at the stage of clinical Phase-I or Phase-II stage.
“We are very pleased by the issuance of these patents to Suven for our drug candidates that are being developed for CNS disorders which targets an $18 billion potential market opportunity globally “says Venkat Jasti, CEO of Suven.
The granted claims of the patents include the class of selective 5-HT compounds discovered by Suven and are being developed as therapeutic agents and are useful in the treatment of cognitive impairment associated with neuro-degenarative disorders like Attention deficient hyperactivity, Alzheimer’s, Parkinson, Schizophrenia and Huntington’s.
Barrier Therapeutics Granted Second Interim Patent Term Extension for Vusion Ointment
Barrier Therapeutics, Inc. (Nasdaq:BTRX), a pharmaceutical company developing and commercializing products in the field of dermatology, announced today that the U.S. Patent and Trademark Office (USPTO) has granted a second one-year interim patent term extension to United States Patent Number 4,911,932. This patent covers the Vusion(r) (0.25% miconazole nitrate, 15% zinc oxide, 81.35% white petrolatum) Ointment formulation and methods of treating diaper dermatitis. This action extends the term of this patent to March 27, 2009. The Company intends to list this extension in the Orange Book published by the U.S. Food and Drug Administration (FDA).
"Vusion is a key brand for Barrier Therapeutics, and we are pleased to receive this second one-year patent term extension from the USPTO as we continue our efforts to secure the full five-year patent term restoration under the Hatch-Waxman Act which, if granted, could protect Vusion to 2012," said Mr. Al Altomari, Chief Operating Officer.
This patent was originally scheduled to expire on March 27, 2007. Barrier Therapeutics has applied for up to five years of patent term extension under the United States Drug Price Competition and Patent Term Restoration Act of 1984, known as the Hatch-Waxman Act. This five year application is currently being reviewed by the USPTO, in consultation with the FDA. The interim extension was granted pursuant to a portion of the Hatch-Waxman Act that provides a process for applying for interim extensions of up to one-year at a time, if a patent is scheduled to expire during the review of the application. This second interim grant extends the patent term until March 27, 2009, or until a final determination on the five year application is made, if earlier. Based on the current stage of the review process, the Company does not anticipate a final determination on the five year application prior to March 2009. Accordingly, the Company anticipates that it will request a 3rd interim extension later this year. While the Company has submitted an application for patent term extension until March 2012, it is possible that the USPTO could reject that application or grant an extension for a shorter period of time.
"Vusion is a key brand for Barrier Therapeutics, and we are pleased to receive this second one-year patent term extension from the USPTO as we continue our efforts to secure the full five-year patent term restoration under the Hatch-Waxman Act which, if granted, could protect Vusion to 2012," said Mr. Al Altomari, Chief Operating Officer.
This patent was originally scheduled to expire on March 27, 2007. Barrier Therapeutics has applied for up to five years of patent term extension under the United States Drug Price Competition and Patent Term Restoration Act of 1984, known as the Hatch-Waxman Act. This five year application is currently being reviewed by the USPTO, in consultation with the FDA. The interim extension was granted pursuant to a portion of the Hatch-Waxman Act that provides a process for applying for interim extensions of up to one-year at a time, if a patent is scheduled to expire during the review of the application. This second interim grant extends the patent term until March 27, 2009, or until a final determination on the five year application is made, if earlier. Based on the current stage of the review process, the Company does not anticipate a final determination on the five year application prior to March 2009. Accordingly, the Company anticipates that it will request a 3rd interim extension later this year. While the Company has submitted an application for patent term extension until March 2012, it is possible that the USPTO could reject that application or grant an extension for a shorter period of time.
HIV/AIDS Update - Tentative Approval of Two Fixed Dose Combination Products for PEPFAR
On March 20, 2008, the Food and Drug Administration (FDA) granted tentative approval to two fixed-dose combination products containing generic versions of stavudine/lamivudine/nevirapine 30mg/150mg/200mg Tablets, and stavudine/lamivudine/nevirapine 40mg/150mg/200mg Tablets, under expedited procedures for the President's Emergency Plan for AIDS Relief (PEPFAR) program. Both fixed dose combinations are manufactured by Strides Arcolab Limited of Bangalore, India, and indicated for the treatment of HIV-1 infection.
Each ingredient of this generic tablet is currently approved to treat HIV-1 in combination with other antiretroviral agents. The safety and effectiveness of the combination of stavudine/lamivudine/nevirapine in lowering viral load and increasing CD4+ cells has been demonstrated in previously conducted controlled studies of the individual ingredients used together.
Combination products such as these can significantly reduce pill burden. potentially resulting in improved therapeutic compliance with complex dosing regimens, as well as facilitating the storage and distribution of these HIV medications.
FDA's "tentative approval "means that although a product meets all of the safety, efficacy, and manufacturing quality standards required for marketing in the U.S., existing patents and/or proprietary issues currently prevent marketing of the product in the United States. Tentative approval, however, does qualify the product for consideration for purchase under the PEPFAR program.
As with all generic applications, FDA conducts an on-site inspection of each manufacturing facility and of the facilities performing the bioequivalence studies prior to granting approval or tentative approval to these applications to evaluate the ability of the manufacturer to produce a quality product and to assess the quality of the bioequivalence data supporting the application.
These products were reviewed under the FDA guidance titled "Fixed Dose Combinations, Co-Packaged Drug Products, and Single-Entity Versions of Previously approved Antiretrovirals for the Treatment of HIV" developed to clarify what regulatory requirements apply to such applications, what issues might be of concern, and how these issues should be addressed. The guidance is intended to encourage sponsors to submit applications for combination and co-packaged products, and to facilitate submission of such applications to FDA.
Each ingredient of this generic tablet is currently approved to treat HIV-1 in combination with other antiretroviral agents. The safety and effectiveness of the combination of stavudine/lamivudine/nevirapine in lowering viral load and increasing CD4+ cells has been demonstrated in previously conducted controlled studies of the individual ingredients used together.
Combination products such as these can significantly reduce pill burden. potentially resulting in improved therapeutic compliance with complex dosing regimens, as well as facilitating the storage and distribution of these HIV medications.
FDA's "tentative approval "means that although a product meets all of the safety, efficacy, and manufacturing quality standards required for marketing in the U.S., existing patents and/or proprietary issues currently prevent marketing of the product in the United States. Tentative approval, however, does qualify the product for consideration for purchase under the PEPFAR program.
As with all generic applications, FDA conducts an on-site inspection of each manufacturing facility and of the facilities performing the bioequivalence studies prior to granting approval or tentative approval to these applications to evaluate the ability of the manufacturer to produce a quality product and to assess the quality of the bioequivalence data supporting the application.
These products were reviewed under the FDA guidance titled "Fixed Dose Combinations, Co-Packaged Drug Products, and Single-Entity Versions of Previously approved Antiretrovirals for the Treatment of HIV" developed to clarify what regulatory requirements apply to such applications, what issues might be of concern, and how these issues should be addressed. The guidance is intended to encourage sponsors to submit applications for combination and co-packaged products, and to facilitate submission of such applications to FDA.
Sunday, March 23, 2008
Merck's cervical cancer vaccine Gardasil gets US FDA priority review
Merck & Co., Inc. said the US Food and Drug Administration (FDA) has accepted, and designated for priority review, the supplemental Biologics License Application (sBLA) for Gardasil [Human Papillomavirus Quadrivalent] (Types 6, 11, 16, 18) Vaccine, Recombinant] for the potential use in women aged 27 through 45. A priority designation is intended for products or indications that address unmet medical needs. Under the Prescription Drug User Fee Act, the FDA's goal is to review and act on 90 percent of BLAs designated as priority review within six months of receipt.
Gardasil is currently indicated for girls and women nine through 26 years of age for the prevention of cervical cancer, precancerous or dysplastic lesions, and genital warts caused by HPV types 6, 11, 16 and 18. Women remain at risk for newly acquired HPV infections and developing HPV-related diseases throughout their lifetime.
Gardasil is contraindicated in individuals who are hypersensitive to the active substances or to any of the excipients of the vaccine. It is not intended to be used for treatment of active genital warts; cervical cancer; CIN, vulvar interepithelial neoplasia (VIN), or vaginal interepithelial neoplasia (VaIN). Gardasil has not been shown to protect against disease due to other HPV types.
In clinical studies for Gardasil, vaccine-related adverse experiences that were observed at a frequency of at least 1.0 per cent among recipients of Gardasil and also greater than those observed among recipients of placebo, respectively, were pain, swelling, erythema, fever, nausea, pruritis and dizziness. In addition, common post-marketing reports include vomiting and syncope.
Gardasil is currently indicated for girls and women nine through 26 years of age for the prevention of cervical cancer, precancerous or dysplastic lesions, and genital warts caused by HPV types 6, 11, 16 and 18. Women remain at risk for newly acquired HPV infections and developing HPV-related diseases throughout their lifetime.
Gardasil is contraindicated in individuals who are hypersensitive to the active substances or to any of the excipients of the vaccine. It is not intended to be used for treatment of active genital warts; cervical cancer; CIN, vulvar interepithelial neoplasia (VIN), or vaginal interepithelial neoplasia (VaIN). Gardasil has not been shown to protect against disease due to other HPV types.
In clinical studies for Gardasil, vaccine-related adverse experiences that were observed at a frequency of at least 1.0 per cent among recipients of Gardasil and also greater than those observed among recipients of placebo, respectively, were pain, swelling, erythema, fever, nausea, pruritis and dizziness. In addition, common post-marketing reports include vomiting and syncope.
Sun Pharmaceutical Announces USFDA Approval to Market Generic Tessalon
MUMBAI, March 21, 2008: Sun Pharmaceutical Industries Ltd. announced that USFDA has granted approval for the Abbreviated New Drug Application (ANDA) to market a generic version of Forest Lab’s Tessalon®, benzonatate capsules.
Benzonatate USP capsules are therapeutically equivalent to Forest Lab’s Tessalon®, and are available in two strengths: capsules containing 100 mg and 200 mg benzonatate USP.
Benzonatate has annual sales of approximately USD 40 million in the US. Benzonatate is an antitussive, used to relieve cough due to the common cold, bronchitis, pneumonia, or other lung infections. This product will reach market shortly.
Benzonatate USP capsules are therapeutically equivalent to Forest Lab’s Tessalon®, and are available in two strengths: capsules containing 100 mg and 200 mg benzonatate USP.
Benzonatate has annual sales of approximately USD 40 million in the US. Benzonatate is an antitussive, used to relieve cough due to the common cold, bronchitis, pneumonia, or other lung infections. This product will reach market shortly.
Federal Court of Appeal in Canada Upholds Lipitor Enantiomer Patent, Decision Prevents Launch of Generic Product by Ranbaxy until 2010
Mar 20, 2008 - Pfizer Inc said today that the Federal Court of Appeal of Canada has reversed a lower court ruling that held that Pfizer's enantiomer patent could not block generic manufacturer Ranbaxy Laboratories Limited from obtaining approval for a competitor product to Lipitor. The appellate court issued an order prohibiting regulatory approval of Ranbaxy's product in Canada until Pfizer's enantiomer (calcium salt) patent--Canadian Patent No. 2,021,546--expires in July 2010.
"This decision sends a strong signal about the importance of protecting intellectual property in Canada, which provides the incentive for research-driven pharmaceutical companies to make the significant high-risk investments necessary to develop new life-saving medicines," said Pfizer Senior Vice President and Associate General Counsel Peter Richardson. "The court's ruling is not only an important one for Pfizer, but also for patients."
Ranbaxy may seek a review of the decision by the Supreme Court of Canada.
"This decision sends a strong signal about the importance of protecting intellectual property in Canada, which provides the incentive for research-driven pharmaceutical companies to make the significant high-risk investments necessary to develop new life-saving medicines," said Pfizer Senior Vice President and Associate General Counsel Peter Richardson. "The court's ruling is not only an important one for Pfizer, but also for patients."
Ranbaxy may seek a review of the decision by the Supreme Court of Canada.
Federal Circuit Addresses Effect of 271(e)(1) "Safe Harbor" in ITC Actions
Amgen holds at least six US patents that relate to erythropoeitin and its derivatives (“EPO”) and processes for making EPO, protecting the Amgen drugs Aranesp and Epogen. Sales of Aranesp alone topped $3.6 million last year. Roche produces EPO in Europe and has been seeking FDA approval for its own EPO drug, Mircera, in the US.
Roche began importing EPO as part of its effort to generate data for its regulatory submissions to the FDA. Amgen did not object to these acts of importation. However, Roche continued importing EPO even after its FDA application was complete (though Roche has not yet sold or contracted to sell any of its EPO in the US). Amgen responded by filing a Section 337 action with the International Trace Commission (ITC), asking the ITC to enjoin Roche’s further importation and future sale in the US of its European-produced EPO.
The ITC denied Amgen’s injunction request because (1) the ITC determined that Roche’s importation of EPO was protected by the FDA “safe harbor” provision of Section 271(e)(1), which provides that conduct cannot infringe a patent when it is reasonably related to securing FDA approval; and (2) the ITC has no jurisdiction absent a sale or contract for sale of EPO in the US. In a decision Wednesday, the Federal Circuit affirmed in part, reversed in part, and remanded the case to the ITC.
Amgen made three arguments on appeal: (1) Section 271(e)(1) provides no exemption for the importation of articles made overseas by patented processes in Section 337 actions before the ITC; (2) Section 271(e)(1) does not provide blanket protection for all pre-FDA-approval conduct; and (3) the ITC has jurisdiction whenever sale of the accused article is imminent. All three Federal Circuit panelists sided with Amgen on the second and third points. On the first point, however, Judges Newman and Lourie agreed with the ITC, while Judge Linn dissented to express his agreement with Amgen’s argument.
On Amgen’s first point, the majority accepted the ITC’s argument, i.e., that the Section 271(e)(1) safe harbor should operate identically in ITC litigation as in federal district court litigation. The importation of an article made by an infringing process constitutes an act of infringement under Section 271(g). But the safe harbor of Section 271(e)(1) holds that certain acts related to gaining regulatory approval are not acts of infringement. Therefore, 271(e)(1) cuts back on 271(g) by declaring that certain types of conduct do not constitute infringement. The ITC, however, does not look to Section 271(g) for its authority. Instead the ITC looks to 19 USC § 337(a)(1)(B)(ii), which declares unlawful the importation of any article “made . . . by means of a process covered by the claims of a valid and enforceable United States patent.” In contrast, Section 271(g) only forbids the importation of articles made by means of a process that infringes the claims of a valid and enforceable US patent. Because the safe harbor of Section 271(e)(1) only addresses infringement, Judge Linn (in dissent) argues that the safe harbor applies to infringement liability under Section 271(g) but not to unlawful trade practices under Section 337(a)(1)(B)(ii). The majority’s holding elects to gloss over these key differences between Section 271(g) and Section 337.
On the other hand, the majority’s holding probably does comport more closely with the policy rationales that support having the regulatory safe harbor. As the majority notes, the legislative history supports this proposition that the 271(e)(1) safe harbor applies identically to importation under Section 271(g) and to importation under Section 337(a)(1)(B)(ii). Moreover, the Supreme Court’s broad reading of the scope of the regulatory safe harbor in Integra v. Merck and Eli Lilly v. Medtronic lends further support for the majority’s policy judgment. Judge Linn even agrees that the majority reaches the policy outcome that makes the most sense. Nevertheless, the text of Section 337(a)(1)(B)(ii) is clearly at odds with such a policy outcome.
On Amgen’s second point, the Court agreed with Amgen. The safe harbor of Section 271(e)(1) does not provide blanket protection for all pre-FDA-approval conduct. For each separate act, the accused party must demonstrate that each act is reasonably related to gaining regulatory approval. Amgen asserted that Roche continued importing EPO after its FDA application was complete and used the imported EPO to conduct marketing studies. The Court remanded the case to the ITC for an act-by-act evaluation of whether Roche’s conduct was indeed within the ambit of Section 271(e)(1).
On Amgen’s third point, the Federal Circuit held that the ITC jurisdiction is invoked “[w]hen it has been shown that infringing acts are reasonably likely to occur . . . .” The court went to great lengths to point out that this standard is not new, and is, in fact, consistent with nearly three decades of ITC precedent. Because Section 337 provides for a prospective remedy, it makes no sense for the complainant to wait for an actual sale to occur, so long as an actual sale is imminent.
The link for decision is as follows: http://www.cafc.uscourts.gov/opinions/07-1014.pdf
(As per the article published on Orange book Blog)
Roche began importing EPO as part of its effort to generate data for its regulatory submissions to the FDA. Amgen did not object to these acts of importation. However, Roche continued importing EPO even after its FDA application was complete (though Roche has not yet sold or contracted to sell any of its EPO in the US). Amgen responded by filing a Section 337 action with the International Trace Commission (ITC), asking the ITC to enjoin Roche’s further importation and future sale in the US of its European-produced EPO.
The ITC denied Amgen’s injunction request because (1) the ITC determined that Roche’s importation of EPO was protected by the FDA “safe harbor” provision of Section 271(e)(1), which provides that conduct cannot infringe a patent when it is reasonably related to securing FDA approval; and (2) the ITC has no jurisdiction absent a sale or contract for sale of EPO in the US. In a decision Wednesday, the Federal Circuit affirmed in part, reversed in part, and remanded the case to the ITC.
Amgen made three arguments on appeal: (1) Section 271(e)(1) provides no exemption for the importation of articles made overseas by patented processes in Section 337 actions before the ITC; (2) Section 271(e)(1) does not provide blanket protection for all pre-FDA-approval conduct; and (3) the ITC has jurisdiction whenever sale of the accused article is imminent. All three Federal Circuit panelists sided with Amgen on the second and third points. On the first point, however, Judges Newman and Lourie agreed with the ITC, while Judge Linn dissented to express his agreement with Amgen’s argument.
On Amgen’s first point, the majority accepted the ITC’s argument, i.e., that the Section 271(e)(1) safe harbor should operate identically in ITC litigation as in federal district court litigation. The importation of an article made by an infringing process constitutes an act of infringement under Section 271(g). But the safe harbor of Section 271(e)(1) holds that certain acts related to gaining regulatory approval are not acts of infringement. Therefore, 271(e)(1) cuts back on 271(g) by declaring that certain types of conduct do not constitute infringement. The ITC, however, does not look to Section 271(g) for its authority. Instead the ITC looks to 19 USC § 337(a)(1)(B)(ii), which declares unlawful the importation of any article “made . . . by means of a process covered by the claims of a valid and enforceable United States patent.” In contrast, Section 271(g) only forbids the importation of articles made by means of a process that infringes the claims of a valid and enforceable US patent. Because the safe harbor of Section 271(e)(1) only addresses infringement, Judge Linn (in dissent) argues that the safe harbor applies to infringement liability under Section 271(g) but not to unlawful trade practices under Section 337(a)(1)(B)(ii). The majority’s holding elects to gloss over these key differences between Section 271(g) and Section 337.
On the other hand, the majority’s holding probably does comport more closely with the policy rationales that support having the regulatory safe harbor. As the majority notes, the legislative history supports this proposition that the 271(e)(1) safe harbor applies identically to importation under Section 271(g) and to importation under Section 337(a)(1)(B)(ii). Moreover, the Supreme Court’s broad reading of the scope of the regulatory safe harbor in Integra v. Merck and Eli Lilly v. Medtronic lends further support for the majority’s policy judgment. Judge Linn even agrees that the majority reaches the policy outcome that makes the most sense. Nevertheless, the text of Section 337(a)(1)(B)(ii) is clearly at odds with such a policy outcome.
On Amgen’s second point, the Court agreed with Amgen. The safe harbor of Section 271(e)(1) does not provide blanket protection for all pre-FDA-approval conduct. For each separate act, the accused party must demonstrate that each act is reasonably related to gaining regulatory approval. Amgen asserted that Roche continued importing EPO after its FDA application was complete and used the imported EPO to conduct marketing studies. The Court remanded the case to the ITC for an act-by-act evaluation of whether Roche’s conduct was indeed within the ambit of Section 271(e)(1).
On Amgen’s third point, the Federal Circuit held that the ITC jurisdiction is invoked “[w]hen it has been shown that infringing acts are reasonably likely to occur . . . .” The court went to great lengths to point out that this standard is not new, and is, in fact, consistent with nearly three decades of ITC precedent. Because Section 337 provides for a prospective remedy, it makes no sense for the complainant to wait for an actual sale to occur, so long as an actual sale is imminent.
The link for decision is as follows: http://www.cafc.uscourts.gov/opinions/07-1014.pdf
(As per the article published on Orange book Blog)
Thursday, March 20, 2008
Happy Holi
Dear Subscribers and Viewers
I wish all of you a very Happy Holi. Holi is a festival of colors and I wish this festival will add colors to your life.
Thanks for your kind support.
Amit
I wish all of you a very Happy Holi. Holi is a festival of colors and I wish this festival will add colors to your life.
Thanks for your kind support.
Amit
Cephalon Receives FDA Approval for Treanda, a Novel Chemotherapy for Chronic Lymphocytic Leukemia
Cephalon, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved TREANDA(R) (bendamustine hydrochloride) for Injection for the treatment of patients with chronic lymphocytic leukemia (CLL), a slowly progressing blood and bone marrow disease. The American Cancer Society estimates that more than 15,000 new cases of this rare disease will be diagnosed in the United States this year. The TREANDA application as a CLL treatment received priority review from the FDA and was approved within six months of the September 2007 submission. Cephalon anticipates that TREANDA will be available to physicians and patients as a CLL treatment in the United States in April 2008.
Baxter Announces FDA Approval of ARTISS Slow-Setting Fibrin Sealant in Treatment of Burn Patients
Baxter Healthcare Corporation announced today the U.S. Food and Drug Administration (FDA) approval of ARTISS (Fibrin Sealant (Human)), the first and only slow-setting fibrin sealant indicated for use in adhering skin grafts in adult and pediatric burn patients. ARTISS was developed using Baxter's proven fibrin sealant technology platform and is the newest agent in the company's expanding BioSurgery portfolio.
ARTISS allows for the delayed setting and controlled manipulation of skin grafts for approximately 60 seconds, relative to rapid-setting fibrin sealants, which set in five to 10 seconds. Skin grafts can be fixed without the use of staples or sutures, which may help reduce post-operative complications and patient anxiety about pain during staple removal. Baxter will launch ARTISS at the American Burn Association (ABA) 40th Annual Meeting held April 29 -- May 2, 2008 in Chicago.
"ARTISS is a safe and effective alternative to staples, reducing discomfort among burn patients requiring skin grafts," said Ron Lloyd, general manager, BioSurgery. "This is another example of Baxter's scientific leadership in specialty biologic products, serving needs of patients and physicians."
The FDA approval is based on Phase III study results, which were also published in the March/April 2008 issue of The Journal of Burn Care and Research. The multi-center, prospective, randomized, controlled and blinded study compared the use of ARTISS to staples in 138 burn patients requiring skin grafting. ARTISS is safe and effective for attaching skin grafts with outcomes as good as staple fixation.
Frequent adverse events, seen in both treatment groups, included bleeding and fluid collection in the tissues, both of which are common during skin grafting procedures.
ARTISS is a biologically active sealant consisting of human fibrinogen and low concentration human thrombin. It will be available in two forms: a pre- filled syringe (frozen) formulation and a lyophilized form. Both dosage forms, once prepared and ready to use, can be sprayed, thus enabling application in a thin and even layer.
ARTISS allows for the delayed setting and controlled manipulation of skin grafts for approximately 60 seconds, relative to rapid-setting fibrin sealants, which set in five to 10 seconds. Skin grafts can be fixed without the use of staples or sutures, which may help reduce post-operative complications and patient anxiety about pain during staple removal. Baxter will launch ARTISS at the American Burn Association (ABA) 40th Annual Meeting held April 29 -- May 2, 2008 in Chicago.
"ARTISS is a safe and effective alternative to staples, reducing discomfort among burn patients requiring skin grafts," said Ron Lloyd, general manager, BioSurgery. "This is another example of Baxter's scientific leadership in specialty biologic products, serving needs of patients and physicians."
The FDA approval is based on Phase III study results, which were also published in the March/April 2008 issue of The Journal of Burn Care and Research. The multi-center, prospective, randomized, controlled and blinded study compared the use of ARTISS to staples in 138 burn patients requiring skin grafting. ARTISS is safe and effective for attaching skin grafts with outcomes as good as staple fixation.
Frequent adverse events, seen in both treatment groups, included bleeding and fluid collection in the tissues, both of which are common during skin grafting procedures.
ARTISS is a biologically active sealant consisting of human fibrinogen and low concentration human thrombin. It will be available in two forms: a pre- filled syringe (frozen) formulation and a lyophilized form. Both dosage forms, once prepared and ready to use, can be sprayed, thus enabling application in a thin and even layer.
Perrigo Company Announces Launch of Clobetasol Propionate Foam
Perrigo Company today announced that the United States District Court for the District of New Jersey has denied Connetics Corporation's motion for a preliminary injunction related to Perrigo's Clobetasol Propionate Foam, the AB-rated generic equivalent to Connetics' Olux(R) Foam and has lifted the temporary restraints that have prevented Perrigo from launching the product. The Court also denied Perrigo's motion for Summary Judgment based on non- infringement. The case will now proceed to trial with the trial date not having been set.
With the temporary restraints lifted, Perrigo has commenced launching the product. As the first filer, this commences its 180 days of generic exclusivity.
Perrigo's Chairman and CEO Joseph C. Papa stated, "We are excited about the launch of Clobetasol Foam, which reflects our on-going efforts to make quality healthcare more affordable for our customers."
Clobetasol Propionate Foam is a topical corticosteroid indicated for the treatment of moderate to severe dermatosis of the scalp. Sales for the brand, Olux(R) Foam, 0.05%, were approximately $85 million according to Wolters Kluwer data for the 12 months ending January 2008.
With the temporary restraints lifted, Perrigo has commenced launching the product. As the first filer, this commences its 180 days of generic exclusivity.
Perrigo's Chairman and CEO Joseph C. Papa stated, "We are excited about the launch of Clobetasol Foam, which reflects our on-going efforts to make quality healthcare more affordable for our customers."
Clobetasol Propionate Foam is a topical corticosteroid indicated for the treatment of moderate to severe dermatosis of the scalp. Sales for the brand, Olux(R) Foam, 0.05%, were approximately $85 million according to Wolters Kluwer data for the 12 months ending January 2008.
Wednesday, March 19, 2008
Arpida Submits New Drug Application for Intravenous Iclaprim for Treatment of Skin Infections
Arpida Ltd. today reported that it has submitted a New Drug Application (NDA) in an electronic format for intravenous iclaprim for the treatment of complicated Skin and Skin Structure Infections (cSSSI) to the US Food and Drug Administration (FDA). Arpida has requested a Priority designation for the review of the NDA. Iclaprim is a synthetic diaminopyrimidine which exhibits a rapidly bactericidal action against an extended spectrum of pathogens, including multidrug-resistant bacteria.
The iclaprim NDA contains data from 15 clinical studies, including two adequate and well-controlled multinational pivotal Phase III trials (ASSIST-1 and ASSIST-2, in which approximately 1,000 patients were enrolled and treated). Patients enrolled in both Phase III trials exhibited high incidences of methicillin-resistant Staphylococcus aureus (MRSA). In these two independent Phase III trials, intravenous iclaprim achieved the pre-specified primary endpoint. In the studies, iclaprim was well-tolerated with a safety profile which was compatible with treatment of patients with cSSSI.
Dr Paul Hadvary, Head of Development of Arpida Ltd., commented: "We are convinced that iclaprim - if approved - has the properties to become a successful drug in the hospital antibiotics market. In this market there is a clear need for novel therapies, as several of the currently available drugs are faced with reduced efficacy, emerging resistance or worrying side effects."
Dr Khalid Islam, President and CEO of Arpida Ltd. added: "We're very proud of reaching this important milestone. Arpida has successfully progressed iclaprim from an early preclinical stage all the way to regulatory filing. This achievement is a credit to our team at Arpida as well as to our external partners. We look forward to working closely with the FDA on their review of our submission."
In addition to the cSSSI indication, intravenous iclaprim is also being developed for the treatment of patients with hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP) or healthcare-associated pneumonia (HCAP) suspected or confirmed to be due to Gram-positive pathogens. This programme is currently in Phase II. Moreover, an oral formulation of iclaprim is currently in Phase II clinical trials as a potential step-down therapy following initial intravenous treatment.
The iclaprim NDA contains data from 15 clinical studies, including two adequate and well-controlled multinational pivotal Phase III trials (ASSIST-1 and ASSIST-2, in which approximately 1,000 patients were enrolled and treated). Patients enrolled in both Phase III trials exhibited high incidences of methicillin-resistant Staphylococcus aureus (MRSA). In these two independent Phase III trials, intravenous iclaprim achieved the pre-specified primary endpoint. In the studies, iclaprim was well-tolerated with a safety profile which was compatible with treatment of patients with cSSSI.
Dr Paul Hadvary, Head of Development of Arpida Ltd., commented: "We are convinced that iclaprim - if approved - has the properties to become a successful drug in the hospital antibiotics market. In this market there is a clear need for novel therapies, as several of the currently available drugs are faced with reduced efficacy, emerging resistance or worrying side effects."
Dr Khalid Islam, President and CEO of Arpida Ltd. added: "We're very proud of reaching this important milestone. Arpida has successfully progressed iclaprim from an early preclinical stage all the way to regulatory filing. This achievement is a credit to our team at Arpida as well as to our external partners. We look forward to working closely with the FDA on their review of our submission."
In addition to the cSSSI indication, intravenous iclaprim is also being developed for the treatment of patients with hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP) or healthcare-associated pneumonia (HCAP) suspected or confirmed to be due to Gram-positive pathogens. This programme is currently in Phase II. Moreover, an oral formulation of iclaprim is currently in Phase II clinical trials as a potential step-down therapy following initial intravenous treatment.
Sirtris Announces First U.S. Patent Issued On Class of SIRT1 Activators; Patent Covers First NCE to Enter Human Clinical Trials
March 19, 2008 - Sirtris Pharmaceuticals, Inc. (NASDAQ: SIRT), a biopharmaceutical company focused on discovering and developing small molecule drugs to treat diseases of aging such as Type 2 Diabetes, announced today that the United States Patent Office issued to Sirtris the first patent covering a broad class of compounds that activate the enzyme SIRT1. Several Sirtris compounds--or new chemical entities (NCEs)--from this class lower glucose and improve insulin sensitivity in preclinical models of Type 2 Diabetes. The patent covers the first NCE that Sirtris plans to take into a human clinical safety trial in the first half of 2008.
"Just five months ago in the publication Nature, we reported the identification of new chemical entities that lower glucose and improve insulin sensitivity in preclinical models that the FDA--in recent draft guidance--recommended for the development of Type 2 Diabetes drugs," says Christoph Westphal, M.D., Ph.D., Chief Executive Officer and Vice Chair of Sirtris Pharmaceuticals. "We are very pleased to have the first patent covering a class of compounds that have the potential to be a frontline therapy for Type 2 Diabetes."
"Sirtris has a strong intellectual property program with over 180 patent applications for broad coverage of sirtuin activators, including composition of matter, formulations, and methods of treatment claims," says Karl Normington, Ph.D., Senior Director of Intellectual Property at Sirtris Pharmaceuticals. "This is the first patent issued by the U.S. Patent Office covering a class of compounds known to activate SIRT1."
In 2006, consecutive papers in the journals Cell and Nature by Sirtris scientists and Sirtris co-founder David Sinclair, Ph.D. of Harvard Medical School, showed that resveratrol, a SIRT1 activator found in red wine, could reduce the impact of a high fat diet, increase stamina two fold and significantly extend lifespan of mice. However, it is estimated that a person would need to drink roughly 1000 bottles of red wine per day to obtain the equivalent dose of resveratrol used in these studies. Sirtris has developed SIRT1 activating molecules that are chemically distinct from, and up to 1000 times more potent in in-vitro studies than resveratrol.
The sirtuins are a family of seven enzymes that help regulate the body's natural defense against disease. In preclinical research, members of the sirtuin family have been shown to have protective effects against various diseases such as Type 2 Diabetes, metabolic diseases, cardiovascular disease, neurodegeneration, inflammation and cancer. Future sirtuin therapeutics may have the potential to treat diseases of aging in a new way.
"Just five months ago in the publication Nature, we reported the identification of new chemical entities that lower glucose and improve insulin sensitivity in preclinical models that the FDA--in recent draft guidance--recommended for the development of Type 2 Diabetes drugs," says Christoph Westphal, M.D., Ph.D., Chief Executive Officer and Vice Chair of Sirtris Pharmaceuticals. "We are very pleased to have the first patent covering a class of compounds that have the potential to be a frontline therapy for Type 2 Diabetes."
"Sirtris has a strong intellectual property program with over 180 patent applications for broad coverage of sirtuin activators, including composition of matter, formulations, and methods of treatment claims," says Karl Normington, Ph.D., Senior Director of Intellectual Property at Sirtris Pharmaceuticals. "This is the first patent issued by the U.S. Patent Office covering a class of compounds known to activate SIRT1."
In 2006, consecutive papers in the journals Cell and Nature by Sirtris scientists and Sirtris co-founder David Sinclair, Ph.D. of Harvard Medical School, showed that resveratrol, a SIRT1 activator found in red wine, could reduce the impact of a high fat diet, increase stamina two fold and significantly extend lifespan of mice. However, it is estimated that a person would need to drink roughly 1000 bottles of red wine per day to obtain the equivalent dose of resveratrol used in these studies. Sirtris has developed SIRT1 activating molecules that are chemically distinct from, and up to 1000 times more potent in in-vitro studies than resveratrol.
The sirtuins are a family of seven enzymes that help regulate the body's natural defense against disease. In preclinical research, members of the sirtuin family have been shown to have protective effects against various diseases such as Type 2 Diabetes, metabolic diseases, cardiovascular disease, neurodegeneration, inflammation and cancer. Future sirtuin therapeutics may have the potential to treat diseases of aging in a new way.
Sagent Pharmaceuticals Launches Ciprofloxacin Injection, USP, 5% Dextrose Premix Bag
March 19, 2008 /PRNewswire/ -- Sagent Pharmaceuticals, Inc., a privately-held specialty pharmaceutical company today announced that it has launched ciprofloxacin injection, USP, 5% dextrose premix bag, a synthetic broad spectrum antimicrobial agent for intravenous (I.V.) administration used to treat bacterial infections. Sagent's ciprofloxacin injection will be available immediately in 200mg and 400mg premix bags. According to IMS data, sales of injectable ciprofloxacin in the United States in 2006 were approximately $60 million.
"We are poised to be one of the first companies to make the I.V. form of this important antibiotic widely available to patients in the U.S.," said Jeffrey M. Yordon, chief executive officer, founder, and chairman of the board of Sagent. "The launch of our ciprofloxacin -- in ready-to-use, customer friendly, barcoded I.V. bags -- simultaneous with the expiry of the innovator's patent exclusivity further demonstrates Sagent's capabilities and expertise in injectable pharmaceutical products and our seasoned management team's commitment to the needs of patients and customers."
Ciprofloxacin is the third product introduced from Sagent's pipeline of more than 200 products since the launch of the company's first product, adenosine injection, USP, in December 2007. Earlier this month, the company launched another antibiotic, cefazolin for injection, USP, which is available in 1g single dose vials and 10g pharmacy bulk package vials.
"We are poised to be one of the first companies to make the I.V. form of this important antibiotic widely available to patients in the U.S.," said Jeffrey M. Yordon, chief executive officer, founder, and chairman of the board of Sagent. "The launch of our ciprofloxacin -- in ready-to-use, customer friendly, barcoded I.V. bags -- simultaneous with the expiry of the innovator's patent exclusivity further demonstrates Sagent's capabilities and expertise in injectable pharmaceutical products and our seasoned management team's commitment to the needs of patients and customers."
Ciprofloxacin is the third product introduced from Sagent's pipeline of more than 200 products since the launch of the company's first product, adenosine injection, USP, in December 2007. Earlier this month, the company launched another antibiotic, cefazolin for injection, USP, which is available in 1g single dose vials and 10g pharmacy bulk package vials.
Sun Pharmaceutical announces USFDA approval to market generic Cerebyx
March 19, 2008: Sun Pharmaceutical Industries Ltd. announced that USFDA has granted approval for the Abbreviated New Drug Application (ANDA) to market a generic version of Parke Davis’s Cerebyx®, fosphenytoin sodium injection.
This fosphenytoin sodium injection USP, 50 mg PE*/ mL, is therapeutically equivalent to Parke Davis’s Cerebyx®, and is available in two packs: 100 mg PE*/ 2 mL and 500 mg PE*/ 10 mL single dose vials. (PE*= Phenytoin sodium equivalents).
Fosphenytoin sodium injection has annual sales of approximately USD 15 million in the US.
Fosphenytoin sodium is used for the control of generalized convulsive status epilepticus as well as for prevention and treatment of seizures occurring during neurosurgery.
This fosphenytoin sodium injection USP, 50 mg PE*/ mL, is therapeutically equivalent to Parke Davis’s Cerebyx®, and is available in two packs: 100 mg PE*/ 2 mL and 500 mg PE*/ 10 mL single dose vials. (PE*= Phenytoin sodium equivalents).
Fosphenytoin sodium injection has annual sales of approximately USD 15 million in the US.
Fosphenytoin sodium is used for the control of generalized convulsive status epilepticus as well as for prevention and treatment of seizures occurring during neurosurgery.
Strides Arcolab receives its third injectable ANDA approval for Fosphenytoin Injection 50mg/mL
March 19, 2008-Strides Arcolab, one of India's largest exporters of branded generic pharmaceutical products, today announced its third ANDA approval for Fosphenytoin Injection 50mg/mL in 2 ml and 10ml vials.
The product is licensed to Akorn-Strides, LLC, which is a Joint Venture that was formed in 2004 by Akorn, Inc [NASDAQ: AKRX] and Strides Arcolab Limited [NSE: STAR, BSE: 532531]
Fosphenytoin is the third approval amongst 22 sterile submissions the Company has submitted with US FDA.
Mr.Arun Kumar - Vice Chairman and Group CEO of Strides Arcolab stated: "We are excited with our third sterile injecatable approval and are delighted having achieved a key milestone in creating a global sterile injectable business"
The product is licensed to Akorn-Strides, LLC, which is a Joint Venture that was formed in 2004 by Akorn, Inc [NASDAQ: AKRX] and Strides Arcolab Limited [NSE: STAR, BSE: 532531]
Fosphenytoin is the third approval amongst 22 sterile submissions the Company has submitted with US FDA.
Mr.Arun Kumar - Vice Chairman and Group CEO of Strides Arcolab stated: "We are excited with our third sterile injecatable approval and are delighted having achieved a key milestone in creating a global sterile injectable business"
Teva Introduces Ciprofloxacin Injection, USP (In 5% Dextrose)
March 18, 2008 – Teva Health Systems is pleased to announce the introduction and availability of Ciprofl oxacin Injection, USP (In 5% Dextrose). This product is AP rated to Cipro®* I.V. for Intravenous Infusion. Ciprofl oxacin Injection is available in 2 mg/mL, 200 mg and 2 mg/mL, 400 mg in fl exible plastic containers.
“Teva offers a broad range of quality health systems generics from a single source,” states Jonathan Zalk, Director of Marketing. “We are pleased to announce this latest addition to our growing line.”
Teva Health Systems is a part of Teva Pharmaceuticals, the leading pharmaceutical manufacturer for both new and total prescriptions.‡ The company has an aggressive Research and Development effort and one of the best overall ANDA approval records in the industry.
“Teva offers a broad range of quality health systems generics from a single source,” states Jonathan Zalk, Director of Marketing. “We are pleased to announce this latest addition to our growing line.”
Teva Health Systems is a part of Teva Pharmaceuticals, the leading pharmaceutical manufacturer for both new and total prescriptions.‡ The company has an aggressive Research and Development effort and one of the best overall ANDA approval records in the industry.
Immunomedics' Milatuzumab Receives FDA Orphan Drug Designation for Therapy of Multiple Myeloma
March 18, 2008 (PRIME NEWSWIRE) -- Immunomedics, Inc., (Nasdaq:IMMU), a biopharmaceutical company focused on developing monoclonal antibodies to treat cancer and other serious diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to milatuzumab for the treatment of multiple myeloma.
The designation allows the Company to have a seven-year market exclusivity for milatuzumab in multiple myeloma upon final approval by the FDA. Other financial benefits and incentives include waiver of Prescription Drug User Fee Act (PDUFA) filing fees, tax credits for the costs of clinical research, and assistance in clinical research study designs.
"We are pleased to receive Orphan Drug designation for milatuzumab. Preclinical studies by us and other scientists have shown that milatuzumab inhibits the growth of human multiple myeloma and lymphoma cells in culture and in mouse models, and blocks the over-expression of CD74 in chronic lymphocytic leukemia cells, which leads to increased cell death. We have initiated Phase I/II studies to evaluate the therapeutic potential of milatuzumab in patients with multiple myeloma, non-Hodgkin's lymphoma (NHL) and chronic lymphocytic leukemia (CLL)," commented Cynthia L. Sullivan, President and CEO.
In addition, John P Leonard, MD, Professor of Medicine at Weill Medical College of Cornell University, is conducting a Phase I study in patients with recurrent NHL or CLL funded in part by a grant from the National Cancer Institute.
The designation allows the Company to have a seven-year market exclusivity for milatuzumab in multiple myeloma upon final approval by the FDA. Other financial benefits and incentives include waiver of Prescription Drug User Fee Act (PDUFA) filing fees, tax credits for the costs of clinical research, and assistance in clinical research study designs.
"We are pleased to receive Orphan Drug designation for milatuzumab. Preclinical studies by us and other scientists have shown that milatuzumab inhibits the growth of human multiple myeloma and lymphoma cells in culture and in mouse models, and blocks the over-expression of CD74 in chronic lymphocytic leukemia cells, which leads to increased cell death. We have initiated Phase I/II studies to evaluate the therapeutic potential of milatuzumab in patients with multiple myeloma, non-Hodgkin's lymphoma (NHL) and chronic lymphocytic leukemia (CLL)," commented Cynthia L. Sullivan, President and CEO.
In addition, John P Leonard, MD, Professor of Medicine at Weill Medical College of Cornell University, is conducting a Phase I study in patients with recurrent NHL or CLL funded in part by a grant from the National Cancer Institute.
FDA Issues Approvable Letter for Ceftobiprole for Treatment of Complicated Skin Infections
March 18, 2008 /PRNewswire/ -- Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD), today announced that it received an approvable letter from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for ceftobiprole for the treatment of complicated skin and skin structure infections, including diabetic foot infections.
J&JPRD, along with its co-development partner, Swiss-based Basilea Pharmaceutica Ltd., is reviewing the agency's letter and will work quickly to resolve any outstanding issues. The NDA for ceftobiprole was submitted to the FDA last May.
An application for the use of ceftobiprole in adults in the same indication is currently under regulatory review in Europe, Australia, Canada and in other countries.
J&JPRD, along with its co-development partner, Swiss-based Basilea Pharmaceutica Ltd., is reviewing the agency's letter and will work quickly to resolve any outstanding issues. The NDA for ceftobiprole was submitted to the FDA last May.
An application for the use of ceftobiprole in adults in the same indication is currently under regulatory review in Europe, Australia, Canada and in other countries.
Centocor, Inc. and Schering-Plough Submit Application Requesting Approval of Golimumab in Europe
March 18, 2008 /PRNewswire/ -- Centocor, Inc. and Schering-Plough Corporation announced today that a Marketing Authorization Application (MAA) has been submitted to the European Medicines Agency (EMEA) requesting the approval of golimumab (CNTO 148) as a monthly subcutaneous treatment for adults with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. The initial submission and Phase 3 development programs are unprecedented among anti-tumor necrosis factor (TNF)- alpha therapies, as they mark the first time that an MAA has been proposed for review inclusive of three unique disease states. Golimumab, Centocor's and Schering-Plough's next-generation human anti-TNF-alpha monoclonal antibody, is being studied as an every four week subcutaneous injection and an intravenous (IV) infusion therapy. Pending regulatory approval in the European Union, Schering-Plough Corporation will assume exclusive marketing rights for golimumab in Europe.
"We look forward to working with the EMEA so that patients and physicians might one day have the opportunity to experience golimumab as a therapeutic option for rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis," said Jerome A. Boscia, M.D., senior vice president, Clinical Research and Development, Centocor, Inc. "We remain focused and on track for global regulatory submissions for golimumab targeted for the first half of 2008."
Phase 3 primary endpoint study findings from the Golimumab - A Randomized Evaluation of Safety and Efficacy in Subjects with Psoriatic Arthritis Using a Human Anti-TNF Monoclonal Antibody (GO-REVEAL) trial and the Golimumab - A Randomized Study in Ankylosing Spondylitis Subjects of a Novel Anti-TNF mAB Injection (SC) Given Every Four Weeks (GO-RAISE) trial were reported at the of Rheumatology Annual Scientific Meeting in November 2007. Phase 3 study findings evaluating the efficacy and safety of golimumab in the treatment of more than 1,400 adults with moderate to severe rheumatoid arthritis will be presented at the European League Against Rheumatism Annual Congress in June 2008.
"We look forward to working with the EMEA so that patients and physicians might one day have the opportunity to experience golimumab as a therapeutic option for rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis," said Jerome A. Boscia, M.D., senior vice president, Clinical Research and Development, Centocor, Inc. "We remain focused and on track for global regulatory submissions for golimumab targeted for the first half of 2008."
Phase 3 primary endpoint study findings from the Golimumab - A Randomized Evaluation of Safety and Efficacy in Subjects with Psoriatic Arthritis Using a Human Anti-TNF Monoclonal Antibody (GO-REVEAL) trial and the Golimumab - A Randomized Study in Ankylosing Spondylitis Subjects of a Novel Anti-TNF mAB Injection (SC) Given Every Four Weeks (GO-RAISE) trial were reported at the of Rheumatology Annual Scientific Meeting in November 2007. Phase 3 study findings evaluating the efficacy and safety of golimumab in the treatment of more than 1,400 adults with moderate to severe rheumatoid arthritis will be presented at the European League Against Rheumatism Annual Congress in June 2008.
OSI Pharmaceuticals Announces That the Prior Revocation of Its European DP-IV Patent Has Been Upheld
Mar 18, 2008 - OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) announced today that the decision of the European Patent Office (EPO) to revoke one of the Company's dipeptidyl peptidase IV (DP-IV) patents, EP0896538, claiming the use of DP-IV inhibitors to treat type II diabetes and related indications, has been upheld in appeal proceedings brought by the Company.
"We are disappointed with the outcome of the appeal proceedings. However, since the revocation applies to only one patent within our licensed DP-IV patent portfolio, any short-term loss in royalty revenue in Europe should be mitigated as additional licensed patents within the portfolio progress through the EPO examination procedure to grant," stated Anker Lundemose, M.D., Ph.D., President of (OSI) Prosidion. "The Company's DP-IV patent estate includes licensed rights to patents and patent applications claiming combinations of DP-IV inhibitors with other oral anti-diabetes drugs such as metformin."
"The Company anticipates that the vast majority of DP-IV sales in 2008 and 2009 are likely to take place in the US, therefore the financial implications of losing this patent in Europe are relatively insignificant and do not impact our prior DP-IV revenue guidance for 2008," stated Michael G. Atieh, Executive Vice President and Chief Financial Officer.
Background
OSI through its U.K. subsidiary, Prosidion Limited, owns or has licensing rights to issued and pending patents and patent applications with claims covering DP-IV as a target for anti-diabetes therapy and related indications. The patents which are subject of these DP-IV licenses will expire between 2017 and 2019. Thirteen pharmaceutical companies, including Merck & Co., Inc., Novartis AG and Bristol-Myers Squibb Company have taken licenses to this patent estate.
"We are disappointed with the outcome of the appeal proceedings. However, since the revocation applies to only one patent within our licensed DP-IV patent portfolio, any short-term loss in royalty revenue in Europe should be mitigated as additional licensed patents within the portfolio progress through the EPO examination procedure to grant," stated Anker Lundemose, M.D., Ph.D., President of (OSI) Prosidion. "The Company's DP-IV patent estate includes licensed rights to patents and patent applications claiming combinations of DP-IV inhibitors with other oral anti-diabetes drugs such as metformin."
"The Company anticipates that the vast majority of DP-IV sales in 2008 and 2009 are likely to take place in the US, therefore the financial implications of losing this patent in Europe are relatively insignificant and do not impact our prior DP-IV revenue guidance for 2008," stated Michael G. Atieh, Executive Vice President and Chief Financial Officer.
Background
OSI through its U.K. subsidiary, Prosidion Limited, owns or has licensing rights to issued and pending patents and patent applications with claims covering DP-IV as a target for anti-diabetes therapy and related indications. The patents which are subject of these DP-IV licenses will expire between 2017 and 2019. Thirteen pharmaceutical companies, including Merck & Co., Inc., Novartis AG and Bristol-Myers Squibb Company have taken licenses to this patent estate.
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