NOVATO, Calif., December 18, 2007 /PRNewswire-FirstCall/ -- BioMarin Pharmaceutical Inc. announced today that it has re-acquired the Canadian rights for tetrahydrobiopterin (BH4), including Kuvan(TM) (sapropterin dihydrochloride), from Merck Serono, a division of Merck KGaA, Darmstadt, Germany. Kuvan is an oral small molecule for the treatment of phenylketonuria (PKU) developed in partnership with Merck Serono. Based on published literature, there are approximately 1,200 to 1,500 people under the age of 40 with PKU in Canada
Acquiring rights to Kuvan in Canada allows BioMarin to better coordinate commercialization efforts in the North American market," said Stephen Aselage, Senior Vice President, Global Commercial Development of BioMarin. "This agreement with Merck Serono comes at an exciting time for the company and the PKU community after Kuvan was approved in the United States last week."
The terms of the agreement specify a reduction in royalties owed to BioMarin on Merck Serono sales outside the United States and Japan. Based on the structure of the amended agreement, the reduction in royalties cannot exceed an undisclosed cap.
Tuesday, December 18, 2007
Endo and Penwest Receive New Paragraph IV Certification Notice From Impax for Opana ER
CHADDS FORD, PA and DANBURY, CT, Dec 17, 2007 (MARKET WIRE via COMTEX News Network) -- Endo Pharmaceuticals Holdings Inc. (NASDAQ: ENDP) and Penwest Pharmaceuticals Co. (NASDAQ: PPCO) announced today that on December 14, 2007, they received a notice from IMPAX Laboratories, Inc. advising of the FDA's acceptance for substantive review, as of November 23, 2007, of IMPAX's Abbreviated New Drug Application (ANDA) containing a new Paragraph IV certification under 21 U.S.C. Section 355(j) for oxymorphone hydrochloride extended-release tablets CII. IMPAX stated in its letter that the FDA requested IMPAX to provide notification to Endo and Penwest of this certification. This Paragraph IV certification notice refers to Penwest's U.S. Patent Nos. 7,276,250, 5,958,456 and 5,662,933, which cover the formulation of OPANA(R) ER. These patents are listed in the FDA's Orange Book and expire in 2022, 2013 and 2013, respectively. In addition to these patents, OPANA ER has a new dosage form (NDA) exclusivity that prevents final approval of any ANDA by the FDA until the exclusivity expires on June 22, 2009.
Endo and Penwest are currently reviewing the details of this new notice from IMPAX and will continue to pursue all available legal and regulatory avenues in defense of OPANA ER, including enforcement of their intellectual property rights and approved labeling.
Endo and Penwest are currently reviewing the details of this new notice from IMPAX and will continue to pursue all available legal and regulatory avenues in defense of OPANA ER, including enforcement of their intellectual property rights and approved labeling.
Eli Lilly Joins Glaxo, Withdraws Application for Osteoporosis Drug
Eli Lilly & Co. has voluntarily withdrawn its Application No. IN/PCT/00/00118 filed July 05, 2000 at Kolkata Patent Office for a stable crystalline form of osteoporosis drug Teriparatide (rDNA origin), globally marketed as Forteo with worldwide annual sales of US $ 600 million. According to the Patent Office, Lilly has withdrawn its application under section 11B (4) of the Patents Act, 1970. The Application claims earliest priority from US provisional application No. 60/069,875 filed December 18, 1997 against which US Patent No. 6,590,081 is issued on July 08, 2003. Earlier in August 2007, Kolkata Patent Office rejected Lilly’s Application for same drug following a pre-grant opposition from a Mumbai-based generic drug manufacturer USV Ltd. The rejection was made on the grounds of prior knowledge, incremental innovation and failure to establish enhancement of known efficacy. Teriparatide is a parathyroid hormone (PTH (1-34) (SEQ. ID NO:2)), a secreted 84-amino acid product of the mammalian parathyroid gland that controls serum calcium levels through its action on various tissues, including bone. Although not very sure about the Application number which got rejected by the Patent Office, but I guess it would be the Application No. IN/PCT/00/00119 filed July 26, 2000 for stabilized parenteral composition of Teriparatide (rDNA origin) claiming earliest priority from US provisional application No. 60/069,075 filed December 09, 1997 against which Orange Book listed US Patent Nos. 6,770,623 and 7,144,861 are issued. There is one more Application No. IN/PCT/00/00336 filed January 09, 2003 which is pending with the Patent Office which claims earliest priority from US provisional application Nos. 60/097,151 and 60/099, 746 filed November 08, 1998 and October 09, 1998 respectively and against which Orange Book listed US Patent Nos. 6,977,077 and 7,163,684 are issued. The Application IN/PCT/00/00336 seems to cover a method for increasing the toughness and/or stiffness of bone and/or reducing the likelihood and/or severity of bone fracture using Teriparatide, which is unlikely to receive a patent in India, as indication and method of treatment are excluded from patentability under section 3(e) of the Patents Act, 1970. So, most likely either Lilly will too withdraw the third application or it would be humbly rejected by the Patent Office.
Monday, December 17, 2007
Patent experts call for Brazilian model of patenting in India
Patent experts have called for a Brazilian model of patenting in India especially in area of examining the relevance of patent applications, to avoid the apathetic approach towards this issue and to limit the controversies to the least possible levels.
The experts noted that the Brazil model where a group of ministers was dealing with all patent-related matters could be effective in a country like India where over 80,000 patent applications are still pending.
The suggestion came from international expert on intellectual property Prof. Carlos M Correa of University of Buenos Aires and Dr Amit Sengupta of People's Health Movement, at a lecture organized by the Campaign for Access to Essential Medicines and the Medecins Sans Frontiers, here recently.
Dr Correa said that there was a big debate on the relevance of patent applications in India and called for more clarity on discovery and invention. He said some organizations applied for the patent registration with some discovery, but claiming it as an invention.
"There should be a standard classification for discovery and invention. If someone is discovering a particular thing that has existed but was not focused, it should not be considered as an invention," he said.
"Genes need not be a part of invention and the patent should not be allowed for their applications. Besides this, microorganisms, plants, computer programmes, business methods etc. should also not be brought into patent jurisdiction,'' the renowned lawyer said.
"A new device to be patented must reveal a flash of creative genius", he said about the invention. There were plenty of `fake' applications seeking to obtain patent but such products are already patented and owned by some other companies, especially in the pharmaceutical and biotechnological field", he added.
He also revealed that there was also a controversy over the subject of patent, that argued whether the applications for having a patent only with some minor changes in component of a particular medicine with no change in medication, should be allowed or not.
He claimed that the WTO was also taking interests in setting up the patent offices in developing countries just to prevent their right especially in case of generic medicines.
He said that in India, patent law had provided flexibility for the Indian companies especially to the generic makers. He appreciated the role of NGOs in India as well as in some of the other developing countries and said they had done remarkable work. "NGOs are playing a big role in some countries including India to challenge the patent law. In India they have done a history making work by fighting Novartis,'' he said.
Dr Amit Sengupta said that India should follow the Brazilian format where a group of ministers used to disclose the applications and deeply examine them.
The experts noted that the Brazil model where a group of ministers was dealing with all patent-related matters could be effective in a country like India where over 80,000 patent applications are still pending.
The suggestion came from international expert on intellectual property Prof. Carlos M Correa of University of Buenos Aires and Dr Amit Sengupta of People's Health Movement, at a lecture organized by the Campaign for Access to Essential Medicines and the Medecins Sans Frontiers, here recently.
Dr Correa said that there was a big debate on the relevance of patent applications in India and called for more clarity on discovery and invention. He said some organizations applied for the patent registration with some discovery, but claiming it as an invention.
"There should be a standard classification for discovery and invention. If someone is discovering a particular thing that has existed but was not focused, it should not be considered as an invention," he said.
"Genes need not be a part of invention and the patent should not be allowed for their applications. Besides this, microorganisms, plants, computer programmes, business methods etc. should also not be brought into patent jurisdiction,'' the renowned lawyer said.
"A new device to be patented must reveal a flash of creative genius", he said about the invention. There were plenty of `fake' applications seeking to obtain patent but such products are already patented and owned by some other companies, especially in the pharmaceutical and biotechnological field", he added.
He also revealed that there was also a controversy over the subject of patent, that argued whether the applications for having a patent only with some minor changes in component of a particular medicine with no change in medication, should be allowed or not.
He claimed that the WTO was also taking interests in setting up the patent offices in developing countries just to prevent their right especially in case of generic medicines.
He said that in India, patent law had provided flexibility for the Indian companies especially to the generic makers. He appreciated the role of NGOs in India as well as in some of the other developing countries and said they had done remarkable work. "NGOs are playing a big role in some countries including India to challenge the patent law. In India they have done a history making work by fighting Novartis,'' he said.
Dr Amit Sengupta said that India should follow the Brazilian format where a group of ministers used to disclose the applications and deeply examine them.
GlaxoSmithKline Receives FDA ‘Complete Response’ Letter for Cervical Cancer Vaccine
LONDON, PHILADELPHIA, Dec. 17, 2007-GlaxoSmithKline (NYSE: GSK) announced today that it has received a complete response letter from the U.S. Food and Drug Administration related to its application for the cervical cancer vaccine, CERVARIX
A complete response letter is issued by FDA’s Center for Biologics Evaluation and Research (CBER) when the review of a file is completed and questions remain to be answered prior to approval. GSK will work closely with the FDA to prepare its response, which it intends to submit to the agency as soon as possible.
"We have already started addressing the questions and will be engaged in discussions with the FDA to finalize our responses,”said Barbara Howe, M.D., Vice President and Director, North American Vaccine Development, GlaxoSmithKline. "Our discussions with the agency continue to be positive and constructive, and we are working diligently to resolve any outstanding questions to bring CERVARIX®to the U.S.market.”
The application filed for the GSK cervical cancer vaccine included safety, efficacy and immune response data from clinical trials involving almost 30,000 females 10 to 55 years of age from ethnically and racially diverse populations.
To date, CERVARIX® has been approved in 45 countries around the world including the 27 member countries of the European Union, Mexico, Australia, Singaporeand the Philippines. Licensing applications have been submitted in more than 27 additional countries including Japan. GSK also submitted CERVARIX®to the World Health Organization (WHO) for prequalification in September 2007.
A complete response letter is issued by FDA’s Center for Biologics Evaluation and Research (CBER) when the review of a file is completed and questions remain to be answered prior to approval. GSK will work closely with the FDA to prepare its response, which it intends to submit to the agency as soon as possible.
"We have already started addressing the questions and will be engaged in discussions with the FDA to finalize our responses,”said Barbara Howe, M.D., Vice President and Director, North American Vaccine Development, GlaxoSmithKline. "Our discussions with the agency continue to be positive and constructive, and we are working diligently to resolve any outstanding questions to bring CERVARIX®to the U.S.market.”
The application filed for the GSK cervical cancer vaccine included safety, efficacy and immune response data from clinical trials involving almost 30,000 females 10 to 55 years of age from ethnically and racially diverse populations.
To date, CERVARIX® has been approved in 45 countries around the world including the 27 member countries of the European Union, Mexico, Australia, Singaporeand the Philippines. Licensing applications have been submitted in more than 27 additional countries including Japan. GSK also submitted CERVARIX®to the World Health Organization (WHO) for prequalification in September 2007.
MGI Pharma Announces Aquavan NDA Accepted for Review by U.S. FDA
MINNEAPOLIS--(BUSINESS WIRE)--Dec 17, 2007 - MGI PHARMA, INC. (Nasdaq:MOGN), a biopharmaceutical company focused in oncology and acute care today announced that the New Drug Application (NDA) for Aquavan(R) (fospropofol disodium) Injection was accepted for filing by the United States Food and Drug Administration (FDA). Aquavan is an investigational drug that is being studied as a sedative-hypnotic agent in patients undergoing diagnostic or therapeutic procedures.
The NDA for Aquavan was submitted to the FDA on September 27, 2007. The acceptance for review of the NDA represents the FDA's determination that the application is sufficiently complete to permit a substantive review of the data. The filing of the application by the FDA does not represent any opinion regarding the safety, efficacy or approvability of Aquavan Injection. Under PDUFA (Prescription Drug User Fee Act) III, the FDA's goal is to review and act on the NDA by July 26, 2008.
Data from phase 2 and phase 3 trials in patients undergoing colonoscopy, a phase 3 trial in patients undergoing bronchoscopy, and an open label study in patients undergoing a variety of minor surgical procedures form the foundation of the Aquavan NDA. In total, data from 21 clinical studies, including 1,611 subjects are included in the application.
About Aquavan(R) (fospropofol disodium) Injection
Aquavan(R) (fospropofol disodium) Injection, a proprietary water-soluble prodrug of propofol that, after intravenous injection, is rapidly converted by an enzyme (alkaline phosphatase) in the body into propofol, is a product candidate in development for sedation of patients undergoing diagnostic or therapeutic procedures. Aquavan has not been approved for marketing by the U.S. Food and Drug Administration (U.S. FDA) or any other regulatory agencies.
The NDA for Aquavan was submitted to the FDA on September 27, 2007. The acceptance for review of the NDA represents the FDA's determination that the application is sufficiently complete to permit a substantive review of the data. The filing of the application by the FDA does not represent any opinion regarding the safety, efficacy or approvability of Aquavan Injection. Under PDUFA (Prescription Drug User Fee Act) III, the FDA's goal is to review and act on the NDA by July 26, 2008.
Data from phase 2 and phase 3 trials in patients undergoing colonoscopy, a phase 3 trial in patients undergoing bronchoscopy, and an open label study in patients undergoing a variety of minor surgical procedures form the foundation of the Aquavan NDA. In total, data from 21 clinical studies, including 1,611 subjects are included in the application.
About Aquavan(R) (fospropofol disodium) Injection
Aquavan(R) (fospropofol disodium) Injection, a proprietary water-soluble prodrug of propofol that, after intravenous injection, is rapidly converted by an enzyme (alkaline phosphatase) in the body into propofol, is a product candidate in development for sedation of patients undergoing diagnostic or therapeutic procedures. Aquavan has not been approved for marketing by the U.S. Food and Drug Administration (U.S. FDA) or any other regulatory agencies.
Genzyme Announces FDA Approval of Thyrogen for Use in Thyroid Cancer Ablation
CAMBRIDGE, Mass., December 17, 2007 /PRNewswire-FirstCall/ -- Genzyme Corp. announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental indication for Thyrogen(R) (thyrotropin alfa for injection) to be used in combination with radioiodine to ablate, or destroy, the remaining thyroid tissue in patients who have had their cancerous thyroids removed. Remnant ablation is a procedure that patients commonly undergo when being treated for thyroid cancer.
"This new indication extends the significant benefits of Thyrogen to patients during their initial treatment for thyroid cancer, in addition to its current use in follow-up diagnostic procedures to detect recurrence," said Mike Heslop, senior vice president and general manager of Genzyme's endocrine business. "This is an important milestone in our ongoing effort to expand the clinical applications of Thyrogen to improve patient care."
The American Cancer Society estimates that in 2007, about 33,550 new cases of thyroid cancer will be diagnosed in the United States. Approximately 90 percent of all thyroid cancers are well-differentiated, making those patients candidates for the remnant ablation procedure.
"The development of new treatment options for thyroid cancer patients is critical, as this disease has the fastest rising incidence of all cancers among women in the U.S.," said clinical investigator Paul Ladenson, M.D., professor and director of endocrinology at The Johns Hopkins University School of Medicine. "The availability of Thyrogen for use in remnant ablation is a notable advance, as it permits patients to maintain a good quality of life during the course of their thyroid cancer treatment and follow-up testing."
Thyrogen was initially approved in the U.S. in 1998 and Europe in 2001 for use as a diagnostic tool in the management of patients being tested for the recurrence of well-differentiated thyroid cancer. The product helps increase the sensitivity of testing while allowing patients to avoid the potentially debilitating symptoms of thyroid hormone withdrawal. Genzyme received additional European approval for Thyrogen's use during remnant ablation procedures in 2005.
Thyrogen Use in Ablation
The new indication allows Thyrogen to be used in conjunction with radioiodine for the most common approach to treating thyroid cancer. This includes surgical removal of the cancerous thyroid followed by remnant ablation, which destroys any remaining thyroid tissue. This can help reduce the risk of disease recurrence and facilitate follow-up monitoring.
In remnant ablation, patients take a drink or a capsule that contains radioactive iodine, which is taken up by any remaining thyroid cells. To enhance the uptake of radioiodine, the level of thyroid stimulating hormone (TSH) in a patient's bloodstream must be enhanced. Patients currently stop taking thyroid hormone supplements to elevate TSH levels. Doing so, however, often causes side effects associated with hypothyroidism, which may include fatigue, difficulty concentrating, short-term memory impairment and depression. Thyrogen is a recombinant form of TSH that is administered by injection, allowing patients to continue taking hormone supplements and avoid the symptoms associated with hormone withdrawal.
The FDA approved Thyrogen for remnant ablation based on results from a pivotal clinical study which suggest that treatment with Thyrogen is similar to withdrawal from thyroid hormone in achieving ablation, and that it could significantly reduce the side effects of thyroid hormone withdrawal by allowing patients to remain on hormone replacement therapy.
Most cases of thyroid cancer are discovered during a routine physical examination when a painless lump is found in the thyroid. It is three times more common in women than in men. Although well-differentiated thyroid cancer is very treatable, ongoing monitoring is important as the disease can recur in up to 30 percent of patients.
"This new indication extends the significant benefits of Thyrogen to patients during their initial treatment for thyroid cancer, in addition to its current use in follow-up diagnostic procedures to detect recurrence," said Mike Heslop, senior vice president and general manager of Genzyme's endocrine business. "This is an important milestone in our ongoing effort to expand the clinical applications of Thyrogen to improve patient care."
The American Cancer Society estimates that in 2007, about 33,550 new cases of thyroid cancer will be diagnosed in the United States. Approximately 90 percent of all thyroid cancers are well-differentiated, making those patients candidates for the remnant ablation procedure.
"The development of new treatment options for thyroid cancer patients is critical, as this disease has the fastest rising incidence of all cancers among women in the U.S.," said clinical investigator Paul Ladenson, M.D., professor and director of endocrinology at The Johns Hopkins University School of Medicine. "The availability of Thyrogen for use in remnant ablation is a notable advance, as it permits patients to maintain a good quality of life during the course of their thyroid cancer treatment and follow-up testing."
Thyrogen was initially approved in the U.S. in 1998 and Europe in 2001 for use as a diagnostic tool in the management of patients being tested for the recurrence of well-differentiated thyroid cancer. The product helps increase the sensitivity of testing while allowing patients to avoid the potentially debilitating symptoms of thyroid hormone withdrawal. Genzyme received additional European approval for Thyrogen's use during remnant ablation procedures in 2005.
Thyrogen Use in Ablation
The new indication allows Thyrogen to be used in conjunction with radioiodine for the most common approach to treating thyroid cancer. This includes surgical removal of the cancerous thyroid followed by remnant ablation, which destroys any remaining thyroid tissue. This can help reduce the risk of disease recurrence and facilitate follow-up monitoring.
In remnant ablation, patients take a drink or a capsule that contains radioactive iodine, which is taken up by any remaining thyroid cells. To enhance the uptake of radioiodine, the level of thyroid stimulating hormone (TSH) in a patient's bloodstream must be enhanced. Patients currently stop taking thyroid hormone supplements to elevate TSH levels. Doing so, however, often causes side effects associated with hypothyroidism, which may include fatigue, difficulty concentrating, short-term memory impairment and depression. Thyrogen is a recombinant form of TSH that is administered by injection, allowing patients to continue taking hormone supplements and avoid the symptoms associated with hormone withdrawal.
The FDA approved Thyrogen for remnant ablation based on results from a pivotal clinical study which suggest that treatment with Thyrogen is similar to withdrawal from thyroid hormone in achieving ablation, and that it could significantly reduce the side effects of thyroid hormone withdrawal by allowing patients to remain on hormone replacement therapy.
Most cases of thyroid cancer are discovered during a routine physical examination when a painless lump is found in the thyroid. It is three times more common in women than in men. Although well-differentiated thyroid cancer is very treatable, ongoing monitoring is important as the disease can recur in up to 30 percent of patients.
IMPAX Announces FDA Acceptance of ANDA for Generic Version of Opana ER
HAYWARD, Calif.--(BUSINESS WIRE)--Dec 17, 2007 - IMPAX Laboratories, Inc. (OTC:IPXL) today announced that its Abbreviated New Drug Application (ANDA) for oxymorphone hydrochloride extended-release tablets CII, a generic version of Opana(R) ER, has been deemed acceptable for filing by the U. S. Food and Drug Administration (FDA) as of November 23, 2007. Despite the acceptance, the Company continues to believe that its ANDA as originally filed met all the requirements for acceptance and thus will continue to pursue its administrative remedies with the FDA to reinstate its original filing date of June 29, 2007.
"We also intend to continue to vigorously defend the ongoing patent litigation as previously announced with Endo and Penwest and look forward to prevailing and bringing this important generic product to market," said Larry Hsu, Ph.D., IMPAX's president and chief executive officer.
"We also intend to continue to vigorously defend the ongoing patent litigation as previously announced with Endo and Penwest and look forward to prevailing and bringing this important generic product to market," said Larry Hsu, Ph.D., IMPAX's president and chief executive officer.
Sunday, December 16, 2007
US panel rejects Merck's bid to sell cholesterol drug Mevacor as OTC drug
Merck & Co., Inc. said certain US advisory panels urged the US Food and Drug Administration (FDA) to reject Merck's request to sell its cholesterol lowering drug Mevacor over the counter.
Mevacor is a prescription medicine that is approved in the US for the treatment of elevated cholesterol levels that lifestyle changes alone cannot control and to reduce the risk of a first heart attack, unstable angina and coronary revascularisation procedures in healthy men and women with average or moderately elevated cholesterol levels.
The joint panel of the Nonprescription Drugs Advisory Committee (NDAC) and the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted against recommending approval of the over-the-counter (OTC) use of Mevacor (lovastatin) 20 mg to help lower LDL cholesterol which may prevent a first heart attack.
"We are disappointed in today's outcome. We felt we presented a compelling case to the committee that non-prescription Mevacor 20 mg would be a valuable option for motivated consumers who know they have moderately elevated cholesterol and certain risk factors, and are already talking with their healthcare provider," said Edwin L. Hemwall, PhD, vice president, Global OTC Regulatory and Scientific Affairs.
The FDA is not bound by the committee's recommendation, but takes its advice into consideration. The anticipated action date by the FDA is Jan. 26, 2008.
According to the prescribing information, Mevacor should not be used by anyone allergic to any of its components, people with liver disease, or by women who are pregnant, breast-feeding, or likely to become pregnant.
Muscle pain or weakness in patients taking prescription Mevacor could be signs of a serious side effect. The most common adverse events reported with Mevacor 20 mg taken once daily were diarrhoea, flatulence, headache and myalgia.
Mevacor is a prescription medicine that is approved in the US for the treatment of elevated cholesterol levels that lifestyle changes alone cannot control and to reduce the risk of a first heart attack, unstable angina and coronary revascularisation procedures in healthy men and women with average or moderately elevated cholesterol levels.
The joint panel of the Nonprescription Drugs Advisory Committee (NDAC) and the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted against recommending approval of the over-the-counter (OTC) use of Mevacor (lovastatin) 20 mg to help lower LDL cholesterol which may prevent a first heart attack.
"We are disappointed in today's outcome. We felt we presented a compelling case to the committee that non-prescription Mevacor 20 mg would be a valuable option for motivated consumers who know they have moderately elevated cholesterol and certain risk factors, and are already talking with their healthcare provider," said Edwin L. Hemwall, PhD, vice president, Global OTC Regulatory and Scientific Affairs.
The FDA is not bound by the committee's recommendation, but takes its advice into consideration. The anticipated action date by the FDA is Jan. 26, 2008.
According to the prescribing information, Mevacor should not be used by anyone allergic to any of its components, people with liver disease, or by women who are pregnant, breast-feeding, or likely to become pregnant.
Muscle pain or weakness in patients taking prescription Mevacor could be signs of a serious side effect. The most common adverse events reported with Mevacor 20 mg taken once daily were diarrhoea, flatulence, headache and myalgia.
FDA Sends Wyeth Warning Letter Over Effexor Ad
ROCKVILLE, Md., Dec. 14, 2007-The FDA today posted on its website a warning letter sent to Wyeth Pharmaceuticals Inc. over a professional journal ad for depression drug Effexor XR. The letter and promotional material is attached.
Downloads
Effexor_XR-wl.pdf
Effexor_XRPromo.pdf
Downloads
Effexor_XR-wl.pdf
Effexor_XRPromo.pdf
Glenmark Received Indian Patent for PDE IV Inhibitors
Mumbai-based Glenmark has lately received an Indian Patent No. 201170 for novel heterocyclic compounds as Phosphodiesterase type IV (PDV IV) inhibitors of the Formula I against the mail-box Application No. 363/MUM/2003 filed April 11, 2003 with the Mumbai Patent Office. Possibly this could be Glenmark’s first drug compound patent to be granted patent protection in India, which already has been granted US Patent No. 7,223,789. According to the ‘789 patent disclosure, the compounds are suggested to have reach through indication over the treatment of variety of allergic and inflammatory diseases including asthma, chronic bronchitis, atopic dermatitis, urticaria, allergic rhinitis, allergic conjunctivitis, vernal conjuctivitis, eosinophilic granuloma, psoriasis, rheumatoid arthritis, septic shock, ulcerative colitis, Crohn's disease, reperfusion injury of the myocardium and reperfusion injury of the brain, chronic glomerulonephritis, endotoxic shock and adult respiratory distress syndrome, particularly for the treatment of asthma or chronic obstructive pulmonary disease (COPD).
Friday, December 14, 2007
Pronova BioPharma and FMC Corporation to Develop New Alginate-Based Capsule Products
LYSAKER, Norway, Dec.14, 2007 - Pronova BioPharma ASA (OSE: PRON) ("Pronova BioPharma" or the "Company") today announces that it has entered into a worldwide licence and development agreement with FMC Corporation (NYSE: FMC) ("FMC") to develop products using a novel capsule technology. The proprietary alginate-based capsule technology is expected to significantly strengthen the product life-cycle management of Pronova BioPharma's products and has the potential for use both with the Company's current active pharmaceutical ingredient ("API"), marketed as Omacor in Europe and Lovaza in the United States, as well as in future products under development.
Under the terms of the agreement, FMC will apply its technology to Pronova BioPharma's products while Pronova BioPharma will be responsible for the clinical development and for securing regulatory approval. Pronova BioPharma plans to initiate clinical trials in early 2009 and launch of the new capsule is anticipated in 2010/2011
FMC's novel proprietary capsule technology uses alginate, a marine plant-derived biopolymer, as the main component in the capsule shell. Alginate is gastro-resistant, providing an enteric release profile that delays release of the drug until passage from the stomach into the intestine. The technology also has the benefit of producing a seamless capsule with a significantly thinner shell wall, thus reducing the size of the capsule by approximately 25%. The enteric release profile and smaller size of capsule are expected to result in increased patient compliance.
Commenting on the announcement, Tomas Settevik, Chief Executive Officer of Pronova BioPharma, said: "The new alginate capsule technology has the potential to deliver significant benefits for patients, as well as creating important patent life-extensions for Omacor/Lovaza and other products under development in our pipeline. We look forward to working with FMC in bringing the new capsule technology to market, which we anticipate taking place by 2010/2011."
Ted Butz, Vice President and General Manager, FMC Specialty Chemicals Group said: "We are delighted to partner with Pronova BioPharma to combine our leading edge oral dose technology with such an important pharmaceutical product franchise."
Under the terms of the agreement, FMC will apply its technology to Pronova BioPharma's products while Pronova BioPharma will be responsible for the clinical development and for securing regulatory approval. Pronova BioPharma plans to initiate clinical trials in early 2009 and launch of the new capsule is anticipated in 2010/2011
FMC's novel proprietary capsule technology uses alginate, a marine plant-derived biopolymer, as the main component in the capsule shell. Alginate is gastro-resistant, providing an enteric release profile that delays release of the drug until passage from the stomach into the intestine. The technology also has the benefit of producing a seamless capsule with a significantly thinner shell wall, thus reducing the size of the capsule by approximately 25%. The enteric release profile and smaller size of capsule are expected to result in increased patient compliance.
Commenting on the announcement, Tomas Settevik, Chief Executive Officer of Pronova BioPharma, said: "The new alginate capsule technology has the potential to deliver significant benefits for patients, as well as creating important patent life-extensions for Omacor/Lovaza and other products under development in our pipeline. We look forward to working with FMC in bringing the new capsule technology to market, which we anticipate taking place by 2010/2011."
Ted Butz, Vice President and General Manager, FMC Specialty Chemicals Group said: "We are delighted to partner with Pronova BioPharma to combine our leading edge oral dose technology with such an important pharmaceutical product franchise."
Forest Laboratories Receives Notification of ANDA Filings for Generic Equivalents of Namenda
NEW YORK, December 13, 2007 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc. , announced today that it has received notification from several companies that they have filed Abbreviated New Drug Applications (ANDA) with Paragraph IV Certifications to obtain approval to market generic equivalents of Namenda, an NMDA receptor antagonist indicated for the treatment of moderate to severe dementia of the Alzheimer's type. The Company intends to pursue all appropriate legal action to defend its intellectual property related to Namenda. Namenda is covered by an issued U.S. patent which is set to expire in April 2010. Forest has applied for patent term restoration which, if granted, would extend Namenda's patent protection until September 2013.
Barr Subsidiary Sues Watson and Sandoz for Seasonale Patent Infringement
MONTVALE, N.J., December 14, 2007 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. today announced that its wholly-owned subsidiary, Duramed Pharmaceuticals, Inc. has filed suits against Watson Pharmaceuticals and against Sandoz, a subsidiary of Novartis for infringement of the patent protecting Duramed's SEASONALE(R) extended-cycle oral contraceptive product. Duramed has initiated patent litigation in the U.S. District Court for the District of New Jersey seeking injunctive relief.
"We will pursue all means to enforce the patent covering our SEASONALE extended-cycle oral contraceptive, which was reissued by the PTO in September," said Bruce L. Downey, Barr's Chairman and CEO. "We believe that Watson's product should be removed from the market, and that the Company is due monetary compensation from Watson. In addition, we intend to protect our intellectual property from potential generic competition by Sandoz while our patent is in force."
In September 2007, the U.S. Patent and Trademark Office (PTO) reissued Duramed's patent, U.S. Patent No. 5,898,032, for SEASONALE. The reissued patent has a new number, RE39861, and the same expiration date of June 23, 2017.
In June 2004, Barr was notified by Watson that it had filed an Abbreviated New Drug Application (ANDA) containing a paragraph IV certification asserting that the patent covering SEASONALE was invalid, unenforceable or would not be infringed by Watson's generic product. At that time, the Company did not initiate patent infringement litigation with respect to Watson's ANDA. In September 2006, Watson launched a generic version of SEASONALE following final approval from the U.S. Food & Drug Administration (FDA).
In November 2007, Sandoz notified Duramed that it had filed an ANDA containing a paragraph IV certification asserting that the patent covering SEASONALE was invalid, unenforceable or would not be infringed by Sandoz's generic product.
"We will pursue all means to enforce the patent covering our SEASONALE extended-cycle oral contraceptive, which was reissued by the PTO in September," said Bruce L. Downey, Barr's Chairman and CEO. "We believe that Watson's product should be removed from the market, and that the Company is due monetary compensation from Watson. In addition, we intend to protect our intellectual property from potential generic competition by Sandoz while our patent is in force."
In September 2007, the U.S. Patent and Trademark Office (PTO) reissued Duramed's patent, U.S. Patent No. 5,898,032, for SEASONALE. The reissued patent has a new number, RE39861, and the same expiration date of June 23, 2017.
In June 2004, Barr was notified by Watson that it had filed an Abbreviated New Drug Application (ANDA) containing a paragraph IV certification asserting that the patent covering SEASONALE was invalid, unenforceable or would not be infringed by Watson's generic product. At that time, the Company did not initiate patent infringement litigation with respect to Watson's ANDA. In September 2006, Watson launched a generic version of SEASONALE following final approval from the U.S. Food & Drug Administration (FDA).
In November 2007, Sandoz notified Duramed that it had filed an ANDA containing a paragraph IV certification asserting that the patent covering SEASONALE was invalid, unenforceable or would not be infringed by Sandoz's generic product.
Watson Confirms Patent Litigation With Barr Related to Seasonale
CORONA, Calif., December 14, 2007 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. , a leading specialty pharmaceutical company, confirmed today that Duramed Pharmaceuticals, Inc., a wholly owned subsidiary of Barr Pharmaceuticals, Inc., has filed a patent lawsuit against Watson and certain of its subsidiaries related to Quasense(TM) (levonorgestrel/ethinyl estradiol tablets USP), Watson's generic version of Seasonale(R), an extended cycle oral contraceptive. The lawsuit asserts that Watson's Quasense(TM) product infringes Duramed's U.S. Patent 5,895,032 ('032).
We fully intend to continue to market Quasense(TM), our generic version of Seasonale(R) and will defend this case vigorously," commented Paul Bisaro, Watson's President and Chief Executive Officer.
Watson launched its Quasense(TM) product in September 2006 following the U.S. Food and Drug Administration's final approval of its abbreviated new drug application. On September 25, 2007, the U.S. Patent and Trademark Office (PTO) issued to Duramed U.S. Patent No. RE39,861 (the '861 Patent) related to Seasonale(R). On December 13, 2007, Barr filed suit against Watson in the U.S. District Court of New Jersey alleging infringement of the '861 Patent seeking to prevent Watson from further commercializing its Quasense(TM) product.
We fully intend to continue to market Quasense(TM), our generic version of Seasonale(R) and will defend this case vigorously," commented Paul Bisaro, Watson's President and Chief Executive Officer.
Watson launched its Quasense(TM) product in September 2006 following the U.S. Food and Drug Administration's final approval of its abbreviated new drug application. On September 25, 2007, the U.S. Patent and Trademark Office (PTO) issued to Duramed U.S. Patent No. RE39,861 (the '861 Patent) related to Seasonale(R). On December 13, 2007, Barr filed suit against Watson in the U.S. District Court of New Jersey alleging infringement of the '861 Patent seeking to prevent Watson from further commercializing its Quasense(TM) product.
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