Dr Reddy's Laboratories Ltd hopes to launch its oral anti-diabetic drug balaglitazone(DRF2593-307), currently under phase III trial, within the next two years, targeting the patients in the US and Europe.
The phase III trials started in Europe in July with a target of 50,000 subjects and the drug would be launched as soon as possible, said Dr Raj Kumar, president of R&D and Commercialisation. The Indian company has tied up with Rheoscience for this insulin sensitizer that acts as a partial PPAR (peroxisome proliferator-activated receptor) gamma agonist.
Balaglitazone, fully developed from ground zero by Reddy's, is a second generation of PPAR gamma agonist with only partial agonistic properties, which in clinical phase II studies have shown to have glucose lowering capabilities and to be body-weight neutral. In preclinical experiments, balaglitazone has been shown to cause less fluid retention than full PPAR gamma agonists.
Dr Raj Kumar, while briefing on R&D programmes to the visiting mediamen, said the company was open to all options including developing NCEs at its own and going with partners to further improve the already discovered molecules.
"Our focus area will be metabolic disorders and thrust is being given to NCE discoveries by the company in the coming times,'' Dr Raj Kumar said. The pipeline molecules include therapeutic areas of metabolic, cancer and cardiovascular disorders.
DRL 16536 (AMPL Activator) is in the pre-clinical stage while DRF10945, another PPAR in the metabolic area, is in the second phase of trials. RUS 3108, targeting cardiovascular disorders as perlecan inducer is in the phase I stage of trials while DRF 1042 in the therapeutic area of cancer is in the pre-clinical stage.
Balaglitazone is being developed under a co-development agreement between the company and Rheoscience. Rheoscience will retain the marketing rights to European Union and China and the company will retain the marketing rights in the territories of United States and rest of the world. Rheoscience shall obtain all necessary regulatory approvals on behalf of the company in the United States.
Thursday, January 31, 2008
Jubilant Organosys consolidated net surges by over 40%
Jubilant Organosys Ltd (JOL), an integrated pharmaceutical industry player and major CRAMS provider in India, has posted strong performance during the third quarter ended December 2007. The company's consolidated net profit increased by 40.3 per cent to Rs 89.4 crore from Rs 63.7 crore in the corresponding period of last year. It's consolidated net sales increased by 36.7 per cent to Rs 641.6 crore from Rs 469.3 crore. With better growth in profits, its earning per share moved up to Rs 6.22 from Rs 4.45 in the last period. The contribution of pharmaceutical segment increased to 62 per cent in total sales during the quarter under review from 49 per cent in the last period. The pharma division recorded net sales of Rs 397.8 crore as against Rs 229.2 crore in the corresponding period of last year. CRAMS sales increased to Rs 342.8 crore from RS 173.3 crore, a growth of 97.8 per cent in third quarter of 2007-08. This includes sales of recently acquired Hollister-Stier of Rs 81.1 crore. The company's export revenue increased by 63.8 per cent to Rs 346.20 crore from Rs 211.40 crore in the corresponding quarter of last year. Commenting on the company's working, Shyam S Bhartia, chairman and managing director, said, "Third quarter results registered a strong growth, which is in continuance of trends witnessed through the first and second quarter. This was possible through spectacular growth in CRAMS and we see more such growth accruing to our business going forward based on improved capacities, new launches and long term contracts. Given the traction we are witnessing from our key customers for their outsourcing requirements of products and services, we remain confident on delivering a healthy increase in revenues and expansion in operating profit margins going forward". For the nine months ended December 2007, JOL has achieved net profit growth of 108.5 per cent to Rs 342.3 crore from RS 164.2 crore in the last period. Its net sales moved up by 33.7 per cent to Rs 1799.9 crore from Rs 1246.4 crore. Revenues from international operations increased by 53.8 per cent to Rs 951.1 crore from Rs 618.3 crore mainly due to noticeable contributions from the regulated markets and China.
Somaxon Pharmaceuticals Submits New Drug Application for Silenor for the Treatment of Insomnia
Jan 31, 2008 - Somaxon Pharmaceuticals, Inc. (Nasdaq:SOMX), a specialty pharmaceutical company focused on the in-licensing and development of proprietary product candidates for the treatment of diseases and disorders in the fields of psychiatry and neurology, today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for SILENOR(TM) (doxepin hydrochloride). Somaxon is seeking marketing approval of SILENOR(TM) for the treatment of insomnia.
Pursuant to Prescription Drug User Fee Act (PDUFA) guidelines, the FDA is expected to determine whether to accept the NDA for filing within 60 days, and to notify the company of its determination within fourteen days thereafter. If the NDA is accepted for filing, under the PDUFA guidelines it is expected that the FDA will complete its review and provide an action letter with respect to the NDA within 10 months following submission of the NDA, or in December 2008.
"The completion and submission of our NDA for SILENOR(TM) represents a significant milestone for Somaxon," said David F. Hale, Somaxon's executive chairman and interim chief executive officer. "It is the culmination of a thorough development program that includes six well controlled clinical trials, all of which met their primary endpoints, and multiple non-clinical studies. We believe that the improvements in sleep onset, sleep maintenance and sleep duration and the favorable safety and tolerability profile demonstrated by our clinical development program are sufficient to support a determination by the FDA that SILENOR(TM) can be approved for the treatment of insomnia. I would like to thank the team at Somaxon, as well as the many clinicians and experts who worked with us, for their efforts in the design and conduct of the SILENOR(TM) development program and the preparation of this NDA for submission."
Pursuant to Prescription Drug User Fee Act (PDUFA) guidelines, the FDA is expected to determine whether to accept the NDA for filing within 60 days, and to notify the company of its determination within fourteen days thereafter. If the NDA is accepted for filing, under the PDUFA guidelines it is expected that the FDA will complete its review and provide an action letter with respect to the NDA within 10 months following submission of the NDA, or in December 2008.
"The completion and submission of our NDA for SILENOR(TM) represents a significant milestone for Somaxon," said David F. Hale, Somaxon's executive chairman and interim chief executive officer. "It is the culmination of a thorough development program that includes six well controlled clinical trials, all of which met their primary endpoints, and multiple non-clinical studies. We believe that the improvements in sleep onset, sleep maintenance and sleep duration and the favorable safety and tolerability profile demonstrated by our clinical development program are sufficient to support a determination by the FDA that SILENOR(TM) can be approved for the treatment of insomnia. I would like to thank the team at Somaxon, as well as the many clinicians and experts who worked with us, for their efforts in the design and conduct of the SILENOR(TM) development program and the preparation of this NDA for submission."
Encysive Pharmaceuticals Launches Thelin (Sitaxentan Sodium) in Sweden
Encysive Pharmaceuticals Inc. (Nasdaq:ENCY) today announced the commercial availability of Thelin(r)(1) (sitaxentan sodium(2)) 100 mg tablets in Sweden.
THELIN is approved for the treatment of pulmonary arterial hypertension (PAH) and has received reimbursement approval for use in Sweden. Encysive received European Union (EU) marketing authorization for THELIN from the European Commission in August 2006. THELIN is the first selective endothelin A receptor antagonist, and the first once-daily oral treatment available for patients with PAH.
THELIN is indicated for improving exercise capacity in PAH patients classified as World Health Organization (WHO) functional class III. Efficacy has been shown in primary pulmonary hypertension(3) and pulmonary hypertension associated with connective tissue disease (CTD).
"A number of evidence-based treatment options for PAH have been developed in recent years. Sitaxentan provides us with another therapy to tailor and optimize treatment for the individual patient," stated Bjorn Ekmehag, MD, Director of the Pulmonary Hypertension Centre, Lund Sweden.
The EU's centralized licensing procedure permits Encysive to market THELIN in all 27 member states of the EU. THELIN has been launched in the United Kingdom, Germany, Ireland, Spain, France, Italy, Belgium, Luxembourg and the Netherlands and will be launched in additional EU member states as local governmental approval for reimbursement is obtained.
THELIN is approved for the treatment of pulmonary arterial hypertension (PAH) and has received reimbursement approval for use in Sweden. Encysive received European Union (EU) marketing authorization for THELIN from the European Commission in August 2006. THELIN is the first selective endothelin A receptor antagonist, and the first once-daily oral treatment available for patients with PAH.
THELIN is indicated for improving exercise capacity in PAH patients classified as World Health Organization (WHO) functional class III. Efficacy has been shown in primary pulmonary hypertension(3) and pulmonary hypertension associated with connective tissue disease (CTD).
"A number of evidence-based treatment options for PAH have been developed in recent years. Sitaxentan provides us with another therapy to tailor and optimize treatment for the individual patient," stated Bjorn Ekmehag, MD, Director of the Pulmonary Hypertension Centre, Lund Sweden.
The EU's centralized licensing procedure permits Encysive to market THELIN in all 27 member states of the EU. THELIN has been launched in the United Kingdom, Germany, Ireland, Spain, France, Italy, Belgium, Luxembourg and the Netherlands and will be launched in additional EU member states as local governmental approval for reimbursement is obtained.
Orexigen Therapeutics Announces Notice of Allowance for U.S. Patent Extending Exclusivity for Composition of Contrave to 2024
(As per the article published in Pharmalive)
Jan 31, 2008 - Orexigen(TM) Therapeutics, Inc. (Nasdaq: OREX), a biopharmaceutical company focused on the treatment of central nervous system disorders, including obesity, today announced that a Notice of Allowance has been electronically posted by the United States Patent and Trademark Office (USPTO) for a patent application covering sustained release (SR) compositions of bupropion and naltrexone combined in a single dosage form. These two drugs are the active constituents in Contrave(TM), Orexigen's lead product candidate for the treatment of obesity, now in Phase III clinical trials. Referred to by the Company as the Weber/Cowley composition patent application, this patent would provide protection for Contrave into the year 2024. This development is an important milestone toward issuance of the patent by the USPTO. Issuance of this patent by the USPTO would extend the Company's exclusive rights on this combination in the United States for an additional 11 years beyond its current patent protection.
"This patent, upon issuance, would further strengthen the intellectual property position for this novel, proprietary drug combination," said Orexigen President and CEO, Gary Tollefson, M.D., Ph.D. "As a composition-of-matter patent it would cover all uses and doses of Contrave into 2024."
Contrave is a proprietary fixed dose combination of bupropion SR and the Company's novel formulation of naltrexone SR in a single tablet. Orexigen chose these two constituent drugs based on preclinical data that suggested that they could both initiate and sustain weight loss. The Contrave Phase IIb clinical trial at 48 weeks demonstrated weight loss from baseline body weight that ranged from 8.0% to 10.7% across the three Contrave dosage groups among patients who completed the trial. The Phase III clinical trials of Contrave are expected to be completed by mid-2009 with the filing of a New Drug Application (NDA) with the FDA projected for late 2009.
Jan 31, 2008 - Orexigen(TM) Therapeutics, Inc. (Nasdaq: OREX), a biopharmaceutical company focused on the treatment of central nervous system disorders, including obesity, today announced that a Notice of Allowance has been electronically posted by the United States Patent and Trademark Office (USPTO) for a patent application covering sustained release (SR) compositions of bupropion and naltrexone combined in a single dosage form. These two drugs are the active constituents in Contrave(TM), Orexigen's lead product candidate for the treatment of obesity, now in Phase III clinical trials. Referred to by the Company as the Weber/Cowley composition patent application, this patent would provide protection for Contrave into the year 2024. This development is an important milestone toward issuance of the patent by the USPTO. Issuance of this patent by the USPTO would extend the Company's exclusive rights on this combination in the United States for an additional 11 years beyond its current patent protection.
"This patent, upon issuance, would further strengthen the intellectual property position for this novel, proprietary drug combination," said Orexigen President and CEO, Gary Tollefson, M.D., Ph.D. "As a composition-of-matter patent it would cover all uses and doses of Contrave into 2024."
Contrave is a proprietary fixed dose combination of bupropion SR and the Company's novel formulation of naltrexone SR in a single tablet. Orexigen chose these two constituent drugs based on preclinical data that suggested that they could both initiate and sustain weight loss. The Contrave Phase IIb clinical trial at 48 weeks demonstrated weight loss from baseline body weight that ranged from 8.0% to 10.7% across the three Contrave dosage groups among patients who completed the trial. The Phase III clinical trials of Contrave are expected to be completed by mid-2009 with the filing of a New Drug Application (NDA) with the FDA projected for late 2009.
Teva Introduces Pantoprazole Sodium Delayed-Release Tablets
January 31, 2008 – Teva Pharmaceuticals is pleased to announce the introduction and availability of Pantoprazole Sodium Delayed-Release Tablets. This product is AB rated and bioequivalent to Protonix®* Delayed-Release Tablets. Pantoprazole Sodium Delayed-Release Tablets are available in 20 mg and 40 mg strengths, in bottle sizes of 90.
Teva Announces Tentative Approval of Generic Flomax Capsules
Jan 31, 2008 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted tentative approval for the Company's Abbreviated New Drug Application (ANDA) for Tamsulosin Hydrochloride Capsules, 0.4 mg. Final approval of this product is expected upon expiry of patent protection for the brand product in October 2009.
Upon final approval, Teva's product will be the AB-rated generic equivalent of Boehringer Ingelheim's Flomax(R) Capsules, a product indicated for the treatment of signs and symptoms of benign prostatic hyperplasia (BPH).
The brand product had annual sales of approximately $1.3 billion in the United States for the twelve months that ended September 30, 2007, based on IMS sales data.
Upon final approval, Teva's product will be the AB-rated generic equivalent of Boehringer Ingelheim's Flomax(R) Capsules, a product indicated for the treatment of signs and symptoms of benign prostatic hyperplasia (BPH).
The brand product had annual sales of approximately $1.3 billion in the United States for the twelve months that ended September 30, 2007, based on IMS sales data.
Wednesday, January 30, 2008
Eisai acquires MGI Pharma for $3.9 billion
As earlier reported by us, Eisai Co., Ltd., a research-based human health care (hhc) company, announced the successful completion of its acquisition of MGI Pharma, Inc. for approximately $3.9 billion through a cash tender offer followed by a short-form merger of its acquisition vehicle, Jaguar Acquisition Corp. (Jaguar), with and into MGI Pharma. As a result of this acquisition, MGI Pharma becomes a wholly-owned subsidiary of Eisai Corporation of North America.
At the effective time of the merger, all outstanding shares of MGI Pharma common stock not validly tendered and accepted for payment in the tender offer were converted into the right to receive US$41.00 per share in cash (the same price paid in the tender offer), without interest and subject to applicable withholding of taxes. Computer share, acting as the paying agent for the merger, will mail to the remaining former shareholders of MGI Pharma materials necessary to exchange their former MGI Pharma shares for such payment. As a result of the merger, MGI Pharma shares will be delisted and cease to trade on the NASDAQ National Market.
At the effective time of the merger, all outstanding shares of MGI Pharma common stock not validly tendered and accepted for payment in the tender offer were converted into the right to receive US$41.00 per share in cash (the same price paid in the tender offer), without interest and subject to applicable withholding of taxes. Computer share, acting as the paying agent for the merger, will mail to the remaining former shareholders of MGI Pharma materials necessary to exchange their former MGI Pharma shares for such payment. As a result of the merger, MGI Pharma shares will be delisted and cease to trade on the NASDAQ National Market.
Warning Letters issued by FDA
The Food and Drug Administration issued a warning letter to Replidyne, Inc. regarding the company's role as applicant of a marketing application in support of an unnamed drug.
The FDA has posted to its a website a warning letter sent to Novartis Vaccines and Diagnostics Gmbh & Co. KG.
The FDA has posted to its a website a warning letter sent to Novartis Vaccines and Diagnostics Gmbh & Co. KG.
FDA Grants Priority Review For Velcade (bortezomib) for Injection In Patients with Newly Diagnosed Multiple Myeloma
January 30, 2008 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals, Inc. today announced the U.S. Food and Drug Administration (FDA) granted priority review for VELCADE in patients with newly diagnosed multiple myeloma (MM). The supplemental New Drug Application (sNDA) submitted to the FDA for this indication included data from the Phase III VISTA(1) study, a large, well-controlled international clinical trial, comparing a VELCADE based regimen to a traditional standard of care. VELCADE is the market-leader for MM and mantle cell lymphoma patients who have received at least one prior therapy.
"Priority review designation puts us on track for a potential label expansion decision by June 20," said Nancy Simonian, M.D., Chief Medical Officer, Millennium. "The rapid action by the FDA puts us one step closer to establishing VELCADE based therapies as a standard of care for patients with newly diagnosed multiple myeloma."
Priority review is granted by the FDA for a treatment that addresses an unmet medical need and demonstrates an improvement over existing therapies. The FDA expedites the approval process for applications granted priority review from ten to six months.
The VISTA trial randomized 682 patients with newly diagnosed MM ineligible for stem cell transplantation and was conducted by the Company and its co- development partner Johnson & Johnson Pharmaceutical Research & Development, L.L.C. The trial compared VELCADE, melphalan and prednisone (VcMP) to the standard regimen of melphalan and prednisone (MP) alone. VcMP achieved a statistically significant improvement across all efficacy endpoints, including complete remission (CR) rates, time-to-disease progression (TTP) and survival (progression-free survival and overall survival). Included in these results, VcMP demonstrated an immunofixation-negative CR rate of 35 percent, which is the highest rate reported in a Phase III trial in patients with newly diagnosed MM, compared to 5 percent in the MP arm.
"Priority review designation puts us on track for a potential label expansion decision by June 20," said Nancy Simonian, M.D., Chief Medical Officer, Millennium. "The rapid action by the FDA puts us one step closer to establishing VELCADE based therapies as a standard of care for patients with newly diagnosed multiple myeloma."
Priority review is granted by the FDA for a treatment that addresses an unmet medical need and demonstrates an improvement over existing therapies. The FDA expedites the approval process for applications granted priority review from ten to six months.
The VISTA trial randomized 682 patients with newly diagnosed MM ineligible for stem cell transplantation and was conducted by the Company and its co- development partner Johnson & Johnson Pharmaceutical Research & Development, L.L.C. The trial compared VELCADE, melphalan and prednisone (VcMP) to the standard regimen of melphalan and prednisone (MP) alone. VcMP achieved a statistically significant improvement across all efficacy endpoints, including complete remission (CR) rates, time-to-disease progression (TTP) and survival (progression-free survival and overall survival). Included in these results, VcMP demonstrated an immunofixation-negative CR rate of 35 percent, which is the highest rate reported in a Phase III trial in patients with newly diagnosed MM, compared to 5 percent in the MP arm.
IMPAX Receives FDA Non-Approvable Letter for Vadova; Company Considering Options
Jan 30, 2008 - IMPAX Laboratories, Inc. (OTC:IPXL) today announced that it has received a non-approvable letter from the U.S. Food and Drug Administration (FDA) concerning its new drug application (NDA) and subsequent submissions for Vadova(R) (carbidopa/levodopa extended release) tablets. The FDA's action was primarily based on unresolved issues relating to product nomenclature and its belief of a likelihood of medication errors resulting from confusion of Vadova with other marketed forms of carbidopa/levodopa. The NDA, which was originally filed in April 2005, was deemed non-approvable in March 2006. IMPAX subsequently filed responses addressing the FDA's earlier concerns, which included clinical pharmacology and chemistry, manufacturing and control components. These concerns were not cited in the most recent non-approvable letter.
"We are very disappointed with the receipt of this letter, and we continue to believe that Vadova represents a significant improvement in the choices available to patients in the treatment of the symptoms of Parkinson's disease," said Larry Hsu, Ph.D., president and chief executive officer of IMPAX Laboratories. "We will continue to pursue discussions with the FDA concerning this decision and we are evaluating all options for the product."
"We are very disappointed with the receipt of this letter, and we continue to believe that Vadova represents a significant improvement in the choices available to patients in the treatment of the symptoms of Parkinson's disease," said Larry Hsu, Ph.D., president and chief executive officer of IMPAX Laboratories. "We will continue to pursue discussions with the FDA concerning this decision and we are evaluating all options for the product."
Iroko Pharmaceuticals Acquires Rights to Cardiovascular Product from Merck & Co., Inc.
Jan 30, 2008 - Iroko Pharmaceuticals announces the acquisition of all non-US commercial rights to Aggrastat(R) (tirofiban HCl) from Merck & Co., Inc.
Outside of the US market, Aggrastat(R) in combination with heparin is indicated for patients with unstable angina or non-Q wave myocardial infarction to prevent cardiac ischemic events, and is also indicated for patients with coronary ischemic syndromes undergoing coronary angioplasty or atherectomy to prevent cardiac ischemic complications related to abrupt closure of the treated coronary artery. Aggrastat(R) is indicated for the treatment of acute coronary syndrome, including patients who are to be managed medically and those undergoing percutaneous transluminal coronary angioplasty (PTCA).
Outside of the US market, Aggrastat(R) in combination with heparin is indicated for patients with unstable angina or non-Q wave myocardial infarction to prevent cardiac ischemic events, and is also indicated for patients with coronary ischemic syndromes undergoing coronary angioplasty or atherectomy to prevent cardiac ischemic complications related to abrupt closure of the treated coronary artery. Aggrastat(R) is indicated for the treatment of acute coronary syndrome, including patients who are to be managed medically and those undergoing percutaneous transluminal coronary angioplasty (PTCA).
New Patent Awarded for Antigen-Sparing Vaccines that Elicit Robust Immunity
A needle-free vaccine platform that elicits a robust immune response against a wide array of viruses and bacteria has been awarded a U.S. patent. The University of Michigan holds the patent and NanoBio Corporation, a spin-off from the university, licenses the patent and its associated technology.
The intranasal vaccines, produced using NanoBio's nanoemulsion technology, have elicited a dramatic immune response in animals vaccinated against influenza, anthrax, hepatitis B and other diseases. In some cases, the immune response is exponentially higher than what is required to provide adequate protection against infection. Such dramatic levels of immunity would confer significantly higher levels of protection to the vaccinated population at large compared with current injectable vaccines.
Because the vaccines trigger such robust immunity, scientists anticipate they will be able to reduce vaccine antigen quantities to a fraction of what current vaccines require, while still mounting an overwhelming immune response.
This "antigen-sparing" capability would enable scientists to rapidly produce large quantities of vaccines using miniscule amounts of antigen, a critical factor when faced with a disease pandemic or biological warfare.
The intranasal vaccines, produced using NanoBio's nanoemulsion technology, have elicited a dramatic immune response in animals vaccinated against influenza, anthrax, hepatitis B and other diseases. In some cases, the immune response is exponentially higher than what is required to provide adequate protection against infection. Such dramatic levels of immunity would confer significantly higher levels of protection to the vaccinated population at large compared with current injectable vaccines.
Because the vaccines trigger such robust immunity, scientists anticipate they will be able to reduce vaccine antigen quantities to a fraction of what current vaccines require, while still mounting an overwhelming immune response.
This "antigen-sparing" capability would enable scientists to rapidly produce large quantities of vaccines using miniscule amounts of antigen, a critical factor when faced with a disease pandemic or biological warfare.
CIS-US Announces Approval of Generic version of Choletec Kit for the Preparation of Technetium Tc-99m Mebrofenin
Jan 30, 2008 - CIS-US, Inc. announced today that it has received approval from the U. S. Food and Drug Administration (FDA) Office of Generic Drugs for its Abbreviated New Drug Application (ANDA) to manufacture and market a generic Kit for the Preparation of Technetium Tc-99m Mebrofenin. The company will begin distribution the week of February 4.
The Kit for the Preparation of Technetium Tc-99 Mebrofenin is the second agent in the CIS-US product line approved with an indication for hepatobiliary imaging.
Jeanne A. Fiore, VP Regulatory Affair and Quality Assurance, stated, "We are pleased to receive approval of our first ANDA filing and the first generic approval for a Kit for the Preparation of Technetium Tc-99 Mebrofenin."
Glenn Alto, President and CEO of CIS-US stated, "Our approval of the Kit for the Preparation of Technetium Tc-99 Mebrofenin is a gratifying start to the expansion of our existing molecular imaging agent product line. Our commitment to the development, production and supply of key products to nuclear medicine practitioners and their patients will be evidenced as we continue to grow our product offerings in the coming months."
The Kit for the Preparation of Technetium Tc-99 Mebrofenin is the second agent in the CIS-US product line approved with an indication for hepatobiliary imaging.
Jeanne A. Fiore, VP Regulatory Affair and Quality Assurance, stated, "We are pleased to receive approval of our first ANDA filing and the first generic approval for a Kit for the Preparation of Technetium Tc-99 Mebrofenin."
Glenn Alto, President and CEO of CIS-US stated, "Our approval of the Kit for the Preparation of Technetium Tc-99 Mebrofenin is a gratifying start to the expansion of our existing molecular imaging agent product line. Our commitment to the development, production and supply of key products to nuclear medicine practitioners and their patients will be evidenced as we continue to grow our product offerings in the coming months."
Caraco Pharmaceutical Laboratories Ltd. to Market Generic Protonix
Caraco Pharmaceutical Laboratories, Ltd. announced today that it has launched Pantoprazole Sodium Delayed-Release Tablets, 40 mg (Pantoprazole Sodium DR), which is AB-rated to Wyeth's Protonix(R) DR Tablets, on behalf of Sun Pharmaceutical Industries, Ltd. (Sun Pharma). Sun Pharma recently received approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for generic Protonix(R), and being one of the first-to-file an ANDA with a Paragraph IV certification, shares a 180-day marketing exclusivity with Teva Pharmaceutical Industries Ltd.
Caraco's launch on behalf of Sun Pharma was initiated after the December 22, 2007 launch by Teva Pharmaceutical Industries Ltd. of generic Pantoprazole Sodium DR tablet products, and after the January 29, 2008 launch by Wyeth of generic Pantoprazole Sodium DR tablets product through its designated distributor.
Sun Pharma is currently involved in patent litigation with Wyeth and Altana (recently acquired by Nycomed) concerning this product in the U.S. District Court for the District of New Jersey. Although no trial date has yet been set, in September 2007, the District Court denied a motion filed by Wyeth and Altana for a preliminary injunction related to Sun's Pantoprazole Tablets. Wyeth and Altana have appealed the District Court's decision.
Pantoprazole Sodium DR is indicated for the short-term treatment (up to eight weeks) in the healing and symptomatic relief of erosive esophagitis, is indicated for the maintenance of healing erosive esophagitis and reduction in relapse rates of daytime and nighttime heartburn symptoms in patients with gastroesophageal reflux disease (GERD), and is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger- Ellison syndrome. This new product is bioequivalent to Protonix(R), a registered trademark of Wyeth Pharmaceuticals Inc. Protonix(R) 40 mg tablets had U.S. sales of approximately $2.3 billion for the 12-month period ended September 30, 2007, according to IMS Data.
Detroit-based Caraco Pharmaceutical Laboratories, Ltd., develops, manufactures, markets and distributes generic and private-label pharmaceuticals to the nation's largest wholesalers, distributors, drugstore chains and managed care providers.
Caraco's launch on behalf of Sun Pharma was initiated after the December 22, 2007 launch by Teva Pharmaceutical Industries Ltd. of generic Pantoprazole Sodium DR tablet products, and after the January 29, 2008 launch by Wyeth of generic Pantoprazole Sodium DR tablets product through its designated distributor.
Sun Pharma is currently involved in patent litigation with Wyeth and Altana (recently acquired by Nycomed) concerning this product in the U.S. District Court for the District of New Jersey. Although no trial date has yet been set, in September 2007, the District Court denied a motion filed by Wyeth and Altana for a preliminary injunction related to Sun's Pantoprazole Tablets. Wyeth and Altana have appealed the District Court's decision.
Pantoprazole Sodium DR is indicated for the short-term treatment (up to eight weeks) in the healing and symptomatic relief of erosive esophagitis, is indicated for the maintenance of healing erosive esophagitis and reduction in relapse rates of daytime and nighttime heartburn symptoms in patients with gastroesophageal reflux disease (GERD), and is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger- Ellison syndrome. This new product is bioequivalent to Protonix(R), a registered trademark of Wyeth Pharmaceuticals Inc. Protonix(R) 40 mg tablets had U.S. sales of approximately $2.3 billion for the 12-month period ended September 30, 2007, according to IMS Data.
Detroit-based Caraco Pharmaceutical Laboratories, Ltd., develops, manufactures, markets and distributes generic and private-label pharmaceuticals to the nation's largest wholesalers, distributors, drugstore chains and managed care providers.
Prasco to Distribute Wyeth's Own Generic Versions of Protonix Delayed-Release Tablets
January 30, 2008 /PRNewswire/ -- Prasco announced today that, pursuant to an agreement it entered into with the ESI Lederle Division of Wyeth ("ESI"), it is shipping the generic version of PROTONIX(R) (Pantoprazole Sodium) Delayed-Release Tablets being offered for sale by ESI. Prasco, as ESI's agent and on ESI's behalf, will solicit orders for and distribute the 20 mg and 40 mg formulations of Pantoprazole Sodium Delayed-Release (DR) Tablets to all trade classes in the U.S. under the ESI Lederle label. Pantoprazole Sodium DR Tablets are AB-rated, therapeutically equivalent and substitutable for the brand PROTONIX Delayed-Release (DR) Tablets.
"We are extremely pleased to have established this agreement with Wyeth, a global leader in the pharmaceutical industry," said Prasco Chief Executive Officer E. Thomas Arington. "Pantoprazole Sodium DR Tablets are identical to PROTONIX DR Tablets, providing the consuming marketplace the benefits of competitive balance and brand-quality at generic prices," stated Arington.
PROTONIX DR Tablets had reported sales of $2.5 billion dollars in the United States, with over 19 million prescriptions filled for the twelve months ended November 30, 2007, based on IMS sales data. PROTONIX is a registered trademark of Wyeth Pharmaceuticals, Inc.
"We are extremely pleased to have established this agreement with Wyeth, a global leader in the pharmaceutical industry," said Prasco Chief Executive Officer E. Thomas Arington. "Pantoprazole Sodium DR Tablets are identical to PROTONIX DR Tablets, providing the consuming marketplace the benefits of competitive balance and brand-quality at generic prices," stated Arington.
PROTONIX DR Tablets had reported sales of $2.5 billion dollars in the United States, with over 19 million prescriptions filled for the twelve months ended November 30, 2007, based on IMS sales data. PROTONIX is a registered trademark of Wyeth Pharmaceuticals, Inc.
Sun Pharma Launches Generic Protonix Tablets
MUMBAI, India, January 30, 2008-Sun Pharmaceutical Industries Ltd. announced today that it has commercially launched generic Pantoprazole Sodium Delayed Release (DR) Tablets, 40 mg, which is AB-rated to Wyeth's Protonix® DR Tablets. Sun's product is being sold in the United States by its marketing partner Caraco Pharmaceutical Laboratories. Sun Pharma had received a USFDA approval for these tablets in Sep 2007. This strength of Pantoprazole Sodium has annual sales of approximately USD 2.3 billion in the US.
Sun's launch was initiated after the December 22, 2007 commercial launch by Teva Pharmaceutical Industries Ltd. of generic Pantoprazole Sodium tablet products, and after the January 29, 2008 commercial launch by Wyeth of generic Pantoprazole Sodium tablets product through its designated distributor.
Sun shares a 180-day period of marketing exclusivity with Teva for this product. Sun is currently involved in patent litigation with Wyeth and Altana (now Nycomed) concerning this product in the U.S. District Court for the District of New Jersey. Although no trial date has yet been set, in September 2007, the District Court denied a motion filed by Wyeth and Altana for a preliminary injunction related to Sun's Pantoprazole Tablets. Wyeth and Altana have appealed the District Court's decision.
Sun's launch was initiated after the December 22, 2007 commercial launch by Teva Pharmaceutical Industries Ltd. of generic Pantoprazole Sodium tablet products, and after the January 29, 2008 commercial launch by Wyeth of generic Pantoprazole Sodium tablets product through its designated distributor.
Sun shares a 180-day period of marketing exclusivity with Teva for this product. Sun is currently involved in patent litigation with Wyeth and Altana (now Nycomed) concerning this product in the U.S. District Court for the District of New Jersey. Although no trial date has yet been set, in September 2007, the District Court denied a motion filed by Wyeth and Altana for a preliminary injunction related to Sun's Pantoprazole Tablets. Wyeth and Altana have appealed the District Court's decision.
Tentative Approval of Generic Lamivudine for Pepfar
Jan. 29, 2008- On January 29, 2008, the FDA granted tentative approval for generic lamivudine tablets, 150 mg and 300 mg, manufactured by Hetero Drugs Limited, Hyderabad, India, for use in combination with other antiretrovirals in the treatment of HIV infection.
"Tentative Approval" means that FDA has concluded that a drug product has met all required quality, safety and efficacy standards, even though it is not yet eligible to be marketed in the U.S. because of existing patents and/or exclusivity rights. However, this tentative approval does make the product eligible for consideration for purchase under the President's Emergency Plan for AIDS Relief (PEPFAR [ http://www.pepfar.gov/ ]) program.
This is a generic version of Epivir, manufactured by GlaxoSmithKline, which is subject to existing patent protection.
Effective patent dates can be found in the agency's publication titled Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the "Orange Book [ http://www.accessdata.fda.gov/scripts/cder/ob/docs/obdetail.cfm?Appl_No=020564&TABLE1=OB_Rx ]"
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.
"Tentative Approval" means that FDA has concluded that a drug product has met all required quality, safety and efficacy standards, even though it is not yet eligible to be marketed in the U.S. because of existing patents and/or exclusivity rights. However, this tentative approval does make the product eligible for consideration for purchase under the President's Emergency Plan for AIDS Relief (PEPFAR [ http://www.pepfar.gov/ ]) program.
This is a generic version of Epivir, manufactured by GlaxoSmithKline, which is subject to existing patent protection.
Effective patent dates can be found in the agency's publication titled Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the "Orange Book [ http://www.accessdata.fda.gov/scripts/cder/ob/docs/obdetail.cfm?Appl_No=020564&TABLE1=OB_Rx ]"
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.
Wyeth Announces Launch of Own Generic Version of Protonix
January 29, 2008 /PRNewswire-FirstCall/ -- Wyeth and its business partner, Nycomed, today announced the U.S. launch of Wyeth's own generic version of PROTONIX(R) tablets, in response to the at-risk launch of generic pantoprazole tablets in the U.S. by Teva Pharmaceuticals USA, Inc. on December 21, 2007. Wyeth's own generic version of PROTONIX will be distributed by Prasco starting today.
"Compound patents, like that infringed by Teva, represent the foundation of pharmaceutical innovation, a critical underpinning in bringing important new medicines to patients," says Bernard Poussot, President and Chief Executive Officer for Wyeth. "We believe the PROTONIX compound patent is strong and we will vigorously pursue our litigation against Teva and other infringing generics. Going forward, we will continue to seek an injunction against any infringement of this patent, as well as monetary damages, including lost profits, from Teva."
Wyeth and Altana Pharma AG (recently acquired by Nycomed) sued Teva and Sun Pharmaceuticals for patent infringement based on Teva's and Sun's filing of Abbreviated New Drug Applications (ANDAs) seeking U.S. Food and Drug Administration (FDA) approval to market generic versions of PROTONIX before the patent expires on July 19, 2010. Under the Hatch-Waxman Act, the filing of the lawsuit stayed final FDA approval of Teva's ANDA until August 2, 2007, and Sun's ANDA until September 8, 2007. On September 6, 2007, The United States District Court for the District of New Jersey denied Wyeth's and Nycomed's motion for preliminary injunction. The Court did not rule on the validity of the patent, but rather concluded that, based on the limited record before it, Wyeth and Nycomed were not entitled to the extraordinary relief of a preliminary injunction. Trial is expected in the second half of 2008.
"Compound patents, like that infringed by Teva, represent the foundation of pharmaceutical innovation, a critical underpinning in bringing important new medicines to patients," says Bernard Poussot, President and Chief Executive Officer for Wyeth. "We believe the PROTONIX compound patent is strong and we will vigorously pursue our litigation against Teva and other infringing generics. Going forward, we will continue to seek an injunction against any infringement of this patent, as well as monetary damages, including lost profits, from Teva."
Wyeth and Altana Pharma AG (recently acquired by Nycomed) sued Teva and Sun Pharmaceuticals for patent infringement based on Teva's and Sun's filing of Abbreviated New Drug Applications (ANDAs) seeking U.S. Food and Drug Administration (FDA) approval to market generic versions of PROTONIX before the patent expires on July 19, 2010. Under the Hatch-Waxman Act, the filing of the lawsuit stayed final FDA approval of Teva's ANDA until August 2, 2007, and Sun's ANDA until September 8, 2007. On September 6, 2007, The United States District Court for the District of New Jersey denied Wyeth's and Nycomed's motion for preliminary injunction. The Court did not rule on the validity of the patent, but rather concluded that, based on the limited record before it, Wyeth and Nycomed were not entitled to the extraordinary relief of a preliminary injunction. Trial is expected in the second half of 2008.
Teva Announces Wyeth Voids Standstill Agreement on Generic Protonix
Jan 29, 2008 - Teva Pharmaceutical Industries Ltd. (Nasdaq:TEVA) announced today that the Company's standstill agreement with Wyeth/Altana regarding additional shipments by Teva of generic Protonix (Pantoprazole Sodium) has terminated as a result of Wyeth's launch of an authorized generic product.
Teva is currently involved in patent litigation with Wyeth/Altana concerning this product in the U.S. District Court for the District of New Jersey. A trial date has not been set.
In September 2007, the District Court denied a motion filed by Wyeth/Altana for a preliminary injunction related to Teva's Pantoprazole Tablets. In that decision, the Court found that Wyeth/Altana did not meet its burden of proving likelihood of success on the merits. Wyeth/Altana have appealed that decision.
Teva is currently involved in patent litigation with Wyeth/Altana concerning this product in the U.S. District Court for the District of New Jersey. A trial date has not been set.
In September 2007, the District Court denied a motion filed by Wyeth/Altana for a preliminary injunction related to Teva's Pantoprazole Tablets. In that decision, the Court found that Wyeth/Altana did not meet its burden of proving likelihood of success on the merits. Wyeth/Altana have appealed that decision.
Akorn, Inc. Announces FDA Approval of Calcitriol Injection, 1 mcg/mL and 2 mcg/mL
Jan 30, 2008 - Akorn, Inc. (NASDAQ:AKRX) today announced that the U.S. Food and Drug Administration (FDA) has granted approval for Akorn's Abbreviated New Drug Application (ANDA) for Calcitriol Injection, 1 mcg/mL and 2 mcg/mL.
Calcitriol Injection is indicated in the management of hypocalcemia in patients undergoing chronic renal dialysis. It significantly reduces elevated levels of parathyroid hormone. Annual sales for Calcitriol were approximately $6 million in 2007, according to IMS sales data.
Arthur S. Przybyl, Akorn's President and Chief Executive Officer stated, "We are pleased to announce the ANDA approval for Calcitriol Injection. This product will be manufactured in our Decatur, IL facility, and represents the second ANDA approval received for this facility in 2008. We expect to be ready to launch Calcitriol Injection in the second half of 2008."
Calcitriol Injection is indicated in the management of hypocalcemia in patients undergoing chronic renal dialysis. It significantly reduces elevated levels of parathyroid hormone. Annual sales for Calcitriol were approximately $6 million in 2007, according to IMS sales data.
Arthur S. Przybyl, Akorn's President and Chief Executive Officer stated, "We are pleased to announce the ANDA approval for Calcitriol Injection. This product will be manufactured in our Decatur, IL facility, and represents the second ANDA approval received for this facility in 2008. We expect to be ready to launch Calcitriol Injection in the second half of 2008."
Tuesday, January 29, 2008
Ipca Lab acquires additional 4.65 % equity of Tonira Pharma
Ipca Laboratories (IPCA) along with Kaygee Investments Pvt Ltd (KIPL) have acquired additional 3,69,450 equity shares of Rs 10/- each representing 4.65 per cent of the paid up equity share capital of Tonira Pharma Ltd. in the price range of Rs 23.85 to Rs 24.60 per share from open market on January 28, 2008.
The company had made a public announcement to the shareholders of Tonira Pharma Ltd for acquiring 23,83,260 fully paid up equity shares of Rs 10/- each at the rate of Rs 29 per share on November 01, 2007.
With this further acquisition, Ipca's holding along with KIPL (PAC) has increased to 15,44,944 fully paid up equity shares of Tonira Pharma Ltd representing 19.45 per cent of its paid up share capital as under.
The company had made a public announcement to the shareholders of Tonira Pharma Ltd for acquiring 23,83,260 fully paid up equity shares of Rs 10/- each at the rate of Rs 29 per share on November 01, 2007.
With this further acquisition, Ipca's holding along with KIPL (PAC) has increased to 15,44,944 fully paid up equity shares of Tonira Pharma Ltd representing 19.45 per cent of its paid up share capital as under.
Pfizer Japan Receives Manufacturing and Marketing Authorization for Champix
Jan 29, 2008 - Pfizer Japan Inc (headquarter in Shibuya-ku, Tokyo; headed by President & Chief Executive Officer, Hiromitsu Iwasaki; and capitalized at Yen 64.8 billion) announced that on January 25, the company received manufacturing and marketing authorization for Champix(R) Tablet 0.5 mg/1mg (varenicline tartrate), a smoking cessation aid for smokers dependent on nicotine.
Champix is Japan's first oral smoking cessation aid developed for smoking cessation treatment. Current 'Nicotine Replacement Therapy' relieves withdrawal symptoms associated with smoking cessation by replacing tobacco with nicotine. Champix brings about a smoking cessation effect as a non-nicotine partial agonist(1) that binds to alpha(4)beta(2) nicotine receptors in the brain with strong affinity.
Champix relieves withdrawal symptoms and tobacco craving associated with smoking cessation by acting as an agonist for alpha(4)beta(2) nicotine receptors in the brain, which are associated with nicotine dependence. At the same time, if a person smokes a cigarette while receiving treatment, Champix acts as an antagonist to inhibit nicotine from binding to alpha(4)beta(2) nicotine receptors, restricting the patient's sense of satisfaction associated with smoking.
In a 12-week, randomized, double-blind, placebo-controlled study in Japanese smokers who wanted to quit smoking, the primary endpoint (the 4 consecutive-week smoking cessation rate between Week 9 and Week 12) was 65.4 percent (85/130 cases) in patients receiving 1mg Champix twice-daily and 39.5 percent in the placebo group (51/129 cases) respectively, showing a statistically significant difference between the two groups.
Many smokers are suffering from nicotine dependence. At the same time, many smokers who desire and attempt to quit smoking end up without cessation.(2) Nicotine dependence is a chronic disease that is difficult to overcome solely with a smoker's willpower. To successfully quit smoking, a combination of medical support and medication is effective. Pfizer Japan believes that by introducing Champix, we will be able to help many nicotine dependent smokers quit smoking successfully, thus creating a healthier environment in Japan.
Champix was launched under the product name of Chantix(R) in August 2006 in the United States and of Champix(R) in December 2006 in European Union. At present, the product is approved in more than 60 countries around the world, and used for smokers who want to quit smoking. In Japan, it was filed for approval by the Ministry of Health, Labor and Welfare (MHLW) in June 2006 and it was approved on January 25, 2008.
Champix is Japan's first oral smoking cessation aid developed for smoking cessation treatment. Current 'Nicotine Replacement Therapy' relieves withdrawal symptoms associated with smoking cessation by replacing tobacco with nicotine. Champix brings about a smoking cessation effect as a non-nicotine partial agonist(1) that binds to alpha(4)beta(2) nicotine receptors in the brain with strong affinity.
Champix relieves withdrawal symptoms and tobacco craving associated with smoking cessation by acting as an agonist for alpha(4)beta(2) nicotine receptors in the brain, which are associated with nicotine dependence. At the same time, if a person smokes a cigarette while receiving treatment, Champix acts as an antagonist to inhibit nicotine from binding to alpha(4)beta(2) nicotine receptors, restricting the patient's sense of satisfaction associated with smoking.
In a 12-week, randomized, double-blind, placebo-controlled study in Japanese smokers who wanted to quit smoking, the primary endpoint (the 4 consecutive-week smoking cessation rate between Week 9 and Week 12) was 65.4 percent (85/130 cases) in patients receiving 1mg Champix twice-daily and 39.5 percent in the placebo group (51/129 cases) respectively, showing a statistically significant difference between the two groups.
Many smokers are suffering from nicotine dependence. At the same time, many smokers who desire and attempt to quit smoking end up without cessation.(2) Nicotine dependence is a chronic disease that is difficult to overcome solely with a smoker's willpower. To successfully quit smoking, a combination of medical support and medication is effective. Pfizer Japan believes that by introducing Champix, we will be able to help many nicotine dependent smokers quit smoking successfully, thus creating a healthier environment in Japan.
Champix was launched under the product name of Chantix(R) in August 2006 in the United States and of Champix(R) in December 2006 in European Union. At present, the product is approved in more than 60 countries around the world, and used for smokers who want to quit smoking. In Japan, it was filed for approval by the Ministry of Health, Labor and Welfare (MHLW) in June 2006 and it was approved on January 25, 2008.
FDA Approves Emend (fosaprepitant dimeglumine) for Injection, Merck's New Intravenous Therapy
Jan 29, 2008 - Merck & Co., Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved EMEND(R) (fosaprepitant dimeglumine) for Injection, a new intravenous therapy for the prevention of chemotherapy-induced nausea and vomiting (CINV). EMEND for Injection is an intravenous prodrug of the oral formulation of EMEND(R) (aprepitant), which means that when EMEND for Injection is administered, fosaprepitant is rapidly converted in the body to aprepitant. EMEND for Injection is approved for use in combination with other antiemetic medicines for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic and highly emetogenic cancer chemotherapy, including high-dose cisplatin.
EMEND for Injection (115 mg) provides a new option for patients receiving an antiemetic on Day 1 of their chemotherapy. EMEND for Injection (115 mg) may be substituted for the 125 mg oral capsule of EMEND on Day 1 and is administered 30 minutes prior to the initiation of chemotherapy over a 15-minute period. The three-day antiemetic regimen includes EMEND for Injection (115 mg) or EMEND (125 mg orally) on Day 1; EMEND (80 mg orally) on Days 2 and 3; in addition to a corticosteroid and a 5-HT3 antagonist.
"Nausea and vomiting are among the top concerns that people have when they receive chemotherapy and, to an oncologist, are very important to control," said Lee Schwartzberg, M.D., clinical oncologist and professor of medicine at the University of Tennessee Health Science Center. "While the oral formulation of EMEND is appropriate for many patients, the approval of EMEND for Injection provides healthcare professionals and their patients with a new option in helping to prevent nausea and vomiting caused by chemotherapy."
The FDA approval for EMEND for Injection was based on a study that showed 115 mg of intravenous EMEND for Injection was biologically equivalent to 125 mg of oral EMEND. Adverse events reported in the study, regardless of causality, included infusion site pain (7.6 percent), infusion site induration (1.5 percent) and headache (3 percent). Because EMEND for Injection is converted to aprepitant, common side effects observed with oral EMEND might also be expected to occur with EMEND for Injection, including tiredness, nausea, hiccups, constipation, diarrhea, loss of appetite, headache and hair loss.
EMEND for Injection (115 mg) provides a new option for patients receiving an antiemetic on Day 1 of their chemotherapy. EMEND for Injection (115 mg) may be substituted for the 125 mg oral capsule of EMEND on Day 1 and is administered 30 minutes prior to the initiation of chemotherapy over a 15-minute period. The three-day antiemetic regimen includes EMEND for Injection (115 mg) or EMEND (125 mg orally) on Day 1; EMEND (80 mg orally) on Days 2 and 3; in addition to a corticosteroid and a 5-HT3 antagonist.
"Nausea and vomiting are among the top concerns that people have when they receive chemotherapy and, to an oncologist, are very important to control," said Lee Schwartzberg, M.D., clinical oncologist and professor of medicine at the University of Tennessee Health Science Center. "While the oral formulation of EMEND is appropriate for many patients, the approval of EMEND for Injection provides healthcare professionals and their patients with a new option in helping to prevent nausea and vomiting caused by chemotherapy."
The FDA approval for EMEND for Injection was based on a study that showed 115 mg of intravenous EMEND for Injection was biologically equivalent to 125 mg of oral EMEND. Adverse events reported in the study, regardless of causality, included infusion site pain (7.6 percent), infusion site induration (1.5 percent) and headache (3 percent). Because EMEND for Injection is converted to aprepitant, common side effects observed with oral EMEND might also be expected to occur with EMEND for Injection, including tiredness, nausea, hiccups, constipation, diarrhea, loss of appetite, headache and hair loss.
EntreMed begins phase II study of ovarian cancer drug
EntreMed, Inc, a clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer and inflammatory diseases, has initiated a phase II study with its novel cell cycle inhibitor, MKC-1, in recurrent or resistant epithelial ovarian cancer and advanced endometrial cancer patients.
The primary objective of this phase II study will be to determine the antitumour activity of MKC-1 administered orally as a single agent in platinum or taxane refractory ovarian and endometrial cancer patients. In addition, safety, response duration in patients with an objective response, and progression free survival (PFS) will also be assessed. The study will be a two arm parallel group design with each group having two stages.
MKC-1 is a novel, orally-active cell cycle inhibitor with in vitro and in vivo efficacy against a broad range of human solid tumour cell lines, including multi-drug resistant cell lines. Data from previous studies with MKC-1 demonstrate broad-acting antitumour effects, showing tumour growth inhibition or regression in multiple preclinical models, including paclitaxel-resistant models.
MKC-1 has been shown to inhibit mitotic spindle formation, prevent chromosome segregation in the M-phase (mitosis) of the cell cycle, and induce apoptosis. Furthermore, MKC-1 inhibits the Akt-mTOR signalling pathways, which may occur through inhibition of the mTOR/rictor pathway. The Akt-mTOR pathway is the most frequently mutated pathway in human tumours and mutations have been shown to promote tumour progression and decrease survival in cancer patients.
The study will be conducted at multiple sites in Canada with Dr. Amit Oza, Senior Staff Physician and Associate Professor of Medicine, Princess Margaret Hospital, University of Toronto, serving as the principal investigator.
Commencement of this phase II multi-centre study represents the continuation of our focus on the development of MKC-1 in diseases where, based on its mechanism of action, we would expect activity," commented Carolyn F. Sidor, M.D., M.B.A., vice president and chief medical officer, EntreMed. "We now have five clinical trials underway to test the safety and efficacy of MKC-1 in solid and haematological cancers, including two clinical development programs in Canada. We expect to invest in further clinical trials during 2008 to test the extent of MKC-1's clinical utility in multiple tumour types.
"Ovarian cancer accounts for 4 per cent of all cancers among women in the United States, and ranks fifth as the cause of cancer deaths. The American Cancer Society estimates that there will be approximately 22,000 newly diagnosed cases of ovarian cancer in the US in 2007 resulting in approximately 15,000 deaths. Whereas, endometrial cancer, the most common cancer found in women's reproductive organs, starts in the inner lining of the uterus (endometrium). The American Cancer Society estimates that there will be approximately 39,000 new cases of cancer of the uterine body diagnosed in the US in 2007, resulting in approximately 7,400 deaths.
The primary objective of this phase II study will be to determine the antitumour activity of MKC-1 administered orally as a single agent in platinum or taxane refractory ovarian and endometrial cancer patients. In addition, safety, response duration in patients with an objective response, and progression free survival (PFS) will also be assessed. The study will be a two arm parallel group design with each group having two stages.
MKC-1 is a novel, orally-active cell cycle inhibitor with in vitro and in vivo efficacy against a broad range of human solid tumour cell lines, including multi-drug resistant cell lines. Data from previous studies with MKC-1 demonstrate broad-acting antitumour effects, showing tumour growth inhibition or regression in multiple preclinical models, including paclitaxel-resistant models.
MKC-1 has been shown to inhibit mitotic spindle formation, prevent chromosome segregation in the M-phase (mitosis) of the cell cycle, and induce apoptosis. Furthermore, MKC-1 inhibits the Akt-mTOR signalling pathways, which may occur through inhibition of the mTOR/rictor pathway. The Akt-mTOR pathway is the most frequently mutated pathway in human tumours and mutations have been shown to promote tumour progression and decrease survival in cancer patients.
The study will be conducted at multiple sites in Canada with Dr. Amit Oza, Senior Staff Physician and Associate Professor of Medicine, Princess Margaret Hospital, University of Toronto, serving as the principal investigator.
Commencement of this phase II multi-centre study represents the continuation of our focus on the development of MKC-1 in diseases where, based on its mechanism of action, we would expect activity," commented Carolyn F. Sidor, M.D., M.B.A., vice president and chief medical officer, EntreMed. "We now have five clinical trials underway to test the safety and efficacy of MKC-1 in solid and haematological cancers, including two clinical development programs in Canada. We expect to invest in further clinical trials during 2008 to test the extent of MKC-1's clinical utility in multiple tumour types.
"Ovarian cancer accounts for 4 per cent of all cancers among women in the United States, and ranks fifth as the cause of cancer deaths. The American Cancer Society estimates that there will be approximately 22,000 newly diagnosed cases of ovarian cancer in the US in 2007 resulting in approximately 15,000 deaths. Whereas, endometrial cancer, the most common cancer found in women's reproductive organs, starts in the inner lining of the uterus (endometrium). The American Cancer Society estimates that there will be approximately 39,000 new cases of cancer of the uterine body diagnosed in the US in 2007, resulting in approximately 7,400 deaths.
First and Only Once-Daily Mesalamine for Active, Mild to Moderate Ulcerative Colitis Now Available in Canada
Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ), the global specialty biopharmaceutical company, today announced the availability in Canada of Mezavant(R)* (mesalamine delayed and extended release tablets) with Multi Matrix System (MMX(TM)(xx)) Technology, indicated for the induction of clinical and endoscopic remission in patients with active, mild to moderate ulcerative colitis (UC), a type of inflammatory bowel disease. Mezavant is the first and only Health Canada approved once-daily oral formulation of mesalamine, and the first mesalamine to be approved by Health Canada for the induction of clinical and endoscopic remission.
MEZAVANT is the only ulcerative colitis treatment that utilizes MMX Technology, which combines a pH dependent gastro-resistant coating, thus delaying and extending the delivery of effective concentrations of mesalamine to the site of inflammation in the colon over an extended period of time (from six hours after dosing to beyond 24 hours post-dose). It is available by prescription for oral administration in dosages of 2.4g/day to 4.8g/day, allowing patients to take as few as two tablets, once-daily. Other currently available mesalamines require two to four times daily dosing and up to eight pills a day.
In a chronic, life-long disease such as ulcerative colitis, complex therapy regimens make it difficult for a patient to strictly adhere to therapy, often leading to non-compliance. Two North American Internet surveys(1) conducted with ulcerative colitis patients (n equals 451) and gastroenterologists (n equals 300) reflected this difficulty of adherence with current 5-ASA therapy. Both patients and gastroenterologists reported that managing UC medication is a struggle for patients (49 per cent and 41 per cent respectively) and that it is difficult for patients to take medication as prescribed every day (42 per cent and 90 per cent respectively). This difficulty is further exemplified by the fact that 46 per cent of patients reported not taking all of their medication in the past week.
"The more complicated and varied a dosing regimen is for a patient, the less likely they are to strictly adhere to it, leading to reduced efficacy and ultimately sub-par disease control and low quality of life," states Dr. A. Hillary Steinhart, Head, Combined Division of Gastroenterology, Mt. Sinai Hospital and the University Health Network, Toronto, Ontario. "The availability of Mezavant, with its convenient once-daily dosing, will go a long way in helping address the compliance issues facing Canadian ulcerative colitis patients, allowing them to overcome the disruptions to their life that can be caused by their disease."
"Although not everyone's experience is the same, my complicated pill schedule seems to consume my life - my next dosage is constantly on my mind, and I still occasionally forget a dose" says James Mireau, an ulcerative colitis patient from Edmonton, Alberta. "I have enough to concern myself with due to my disease; taking my pills once-a-day will certainly make my life easier by allowing me the freedom to focus on the more important things, like family." The approval of MEZAVANT was based on the results of two, three-armed, Phase III clinical studies comparing the efficacy of MEZAVANT 2.4g/day, 4.8g/day and placebo after eight weeks of treatment. The primary efficacy endpoint in both trials was based on a composite endpoint indicative of clinical remission and mucosal healing, the first time a mesalamine trial has included both. Remission was defined as a modified Ulcerative Colitis Disease Activity Index (UC-DAI) score of less than 1.
The first study(2) assessed the efficacy and safety of MEZAVANT at 2.4g/day given in divided doses twice-daily and at 4.8g/day given once-daily against placebo (n equals 262). At eight weeks, both doses demonstrated statistically significant superiority over placebo in the induction of remission. The second study(3) assessed the efficacy and safety of MEZAVANT 2.4g/day and 4.8g/day, both given once-daily versus placebo (n equals 255). At eight weeks, both once-daily doses demonstrated statistically significant superiority over placebo in the induction of remission. "Effective, safe and convenient therapy options are imperative for gastroenterologists treating ulcerative colitis. Based on the results from its clinical trials, Mezavant will be a welcome addition to our armamentarium to help induce remission in ulcerative colitis patients," adds Dr. Steinhart.
Important Safety Information
MEZAVANT is generally well tolerated. The majority of adverse events in the double-blind, placebo-controlled trials were mild or moderate. In clinical trials (n equals 535), the most common treatment-related adverse events with MEZAVANT were headache and flatulence.
MEZAVANT is the only ulcerative colitis treatment that utilizes MMX Technology, which combines a pH dependent gastro-resistant coating, thus delaying and extending the delivery of effective concentrations of mesalamine to the site of inflammation in the colon over an extended period of time (from six hours after dosing to beyond 24 hours post-dose). It is available by prescription for oral administration in dosages of 2.4g/day to 4.8g/day, allowing patients to take as few as two tablets, once-daily. Other currently available mesalamines require two to four times daily dosing and up to eight pills a day.
In a chronic, life-long disease such as ulcerative colitis, complex therapy regimens make it difficult for a patient to strictly adhere to therapy, often leading to non-compliance. Two North American Internet surveys(1) conducted with ulcerative colitis patients (n equals 451) and gastroenterologists (n equals 300) reflected this difficulty of adherence with current 5-ASA therapy. Both patients and gastroenterologists reported that managing UC medication is a struggle for patients (49 per cent and 41 per cent respectively) and that it is difficult for patients to take medication as prescribed every day (42 per cent and 90 per cent respectively). This difficulty is further exemplified by the fact that 46 per cent of patients reported not taking all of their medication in the past week.
"The more complicated and varied a dosing regimen is for a patient, the less likely they are to strictly adhere to it, leading to reduced efficacy and ultimately sub-par disease control and low quality of life," states Dr. A. Hillary Steinhart, Head, Combined Division of Gastroenterology, Mt. Sinai Hospital and the University Health Network, Toronto, Ontario. "The availability of Mezavant, with its convenient once-daily dosing, will go a long way in helping address the compliance issues facing Canadian ulcerative colitis patients, allowing them to overcome the disruptions to their life that can be caused by their disease."
"Although not everyone's experience is the same, my complicated pill schedule seems to consume my life - my next dosage is constantly on my mind, and I still occasionally forget a dose" says James Mireau, an ulcerative colitis patient from Edmonton, Alberta. "I have enough to concern myself with due to my disease; taking my pills once-a-day will certainly make my life easier by allowing me the freedom to focus on the more important things, like family." The approval of MEZAVANT was based on the results of two, three-armed, Phase III clinical studies comparing the efficacy of MEZAVANT 2.4g/day, 4.8g/day and placebo after eight weeks of treatment. The primary efficacy endpoint in both trials was based on a composite endpoint indicative of clinical remission and mucosal healing, the first time a mesalamine trial has included both. Remission was defined as a modified Ulcerative Colitis Disease Activity Index (UC-DAI) score of less than 1.
The first study(2) assessed the efficacy and safety of MEZAVANT at 2.4g/day given in divided doses twice-daily and at 4.8g/day given once-daily against placebo (n equals 262). At eight weeks, both doses demonstrated statistically significant superiority over placebo in the induction of remission. The second study(3) assessed the efficacy and safety of MEZAVANT 2.4g/day and 4.8g/day, both given once-daily versus placebo (n equals 255). At eight weeks, both once-daily doses demonstrated statistically significant superiority over placebo in the induction of remission. "Effective, safe and convenient therapy options are imperative for gastroenterologists treating ulcerative colitis. Based on the results from its clinical trials, Mezavant will be a welcome addition to our armamentarium to help induce remission in ulcerative colitis patients," adds Dr. Steinhart.
Important Safety Information
MEZAVANT is generally well tolerated. The majority of adverse events in the double-blind, placebo-controlled trials were mild or moderate. In clinical trials (n equals 535), the most common treatment-related adverse events with MEZAVANT were headache and flatulence.
Johnson and Johnson submits NDA for tapentadol
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for tapentadol hydrochloride immediate release (IR) tablets, an investigational oral analgesic for the relief of moderate to severe acute pain.
Tapentadol is a novel investigational, centrally acting oral analgesic. It has a unique profile with two mechanisms of action, combining mu-opioid receptor agonism and norepinephrine reuptake inhibition in a single molecule. It is being developed in immediate-release and extended-release formulations.
According to the American Pain Foundation, more than 25 million Americans experience acute pain each year as a result of injuries or surgeries, and a recent study estimated that 42 per cent of US hospital emergency department visits were due to pain-related problems.
Mu-opioid agonists are drugs that bind to mu-opioid receptors in the central nervous system. These drugs modify sensory and affective (mood) aspects of pain, inhibit the transmission of pain at the spinal cord and affect activity at parts of the brain that control how pain is perceived. Norepinephrine reuptake inhibitors are a type of central nervous system medication that increases the level of norepinephrine in the brain by inhibiting its re-absorption into nerve cells; these compounds have analgesic properties.
The submission is based on a full clinical development program for tapentadol. The program includes two phase III multi-centre studies that explored the efficacy and safety of multiple doses of the tapentadol IR formulation either for the treatment of acute pain in patients undergoing bunionectomy surgery or for patients with degenerative, end-stage joint disease of the hip or knee. The data from these clinical trials suggest that tapentadol has efficacy comparable to strong opioids.
Bunionectomy is a standard foot surgery. The predictable level of moderate to severe pain for several days following this surgery makes bunionectomy an appropriate model for assessing the efficacy of potent analgesics.
Data also were submitted to the FDA from an additional Phase 3 study that supported the safety profile of multiple doses of tapentadol IR in the treatment of outpatients with low back pain or pain from osteoarthritis of the hip or the knee.
More than 1,800 patients have been treated with tapentadol immediate release tablets in clinical trials to date.The most common adverse reactions in tapentadol phase II/III multiple dose, placebo- and active-controlled efficacy and safety studies (=10 per cent) were nausea, dizziness, vomiting, somnolence (sleepiness) and headache.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) is conducting the clinical program for tapentadol in the United States. J&JPRD submitted the new drug application (NDA) for tapentadol on behalf of Ortho-McNeil-Janssen Pharmaceuticals, Inc., an affiliated company that will hold the NDA for tapentadol.
Tapentadol is a novel investigational, centrally acting oral analgesic. It has a unique profile with two mechanisms of action, combining mu-opioid receptor agonism and norepinephrine reuptake inhibition in a single molecule. It is being developed in immediate-release and extended-release formulations.
According to the American Pain Foundation, more than 25 million Americans experience acute pain each year as a result of injuries or surgeries, and a recent study estimated that 42 per cent of US hospital emergency department visits were due to pain-related problems.
Mu-opioid agonists are drugs that bind to mu-opioid receptors in the central nervous system. These drugs modify sensory and affective (mood) aspects of pain, inhibit the transmission of pain at the spinal cord and affect activity at parts of the brain that control how pain is perceived. Norepinephrine reuptake inhibitors are a type of central nervous system medication that increases the level of norepinephrine in the brain by inhibiting its re-absorption into nerve cells; these compounds have analgesic properties.
The submission is based on a full clinical development program for tapentadol. The program includes two phase III multi-centre studies that explored the efficacy and safety of multiple doses of the tapentadol IR formulation either for the treatment of acute pain in patients undergoing bunionectomy surgery or for patients with degenerative, end-stage joint disease of the hip or knee. The data from these clinical trials suggest that tapentadol has efficacy comparable to strong opioids.
Bunionectomy is a standard foot surgery. The predictable level of moderate to severe pain for several days following this surgery makes bunionectomy an appropriate model for assessing the efficacy of potent analgesics.
Data also were submitted to the FDA from an additional Phase 3 study that supported the safety profile of multiple doses of tapentadol IR in the treatment of outpatients with low back pain or pain from osteoarthritis of the hip or the knee.
More than 1,800 patients have been treated with tapentadol immediate release tablets in clinical trials to date.The most common adverse reactions in tapentadol phase II/III multiple dose, placebo- and active-controlled efficacy and safety studies (=10 per cent) were nausea, dizziness, vomiting, somnolence (sleepiness) and headache.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) is conducting the clinical program for tapentadol in the United States. J&JPRD submitted the new drug application (NDA) for tapentadol on behalf of Ortho-McNeil-Janssen Pharmaceuticals, Inc., an affiliated company that will hold the NDA for tapentadol.
Oncolytics Biotech Inc. Announces Issuance of 8th Canadian Patent
Oncolytics Biotech Inc. ("Oncolytics") has been granted Canadian Patent 2,408,251 entitled "Clearance of Neoplastic Cells from Mixed Cellular Compositions using Viruses." The claims describe methods of selectively removing cancer cells ex vivo from blood stem cells and other organs using various viruses including modified vaccinia viruses, herpes simplex viruses, parapoxviruses and adenoviruses.
"This patent broadens coverage in the area of using other modified oncolytic viruses to purge contaminating cancer cells from stem cell preparations used for transplants," said Dr. Matt Coffey, Chief Scientific Officer of Oncolytics.
"This patent broadens coverage in the area of using other modified oncolytic viruses to purge contaminating cancer cells from stem cell preparations used for transplants," said Dr. Matt Coffey, Chief Scientific Officer of Oncolytics.
Generex Biotechnology Awarded New European Patent
Generex Biotechnology Corporation (Nasdaq:GNBT) announced today that the European Patent Office has granted the Company a new European patent, titled "Mixed Micellar Delivery System and Method of Preparation."
The patent will be validated in eleven European countries including the U.K., France and Germany. The patent contains process and formulation claims to a pharmaceutical formulation for delivery through the mucosal membranes.
"We are pleased to continue to expand our patent portfolio in Europe, which is part of the Company's European and global growth strategy," said Rose C. Perri, the Company's Chief Operating Officer.
Generex currently holds an aggregate of 123 patents worldwide (21 of which are United States Patents) and has an aggregate of 92 patent applications pending in various jurisdictions.
The patent will be validated in eleven European countries including the U.K., France and Germany. The patent contains process and formulation claims to a pharmaceutical formulation for delivery through the mucosal membranes.
"We are pleased to continue to expand our patent portfolio in Europe, which is part of the Company's European and global growth strategy," said Rose C. Perri, the Company's Chief Operating Officer.
Generex currently holds an aggregate of 123 patents worldwide (21 of which are United States Patents) and has an aggregate of 92 patent applications pending in various jurisdictions.
China Pharma Holdings, Inc. Receives Chinese SFDA Approval for Generic Bumetanide Injection
China Pharma Holdings, Inc. ("China Pharma") which develops, manufactures, and markets generic and brand bio-pharmaceutical products in China, announced today that it has received approval from the Chinese State Food and Drug Administration (SFDA) for the production of generic Bumetanide injection which is used to manage hypertension and edema associated with congestive heart failure, cirrhosis, and renal disease, including the nephrotic syndrome by inducing dieresis.
Monday, January 28, 2008
Natco gets a stay for Imatinib
As per the article published by Mr. Sandeep Rathod on http://genericpharmaceuticals.blogspot.com/
Natco has received a stay from the Supreme Court against the Chennai High Courts’ order for the IPAB hearing of Novartis’ appeals [for Imatinib] without a technical member.
The Chennai High Court had earlier decided that the IPAB could hear an appeal without a technical member.
Natco had then declared that it would go to the Supreme Court to against this decision for the constitution of the Bench comprising its Chairman and Vice-Chairman to hear the appeals, without a technical member
Natco has received a stay from the Supreme Court against the Chennai High Courts’ order for the IPAB hearing of Novartis’ appeals [for Imatinib] without a technical member.
The Chennai High Court had earlier decided that the IPAB could hear an appeal without a technical member.
Natco had then declared that it would go to the Supreme Court to against this decision for the constitution of the Bench comprising its Chairman and Vice-Chairman to hear the appeals, without a technical member
GSK to revise labelling for Avandia to add new warnings
As per the recommendations made by the European regulators, GlaxoSmithKline (GSK) will revise labelling on its diabetes product Avandia to include additional warnings that the product may be associated with an increased risk of heart attacks.
The label will be revised to state that available data indicate that rosiglitazone may be associated with an increased risk of myocardial ischaemic events. It will also state that this risk was not confirmed or excluded in three long-term clinical trials and the data in their entirety on myocardial ischaemia are inconclusive.
The EMEA's Committee for Medicinal Products for Human Use (CHMP) completed a positive benefit risk review of the thiazolidinediones (TZDs) including rosiglitazone in October 2007 and these label amendments are the result of this process.
There are limited clinical trial data in patients with ischaemic heart disease and/or peripheral arterial disease, especially those with myocardial ischaemic symptoms. The revised label will state that as a precaution, the use of rosiglitazone is not recommended in these patients. This information will appear in the warnings and precautions section of the label.
Patients with acute coronary syndrome (unstable angina, NSTEMI and STEMI) require urgent hospital treatment and have an increased risk of developing heart failure. This high-risk patient population has not been studied in rosiglitazone controlled clinical trials, and revised labelling will advise prescribers that rosiglitazone is contraindicated in patients with acute coronary syndrome.
"The EMEA has previously concluded that the benefits of rosiglitazone continue to outweigh its risks. The revisions to the rosiglitazone label resulting from this review will provide some additional guidance to physicians prescribing rosiglitazone," said Dr Alastair Benbow, vice president and European medical director, GSK.
The label changes will be applied to all approved rosiglitazone-containing products: Avandia (rosiglitazone maleate), Avandamet (rosiglitazone maleate and metformin hydrochloride) and Avaglim (rosiglitazone maleate and glimepiride).
"Long-term glycaemic control is important to help prevent the serious complications of diabetes, especially microvascular complications leading to blindness, amputation and kidney failure. Rosiglitazone has been shown to control blood sugar for longer than the most commonly used oral anti-diabetic medicines, metformin and glibenclamide (a sulfonylurea) - for nearly five years. Rosiglitazone is a valuable medicine for many patients with type 2 diabetes and remains an important treatment option for physicians." added Dr Benbow.
Rosiglitazone helps improve blood sugar control in Type 2 diabetes. It may be taken alone by diabetic patients who cannot take metformin, in combination with metformin or a sulphonylurea, or with both metformin and a sulphonylurea. It is contraindicated for use in combination with insulin.
The label will be revised to state that available data indicate that rosiglitazone may be associated with an increased risk of myocardial ischaemic events. It will also state that this risk was not confirmed or excluded in three long-term clinical trials and the data in their entirety on myocardial ischaemia are inconclusive.
The EMEA's Committee for Medicinal Products for Human Use (CHMP) completed a positive benefit risk review of the thiazolidinediones (TZDs) including rosiglitazone in October 2007 and these label amendments are the result of this process.
There are limited clinical trial data in patients with ischaemic heart disease and/or peripheral arterial disease, especially those with myocardial ischaemic symptoms. The revised label will state that as a precaution, the use of rosiglitazone is not recommended in these patients. This information will appear in the warnings and precautions section of the label.
Patients with acute coronary syndrome (unstable angina, NSTEMI and STEMI) require urgent hospital treatment and have an increased risk of developing heart failure. This high-risk patient population has not been studied in rosiglitazone controlled clinical trials, and revised labelling will advise prescribers that rosiglitazone is contraindicated in patients with acute coronary syndrome.
"The EMEA has previously concluded that the benefits of rosiglitazone continue to outweigh its risks. The revisions to the rosiglitazone label resulting from this review will provide some additional guidance to physicians prescribing rosiglitazone," said Dr Alastair Benbow, vice president and European medical director, GSK.
The label changes will be applied to all approved rosiglitazone-containing products: Avandia (rosiglitazone maleate), Avandamet (rosiglitazone maleate and metformin hydrochloride) and Avaglim (rosiglitazone maleate and glimepiride).
"Long-term glycaemic control is important to help prevent the serious complications of diabetes, especially microvascular complications leading to blindness, amputation and kidney failure. Rosiglitazone has been shown to control blood sugar for longer than the most commonly used oral anti-diabetic medicines, metformin and glibenclamide (a sulfonylurea) - for nearly five years. Rosiglitazone is a valuable medicine for many patients with type 2 diabetes and remains an important treatment option for physicians." added Dr Benbow.
Rosiglitazone helps improve blood sugar control in Type 2 diabetes. It may be taken alone by diabetic patients who cannot take metformin, in combination with metformin or a sulphonylurea, or with both metformin and a sulphonylurea. It is contraindicated for use in combination with insulin.
Matrix acquires residual holding in MChem, China
Matrix Laboratories Ltd, through its wholly owned subsidiary, has acquired the residual shareholding in MChem group of companies, China. Consequent upon the receipt of the applicable approvals, the transaction for purchase of the residual stake has been completed. With the purchase of the residual stake, the effective holding of the company in MChem group of companies, through its wholly owned subsidiary, stands at 97 per cent.
MChem manufactures a number of intermediates and Active Pharmaceutical Ingredients (APIs). Therefore, the acquisition of the residual stake of erstwhile promoter is strategic for enhancing the vertical integration opportunities for Mylan and Matrix.
MChem manufactures a number of intermediates and Active Pharmaceutical Ingredients (APIs). Therefore, the acquisition of the residual stake of erstwhile promoter is strategic for enhancing the vertical integration opportunities for Mylan and Matrix.
Clexane/Lovenox Approved in Japan
Sanofi-aventis announced today that the anticoagulant Clexane(R) (enoxaparin sodium injection) has been approved for marketing in Japan by the Ministry of Health, Labour and Welfare for the prevention of venous thromboembolism (VTE) in patients undergoing orthopaedic surgery of the lower limbs such as total hip replacement, total knee replacement and hip fracture surgery.
Nexavar Approved for the Treatment of Kidney Cancer in Japan
According to the article published in Pharmalive
Bayer has been granted marketing approval of Nexavar® in Japan for the treatment of advanced renall cell carcinoma (RCC), the most common form of kidney cancer. Nexavar is an oral multi-kinase inhibitor jointly developed by Bayer HealthCare AG and Onyx Pharmaceuticals, Inc. which targets both the tumor cell and tumor vasculature. In Japan, Nexavar is the first approved oral targeted therapy for metastatic RCC.
“This approval of Nexavar is a crucial step for patients with advanced kidney cancer in Japan”, said Dr. Gunnar Riemann, member of the Board of Management of Bayer Schering Pharma AG. “This is also a major accomplishment for the company's oncology franchise in Japan.”
The new drug application (NDA) for Nexavar in RCC was filed in June 2006. In September 2007, an additional application for the treatment of hepatocellular carcinoma (HCC) was filed. Japanese authorities recently granted priority review status for Nexavar in this indication.
Bayer has been granted marketing approval of Nexavar® in Japan for the treatment of advanced renall cell carcinoma (RCC), the most common form of kidney cancer. Nexavar is an oral multi-kinase inhibitor jointly developed by Bayer HealthCare AG and Onyx Pharmaceuticals, Inc. which targets both the tumor cell and tumor vasculature. In Japan, Nexavar is the first approved oral targeted therapy for metastatic RCC.
“This approval of Nexavar is a crucial step for patients with advanced kidney cancer in Japan”, said Dr. Gunnar Riemann, member of the Board of Management of Bayer Schering Pharma AG. “This is also a major accomplishment for the company's oncology franchise in Japan.”
The new drug application (NDA) for Nexavar in RCC was filed in June 2006. In September 2007, an additional application for the treatment of hepatocellular carcinoma (HCC) was filed. Japanese authorities recently granted priority review status for Nexavar in this indication.
Alnylam Announces Grant of New Patent Covering RNAi Therapeutics in the United Kingdom
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced today that the United Kingdom Patent Office has granted a patent (UK 2417727 or "'727 patent") for the Woppman et al. patent series, entitled "Double-stranded ribonucleic acid with increased effectiveness in an organism." The newly granted patent includes 32 claims broadly covering compositions and methods, including pharmaceutical compositions, for small interfering RNAs (siRNAs), the molecules that mediate RNAi. The claims cover siRNA molecules of any length that contain "overhang" and "blunt end" design features, including siRNAs containing chemical modifications and certain novel motifs.
"Our intellectual property estate for RNAi therapeutics continues to grow substantially as evidenced by this new patent grant, the first in a distinct patent series that describes important design features for RNAi therapeutics. With this progress, we are extending the scope of our comprehensive 'first-mover' consolidation of early filed RNAi fundamental patents and patent applications," said Barry Greene, President and Chief Operating Officer of Alnylam. "We expect that many additional patents owned or licensed exclusively to Alnylam will be awarded this year and in the years to come, broadening the sphere of our patent portfolio for siRNAs in markets across the world."
"Our intellectual property estate for RNAi therapeutics continues to grow substantially as evidenced by this new patent grant, the first in a distinct patent series that describes important design features for RNAi therapeutics. With this progress, we are extending the scope of our comprehensive 'first-mover' consolidation of early filed RNAi fundamental patents and patent applications," said Barry Greene, President and Chief Operating Officer of Alnylam. "We expect that many additional patents owned or licensed exclusively to Alnylam will be awarded this year and in the years to come, broadening the sphere of our patent portfolio for siRNAs in markets across the world."
Mylan Provides Update Relating to Ongoing Lorazepam and Clorazepate Litigation
Mylan Inc. today announced that it intends to appeal a Jan. 24, 2008 decision by the U.S. District Court for the District of Columbia against Mylan and its co- defendants Cambrex Corporation and Gyma Laboratories in the last of the pending Lorazepam and Clorazepate antitrust cases. The first related suit had been filed in 1998.
As previously disclosed, in June 2005, a jury in the district court had rendered a verdict against Mylan and its co-defendants. The parties subsequently filed various post-trial motions, and the January 24 decision resolved several of those motions. The district court ordered Mylan to pay $35,906,922. The court also ordered Cambrex and Gyma to pay $16,709,242 each, some or all of which may be subject to indemnification obligations by Mylan. Plaintiffs' motion for attorneys' fees remains pending.
Mylan intends to immediately appeal the decision and will continue to vigorously defend itself in the litigation.
Mylan Inc. is one of the world's leading quality generic and specialty pharmaceutical companies. The Company offers one of the industry's broadest and highest quality product portfolios, a robust product pipeline and a global commercial footprint through operations in more than 90 countries. Through its controlling interest in Matrix Laboratories Limited, Mylan has direct access to one of the largest active pharmaceutical ingredient (API) manufacturers in the world. Dey, L.P., Mylan's fully integrated specialty business, provides the Company with innovative and diversified opportunities in the respiratory and allergy therapeutic areas.
As previously disclosed, in June 2005, a jury in the district court had rendered a verdict against Mylan and its co-defendants. The parties subsequently filed various post-trial motions, and the January 24 decision resolved several of those motions. The district court ordered Mylan to pay $35,906,922. The court also ordered Cambrex and Gyma to pay $16,709,242 each, some or all of which may be subject to indemnification obligations by Mylan. Plaintiffs' motion for attorneys' fees remains pending.
Mylan intends to immediately appeal the decision and will continue to vigorously defend itself in the litigation.
Mylan Inc. is one of the world's leading quality generic and specialty pharmaceutical companies. The Company offers one of the industry's broadest and highest quality product portfolios, a robust product pipeline and a global commercial footprint through operations in more than 90 countries. Through its controlling interest in Matrix Laboratories Limited, Mylan has direct access to one of the largest active pharmaceutical ingredient (API) manufacturers in the world. Dey, L.P., Mylan's fully integrated specialty business, provides the Company with innovative and diversified opportunities in the respiratory and allergy therapeutic areas.
Endo and Penwest File Lawsuit Against Impax Laboratories Relating to Opana ER
CHADDS FORD, PA and DANBURY, CT, Jan 25, 2008 (MARKET WIRE via COMTEX News Network) -- 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 Impax Laboratories, Inc. in the United States District Court for the District of Delaware in connection with Impax's Abbreviated New Drug Application (ANDA) for Opana ER (oxymorphone HCl) extended-release tablets CII. The lawsuit is in response to IMPAX's notice to Endo and Penwest, announced on December 17, 2007, advising of the FDA's acceptance for substantive review, as of November 23, 2007, of IMPAX's ANDA containing a Paragraph IV certification under 21 U.S.C. Section 355(j) for oxymorphone hydrochloride extended-release tablets CII. IMPAX stated in its Paragraph IV certification notice letter that the FDA requested IMPAX to provide notification to Endo and Penwest of this certification.
IMPAX's Paragraph IV certification notice refers to certain Penwest patents listed in the FDA's Orange Book relating to the formulation of OPANA ER. The complaint filed today alleges infringement of certain of these Orange Book-listed patents.
As previously disclosed, Endo and Penwest filed a lawsuit against IMPAX on November 15, 2007 in the United States District Court for the District of Delaware in response to a series of Paragraph IV certification notices that Endo and Penwest assert were wrongfully served on them by IMPAX. These prior Paragraph IV Certification Notices related to the same Orange Book-listed patents for OPANA ER and were served on Endo and Penwest after the acceptance of IMPAX's ANDA was rescinded by the FDA. Endo and Penwest continue to believe that these prior Paragraph IV Certification Notices are null, void and of no legal effect.
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.
IMPAX's Paragraph IV certification notice refers to certain Penwest patents listed in the FDA's Orange Book relating to the formulation of OPANA ER. The complaint filed today alleges infringement of certain of these Orange Book-listed patents.
As previously disclosed, Endo and Penwest filed a lawsuit against IMPAX on November 15, 2007 in the United States District Court for the District of Delaware in response to a series of Paragraph IV certification notices that Endo and Penwest assert were wrongfully served on them by IMPAX. These prior Paragraph IV Certification Notices related to the same Orange Book-listed patents for OPANA ER and were served on Endo and Penwest after the acceptance of IMPAX's ANDA was rescinded by the FDA. Endo and Penwest continue to believe that these prior Paragraph IV Certification Notices are null, void and of no legal effect.
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.
Sunday, January 27, 2008
Japan grants priority review status to Bayer's Nexavar
The Japanese health authority (MHLW) has granted Bayer priority review status (fast-track procedure) for marketing authorization of its anticancer drug product Nexavar (sorafenib) for the treatment of hepatocellular carcinoma (HCC). In addition, the contrast agent Primovist (gadoxetic acid disodium) for magnetic resonance imaging of the liver was recently granted regulatory approval in Japan. This product is scheduled to be launched on the Japanese market in the immediate future.
Nexavar, an oral anti-cancer drug, is the first and only drug shown to significantly improve overall survival in patients with HCC. In Japan, Nexavar was filed in June 2006 for the treatment of renal cell carcinoma (RCC) and an additional application for HCC was submitted in September 2007.
Liver cancer is the sixth most common cancer in the world and the third leading cause of cancer-related deaths globally. More than 600,000 cases of liver cancer are diagnosed worldwide each year and incidence is increasing. Japan has the second largest population of liver cancer patients in the world; most of them suffer from HCC which claims 36,000 lives every year. Thus, the medical need for an early and reliable diagnosis and for life-prolonging treatment is high.
"The fact that the Japanese authorities granted priority review status underlines the high medical need for innovative treatments options for patients with liver cancer. This devastating disease is one of the cancers in which the number of related deaths continues to increase," said Paolo Pucci, president, Global Business Unit Oncology, Bayer HealthCare. "We at Bayer are highly committed to expediting the clinical development of this innovative therapy also across additional tumour types."
Primovist is authorized for the detection and characterization of liver lesions by magnetic resonance imaging (MRI) including liver tumours such as hepatocellular carcinomas (HCC), liver metastases and other malignant and benign lesions.
"Primovist is a gadolinium-based contrast medium that offers the possibility to simultaneously detect, locate and distinguish various types of liver lesions, thus providing a powerful tool that increases the diagnostic confidence", said Professor Hans Maier, Head, Global Business Unit Diagnostic Imaging, Bayer Schering Pharma. "Primovist enables radiologists to identify even tiny pathological liver lesions; it thus helps to guide and follow-up on treatment decisions and has the potential to considerably optimize patient benefit."
Nexavar, an oral anti-cancer drug, is the first and only drug shown to significantly improve overall survival in patients with HCC. In Japan, Nexavar was filed in June 2006 for the treatment of renal cell carcinoma (RCC) and an additional application for HCC was submitted in September 2007.
Liver cancer is the sixth most common cancer in the world and the third leading cause of cancer-related deaths globally. More than 600,000 cases of liver cancer are diagnosed worldwide each year and incidence is increasing. Japan has the second largest population of liver cancer patients in the world; most of them suffer from HCC which claims 36,000 lives every year. Thus, the medical need for an early and reliable diagnosis and for life-prolonging treatment is high.
"The fact that the Japanese authorities granted priority review status underlines the high medical need for innovative treatments options for patients with liver cancer. This devastating disease is one of the cancers in which the number of related deaths continues to increase," said Paolo Pucci, president, Global Business Unit Oncology, Bayer HealthCare. "We at Bayer are highly committed to expediting the clinical development of this innovative therapy also across additional tumour types."
Primovist is authorized for the detection and characterization of liver lesions by magnetic resonance imaging (MRI) including liver tumours such as hepatocellular carcinomas (HCC), liver metastases and other malignant and benign lesions.
"Primovist is a gadolinium-based contrast medium that offers the possibility to simultaneously detect, locate and distinguish various types of liver lesions, thus providing a powerful tool that increases the diagnostic confidence", said Professor Hans Maier, Head, Global Business Unit Diagnostic Imaging, Bayer Schering Pharma. "Primovist enables radiologists to identify even tiny pathological liver lesions; it thus helps to guide and follow-up on treatment decisions and has the potential to considerably optimize patient benefit."
Novexel, Forest Labs agreement on NXL104
Novexel, the pharmaceutical company focused on the discovery and development of novel antibacterials and anti-fungals, has entered into an agreement with Forest Laboratories Holdings Limited, a wholly owned subsidiary of Forest Laboratories, Inc., for the development, manufacture and commercialization of Novexel's novel intravenous beta lactamase inhibitor, NXL104 in combination with Forest's ceftaroline. NXL104 is designed to be co-administered with select antibiotics to enhance their spectrum of activity.
Under the terms of the license, Forest will receive the exclusive rights to administer NXL104 with ceftaroline as a combination product in North America.
Ceftaroline is a novel, bactericidal injectable broad spectrum cephalosporin being developed as a therapeutic agent for the treatment of gram-positive pathogens including methicillin resistant staphylococcus aureus (MRSA), and multi-drug resistant streptococcus pneumoniae (MDRSP), as well as common gram-negative organisms. Ceftaroline is being studied as a monotherapy in Phase III clinical trials for complicated skin and skin structure infections and community acquired pneumonia. Forest intends to initiate Phase I studies of the ceftaroline/NXL104 combination in the next fiscal year.
Forest will also receive a first negotiation right in North America to an additional NXL104 combination with ceftazidime, a cephalosporin antibiotic having a different spectrum of activity compared to ceftaroline. This combination is currently being studied in Phase I clinical trials conducted by Novexel. NXL104 inhibits bacterial enzymes called beta-lactamases that break down beta-lactam antibiotics (in particular Penicillins and Cephalosporins). Beta-lactamase inhibition represents a mechanism for counteracting resistance and enhancing broad-spectrum activity of beta-lactam antibiotics. A composition of matter patent which claims NXL104 would provide protection for the ceftaroline/NXL104 combination product until 2022, subject to possible patent term extension.
Under the terms of the agreement, Forest will pay Novexel an upfront license payment of €75 million. Forest will fund development and commercialization of the ceftaroline/NXL104 combination. Additional milestone payments to Novexel if the combination product is successfully developed could total €75 million. Following the product's regulatory marketing approval, Forest will pay Novexel a low double digit royalty on product sales throughout North America.
Under the terms of the license, Forest will receive the exclusive rights to administer NXL104 with ceftaroline as a combination product in North America.
Ceftaroline is a novel, bactericidal injectable broad spectrum cephalosporin being developed as a therapeutic agent for the treatment of gram-positive pathogens including methicillin resistant staphylococcus aureus (MRSA), and multi-drug resistant streptococcus pneumoniae (MDRSP), as well as common gram-negative organisms. Ceftaroline is being studied as a monotherapy in Phase III clinical trials for complicated skin and skin structure infections and community acquired pneumonia. Forest intends to initiate Phase I studies of the ceftaroline/NXL104 combination in the next fiscal year.
Forest will also receive a first negotiation right in North America to an additional NXL104 combination with ceftazidime, a cephalosporin antibiotic having a different spectrum of activity compared to ceftaroline. This combination is currently being studied in Phase I clinical trials conducted by Novexel. NXL104 inhibits bacterial enzymes called beta-lactamases that break down beta-lactam antibiotics (in particular Penicillins and Cephalosporins). Beta-lactamase inhibition represents a mechanism for counteracting resistance and enhancing broad-spectrum activity of beta-lactam antibiotics. A composition of matter patent which claims NXL104 would provide protection for the ceftaroline/NXL104 combination product until 2022, subject to possible patent term extension.
Under the terms of the agreement, Forest will pay Novexel an upfront license payment of €75 million. Forest will fund development and commercialization of the ceftaroline/NXL104 combination. Additional milestone payments to Novexel if the combination product is successfully developed could total €75 million. Following the product's regulatory marketing approval, Forest will pay Novexel a low double digit royalty on product sales throughout North America.
Cephalon Provides Update on Regulatory Status of the Fentora Supplemental New Drug Application
FRAZER, Pa., January 25, 2008 /PRNewswire-FirstCall/ -- Cephalon, Inc., today announced that the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental New Drug Application (sNDA) for FENTORA(R) (fentanyl buccal tablet) [C-II] for the management of breakthrough pain in opioid-tolerant patients with chronic pain. In addition, the FDA notified the Company that it will convene an advisory committee panel on May 6, 2008, to consider this application.
"We are pleased that the FENTORA application remains on schedule with an FDA action date of September 13, 2008," said Dr. Lesley Russell, Executive Vice President, Worldwide Medical and Regulatory Operations. "FENTORA is the first medication that has been evaluated in controlled clinical trials for the management of breakthrough pain in opioid-tolerant patients with chronic pain. Therefore, it is not surprising that the agency decided to convene a panel to consider data on the use of FENTORA beyond the initial indication for breakthrough pain in cancer patients."
Included in the FENTORA sNDA are data from three randomized, placebo- controlled clinical trials and one long-term open-label safety study; including data from opioid-tolerant patients with chronic low back and neuropathic pain. The sNDA provides an evaluation of the onset of pain relief from 10 minutes to two hours, and has information regarding bioequivalence data for two routes of administration.
In 2006, FENTORA and an accompanying Risk Minimization Action Plan (RiskMAP) were approved by the FDA only for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain. The company developed and maintains a FENTORA RiskMAP to address the appropriate patient selection, dosing and administration of the medication.
"We are pleased that the FENTORA application remains on schedule with an FDA action date of September 13, 2008," said Dr. Lesley Russell, Executive Vice President, Worldwide Medical and Regulatory Operations. "FENTORA is the first medication that has been evaluated in controlled clinical trials for the management of breakthrough pain in opioid-tolerant patients with chronic pain. Therefore, it is not surprising that the agency decided to convene a panel to consider data on the use of FENTORA beyond the initial indication for breakthrough pain in cancer patients."
Included in the FENTORA sNDA are data from three randomized, placebo- controlled clinical trials and one long-term open-label safety study; including data from opioid-tolerant patients with chronic low back and neuropathic pain. The sNDA provides an evaluation of the onset of pain relief from 10 minutes to two hours, and has information regarding bioequivalence data for two routes of administration.
In 2006, FENTORA and an accompanying Risk Minimization Action Plan (RiskMAP) were approved by the FDA only for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain. The company developed and maintains a FENTORA RiskMAP to address the appropriate patient selection, dosing and administration of the medication.
ImaRx Therapeutics Receives Urokinase Lot Release Approval With Extended Expiration Dating
TUCSON, Ariz., Jan. 25 /PRNewswire-FirstCall/ -- ImaRx Therapeutics, Inc. today announced that the Food and Drug Administration (FDA) has approved the company's most current lot release request for urokinase drug product. This is the first lot to be released with extended expiration dating. Urokinase, ImaRx's first commercially available FDA-approved product, is a thrombolytic or clot-dissolving agent indicated for the treatment of acute massive pulmonary embolism.
"The FDA approval of urokinase lot release brings several advantages to ImaRx," said Bradford A. Zakes, President and CEO of ImaRx. "The extended expiration dating allows us to unlock the value from our unlabeled urokinase inventory. We will also benefit from cost-savings associated with prolonged shelf-life for future urokinase supplies."
ImaRx is continuing its stability program to evaluate the potential for further expiration extensions beyond September 2009 for unlabeled vials of urokinase inventory.
In January 2008, ImaRx and Microbix Biosystems Inc. signed a letter of intent to manufacture urokinase and explore development of additional indications. Microbix is believed to be the only supplier capable of producing urokinase on a commercial scale at its production facility in Toronto. As part of the agreement, ImaRx will retain existing urokinase inventory and intends to transfer the manufacturing process and NDA to Microbix. With Microbix as its long-term supplier, ImaRx will continue to market urokinase for acute massive pulmonary embolism, while Microbix will have development rights for certain new indications.
"The FDA approval of urokinase lot release brings several advantages to ImaRx," said Bradford A. Zakes, President and CEO of ImaRx. "The extended expiration dating allows us to unlock the value from our unlabeled urokinase inventory. We will also benefit from cost-savings associated with prolonged shelf-life for future urokinase supplies."
ImaRx is continuing its stability program to evaluate the potential for further expiration extensions beyond September 2009 for unlabeled vials of urokinase inventory.
In January 2008, ImaRx and Microbix Biosystems Inc. signed a letter of intent to manufacture urokinase and explore development of additional indications. Microbix is believed to be the only supplier capable of producing urokinase on a commercial scale at its production facility in Toronto. As part of the agreement, ImaRx will retain existing urokinase inventory and intends to transfer the manufacturing process and NDA to Microbix. With Microbix as its long-term supplier, ImaRx will continue to market urokinase for acute massive pulmonary embolism, while Microbix will have development rights for certain new indications.
Lawsuit Online Signup over Avandia (Rosiglitazone) Side Effects is Announced by the Law Offices of Howard G. Smith
PHILADELPHIA--(BUSINESS WIRE)--Jan 25, 2008 - The Law Offices of Howard G. Smith announces that an online sign up is available for a lawsuit on the behalf of people injured by taking Avandia. The suit will allege that the manufacturer of the drug, GlaxoSmithKline, failed to properly warn patients and their doctors of the known Avandia side effects.
Avandia (rosiglitazone) is a widely prescribed medication used to treat Type-2 Diabetes Mellitus, a condition also known as Adult-Onset Diabetes. On May 21, 2007, the FDA issued a Safety Alert regarding Avandia. The FDA Safety Alert warns that patients who are taking Avandia, especially those who are known to have underlying heart disease or who are at high risk of heart attack, should speak to their physicians about their continued use of Avandia (rosiglitazone).
The FDA's Safety Alert follows a study released on the same day. The study concluded that patients taking Avandia face both an increased risk of suffering a heart attack and an increased risk of dying from heart related disease, such as congestive heart failure or CHF.
Avandia (rosiglitazone) is a widely prescribed medication used to treat Type-2 Diabetes Mellitus, a condition also known as Adult-Onset Diabetes. On May 21, 2007, the FDA issued a Safety Alert regarding Avandia. The FDA Safety Alert warns that patients who are taking Avandia, especially those who are known to have underlying heart disease or who are at high risk of heart attack, should speak to their physicians about their continued use of Avandia (rosiglitazone).
The FDA's Safety Alert follows a study released on the same day. The study concluded that patients taking Avandia face both an increased risk of suffering a heart attack and an increased risk of dying from heart related disease, such as congestive heart failure or CHF.
Cypress Reaches Settlement with Glaxo Group Limited Relating to Ranitidine Oral Syrup Products
MADISON, Miss.--(BUSINESS WIRE)--Jan 25, 2008 - Cypress Pharmaceutical, Inc. today announced that it has reached a settlement with Glaxo Group Limited (Glaxo), part of the GlaxoSmithKline group of companies, resolving all disputes between the companies related to Cypress' generic ranitidine oral solution products and Glaxo's Zantac(R) syrup.
Under the terms of the settlement, Glaxo has agreed not to assert its patent against Cypress' new alcohol-free formulation of its generic ranitidine oral syrup. Cypress expects to launch the product immediately upon receiving FDA approval. As a result of the settlement, the parties filed a stipulation to dismiss their patent litigation pending in the U.S. District Court for the Southern District of New York.
Under the terms of the settlement, Glaxo has agreed not to assert its patent against Cypress' new alcohol-free formulation of its generic ranitidine oral syrup. Cypress expects to launch the product immediately upon receiving FDA approval. As a result of the settlement, the parties filed a stipulation to dismiss their patent litigation pending in the U.S. District Court for the Southern District of New York.
Teva Introduces Oxytocin Injection, USP (Synthetic)
IRVINE, Calif., January 24, 2008 – Teva Health Systems is pleased to announce the introduction and availability of Oxytocin Injection, USP (Synthetic). This product is AP Rated* and available in 10 Units/mL, 10 Units in Single Dose Glass Vials, and 10 Units/mL, 100 Units in Multiple Dose Glass Vials.
“Our generic injectable and unit-dose pharmaceuticals are an economical choice for our health system customers,” states Jonathan Zalk, Director of Marketing. “We continue to add new products to meet the growing demand for quality, affordable alternatives to brand pharmaceuticals.”
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.
“Our generic injectable and unit-dose pharmaceuticals are an economical choice for our health system customers,” states Jonathan Zalk, Director of Marketing. “We continue to add new products to meet the growing demand for quality, affordable alternatives to brand pharmaceuticals.”
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.
Forest Laboratories, Inc. and Merz Pharma GmbH & Co. KgaA File Additional Lawsuit Against Several Companies for Patent Infringement
NEW YORK, January 25, 2008 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc. , Forest Laboratories Holdings, Ltd., Merz Pharma GmbH & Co. KgaA, and Merz Pharmaceuticals GmbH announced that they have filed a second lawsuit in the U.S. District Court for the District of Delaware against additional companies for infringement of U.S. Patent No. 5,061,703 (the '703 patent), which relates to Forest's Namenda(R) product. The defendants named in the lawsuit include Dr. Reddy's Laboratories Limited, Genpharm Inc., Interpharm Inc., Mylan Pharmaceuticals Inc., Ranbaxy Laboratories Limited, Sun India Pharmaceutical Industries Limited, and related companies and subsidiaries thereof. The '703 patent expires in April 2010. Forest has applied for patent term extension which, if granted, would extend the '703 patent until September 2013.
As previously reported, Forest and Merz had received notification from several companies that they had filed Abbreviated New Drug Applications with Paragraph IV certifications to obtain approval to market generic versions of Namenda and commenced an action in patent infringement in the U.S. District Court in Delaware against such filers.
Except for the historical information contained herein, this release contains forward-looking statements within the meaning of the Private Securities Litigation Reform act of 1995. These statements involve a number of risks and uncertainties, including the difficulty of predicting FDA approvals, the acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, the timely development and launch of new products, and the risk factors listed from time to time in each of Forest Laboratories' Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, and any subsequent SEC filings.
As previously reported, Forest and Merz had received notification from several companies that they had filed Abbreviated New Drug Applications with Paragraph IV certifications to obtain approval to market generic versions of Namenda and commenced an action in patent infringement in the U.S. District Court in Delaware against such filers.
Except for the historical information contained herein, this release contains forward-looking statements within the meaning of the Private Securities Litigation Reform act of 1995. These statements involve a number of risks and uncertainties, including the difficulty of predicting FDA approvals, the acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, the timely development and launch of new products, and the risk factors listed from time to time in each of Forest Laboratories' Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, and any subsequent SEC filings.
Patent Granted for Hydrate form of Rosiglitazone Maleate
GlaxoSmithKline has received an Indian Patent No. 213203 (the ‘203 patent) for a novel hydrate form of Rosiglitazone Maleate against the mail-box Application No. IN/PCT/2000/00076/MUM filed December 14, 1998 claiming earliest priority from British patent application dated December 16, 1997. The ‘203 patent titled ‘Hydrate of 5-[4-[2-(N-methyl-N-(2-pyridil) amino) ethoxy] benzyl] thiazolidine-2, 4-dione maleic acid salt’ is lately published in the Patent Office Journal Issue No. 04/2008. Abstract of IN/PCT/2000/00076/MUM reads as –
A hydrate of 5-[4-[2-(N-methyl-N-(2-pryidyl) amino) ethoxy] benzyl] thiazolidine-2, 4-dione, maleic acid salt, characterised in that it: (i) contains water in the range of from 0.2 to 1.1% w/w, and (ii) provides an infrared spectrum containing peaks at 764 and 579 cm-1; and/or (iii) provides an X-ray powder diffraction (XRPD) pattern substantially as set out in Figure II; a process for the preparation of such a compound, a pharmaceutical composition containing such a compound and the use of such a compound or composition in medicine.
Rosiglitazone Maleate, globally marketed as Avandia is patented anti-diabetic drug in US and EU valid till October 2015 and September 2014 respectively. Although not sure exactly in what form claims are issued by the Mumbai Patent Office, but certainly would be interested knowing that. For close reference, refer equivalent US Patent Nos. 6,664,278 and 7,045,633.
(Article published in Patent circle by Mr. Varun)
A hydrate of 5-[4-[2-(N-methyl-N-(2-pryidyl) amino) ethoxy] benzyl] thiazolidine-2, 4-dione, maleic acid salt, characterised in that it: (i) contains water in the range of from 0.2 to 1.1% w/w, and (ii) provides an infrared spectrum containing peaks at 764 and 579 cm-1; and/or (iii) provides an X-ray powder diffraction (XRPD) pattern substantially as set out in Figure II; a process for the preparation of such a compound, a pharmaceutical composition containing such a compound and the use of such a compound or composition in medicine.
Rosiglitazone Maleate, globally marketed as Avandia is patented anti-diabetic drug in US and EU valid till October 2015 and September 2014 respectively. Although not sure exactly in what form claims are issued by the Mumbai Patent Office, but certainly would be interested knowing that. For close reference, refer equivalent US Patent Nos. 6,664,278 and 7,045,633.
(Article published in Patent circle by Mr. Varun)
Thursday, January 24, 2008
Peregrine receives DCGI approval for phase II trial of Bavituximab
Peregrine Pharmaceuticals, Inc, a clinical stage biopharmaceutical company, has received approval from the Drug Controller General of India (DCGI) to its phase II clinical protocol to study bavituximab in combination with chemotherapy in patients with non-small cell lung cancer (NSCLC).
Bavituximab is a monoclonal antibody that binds to a phospholipid called phosphatidylserine that is usually located inside normal cells, but which becomes exposed on the outside of the cells that line the blood vessels of tumours, creating a specific target for anti-cancer treatments. Bavituximab is believed to help mobilize the body's immune system to destroy the blood vessels needed for tumour growth and spread. In a phase Ib pilot trial in advanced cancer patients, bavituximab plus chemotherapy appeared to have a safety profile consistent with chemotherapy alone and showed positive signs of clinical activity, achieving objective response or disease stabilization in 50 per cent of the evaluable patients.
Bavituximab is a monoclonal antibody that binds to a phospholipid called phosphatidylserine that is usually located inside normal cells, but which becomes exposed on the outside of the cells that line the blood vessels of tumours, creating a specific target for anti-cancer treatments. Bavituximab is believed to help mobilize the body's immune system to destroy the blood vessels needed for tumour growth and spread. In a phase Ib pilot trial in advanced cancer patients, bavituximab plus chemotherapy appeared to have a safety profile consistent with chemotherapy alone and showed positive signs of clinical activity, achieving objective response or disease stabilization in 50 per cent of the evaluable patients.
Cadila, Prolong ink pact to develop anaemia drug
Cadila Healthcare Ltd has entered into pact for collaboration for development of a next generation therapeutic protein, 'PEG-EPO', for the treatment of severe anaemia with Prolong Pharmaceuticals Inc., a US-based, venture-backed drug delivery research and development company.
Severe Anaemia is a condition where the haemoglobin (Hb) level or number of circulating red blood cells (RBCs) is significantly reduced. This is common in chronic renal failure (CRF), cancer patients undergoing chemotherapy, some chronic inflammatory diseases, heart failure, surgical settings and critically ill patients. The first generation drug, EPO, did wonders to the treatment of this condition. However, new advances in therapy can improve EPO's therapeutic profile, offer greater convenience, and lower treatment costs. PEG-EPO promises to be a third generation drug.
Speaking on the occasion, Pankaj Patel, chairman and Managing Director Zydus Cadila, mentioned "This deal marks Zydus's foray into the area of novel improved biologicals. There is a strong unmet medical need in this space, and we are committed to discover, develop and provide better as well as safer alternatives to patients at affordable prices".
Severe Anaemia is a condition where the haemoglobin (Hb) level or number of circulating red blood cells (RBCs) is significantly reduced. This is common in chronic renal failure (CRF), cancer patients undergoing chemotherapy, some chronic inflammatory diseases, heart failure, surgical settings and critically ill patients. The first generation drug, EPO, did wonders to the treatment of this condition. However, new advances in therapy can improve EPO's therapeutic profile, offer greater convenience, and lower treatment costs. PEG-EPO promises to be a third generation drug.
Speaking on the occasion, Pankaj Patel, chairman and Managing Director Zydus Cadila, mentioned "This deal marks Zydus's foray into the area of novel improved biologicals. There is a strong unmet medical need in this space, and we are committed to discover, develop and provide better as well as safer alternatives to patients at affordable prices".
Bayer Extends Product Portfolio for Liver Cancer Patients in Japan
BERLIN, January 24, 2008 – Bayer is coming closer to its goal of extending its product portfolio for liver cancer patients in Japan to provide a comprehensive range of services from diagnosis to life-prolonging therapies. The Japanese health authority (MHLW) has granted Bayer priority review status (fast-track procedure) for marketing authorization of its anticancer drug product Nexavar® (sorafenib) for the treatment of hepatocellular carcinoma (HCC). In addition, the contrast agent Primovist® (gadoxetic acid disodium) for magnetic resonance imaging of the liver was recently granted regulatory approval in Japan. This product is scheduled to be launched on the Japanese market in the immediate future.
Liver cancer is the sixth most common cancer in the world and the third leading cause of cancer-related deaths globally. More than 600,000 cases of liver cancer are diagnosed worldwide each year and incidence is increasing. Japan has the second largest population of liver cancer patients in the world; most of them suffer from HCC which claims 36,000 lives every year. Thus, the medical need for an early and reliable diagnosis and for life-prolonging treatment is high.
Nexavar, an oral anti-cancer drug, is the first and only drug shown to significantly improve overall survival in patients with HCC. In Japan, Nexavar was filed in June 2006 for the treatment of renal cell carcinoma (RCC) and an additional application for HCC was submitted in September 2007.
“The fact that the Japanese authorities granted priority review status underlines the high medical need for innovative treatments options for patients with liver cancer. This devastating disease is one of the cancers in which the number of related deaths continues to increase,” said Paolo Pucci, President of Bayer HealthCare’s Global Business Unit Oncology. “We at Bayer are highly committed to expediting the clinical development of this innovative therapy also across additional tumour types.”
Primovist is authorized for the detection and characterization of liver lesions by magnetic resonance imaging (MRI) including liver tumors such as hepatocellular carcinomas (HCC), liver metastases and other malignant and benign lesions.
“Primovist is a gadolinium-based contrast medium that offers the possibility to simultaneously detect, locate and distinguish various types of liver lesions, thus providing a powerful tool that increases the diagnostic confidence“, said Professor Hans Maier, Head of the Global Business Unit Diagnostic Imaging at Bayer Schering Pharma. “Primovist enables radiologists to identify even tiny pathological liver lesions; it thus helps to guide and follow-up on treatment decisions and has the potential to considerably optimize patient benefit.”
Liver cancer is the sixth most common cancer in the world and the third leading cause of cancer-related deaths globally. More than 600,000 cases of liver cancer are diagnosed worldwide each year and incidence is increasing. Japan has the second largest population of liver cancer patients in the world; most of them suffer from HCC which claims 36,000 lives every year. Thus, the medical need for an early and reliable diagnosis and for life-prolonging treatment is high.
Nexavar, an oral anti-cancer drug, is the first and only drug shown to significantly improve overall survival in patients with HCC. In Japan, Nexavar was filed in June 2006 for the treatment of renal cell carcinoma (RCC) and an additional application for HCC was submitted in September 2007.
“The fact that the Japanese authorities granted priority review status underlines the high medical need for innovative treatments options for patients with liver cancer. This devastating disease is one of the cancers in which the number of related deaths continues to increase,” said Paolo Pucci, President of Bayer HealthCare’s Global Business Unit Oncology. “We at Bayer are highly committed to expediting the clinical development of this innovative therapy also across additional tumour types.”
Primovist is authorized for the detection and characterization of liver lesions by magnetic resonance imaging (MRI) including liver tumors such as hepatocellular carcinomas (HCC), liver metastases and other malignant and benign lesions.
“Primovist is a gadolinium-based contrast medium that offers the possibility to simultaneously detect, locate and distinguish various types of liver lesions, thus providing a powerful tool that increases the diagnostic confidence“, said Professor Hans Maier, Head of the Global Business Unit Diagnostic Imaging at Bayer Schering Pharma. “Primovist enables radiologists to identify even tiny pathological liver lesions; it thus helps to guide and follow-up on treatment decisions and has the potential to considerably optimize patient benefit.”
FDA Approves MiddleBrook's Amoxicillin PULSYS for Pharyngitis/Tonsillitis in Adolescents and Adults
January 24, 2008 /PRNewswire-FirstCall/ -- MiddleBrook Pharmaceuticals, Inc. , a pharmaceutical company focused on developing and commercializing novel anti-infective products, today announced that it has received approval of its New Drug Application (NDA) from the U.S. Food and Drug Administration (FDA), for its once-daily Moxatag(TM) Tablets 775 mg (amoxicillin extended-release tablets) for the treatment of adults and pediatric patients 12 years and older with pharyngitis and/or tonsillitis secondary to Streptococcus pyogenes (commonly referred to as strep throat).
The FDA approval was based on results from a Phase 3 clinical study conducted with more than 600 patients that found once-daily MOXATAG for 10 days was effective in eradicating bacteria responsible for strep throat and demonstrated statistical non-inferiority to a four times daily dose of penicillin for 10 days. MOXATAG was very well tolerated in the clinical trial.
"We are extremely gratified to have received FDA approval of our MOXATAG NDA," stated Edward Rudnic, Ph.D., president and CEO of MiddleBrook. "As the first and only once-daily amoxicillin therapy approved for marketing in the United States, we believe MOXATAG represents a major advance for patients and doctors seeking safe, effective, and convenient treatment options for strep throat. We now look forward to continuing our ongoing strategic evaluation process from a position of greater strength with this approval in hand."
In accordance with the requirements of the Pediatric Research Equity Act, MiddleBrook has agreed with the FDA to further evaluate its MOXATAG product candidate for pediatric patients less than 12 years of age with pharyngitis and/or tonsillitis as part of a post-marketing commitment. The Company has agreed to submit a completed study report and data set for MOXATAG in pediatric patients less than 12 years old within the next five years as part of this commitment.
"Compared to four times daily penicillin, once-daily MOXATAG has shown comparable efficacy and tolerability in eradicating Group A streptococcal infections of the pharynx. However, the once-daily dosing of MOXATAG is a major advantage," said lead study investigator Stan L. Block, M.D., professor of clinical pediatrics at the Universities of Louisville and Kentucky Medical Schools. "For the first time, physicians in the U.S. have the option of an FDA-approved once-daily amoxicillin therapy to treat their adolescent and adult patients with pharyngitis/tonsillitis. This should ensure better first- line therapy compliance with a penicillin class of antibiotic."
The FDA approval was based on results from a Phase 3 clinical study conducted with more than 600 patients that found once-daily MOXATAG for 10 days was effective in eradicating bacteria responsible for strep throat and demonstrated statistical non-inferiority to a four times daily dose of penicillin for 10 days. MOXATAG was very well tolerated in the clinical trial.
"We are extremely gratified to have received FDA approval of our MOXATAG NDA," stated Edward Rudnic, Ph.D., president and CEO of MiddleBrook. "As the first and only once-daily amoxicillin therapy approved for marketing in the United States, we believe MOXATAG represents a major advance for patients and doctors seeking safe, effective, and convenient treatment options for strep throat. We now look forward to continuing our ongoing strategic evaluation process from a position of greater strength with this approval in hand."
In accordance with the requirements of the Pediatric Research Equity Act, MiddleBrook has agreed with the FDA to further evaluate its MOXATAG product candidate for pediatric patients less than 12 years of age with pharyngitis and/or tonsillitis as part of a post-marketing commitment. The Company has agreed to submit a completed study report and data set for MOXATAG in pediatric patients less than 12 years old within the next five years as part of this commitment.
"Compared to four times daily penicillin, once-daily MOXATAG has shown comparable efficacy and tolerability in eradicating Group A streptococcal infections of the pharynx. However, the once-daily dosing of MOXATAG is a major advantage," said lead study investigator Stan L. Block, M.D., professor of clinical pediatrics at the Universities of Louisville and Kentucky Medical Schools. "For the first time, physicians in the U.S. have the option of an FDA-approved once-daily amoxicillin therapy to treat their adolescent and adult patients with pharyngitis/tonsillitis. This should ensure better first- line therapy compliance with a penicillin class of antibiotic."
New Drug Application Submitted to FDA for Investigational Analgesic Tapentadol Immediate Release Tablets
January 23, 2008 /PRNewswire-USNewswire/ -- Johnson & Johnson Pharmaceutical Research & Development, L.L.C. announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tapentadol hydrochloride immediate release (IR) tablets, an investigational oral analgesic for the relief of moderate to severe acute pain.
According to the American Pain Foundation, more than 25 million Americans experience acute pain each year as a result of injuries or surgeries, and a recent study estimated that 42 percent of U.S. hospital emergency department visits were due to pain-related problems.
Tapentadol is a novel investigational, centrally acting oral analgesic. It has a unique profile with two mechanisms of action, combining mu-opioid receptor agonism and norepinephrine reuptake inhibition in a single molecule. It is being developed in immediate-release and extended-release formulations.
Mu-opioid agonists are drugs that bind to mu-opioid receptors in the central nervous system. These drugs modify sensory and affective (mood) aspects of pain, inhibit the transmission of pain at the spinal cord and affect activity at parts of the brain that control how pain is perceived. Norepinephrine reuptake inhibitors are a type of central nervous system medication that increase the level of norepinephrine in the brain by inhibiting its re-absorption into nerve cells; these compounds have analgesic properties.
The submission is based on a full clinical development program for tapentadol. The program includes two Phase 3 multi-center studies that explored the efficacy and safety of multiple doses of the tapentadol IR formulation either for the treatment of acute pain in patients undergoing bunionectomy surgery or for patients with degenerative, end-stage joint disease of the hip or knee. The data from these clinical trials suggest that tapentadol has efficacy comparable to strong opioids.
Bunionectomy is a standard foot surgery. The predictable level of moderate to severe pain for several days following this surgery makes bunionectomy an appropriate model for assessing the efficacy of potent analgesics.
Data also were submitted to the FDA from an additional Phase 3 study that supported the safety profile of multiple doses of tapentadol IR in the treatment of outpatients with low back pain or pain from osteoarthritis of the hip or knee.
More than 1,800 patients have been treated with tapentadol IR tablets in clinical trials to date.
The most common adverse reactions in tapentadol Phase 2/3 multiple dose, placebo- and active-controlled efficacy and safety studies (10%) were nausea, dizziness, vomiting, somnolence (sleepiness) and headache.
According to the American Pain Foundation, more than 25 million Americans experience acute pain each year as a result of injuries or surgeries, and a recent study estimated that 42 percent of U.S. hospital emergency department visits were due to pain-related problems.
Tapentadol is a novel investigational, centrally acting oral analgesic. It has a unique profile with two mechanisms of action, combining mu-opioid receptor agonism and norepinephrine reuptake inhibition in a single molecule. It is being developed in immediate-release and extended-release formulations.
Mu-opioid agonists are drugs that bind to mu-opioid receptors in the central nervous system. These drugs modify sensory and affective (mood) aspects of pain, inhibit the transmission of pain at the spinal cord and affect activity at parts of the brain that control how pain is perceived. Norepinephrine reuptake inhibitors are a type of central nervous system medication that increase the level of norepinephrine in the brain by inhibiting its re-absorption into nerve cells; these compounds have analgesic properties.
The submission is based on a full clinical development program for tapentadol. The program includes two Phase 3 multi-center studies that explored the efficacy and safety of multiple doses of the tapentadol IR formulation either for the treatment of acute pain in patients undergoing bunionectomy surgery or for patients with degenerative, end-stage joint disease of the hip or knee. The data from these clinical trials suggest that tapentadol has efficacy comparable to strong opioids.
Bunionectomy is a standard foot surgery. The predictable level of moderate to severe pain for several days following this surgery makes bunionectomy an appropriate model for assessing the efficacy of potent analgesics.
Data also were submitted to the FDA from an additional Phase 3 study that supported the safety profile of multiple doses of tapentadol IR in the treatment of outpatients with low back pain or pain from osteoarthritis of the hip or knee.
More than 1,800 patients have been treated with tapentadol IR tablets in clinical trials to date.
The most common adverse reactions in tapentadol Phase 2/3 multiple dose, placebo- and active-controlled efficacy and safety studies (10%) were nausea, dizziness, vomiting, somnolence (sleepiness) and headache.
Navamedic Takes Over Marketing of Glucomed in Sweden, Denmark, Norway and Finland
January 24, 2008- Through its subsidiary Vitaflo Scandinavia AB, Navamedic will take responsibility for the marketing and distribution of Glucomed in Sweden, Denmark, Norway and Finland
Vitaflo has for several years shown a good track record for marketing of pharmaceutical products in the Nordic countries. Through Vitaflo, the company strongly believes that it is in position to take a larger part of the Nordic market for glucosamine products. The change will strengthen Navamedic's position within marketing and distribution of pharmaceuticals in the region, and the change will give a higher gross margin on future sales of Glucomed in these countries.
The change is initiated by Navamedic, as a result of Meda's acquisition of the pharmaceutical company Recip towards the end of 2007. Meda thus became the owner of Glucosine, one of Glucomed's competitors in some of the Nordic markets. The change will be effective from 1 March 2008.
In Q4 2007, Navamedic will state as income the rest of a provision related to a possible regulation of prices on earlier sales of Glucomed to Meda. In Q1 2008, the remaining provisions related to the received license income will be stated as income.
Vitaflo has for several years shown a good track record for marketing of pharmaceutical products in the Nordic countries. Through Vitaflo, the company strongly believes that it is in position to take a larger part of the Nordic market for glucosamine products. The change will strengthen Navamedic's position within marketing and distribution of pharmaceuticals in the region, and the change will give a higher gross margin on future sales of Glucomed in these countries.
The change is initiated by Navamedic, as a result of Meda's acquisition of the pharmaceutical company Recip towards the end of 2007. Meda thus became the owner of Glucosine, one of Glucomed's competitors in some of the Nordic markets. The change will be effective from 1 March 2008.
In Q4 2007, Navamedic will state as income the rest of a provision related to a possible regulation of prices on earlier sales of Glucomed to Meda. In Q1 2008, the remaining provisions related to the received license income will be stated as income.
Wednesday, January 23, 2008
Daiichi's cholesterol drug Welchol gets US FDA approval
Daiichi Sankyo, Inc, said the United States Food and Drug Administration (FDA) has approved its cholesterol drug Welchol (colesevelam HCl) to reduce both glucose levels and low density lipoprotein cholesterol levels (LDL-C) in adults with type 2 diabetes.
Welchol is now the first and only medication approved to improve glycemic control (measured as haemoglobin A1C) in adults with type 2 diabetes mellitus in combination with metformin, sulfonylureas, or insulin, either alone or in combination with other anti-diabetic agents.
The ADA estimates that 20.8 million people in the United States have diabetes with more than 90 per cent of these people having type 2 diabetes. Forty per cent of patients with type 2 diabetes also have high LDL-cholesterol . Welchol is a new option that addresses both these chronic health conditions and provides physicians with a unique therapeutic approach for treating patients with type 2 diabetes.
The data from the study demonstrated that Welchol can lower both A1C and LDL-C levels in patients with type 2 diabetes who were uncontrolled on a metformin-based regimen. Patients in the study were randomly assigned to two groups. The addition of Welchol was compared to the addition of placebo in patients on a metformin-based regimen. The addition of Welchol (n=79) to pre-existing metformin monotherapy achieved a significant mean reduction in A1C levels of 0.47 percent relative to placebo (p<0.0024).
"Welchol now offers physicians a treatment option that addresses two major cardiovascular risk factors; elevated LDL cholesterol and blood glucose in patients with type 2 diabetes," said Ronald B. Goldberg, MD, an investigator in the insulin and metformin pivotal studies and Professor of Medicine at the Division of Diabetes and Metabolism and Associate Director of the Diabetes Research Institute at the University of Miami, Miller School of Medicine in Florida. "Cardiovascular risk factors are of great concern because patients with type 2 diabetes have a significantly increased risk of developing cardiovascular disease. Once clinical cardiovascular disease develops, these patients have a poorer prognosis than normoglycemic patients."Since 2000, Welchol, a bile acid sequestrant, has been indicated, alone or in combination with a statin, for the reduction of elevated LDL-C in patients with primary hypercholesterolemia. It is different from most other cholesterol-lowering drugs on the market because it is non-systemic, meaning that the body does not absorb it and it is eliminated without traveling to the liver or kidneys. Therefore, Welchol is not expected to have drug interactions via the cytochrome P450 pathway. Systemic medications, which include statins, fibrates and cholesterol absorption inhibitors, are those that are absorbed from the intestine into the bloodstream and travel throughout the body, specifically to the liver and/or kidneys.
Welchol is indicated as an adjunct to diet and exercise to reduce elevated low-density lipoprotein cholesterol (LDL-C) in patients with primary hyperlipidemia (Fredrickson Type IIa) as monotherapy or in combination with an hydroxymethyl-glutaryl-coenzyme A (HMG CoA) reductase inhibitor. Welchol is also indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Welchol is now the first and only medication approved to improve glycemic control (measured as haemoglobin A1C) in adults with type 2 diabetes mellitus in combination with metformin, sulfonylureas, or insulin, either alone or in combination with other anti-diabetic agents.
The ADA estimates that 20.8 million people in the United States have diabetes with more than 90 per cent of these people having type 2 diabetes. Forty per cent of patients with type 2 diabetes also have high LDL-cholesterol . Welchol is a new option that addresses both these chronic health conditions and provides physicians with a unique therapeutic approach for treating patients with type 2 diabetes.
The data from the study demonstrated that Welchol can lower both A1C and LDL-C levels in patients with type 2 diabetes who were uncontrolled on a metformin-based regimen. Patients in the study were randomly assigned to two groups. The addition of Welchol was compared to the addition of placebo in patients on a metformin-based regimen. The addition of Welchol (n=79) to pre-existing metformin monotherapy achieved a significant mean reduction in A1C levels of 0.47 percent relative to placebo (p<0.0024).
"Welchol now offers physicians a treatment option that addresses two major cardiovascular risk factors; elevated LDL cholesterol and blood glucose in patients with type 2 diabetes," said Ronald B. Goldberg, MD, an investigator in the insulin and metformin pivotal studies and Professor of Medicine at the Division of Diabetes and Metabolism and Associate Director of the Diabetes Research Institute at the University of Miami, Miller School of Medicine in Florida. "Cardiovascular risk factors are of great concern because patients with type 2 diabetes have a significantly increased risk of developing cardiovascular disease. Once clinical cardiovascular disease develops, these patients have a poorer prognosis than normoglycemic patients."Since 2000, Welchol, a bile acid sequestrant, has been indicated, alone or in combination with a statin, for the reduction of elevated LDL-C in patients with primary hypercholesterolemia. It is different from most other cholesterol-lowering drugs on the market because it is non-systemic, meaning that the body does not absorb it and it is eliminated without traveling to the liver or kidneys. Therefore, Welchol is not expected to have drug interactions via the cytochrome P450 pathway. Systemic medications, which include statins, fibrates and cholesterol absorption inhibitors, are those that are absorbed from the intestine into the bloodstream and travel throughout the body, specifically to the liver and/or kidneys.
Welchol is indicated as an adjunct to diet and exercise to reduce elevated low-density lipoprotein cholesterol (LDL-C) in patients with primary hyperlipidemia (Fredrickson Type IIa) as monotherapy or in combination with an hydroxymethyl-glutaryl-coenzyme A (HMG CoA) reductase inhibitor. Welchol is also indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Nicholas Piramal buys Healthline's pharma business for Rs 150m
Nicholas Piramal India Ltd and Healthline Pvt. Ltd (HLPL) have signed a definitive agreement for purchase of HLPL's Pharmaceuticals business by the company for a consideration of Rs 150 million.
HLPL has a modern injectables manufacturing unit at Bangalore for small and large volume injectable products. The current facility was commissioned in 2004 and has a capacity of 10 million vials per annum on a single shift basis. The company will invest additional resources at the facility to expand capacity and secure US FDA standards.
Commenting on the acquisition, Ajay Piramal, chairman, of the company said, "NPIL is committed to expand its Custom Manufacturing offering to global customers. HLPL is a good asset, which will expand our high-end manufacturing solutions from India".
Allegro Capital was HLPL's advisors on the transaction.
HLPL has a modern injectables manufacturing unit at Bangalore for small and large volume injectable products. The current facility was commissioned in 2004 and has a capacity of 10 million vials per annum on a single shift basis. The company will invest additional resources at the facility to expand capacity and secure US FDA standards.
Commenting on the acquisition, Ajay Piramal, chairman, of the company said, "NPIL is committed to expand its Custom Manufacturing offering to global customers. HLPL is a good asset, which will expand our high-end manufacturing solutions from India".
Allegro Capital was HLPL's advisors on the transaction.
NovaDel's New Drug Application for ZolpiMist Oral Spray to Treat Insomnia Accepted for Filing by the U.S. Food and Drug Administration
NovaDel Pharma Inc. (AMEX: NVD), a specialty pharmaceutical company developing oral spray formulations for a broad range of marketed treatments, announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing its New Drug Application (NDA) for ZolpiMist(TM) (zolpidem tartrate) Oral Spray for the short-term treatment of insomnia. The company anticipates the FDA will complete its review by the end of the year consistent with PDUFA guidelines.
NovaDel submitted its ZolpiMist(TM) application using the FDA's 505(b)(2) process based on data from two randomized, open-label, dose-ranging studies comparing ZolpiMist(TM) with Ambien(R) tablets in young and elderly healthy volunteers. Both studies compared the pharmacokinetics and safety of comparable doses of zolpidem administered as an oral spray versus tablets. The pharmacokinetic profiles were assessed by the maximum drug concentration (Cmax) and total exposure to drug (area-under-the-curve/AUC0-inf). The speed of drug absorption and level of sedation were also assessed in these studies. The results demonstrated bioequivalence between ZolpiMist(TM) and Ambien(R). Also included in the submission were data from process validation and registration stability batches produced at the intended commercial manufacturing facility.
NovaDel submitted its ZolpiMist(TM) application using the FDA's 505(b)(2) process based on data from two randomized, open-label, dose-ranging studies comparing ZolpiMist(TM) with Ambien(R) tablets in young and elderly healthy volunteers. Both studies compared the pharmacokinetics and safety of comparable doses of zolpidem administered as an oral spray versus tablets. The pharmacokinetic profiles were assessed by the maximum drug concentration (Cmax) and total exposure to drug (area-under-the-curve/AUC0-inf). The speed of drug absorption and level of sedation were also assessed in these studies. The results demonstrated bioequivalence between ZolpiMist(TM) and Ambien(R). Also included in the submission were data from process validation and registration stability batches produced at the intended commercial manufacturing facility.
FDA Approves Additional Indication for Astellas’ Mycamine
Astellas Pharma Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved their Supplemental New Drug Application (sNDA) seeking approval for the use of MYCAMINE® (micafungin sodium) for Injection in the treatment of patients with Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses. MYCAMINE was approved in 2005 for the treatment of patients with esophageal candidiasis and is the only echinocandin approved for the prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplantation.
"The FDA’s approval of this sNDA further confirms the safety and efficacy profile of MYCAMINE and its importance in the treatment of candidemia and other Candida infections," said Yoshihiko Hatanaka, President and Chief Executive Officer, Astellas Pharma US, Inc. "The approval of this additional indication is another step toward fulfilling our mission to provide innovative treatments such as MYCAMINE to help patients with significant medical needs."
"The FDA’s approval of this sNDA further confirms the safety and efficacy profile of MYCAMINE and its importance in the treatment of candidemia and other Candida infections," said Yoshihiko Hatanaka, President and Chief Executive Officer, Astellas Pharma US, Inc. "The approval of this additional indication is another step toward fulfilling our mission to provide innovative treatments such as MYCAMINE to help patients with significant medical needs."
Suven Obtains 2nd Product Patent from US Patent Office
Suven Life Sciences Ltd announces today that the US Patent office has granted Product Patent # US 7,317,035 to Suven. This is Suven’s second product patent granted in USA. The granted claims of the patent include the class of selective Serotonin receptor affinity compounds discovered by Suven and are being developed as therapeutic agents. According to the invention ‘035 patent disclosure, the compounds are useful in the treatment of neuro-degenarative disorders like Alzheimer’s, Parkinson, Schizophrenia and Huntington’s.
Suven has so far filed 29 product patent applications through PCT covering more than 145 countries, out of which 5 product patents are granted in various countries. There are several other patent applications from Suven Discovery Research are in the pipeline that have completed the administrative and technical diligence from the patent offices from major countries and would be granted shortly.
Suven has filed its first Investigational New Drug (IND) application with DCGI to conduct the clinical Phase-I study on their developmental candidate SUVN-502 and several candidates are in discovery pipeline undergoing GLP pre-clinical studies.
“We are very pleased by the issuance of this patent to Suven by US Patent office for our drug candidates that are being developed for CNS disorders which targets a $18 billion potential market opportunity “ says Venkat Jasti, CEO of Suven.
Suven has so far filed 29 product patent applications through PCT covering more than 145 countries, out of which 5 product patents are granted in various countries. There are several other patent applications from Suven Discovery Research are in the pipeline that have completed the administrative and technical diligence from the patent offices from major countries and would be granted shortly.
Suven has filed its first Investigational New Drug (IND) application with DCGI to conduct the clinical Phase-I study on their developmental candidate SUVN-502 and several candidates are in discovery pipeline undergoing GLP pre-clinical studies.
“We are very pleased by the issuance of this patent to Suven by US Patent office for our drug candidates that are being developed for CNS disorders which targets a $18 billion potential market opportunity “ says Venkat Jasti, CEO of Suven.
U.S. Patent Office Rejects Key HIV/AIDS Drug Patents at PUBPAT Request: Government Finds Prior Art Submitted By PUBPAT Invalidates All of Gilead
The Public Patent Foundation ("PUBPAT") announced today that the U.S. Patent & Trademark Office has rejected four key HIV/AIDS drug patents held by Gilead Sciences that relate to the drug known generically as tenofovir disoproxil fumarate (TDF), a key weapon in the battle against HIV/AIDS. Gilead markets TDF in the United States under the brand name VIREAD and as a part of its ATRIPLA combination product.
Roughly 40 million people worldwide are infected with HIV/AIDS, including more than 1.2 million Americans. The U.S. Food and Drug Administration will not allow anyone other than Gilead distribute TDF in the United States because Gilead claims the four patents challenged by PUBPAT and now rejected by the Patent Office give them the exclusive right to do so.
"Every person suffering from HIV/AIDS has a right to get the best medical treatment science can offer, without any unjustified impediments placed in their way," said Dan Ravicher, PUBPAT's Executive Director. "This includes Americans infected with HIV/AIDS, who are entitled to the best pharmaceuticals possible without undeserved patents making them exorbitantly expensive."
In its filings challenging the patents, PUBPAT submitted prior art that Gilead had not disclosed to the Patent Office during the patent application process that resulted in the patents being granted to the Foster City, California, biopharmaceutical giant. PUBPAT also described in detail how the prior art would have prohibited the patents from being issued in the first place, had the Patent Office had been aware of it. The Patent Office has now agreed with PUBPAT and found that each of the four Gilead Sciences patents are undeserved. Although Gilead has the right to respond to the Patent Office's rejections of the patents, third party requests for re-examination, like the ones filed by PUBPAT against the four Gilead TDF patents, are successful in causing the reviewed patents to either be revoked or changed more than two-thirds of the time.
"We are extremely pleased that the Patent Office has agreed with us that Gilead's TDF patents are invalid," said Ravicher. "This means that we are now well on the way towards ending the harm being caused to the public by Gilead's use of the patents to prevent anyone else from offering TDF to HIV/AIDS patients in the United States."
The Gilead Sciences TDF patents challenged by PUBPAT that have now been rejected by the Patent Office are U.S. Patents No. 5,922,695, 5,935,946, 5,977,089 and 6,043,230. Gilead has applied for similar patents on TDF in other countries throughout the world, including India, where they have received fierce opposition by non-profit AIDS patient groups.
(Article published on Pharmalive)
Roughly 40 million people worldwide are infected with HIV/AIDS, including more than 1.2 million Americans. The U.S. Food and Drug Administration will not allow anyone other than Gilead distribute TDF in the United States because Gilead claims the four patents challenged by PUBPAT and now rejected by the Patent Office give them the exclusive right to do so.
"Every person suffering from HIV/AIDS has a right to get the best medical treatment science can offer, without any unjustified impediments placed in their way," said Dan Ravicher, PUBPAT's Executive Director. "This includes Americans infected with HIV/AIDS, who are entitled to the best pharmaceuticals possible without undeserved patents making them exorbitantly expensive."
In its filings challenging the patents, PUBPAT submitted prior art that Gilead had not disclosed to the Patent Office during the patent application process that resulted in the patents being granted to the Foster City, California, biopharmaceutical giant. PUBPAT also described in detail how the prior art would have prohibited the patents from being issued in the first place, had the Patent Office had been aware of it. The Patent Office has now agreed with PUBPAT and found that each of the four Gilead Sciences patents are undeserved. Although Gilead has the right to respond to the Patent Office's rejections of the patents, third party requests for re-examination, like the ones filed by PUBPAT against the four Gilead TDF patents, are successful in causing the reviewed patents to either be revoked or changed more than two-thirds of the time.
"We are extremely pleased that the Patent Office has agreed with us that Gilead's TDF patents are invalid," said Ravicher. "This means that we are now well on the way towards ending the harm being caused to the public by Gilead's use of the patents to prevent anyone else from offering TDF to HIV/AIDS patients in the United States."
The Gilead Sciences TDF patents challenged by PUBPAT that have now been rejected by the Patent Office are U.S. Patents No. 5,922,695, 5,935,946, 5,977,089 and 6,043,230. Gilead has applied for similar patents on TDF in other countries throughout the world, including India, where they have received fierce opposition by non-profit AIDS patient groups.
(Article published on Pharmalive)
Banner Pharmacaps Receives FDA Approval for Nimodipine Softgel Capsules
Banner Pharmacaps Inc., a leader in the pharmaceutical industry for the development of soft gelatin dosage form technology, today announced that the US Food & Drug Administration has granted approval for the Company's Abbreviated New Drug Application (ANDA) for Nimodipine 30 mg soft gelatin capsules.
Banner's Nimodipine 30 mg capsules are the AB-rated generic equivalent of Bayer's Nimotop(R) 30 mg capsules, and are indicated for the treatment of subarachnoid hemorrhage, a form of cerebral bleed. Banner's product can be dispensed either in blister packaging or in bottles.
Banner has partnered with Heritage Pharmaceuticals Inc., an Edison, New Jersey based generics company, for the exclusive US sales and marketing rights for Nimodipine.
Banner's Nimodipine 30 mg capsules are the AB-rated generic equivalent of Bayer's Nimotop(R) 30 mg capsules, and are indicated for the treatment of subarachnoid hemorrhage, a form of cerebral bleed. Banner's product can be dispensed either in blister packaging or in bottles.
Banner has partnered with Heritage Pharmaceuticals Inc., an Edison, New Jersey based generics company, for the exclusive US sales and marketing rights for Nimodipine.
Seasonique Patent Issues
Barr Pharmaceuticals, Inc. today announced the U.S. Patent and Trademark Office (PTO) issued U.S. Patent No. 7,320,969 for the Company's SEASONIQUE(R) extended- cycle oral contraceptive. The patent will expire on January 30, 2024. The Company also announced that it has submitted the patent to the U.S. Food and Drug Administration (FDA) for issuance in the Orange Book.
"We are very pleased that the PTO has issued this important patent to protect our SEASONIQUE extended-cycle oral contraception intellectual property," said Bruce L. Downey, Barr's Chairman and CEO. "We remain committed to developing new products for our portfolio of extended-cycle oral contraceptives and to providing women with options as they consider their contraceptive alternatives."
The Company received FDA approval for SEASONIQUE (levonorgestrel/ethinyl estradiol tablets 0.15 mg/0.03 mg and ethinyl estradiol tablets 0.01 mg) extended-cycle oral contraceptive in May 2006. SEASONIQUE is indicated for the prevention of pregnancy and represents the next generation of extended-cycle oral contraceptives in a category the Company created with the launch of the SEASONALE extended-cycle oral contraceptive in 2003.
"We are very pleased that the PTO has issued this important patent to protect our SEASONIQUE extended-cycle oral contraception intellectual property," said Bruce L. Downey, Barr's Chairman and CEO. "We remain committed to developing new products for our portfolio of extended-cycle oral contraceptives and to providing women with options as they consider their contraceptive alternatives."
The Company received FDA approval for SEASONIQUE (levonorgestrel/ethinyl estradiol tablets 0.15 mg/0.03 mg and ethinyl estradiol tablets 0.01 mg) extended-cycle oral contraceptive in May 2006. SEASONIQUE is indicated for the prevention of pregnancy and represents the next generation of extended-cycle oral contraceptives in a category the Company created with the launch of the SEASONALE extended-cycle oral contraceptive in 2003.
Fournier Laboratories Ireland Ltd was informed of anda filing for generic Tricor in the USA
Fournier Laboratories Ireland Ltd, a wholly-owned subsidiary of Solvay Pharmaceuticals, was informed by Teva Pharmaceuticals that it has filed an ANDA - Abbreviated New Drug Application - with a Paragraph IV certification, seeking the approval of a generic version of TriCor® (fenofibrate) 145mg NFE tablets in the United States.
The Paragraph IV certification procedure challenges a number of US patents relating to TriCor® which run through the next decade.
Such procedures are not unusual for branded products in the United States.
Fournier Laboratories Ireland Ltd. remains fully committed to its fenofibrate franchise and is currently evaluating its options.
The Paragraph IV certification procedure challenges a number of US patents relating to TriCor® which run through the next decade.
Such procedures are not unusual for branded products in the United States.
Fournier Laboratories Ireland Ltd. remains fully committed to its fenofibrate franchise and is currently evaluating its options.
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