|FDA Acknowledges Receipt of Resubmission of ELIQUIS; Endo Health Announces Receipt of Paragraph IV Certifications for OPANA® ER|
|By Staff and Wire Reports|
|Wednesday, 26 September 2012 18:38|
Bristol-Myers Squibb Company (NYSE: BMY) and Pfizer (NYSE: PFE) announced the U.S. FDA has acknowledged receipt of the New Drug Application (NDA) resubmission for ELIQUIS® (apixaban) to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (NVAF). The FDA assigned a new Prescription Drug User Fee Act (PDUFA) goal date of March 17, 2013. The FDA has deemed the resubmission a complete response to its June 22, 2012 Complete Response Letter that requested additional information on data management and verification from the ARISTOTLE trial.
The ELIQUIS NDA is based on the results of the ARISTOTLE and AVERROES studies. These clinical studies evaluated ELIQUIS in approximately 24,000 patients with NVAF, in the largest clinical trial program conducted to date in this patient population. The landmark ARISTOTLE trial compared apixaban to warfarin, the standard of care, in more than 18,000 NVAF patients, while AVERROES compared apixaban to aspirin in 5,598 NVAF patients who were unsuitable for vitamin K antagonist (VKA) therapy.
Endo Pharmaceuticals a subsidiary of Endo Health Solutions (Nasdaq: ENDP), announced the company has received Paragraph IV Certification Notices from Teva Pharmaceuticals and Amneal Pharmaceuticals each advising of the filing of Abbreviated New Drug Applications (ANDAs) for generic versions of OPANA® ER (Oxymorphone HCl).
Endo intends to vigorously defend OPANA ER's intellectual property rights and will pursue all available legal and regulatory pathways in defense of OPANA ER. The company is currently reviewing the details of these notices.
"With the decision last week by FDA to designate a reference listed drug for the new formulation of OPANA ER, we are not surprised by the receipt of the filing of ANDAs for a generic version of OPANA ER. OPANA ER remains an important growth driver for Endo and we expect the product to retain exclusivity for many years to come," said Julie McHugh, chief operating officer of Endo Health Solutions. "We anticipate that over the next few months FDA will establish standards for developing abuse deterrant drugs that will require generic manufacturers to do additional studies for their ANDAs to be approved. We continue to believe that any ANDA referencing OPANA ER should contain data and information demonstrating that the proposed product is similarly crush-resistant to the reformulated OPANA ER. We also believe in OPANA ER's very strong patent estate, including patents currently under review by the U.S. Patent and Trademark Office. We expect these patents will be allowed shortly and will provide additional protection for the new formulation of OPANA ER."
The Paragraph IV certification notices refer to U.S. Patent Nos. 8,075,872, 8,114,383, 8,192,722 and 7,851,482, which collectively cover the formulation and drug substance of OPANA ER, an opioid agonist indicated for the relief of moderate to severe pain in patients requiring continuous around-the-clock opioid treatment for an extended period of time. These patents are listed in the U.S. Food and Drug Administration's (FDA) Orange Book and expire in November 2023, August 2024, September 2025 and July 2029, respectively.
Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company") today announced that it continues to expect to file a New Drug Application (NDA) early next year, for its oral ghrelin agonist, AEZS-130, as a diagnostic test for adult growth hormone deficiency (AGHD), after receiving notification from the United States Food and Drug Administration (FDA) that Fast Track designation had not been granted.
Amarantus BioSciences, Inc. (OTCBB: AMBS), a biotechnology company developing new treatments and diagnostics for Parkinson's disease (PD) and Traumatic Brain Injury (TBI) centered around its patented anti-apoptotic therapeutic protein MANF, today announced the publication of positive, peer-reviewed efficacy data for MANF in an animal model of myocardial infarction.
GeoVax Labs, Inc. (OTCQB: GOVX), a biotechnology company developing vaccines to prevent and fight HIV/AIDS, was featured in several presentations at the AIDS Vaccine 2012 Conference in Boston, September 10-12.
The board of directors of Arizona-based algae producer Health Enhancement Products (OTCBB: HEPI) has accepted the draft report issued by a research laboratory and directed management to release those findings.
Medicure Inc. (TSX VENTURE:MPH) (PINKSHEETS:MCUJ), is pleased to announce the development of a transdermal delivery formulation of its lead drug, AGGRASTAT® (tirofiban HCl).
Savient Pharmaceuticals, Inc. (Nasdaq: SVNT) today announced that it has granted time-based restricted shares, and time-based and performance-based options to purchase shares of common stock to John P. Hamill, the Company's newly appointed Senior Vice President & Chief Financial Officer.
Shire plc (LSE: SHP; NASDAQ: SHPG), today announced the appointment of Frederic Chereau as Senior Vice President and Franchise Lead, Angioedema, for its Human Genetic Therapies (HGT) business.
ThermoSafe Brands, a unit of Sonoco (NYSE: SON), has launched a family of new temperature-assured polyurethane-insulated pallet shippers for use in the United States and Europe for the bulk distribution of pharmaceuticals and other biotechnology products.
Her Excellency, Mrs. Joyce Banda, the President of the Republic of Malawi, announced today that an agreement has been reached to open an outpatient's clinic at Queen Elizabeth Central Hospital for the treatment of cancer and infectious diseases with US-based biotech firms TNI BioTech, Inc. (TNIB) (PINKSHEETS: TNIB) and GB Oncology & Imaging Group LLC (GBOIG).
Unigene Laboratories, Inc. (OTCBB: UGNE), today announced the Company has entered into a Forbearance Agreement and First Amendment to Amended and Restated Financing Agreement with affiliates of Victory Park Capital Advisors, LLC, dated September 21, 2012, whereby Victory Park Capital has loaned the Company $4 million and agreed to forbear from exercising certain rights due to designated events of default through September 21, 2013, subject to the terms and conditions of such agreement.
Uroplasty, Inc. (NASDAQ: UPI), a medical device company that develops, manufactures and markets innovative proprietary products to treat voiding dysfunctions, today announced that ConnectiCare of the Emblem Health family of insurers began coverage of percutaneous tibial nerve stimulation (PTNS) using its Urgent® PC neuromodulation system for the treatment of the symptoms of overactive bladder syndrome (OAB).