Below is a summary of updates to the <font> BioMedReports.com </font> database of over 200 entries included in the <font> FDA and Clinical Trial Calendars </font> . The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted.
Genzyme (NASDAQ:GENZ) : On 5/21/09, GENZ announced that it has submitted the final documentation to address all items in the FDA’s complete response letter from 3/2/09 (CRL) for Lumizyme (alglucosidase alfa), which is produced at the 2,000 L bioreactor scale. The submission included clinical data requested by the FDA from Genzyme’s Pompe Registry. The FDA has agreed that these data can fulfill the requirements for a verification study to demonstrate the clinical benefit of Lumizyme. Also included in the submission were the Risk Evaluation and Mitigation Strategy (REMS) and the final label for the product.
Because the submission will include clinical data, GENZ anticipates that its filing will be designated as a Class 2 resubmission with a six-month PDUFA decision date of 11/21/09. However, given the ongoing dialogue between Genzyme and the FDA, the Company expects that the agency will expedite the review process. The Company is also in active discussions with the FDA regarding the submission of a sBLA for the 4,000 L bioreactor scale manufacturing process with an expected regulatory filing during 2Q09.
Human Genome Sciences (NASDAQ:HGSI) : On 5/21/09, HGSI announced that it submitted a Biologics License Application (BLA) to the FDA for its human monoclonal antibody drug ABthrax (raxibacumab) for the treatment of inhalation anthrax. Raxibacumab is a first-in-class treatment for anthrax, and is being developed under a contract entered into in 2006 with the Biomedical Advanced Research and Development Authority of the Office of the Assistant Secretary for Preparedness and Response, U.S. Department of Health and Human Services (HHS).
In the first quarter of 2009, under the BARDA contract, HGSI achieved its first product sales by initiating the delivery of 20,000 doses of raxibacumab to the U.S. Strategic National Stockpile for emergency use in the treatment of inhalation anthrax. HGSI recognized $153.8 million in raxibacumab revenue in the first quarter, including $127.8 million in product sales. The Company has now completed delivery and expects to recognize at least $8.0 million in additional raxibacumab revenue in the second quarter of 2009. The BLA is also being filed under the BARDA contract, and HGSI will receive $10 million from the U.S. Government upon FDA licensure of raxibacumab.
Eli Lilly (NYSE:LLY) : On 5/21/09, LLY announced that it will begin enrolling patients this month in two separate but identical Phase 3 clinical trials of solanezumab, which is an anti-amyloid beta monoclonal antibody being investigated as a potential treatment to delay the progression of mild to moderate Alzheimer's disease. The trials, called EXPEDITION and EXPEDITION 2, will each include a treatment period that lasts 18 months and are expected to enroll a total of 2,000 patients age 55 and over from 16 countries. In 2008, Lilly began enrolling patients in two Phase 3 clinical trials called IDENTITY and IDENTITY 2 for a different potential treatment for Alzheimer's disease, a gamma-secretase inhibitor that also affects amyloid beta, which is believed to be one of the underlying pathologies of the disease.
NeurogesX (NASDAQ:NGSX) : On 5/21/09, NGSX announced that the European Commission has formally granted marketing authorization of Qutenza 179 mg cutaneous patch for the prescription-only treatment of peripheral neuropathic pain in non-diabetic adults either alone or in combination with other medicinal products for pain. The centralized marketing authorization allows Qutenza to be marketed in all 27 countries of the European Union. Qutenza is a skin patch that is designed to locally deliver a high-concentration (8%) of the active substance capsaicin to provide sustained relief from peripheral nerve pain.
NGSX expects to launch Qutenza in the E.U through a commercial partner in early 2010. In October 2008, the Company submitted a new drug application (NDA) to the FDA requesting marketing approval of Qutenza for the management of pain associated with postherpetic neuralgia (PHN) with an expected PDUFA decision date of 8/16/09.
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