FDA and Clinical Trial Calendars: Favorable Vote for Sanofi's Multaq

Below is a summary of updates to the BioMedReports.com database of 241 entries included in the FDA and Clinical Trial Calendars.

The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA deadline dates. The entries are updated on a daily basis as new information becomes available with a total of 104 entries through 3/20/09. The FDA Calendar includes the following information: company name, ticker, decision date, and description.

The Clinical Trial Calendar includes 137 entries through 3/20/09 and 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.

1.) OSI Pharma (OSIP) and Roche (RHHBY.PK): Supplemental new drug application (sNDA) to expand the labeled use of Tarceva (erlotinib) as a first-line maintenance therapy for people with advanced non-small cell lung cancer (NSCLC) who have not progressed following first-line treatment with platinum-based chemotherapy. The PDUFA decision date would be 1/19/09 for a standard, 10-month review.

Both the U.S. and EU submissions are based on a pivotal Phase 3 clinical trial known as SATURN.. In November 2008, OSI, Genentech and Roche announced that SATURN met its primary endpoint and showed that Tarceva significantly extended the time patients with advanced NSCLC lived without their cancer getting worse (progression-free survival or PFS) when given immediately following initial treatment with platinum-based chemotherapy, compared to placebo.

The SATURN data will be presented at the 45th Annual Meeting of the American Society of Clinical Oncology being held May 29-June 2, 2009 in Orlando, Fla.. Overall survival data, a secondary endpoint of the study, are expected in 2H09 and will be part of the FDA review process. Roche also filed in parallel for EU approval for this indication with the EMEA.

2.) Johnson & Johnson (JNJ) and Bayer's (BAYRY.PK) anticoagulant drug Xarelto (rivaroxaban) was backed by a U.S. advisory panel on Thursday by a 15-2 vote despite concerns over possible side effects (bleeding and liver damage). The companies are seeking marketing approval for the once-a-day pill to prevent dangerous blood clots for up to 14 days in patients following knee replacement surgery and up to 35 days for hip replacements. The drug is already used in Europe and Canada with a PDUFA decision date of 5/28/09 for the final FDA decision.

3.) Sanofi-Aventis (SNY): An FDA Advisory Panel of cardiology experts voted 10-3 in favor of Multaq (dronedarone) as a treatment for atrial fibrillation (a-fib), which is the most common type of irregular heartbeat that affects the upper chambers of the heart and carries a significant risk of causing a stroke. A final FDA decision is expected by the end of April. Analysts are predicting blockbuster sales of over $1B per year for Multaq and, if approved, it would represent the first new treatment for a-fib in over two decades.

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