The table below features an updated calendar of 79 expected FDA new product decisions while the table below highlights 91 pending clinical trial result estimates and pending FDA re-submissions or new submissions for regulatory approval. Click here for a link to my previous calendars.
1.) Eli Lilly (LLY) and Daiichi Sanky (DSKYY.PK) have a FDA advisory panel meeting today to review their potential blockbuster blood thinner Effient (prasugrel) – click here for the PDF review document. The panel debate will center on safety issues for Effient, which has unquestioned effectiveness as a blood thinner to compete with the world's second best-selling drug, Plavix.
Rumors are also circulating that Sanofi-Aventis (SNY) may be considering a bid for its Plavix marketing partner, Bristol-Myers (BMY). While there are no doubts that Effient is effective as a blood thinner, safety concerns will limit the target population for the drug to avoid bleeding complications in high-risk patients.
2.) Dyax Corp (DYAX) will also face a FDA advisory panel vote on 2/4/09 for Kalbitor (ecallantide) for the treatment of acute attacks of hereditary angioedema (HAE), which as a PDUFA decision date of 3/23/09 for the priority review BLA. Summary documents (link to PDF) posted at the FDA website raise possible concerns over allergic reactions, which occurred at a 3% higher incidence among patients taking the drug, as well as the patient questionnaires used by the Company to assess patient outcomes.
3.) OraSure Technologies (OSUR): A pre-market approval application (PMA) was submitted in late October 2008 to the FDA for a new test, the OraQuick Hepatitis C Virus (HCV) Rapid Test, with a possible decision by late 2009, although there are no decision deadlines issued by the FDA for PMAs. Schering-Plough (SGP) will reimburse OSUR for a portion of the development expenses and help to market the test to physicians in the U.S. and international markets.
The HCV test is one of two key catalysts for OSUR in addition to the development of an oral fluid based diagnostic test for HIV being developed for over-the-counter (OTC) sale directly to consumers. OSUR recently received FDA approval for a 12-month shelf life from the date of manufacture for its OraQuick ADVANCE Rapid HIV-1/2 Antibody Test, which is already on the market for use by healthcare professionals.
The OTC test for HIV has been in development for years as OSUR must conduct clinical trials to establish that consumers are able to use the test and correctly interpret the results. Also, a strategy must be in place to provide follow-up support and healthcare referrals for those who test positive for the disease, based on input from the FDA Blood Products Advisory Panel in March 2006.
OSUR currently trades at a market cap of $128M despite net cash and investments of about $75M and revenue of about $54M through the first nine months of 2008. The HCV and HIV tests are crucial for the Company to restore profitability and long-term growth, as OSUR used $3.7M of cash flow for operating activities for the first three quarters of 2008. The Company also repurchased about $3M of its common stock in the last quarter while trading at multi-year lows.