Trading the Trials and FDA Decision Calendar

by: Mike Havrilla

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The table above features an updated calendar of 80 expected FDA new product decisions while the table below highlights 89 pending clinical trial result estimates and pending FDA re-submissions. Click here for a link to my previous FDA calendars and click here for a list of 14 extreme trades of companies with market caps below $100M and pending new drug decisions at the FDA.

Below is a summary of the major updates on the calendars since I last posted and a two-week outlook of expected decisions. Last week was notable for FDA clearance to begin human testing of embryonic stem cells in addition to big pharma M&A, with Pfizer (NYSE:PFE) putting its cash hoard to use and reportedly close to finalizing a deal to buy Wyeth (WYE) for 50 bucks per share.

1.) United Therapeutics (NASDAQ:UTHR): UTHR clarified the PDUFA date for tadalafil NDA in the treatment of pulmonary arterial hypertension (NYSE:PAH) as 5/24/09. The drug is better known to many as Cialis and is currently marketed for the treatment of erectile dysfunction and is being licensed from Eli Lilly (NYSE:LLY) with expected pricing of $10,000 per year for PAH. UTHR also modified the ongoing Freedom M Trial of Remodulin oral drug monotherapy for PAH, with results now expected in 1H10.

2.) Osiris Therapeutics (NASDAQ:OSIR): OSIR held a successful pre-BLA meeting with the FDA in mid-January to set the stage for the first regulatory submission for a stem cell therapeutic. Prochymal Phase 3 Results in the treatment of graft-vs-host disease (GvHD) are expected in 2Q09 and OSIR plans to ask for a priority review as part of a rolling BLA submission to speed up the potential path to approval. Last November, OSIR signed a major deal with Genzyme (GENZ) to market the former's two late-stage adult stem cell treatments, Prochymal and Chondrogen.

3.) Geron (NASDAQ:GERN): A new era for embryonic stem cell research was ushered in last week as GERN surprised the market with FDA approval to begin testing its experimental treatment in a small Phase 1 study in 8-10 humans with spinal cord injuries. In the near-term, look for President Obama to reverse the former administration's ban on federal funding for embryonic stem cell research, fueling more stock price gains that include over 50% each for GERN and OSIR and over 100% for StemCells (STEM) in the past year.

4.) Alnylam Pharma (NASDAQ:ALNY): ALNY received FDA approval to begin Phase 1 human clinical trials of an experimental treatment (ALN-VSP) for liver cancer based on its extensive RNA interference (RNAi) drug discovery platform, with patient dosing expected to begin in 1H09.

5.) KV Pharma (KV-A): Hologic's (NASDAQ:HOLX) could receive a ruling by Monday for its Gestiva NDA for prevention of pre-term births in women with a previous occurrence, with KV set to buy the rights to the drug if it is approved.

6.) Sanofi-Aventis (NYSE:SNY): SNY has a PDUFA date of 1/31/09 for its Multaq (dronedarone) NDA (priority review) for atrial fibrillation (a type of irregular heartbeat).

7.) Takeda Pharma (OTC:TKPHY): Takeda has a PDUFA date of 1/31/09 for its TAK-390MR (a proton pump inhibitor) NDA for the treatment of gastroesophageal reflux disease (GERD).

8.) Eli Lilly: LLY and Daiichi Sankyo (OTC:DSKYY) have a FDA advisory panel meeting scheduled for 2/3/09 to review their long overdue pending NDA for prasugrel (Effient) as a new blood thinner in the treatment of acute coronary syndrome (ACS) to compete with Plavix, which is a multi-billion dollar drug for SNY and Bristol-Myers (NYSE:BMY).

9.) Merck KGaA: MKGAY plans to seek accelerated approval by mid-09 in both the E.U. and U.S. markets for cladribine oral tablets to reduce the incidence of relapses in multiple sclerosis (NYSE:MS) after reporting positive results (over 50% fewer relapses compared to placebo) in a two year clinical trial. Novartis (NYSE:NVS) also plans to file for an oral therapy (fingolimod) to compete in the multi-billion dollar market for MS drugs, which currently is limited to injectable treatments such as Teva Pharma's (NYSE:TEVA) Copaxone, Biogen's (NASDAQ:BIIB) Avonex, and others.