FDA Decisions and Clinical Trials: An Updated Calendar

by: Mike Havrilla

The accompanying table includes 84 pending FDA new product decision dates. Click here for a link to my previous calendars and here for 16 extreme FDA trades of companies with market caps below $150M with pending decisions. Click here for a calendar of 89 clinical trial result estimates along with pending FDA new filings or re-submissions for regulatory approval.

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New Entries on the FDA Calendar:

1) Acorda Therapeutics (NASDAQ:ACOR): ACOR filed a NDA for Fampridine-SR Oral Tablet to improve the walking ability of people with multiple sclerosis (NYSE:MS) with a standard review expected and a PDUFA date of 11/30/09. ACOR also plans to file for marketing approval in the E.U. with the European Medicines Agency after it determines its strategy for commercialization in that region.

2.) Boston Scientific (NYSE:BSX) and Angiotech Pharma (ANPI): BSX filed a PMA on 2/5/09 for two TAXUS (Liberte Atom & Long) drug-eluting coronary stents (DES) with a decision possible by year-end, although PMAs do not have decision deadlines.

3.) BioForm Medical (BFRM): BFRM filed a PMA for its Radiesse Dermal Filler (which is already on the market) combined with lidocaine (as a numbing agent for the skin) with a decision possible by year-end. The company also plans to file for FDA approval during 1H09 for polidocanol as a treatment for varicose veins (sclerosing agent).

Review of FDA Advisory Panels this Week:

1.) Dyax Corp. (NASDAQ:DYAX): DYAX secured a narrow approval (with a 6-5-2 vote) for its Kalbitor (ecallantide or DX-88) BLA with a PDUFA date of 3/23/09, which is designated for priority review in the treatment of acute attacks of hereditary angioedema (HAE is a rare disorder marked by severe swelling which can be fatal if the throat area is involved).

The panel debated the need for an effective treatment for this rare, potentially dangerous condition against the 3% higher incidence of allergic reactions (13% versus 10%) in patients taking the drug along with questions about the data generated in the clinical trials. ViroPharma (VPHM) has a PDUFA date of 10/1/09 for its Cinryze C1 Inhibitor sBLA to expand its label to include the treatment of HAE.

2.) Eli Lilly (NYSE:LLY) and Daiichi Sankyo (OTC:DSKYY): They received unanimous FDA panel recommendation (9-0) for approval of Effient (prasugrel) to compete with multi-billion dollar Plavix from Sanofi-Aventis (NYSE:SNY) and Bristol-Myers (NYSE:BMY) for the treatment of acute coronary syndrome. It appears likely Effient will receive FDA approval for a smaller patient population (i.e. excluding patients with a history of stroke) due to the increased risk of bleeding complications.

One-Week Outlook:

GTC Biotherapeutics (GTCB): GTCB has a PDUFA date of 2/7/09 (which falls on Saturday, so a decision may not be issued until Monday if the FDA sticks to its deadline) for its Atryn (recombinant human anti-thrombin) BLA for deep vein thrombosis (DVTs or blood clots), which would represent the world's first therapeutic from genetically engineered animals (goats). An FDA advisory panel already voted that Atryn is safe + effective and the stock price has been rising steadily ever since.

Also, the FDA issued its final guidance in mid-January for the regulation and review of products made from genetically engineered animals. This sets the stage for approval of Atryn (any day now, since there are no outstanding issues to prevent or delay FDA approval) and adds substantial value to GTC Bio's technology platform, which can be applied for large-scale, low-cost production of a variety of therapeutic proteins and other complex biological agents.