Three-Month, Updated FDA Decision Calendar

by: Mike Havrilla

The accompanying table includes an updated calendar of FDA decisions expected to occur within the next three months. Most recently, the FDA continued its tough stance toward new antibiotic approvals and issued a complete response letter for ceftobiprole to Johnson & Johnson (NYSE:JNJ) and its Swiss partner, Basilea Pharma (Switzerland: BSLN) – sending the latter down sharply to new lows before the holiday with a sharp rebound of 30% by the end of the week, but still down by about 43% in the last year.

The FDA cited concerns over auditing and monitoring of clinical trial sites, which is similar to the reasons for delaying a decision on telavancin from Theravance (THRX). However, as I wrote last week, telavancin received an endorsement from a FDA panel while Targanta's (TARG) oritavancin was not recommended.

Genzyme (GENZ) could hear back from the FDA as early as today for approval of Myozyme at the 2,000L bioreactor scale for large-scale production, which was endorsed by an FDA panel in late October. Genzyme also submitted a sNDA earlier this week to expand the use of Clolar for adults with acute myeloid leukemia (AML) and should hear back from the FDA by the end of January whether the application is accepted and granted a priority review of six months.

A decision is also possible in December for JNJ and Medarex (MEDX) for a biological agent, Stelara (ustekinumab), in the treatment of psoriasis – with a FDA panel endorsement this past June and clinical trial results in September which showed it was more effective than Amgen's (NASDAQ:AMGN) Enbrel in a short-term, 12-week study of patients with moderate to severe plaque psoriasis.

After reviewing the transcript of JNJ's most recent conference call, I have a correction on this calendar for ustekinumab as the BLA was originally filed on 11/29/07, resulting in a standard 10-month review target date of 9/29/08, which was then delayed by three months for a new PDUFA target of 12/29/08. Also, the correct PDUFA date for another biological agent for JNJ, golimumab (CNTO 148), should be 4/27/09 (instead of 3/27/09 as previously published) since the BLA was filed 6/27/08.

Click here for my previous articles and FDA calendars, including several companies with expected decisions before year-end expected to have major stock price impacts, but keep in mind the backlog of delayed decisions that is building means that none of the dates are certain to produce final decisions.