Below is a summary of updates to the
BioMedReports.com FDA Calendar, which includes a database of over 200 entries. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of
BioMedReports.com, the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-stage pivotal Phase 3 clinical trial results which are designed to support a filing for FDA approval.
Auxilium Pharma (NASDAQ:AUXL) and BioSpecifics Technologies (NASDAQ:BSTC)
On 6/18/09, AUXL announced that the FDA's Arthritis Advisory Committee will review Xiaflex during an advisory committee hearing, which is tentatively scheduled to take place on 9/16/09. Xiaflex (collagenase clostridium histolyticum) is a novel, first-in-class, orphan-designated, biological agent for the treatment of Dupuytren's contracture (this is a progressive condition that affects the connective tissue that lies beneath the skin in the palm, resulting in collagen deposits which impair normal hand function).
AUXL filed its Biologics License Application (BLA) for Xiaflex for the treatment of Dupuytren's contracture on 2/27/09 and the FDA accepted the BLA filing with a priority review (six-month) designation on 4/28/09. The FDA has not updated the PDUFA action date of 8/28/09, but a final decision by the Agency would be expected to occur sometime after the Advisory Panel Meeting. AUXL is also conducting a randomized, double-blind, placebo-controlled U.S. Phase 2b clinical trial for Xiaflex for Peyronie's disease with over 120 patients enrolled and all dosing completed on 4/30/09 and top-line results from the study expected during 4Q09.
On 2/3/09, BSTC received $6.375 million of the $75 million upfront payment paid to AUXL by Pfizer (NYSE:PFE) and will receive 8.5% of the $410 million in potential additional milestone payments that may be made by PFE to AUXL. Of these additional milestone payments, $150 million are tied to regulatory milestones and $260 million are based on sales milestones. In addition, BSTC will continue to receive milestone and royalty payments from AUXL in accordance with its original agreement.
Disclosure: No positions.
