On 4/28/09, the FDA accepted for priority review (six-month) Auxilium's (NASDAQ:AUXL) BLA for Xiaflex (clostridial collagenase for injection) for the treatment of Dupuytren's contracture. AUXL filed the BLA on 2/27/09 and included data from 1,082 subjects and over 2,600 injections. The PDUFA decision date is 8/28/09 for the Xiaflex BLA. If approved by the FDA, AUXL plans to launch Xiaflex in the U.S. within 60 days during 2H09.
On 2/2/09, AUXL announced the completion of enrollment in a randomized, double-blind, placebo-controlled U.S. Phase 2b clinical trial for Xiaflex for Peyronie's disease. Over 120 patients were enrolled and all dosing was completed on 4/30/09 with top-line results from the study expected during 4Q09 based on Auxilium's guidance provided along with quarterly results on 5/6/09.
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.
$25.8897 (06/10/09)
