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.
On 7/1/09, RPRX announced that an end of Phase 2 meeting is scheduled with the FDA for late September 2009 to discuss a Phase 3 program investigating the use of Proellex in the treatment of endometriosis. The Phase 2 study that RPRX completed earlier this year demonstrated clinically and statistically significant reductions of the three key pain symptoms commonly experienced by women with endometriosis: dysmenorrhea (painful menses), non-menstrual pelvic pain, and dyspareunia (painful intercourse).
Additionally, the reduction of pain was accompanied by a statistically significant reduction in the number of patients requiring pain medication in both doses in this Phase II study compared with placebo. The study showed no efficacy differences between the 25 mg and 50 mg doses. At the upcoming end of Phase II meeting, RPRX anticipates obtaining direction from the FDA on the objectives and endpoints the Agency would like to see used in the pivotal phase 3 efficacy and safety studies in endometriosis. Repros plans to initiate these studies with doses of 12.5 and 25 mg during 4Q09 and 1Q10, in both the U.S. and Europe. RPRX expects to file NDAs for the uterine fibroids indications in the second half of 2010.
On 7/1/09, ACOR announced an exclusive deal with Biogen (BIIB) to develop and commercialize Fampridine-SR in markets outside the U.S. while Acorda will continue to develop and commercialize Fampridine-SR in the U.S. Acorda will receive an upfront payment of $110 million and additional payments of up to $400 million based on the successful achievement of future regulatory and sales milestones along with tiered, double-digit royalty payments on ex-US sales. The FDA is currently reviewing a New Drug Application (NDA) for Fampridine-SR with a Priority Review (six-month) designation and a PDUFA action date of 10/22/09 for a possible FDA decision.
