BioDelivery Awaits Final FDA Word

This morning, BioDelivery Sciences International (BDSI) announced that it has reached an agreement with the U.S. Food and Drug Administration's (FDA) Division of Anesthesia, Analgesia and Rheumatology Product on all aspects of the company's New Drug Application (NDA) on Onsolis.

The agreement includes the Risk Evaluation and Mitigation Strategy (REMS), which was the previous hurdle to approval and the key reason for the complete response letter received in August 2008. BDSI refilled the NDA in December 2008 with the updated REMS requirement.

We expect final FDA action in the next few weeks. Coming to an agreement with the reviewing division and the review team on all aspects of the NDA, including the REMS, clearly bodes well for final approval of the drug.

Approval will be a transformational event for BDSI. Not only will it bring about a $30 million milestone payment from worldwide commercialization partner, Meda AB, but BDSI will also receive double-digit royalties (we estimate 20%) on sales of Onsolis upon launch.

The breakthrough cancer pain market is highly competitive, and there are several formulations of fentanyl already on the market, with several more in late-stage development, but we believe that BDSI's BEMA technology offers significant advantages over existing delivery technologies and could allow for Onsolis to be at least a $250 million peak sales drug.

The company plans to host a conference call at 11AM EST today (June 15, 2009) to discuss the NDA status of Onsolis.

Read the full analyst report on BDSI