BioDelivery Sciences (NASDAQ:
BDSI) is a specialty pharmaceutical company that develops new indications for approved drug compounds by applying its proprietary drug delivery technology platform, BEMA (BioErodible MucoAdhesive) Film Technology, while seeking FDA approval through the 505(b)(2) pathway, which represents a lower risk / cost and quicker route to commercialization as compared to the process of developing new chemical entities or biological agents. BDSI focuses on the niche market of pain management and supportive cancer care.
On 7/22/09, BDSI announced receipt of $26.7 million in milestone payments from its commercial partner Meda AB in connection with the FDA approval of the Company's breakthrough cancer pain product Onsolis (fentanyl buccal soluble film) and manufacture of commercial launch supplies. BDSI is also set to receive a double-digit royalty on net sales of Onsolis, in addition to potential milestone payments (up to another $30 million) based on the achievement of sales targets. On 10/8/09, BDSI announced that Meda AB plans to launch Onsolis during the following week.
Together with approximately $5 million received from the previous exercise of warrants, BDSI maintains a strong balance sheet with about $30 million in cash (compared to a current market cap around $110 million) and no long-term debt along with future cash flow based on double-digit royalties on the net sale of Onsolis from Meda AB. The Company will focus on developing its pipeline, including BEMA Buprenorphine, Bioral Amphotericin B, and bring a third BEMA product into clinical testing next year and estimates adequate liquidity through 2010 based on current plans / status.
Expected milestones for BDSI through next year include:
1.) Will begin receiving double-digit royalties from Meda AB on net sales of Onsolis following U.S. commercial launch on 10/12/09
2.) Preliminary Phase 2 dental pain BEMA Buprenorphine study results are expected in December 2009
3.) A study evaluating Onsolis for non-cancer breakthrough pain is expected to start during 1Q10 and will be funded by Meda AB
4.) A Phase 3 acute pain study for BEMA Buprenorphine is expected to start during 2Q10
5.) The E.U. approval of Onsolis is expected during 1H10 and a New Drug Submission for BEMA Fentanyl was made to Health Canada in early October 2009 by partner Meda Valeant Pharma Canada Inc.
