U.S. Patent Office’s patent issuance provides extensive protection to BDSI's drug delivery technology platforms

Aug 26 2009

BioDelivery Sciences International, Inc. (Nasdaq: BDSI) today announced the issuance of United States Patent 7,579,019, which will provide additional patent exclusivity for both ONSOLIS^™ and BDSI’s BEMA^® drug delivery technology platform until at least 2019.

“The United States Patent Office’s issuance of this patent provides BDSI longer and more extensive protection for both ONSOLIS and the BEMA platform technology,” stated Charles Dadswell, General Counsel for BDSI. “The U.S. Patent Office has acknowledged and extended the expiration date of the patent by 835 days. However, BDSI believes it is entitled to, and will request, a further extension of this period that would move the expiration date into early 2020.”

“Issuance of this patent is significant as it not only extends the exclusivity window for ONSOLIS but also expands and extends our patent exclusivity for products utilizing the BEMA technology, including our follow on pain product in development, BEMA Buprenorphine,” said Dr. Mark A. Sirgo, President and Chief Executive Officer of BDSI.

BDSI recently announced approval from the U.S. Food and Drug Administration (FDA) to market ONSOLIS (fentanyl buccal soluble film), formerly referred to as BEMA Fentanyl, for the management of breakthrough pain (BTP) in patients with cancer, eighteen years of age and older, who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. ONSOLIS is the first product to utilize the company’s proprietary BioErodible MucoAdhesive (BEMA) drug delivery technology, which consists of a small, dissolvable, polymer film for application to the buccal mucosa (inner lining of the cheek). ONSOLIS will be commercialized in the U.S. by Meda Pharmaceuticals, the U.S. subsidiary of Meda AB, and is expected to be available for sale early fourth quarter of this year.

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