BioDelivery Sciences has revealed the issuance of US Patent No. 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 company has recently revealed approval from the FDA to market Onsolis, formerly referred to as BEMA Fentanyl. It is meant for the management of breakthrough pain (BTP) in patients with cancer, who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain.
The company claims that Onsolis is the first product to utilize its BioErodible MucoAdhesive (BEMA) drug delivery technology, which consists of a small, dissolvable, polymer film for application to the buccal mucosa.
The company said that Onsolis will be commercialized in the US by Meda Pharmaceuticals, the US subsidiary of Meda.
Charles Dadswell, general counsel for BDSI, said: “The US Patent office’s issuance of this patent provides BDSI longer and more extensive protection for both Onsolis and the BEMA platform technology. The US 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.”
Mark Sirgo, president and CEO of BDSI, said: “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.”
BioDelivery Sciences International is a specialty pharmaceutical company which utilizes its owned and licensed patented drug delivery technologies to develop, partner, and commercialize new products using proven therapeutics.