One of Biodelivery Sciences International’s competitors within the Biotechnology space, Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP), reported on March 09, 2017, its financial results for the year ended December 31, 2016. AWS will be initiating a research report on Corbus Pharma in the coming days.
Today, AWS is promoting its blog coverage on BDSI; touching on CRBP. Get all of our free blog coverage and more by clicking on the link below:
The Two Patents
BioDelivery Sciences filed a patent application (US Patent Application Serial No. 15/212,913) regarding the composition of the BioErodible MucoAdhesive drug delivery technology, which is the basis of the Company’s two major products, the BELBUCA and BUNAVAIL. A Notice of Allowance was issued considering the application, and providing additional patent coverage for BELBUCA and BUNAVAIL to July 2027.
On March 21, 2017, a different patent (US Patent No. 9,597,288) was issued which extended the patent protection on ONSOLIS from January 2020 to July 2027. BioDelivery Sciences signed a licensing agreement with Collegium Pharmaceutical, Inc. (NASDAQ:COLL) on May 11, 2016, pursuant to which Collegium was granted exclusive rights to develop and commercialize ONSOLIS in the US. Under terms of the agreement, Collegium would manage all the operations ranging from manufacturing to sales, while BioDelivery Sciences was offered an initial $2.5 million upfront non-refundable payment in addition to $4 million payment upon the first commercial sale of ONSOLIS. Eventually, the Companies agreed upon $17 million in potential payments based on achievement of performance and sales milestones.
The Product Portfolio
ONSOLIS is an opioid agonist indicated for the management of breakthrough pain in cancer patients 18 years of age and older. The patients are the ones already receiving and are tolerant to opioid therapy for their underlying persistent cancer pain. ONSOLIS was originally licensed and launched in the US by Meda where it sold the marketing authorizations for ONSOLIS back to BDSI in January 2015. Currently, ONSOLIS is licensed to Collegium Pharmaceutical in the US, while outside US it is licensed to Meda, with the exception of Taiwan, where it is licensed to TTY Biopharm.
BELBUCA buccal film is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which, alternative treatment options are inadequate. BELBUCA was approved by the US Food and Drug Administration (FDA) on October 23, 2015. Recently, on January 09, 2017, BioDelivery Sciences announced the closing of previously announced agreement with Endo Pharmaceuticals, Inc., pursuant to which it terminated Endo’s licensing of rights for BELBUCA. As a result of the closing, the worldwide rights for BELVBUCA were transferred back to BioDelivery Sciences.
BUNAVIL, designed using BDSI’s drug delivery technology, BioErodible MucoAdhesive (BEMA®), is the first and only formulation of buprenorphine and naloxone for buccal (inside of cheek) administration. The unique technology enables efficient and convenient delivery of buprenorphine while potentially overcoming some of the administration challenges presented by the sublingual dosage forms currently available. BioDeliver Sciences received approval of the New Drug Application (NDA) for BUNAVIL from the FDA.
At the close of trading session on Friday, March 31, 2017, Biodelivery Sciences International’s stock price rose 1.06% to end the day at $1.90. A total volume of 869.05 thousand shares were exchanged during the session, which was above the 3-month average volume of 414.97 thousand shares. The Company’s share price has gained 11.76% in the past three months and 8.57% on YTD basis. The stock currently has a market cap of $105.49 million.