Key Developments For BioDelivery Sciences International Inc
BioDelivery Sciences International Inc (BDSI.O) (Consolidated Issue listed on NASDAQ Capital Market)
BioDelivery Sciences International, Inc. Announces New Drug Submission In Canada For BEMA Fentanyl
BioDelivery Sciences International, Inc. (BDSI) announced the filing of a New Drug Submission (NDS) to Health Canada, the regulatory authority in Canada, for BEMA Fentanyl, also known as fentanyl buccal soluble film. BEMA Fentanyl is marketed in the U.S. as ONSOLIS, and the Canadian tradename is to be determined. BEMA Fentanyl was submitted to Health Canada by Meda Valeant Pharma Canada Inc. In addition to approval from the U.S. FDA on July 16, 2009, BEMA Fentanyl is currently under regulatory review in the European Union with approval expected in 2010. Under agreements with BDSI, Meda AB has the worldwide rights to commercialize and market BEMA Fentanyl, except in South Korea and Taiwan, the rights to which remain with BDSI.
BioDelivery Sciences International, Inc. To Consolidate Newark Operations and Bioral Amphotericin B Development At Raleigh Headquarters
BioDelivery Sciences International, Inc. announced the consolidation of the Company's laboratory and other operations in Newark, New Jersey to the Company's headquarters in Raleigh, North Carolina. The Company will vacate its Newark facility by September 30, 2009.
BioDelivery Sciences International, Inc. Announces U.S. Patent For BEMA Delivery Technology
BioDelivery Sciences International, Inc. announced the issuance of United States Patent 7,579,019, which will provide additional patent for both ONSOLIS and BDSI`s BEMA drug delivery technology platform until at least 2019.
BioDelivery Sciences International, Inc. And Meda AB Announce FDA Approval Of ONSOLIS
BioDelivery Sciences International, Inc. and Meda AB announced approval from the U.S. Food and Drug Administration (FDA) to market ONSOLIS, formerly referred to as BEMA Fentanyl, for the management of breakthrough pain 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 anticipated to be available in the fourth quarter of 2009 and will be commercialized in the U.S. by Meda Pharmaceuticals, the U.S. subsidiary of Meda AB. Meda is BioDelivery Sciences 's commercialization partner for the product worldwide, with the exception of Taiwan and South Korea, the rights to which remain with BioDelivery. Under the terms of its commercialization agreement with Meda, BioDelivery Sciences will receive an aggregate of approximately $27 million in milestone payments. The first is based upon FDA approval of ONSOLIS which is in the amount of approximately $12 million. Meda had already advanced BioDelivery Sciences $3 million in January 2009 against the $15 million milestone payment. A second payment of $15 million will be received following the manufacture of launch stocks of ONSOLIS, a target BioDelivery Sciences has also achieved. In addition, BioDelivery Sciences will receive a double-digit royalty on net sales as well as the potential for up to another $30 million in milestone payments upon the achievement of certain sales thresholds.
BioDelivery Sciences International, Inc. Reaches Agreement on REMS With FDA Review Division
BioDelivery Sciences International, Inc. announced that it has reached agreement with the U.S. Food and Drug Administration's (FDA) Division of Anesthesia, Analgesia and Rheumatology Products and a multidisciplinary review team on all aspects of the Company's New Drug Application (NDA) for ONSOLIS (fentanyl buccal soluble film), including the Risk Evaluation and Mitigation Strategy (REMS). Although the FDA did not meet its action date of last for this NDA, the Division has informed the Company that FDA will not be issuing a review extension letter as their action on the NDA is forthcoming. BDSI received a Complete Response letter from FDA on the NDA for ONSOLIS on August 28, 2008, with the only deficiency being the new requirement for a REMS. The REMS was not required at the time the NDA was originally submitted to FDA in October 2007. The REMS was formally submitted to the FDA on December 12, 2008 and the submission was placed under a six month review period.
