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BioDelivery Sciences on track to report data from two Phase 3 studies in 2014

As recently announced, a significant milestone was achieved by BDSI with the submission of a New Drug Application, or NDA, to the FDA for Bunavail for the maintenance treatment of opioid dependence. Under the 505(b)(2) regulatory statute, the NDA for Bunavail, which was submitted on July 31, 2013, will be subject to a ten month review. If approved, Bunavail will be the first buccal film dosage form containing buprenorphine for the treatment of opioid dependence that will compete with the market leader Suboxone, which achieved sales in excess of $1.5B in 2012 according to data from Wolters Kluwer. BDSI also remains on track to report data, expected in early 2014, from two pivotal Phase 3 studies of BEMA Buprenorphine for the treatment of chronic pain, a product with peak U.S. sales potential of $500M. These trials, one in opioid naive and the other in opioid experienced patients, are being conducted along with BDSI's partner, Endo Health Solutions. Both trials are expected to complete in late 2013 or early 2014, and with database lock for each trial, BDSI expects milestone payments from Endo which, along with a milestone payment for NDA filing, total an aggregate of $30M to BDSI.