RALEIGH, N.C., May 8, 2014 /PRNewswire/ -- BioDelivery Sciences International, Inc. (NASDAQ: BDSI) announced that it has filed its Quarterly Report on Form 10-Q for the quarter ended March 31, 2014 with the U.S. Securities and Exchange Commission and, in connection therewith, is providing a review of BDSI's recent achievements and an update on business operations and upcoming milestones for 2014.
BDSI is expecting to hear from the U.S. Food and Drug Administration (FDA) on its New Drug Application (NDA) for BUNAVAIL (buprenorphine and naloxone buccal film) on or about June 7, 2014. Assuming BUNAVAIL is approved, BDSI intends to launch BUNAVAIL, a proposed maintenance treatment for opioid dependence, in the latter part of the third quarter of 2014. In March, BDSI announced that it entered into an agreement with Quintiles to provide a range of services to support the anticipated launch including the establishment of a sales team. Separately, BDSI entered into an agreement with Ashfield Market Access, led by former GSK veteran Steve Stefano, to provide managed markets and trade support for BUNAVAIL.
As recently reported, data from clinical studies of BUNAVAIL were presented at the American Society of Addiction Medicine (ASAM) 45th Annual Medical-Scientific Conference, April 10-13, 2014 in Orlando, Florida. Four posters were presented highlighting data from the clinical development program, which included the pivotal bioequivalence study of BUNAVAIL compared to Suboxone tablets. Also highlighted was a safety study conducted in 249 subjects undergoing maintenance treatment for opioid dependence with Suboxone film or tablets who were converted to BUNAVAIL for 12 weeks. The posters are accessible at www.bdsi.com.
On January 23, 2014, Endo Pharmaceuticals and BDSI announced positive top-line results from its pivotal Phase 3 efficacy study of BEMA Buprenorphine in opioid "naïve" subjects, and in conjunction with database lock, BDSI received a milestone payment from Endo in the amount of $10 million. BEMA Buprenorphine is being developed for the treatment of moderate to severe chronic pain in patients requiring around-the-clock opioid therapy for an extended period of time. Results of the second Phase 3 study, which was conducted in opioid "experienced" patients, are anticipated in early July. If successful, an NDA for an indication of the treatment of moderate to severe chronic pain would be anticipated to be submitted in late 2014 or early 2015.On April 3, 2014, BDSI announced the enrollment of the first patient in the RHAPSODY Study, a Phase 3 clinical trial of Clonidine Topical Gel for the treatment of painful diabetic neuropathy (PDN). The Phase 3 trial is a multicenter, randomized, double-blind, placebo-controlled study in 140 subjects to determine the efficacy and safety of Clonidine Topical Gel in the treatment of pain associated with PDN. As of the beginning of May, over 50% of subjects had been randomized in this trial with the interim analysis anticipated to occur in the third quarter of 2014. The purpose of the interim analysis is to confirm the assumptions regarding the study sample size and allow for an adjustment in size if needed. Clonidine Topical Gel has the opportunity to be the first topical product approved by FDA for the treatment of PDN. As such, BDSI currently estimates annual peak sales potential for this product in excess of $300 million. In February 2014, BDSI closed a $60 million registered common stock financing with a select group of institutional investors led by Federated Kaufmann. This financing strengthened BDSI's balance sheet in front of its anticipated 2014-2015 activities, and at March 31, 2014, BDSI had $88.2 million in cash compared to $23.2 million at December 31, 2013. Research and development costs were $14.6 million in the first quarter of 2014, compared to a corresponding $12.0 million in the first quarter of 2013. The current quarter increase in research and development expense was due primarily to additional research and development costs associated with the BEMA Buprenorphine for chronic pain late stage development program and the initiation of the Clonidine Topical Gel Phase 3 program. Overall R&D costs for 2014 will fall below 2013 levels. "There has never been a more exciting time at BDSI as we move closer to the PDUFA date of June 7 th and potential launch of BUNAVAIL this year, as well as the data read out of our second pivotal trial for BEMA Buprenorphine for chronic pain in early July," said Dr. Mark A. Sirgo, President and Chief Executive Officer of BDSI. "As it relates to BUNAVAIL, opioid dependence has unfortunately become a national epidemic and a clear need exists for new treatment options. To help address this need, we are currently readying launch plans for BUNAVAIL and have entered into agreements with Quintiles and Ashfield Market Access to provide the services and infrastructure needed to support our planned sales and managed markets activities. Additionally, we are working aggressively with our commercial partner Endo to complete the Phase 3 program and believe the market opportunity for BEMA Buprenorphine for chronic pain continues to expand for a differentiated Schedule 3 opioid. Furthermore, we are excited to have expanded our late-stage product pipeline with the initiation of the Phase 3 clinical trial of Clonidine Topical Gel for the treatment of painful diabetic neuropathy." "With a strengthened balance sheet, BUNAVAIL approaching its PDUFA date, the final pivotal study for BEMA Buprenorphine for chronic pain reporting out mid-year and Clonidine Topical Gel in Phase 3, we believe BDSI has the strongest potential in it's history to generate sustainable value for our shareholders," concluded Dr. Sirgo.