BioDelivery Sciences International, Inc. (NASDAQ: BDSI) announced that it has entered into an agreement with Quintiles to provide a range of services to support the anticipated launch of BUNAVAIL (buprenorphine and naloxone buccal film), BDSI's proposed maintenance treatment for opioid dependence.
BUNAVAIL is currently under review at the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) date of June 7, 2014. Assuming BUNAVAIL is approved, BDSI intends to launch BUNAVAIL in the latter part of third quarter 2014.
Under terms of the agreement, Quintiles will provide a range of services to support the launch and subsequent commercialization of BUNAVAIL in the U.S., including a field sales force. Under the direction of BDSI, Quintiles will support the recruitment, training and deployment of a competitively sized sales force capable of reaching the physician base treating the majority of patients with buprenorphine for opioid dependence. In the U.S., nearly 5,000 physicians are responsible for approximately 90% of prescriptions for buprenorphine products for the treatment of opioid dependence according to most recent data from Symphony Health Solutions.
Separately, BDSI has entered into an agreement with Ashfield Market Access to provide managed markets and trade support for BUNAVAIL. Ashfield Market Access, which is led by industry veterans including Steve Stefano, who led GlaxoSmithKline's managed markets group for more than 20 years, will be responsible for executing a payer strategy aimed at maximizing patient access to BUNAVAIL.
"We have been working with and have formed strong relationships with these two companies over the past year, and in conjunction with them have developed a commercial plan that will support what we believe will be a successful launch of BUNAVAIL in the U.S. later this year," said Dr. Mark A. Sirgo, President and Chief Executive Officer of BDSI. "Both Quintiles and Ashfield Market Access have an excellent history of supporting companies like BDSI in successfully launching and commercializing important new products. We are very pleased to now formalize our collaborations. We will provide greater details around our plans for the launch of BUNAVAIL as we approach our June 7th PDUFA date and the product's potential approval."
"As part of our collaboration with Quintiles, BDSI will have input in the selection of a newly developed sales force that will be dedicated solely to support the introduction of BUNAVAIL," said David Acheson, Vice President of Sales and Managed Markets for BDSI. "Leading this collaborative effort with Quintiles, BDSI will be in a position to build an experienced and highly committed sales force. Additionally, the added strength of Ashfield Market Access provides us critical access to trade and managed markets by tapping into the resources of individuals with significant experience and long-term relationships with payers. We believe the combined resources of Quintiles and Ashfield Market Access, along with our other partners, our internal commercial experience, and a well differentiated product in BUNAVAIL, will help support a strong introduction."
BioDelivery Sciences International, Inc.