BioDelivery Sciences International, Inc. (BDSI) has inked a deal with Quintiles Transnational Holdings Inc. (Q) for supporting the anticipated launch of BioDelivery Sciences’ Bunavail. The company is looking to get Bunavail approved as a maintenance therapy for opioid dependence.
Bunavail, which utilizes the BEMA drug delivery technology, is under the review by the U.S. Food and Drug Administration (:FDA). The company expects a decision from the FDA on June 7, 2014. BioDelivery Sciences expects to launch Bunavail in the third quarter of 2014, on approval.
Currently approved maintenance treatments for opioid dependence include Orexo’s Zubsolv and Reckitt Benckiser’s Suboxone.
According to the agreement, BioDelivery Sciences will receive a field sales force from Quintiles. Quintiles will also support the recruitment, training and deployment activities of the sales force.
In addition, BioDelivery Sciences has entered into a separate agreement with Ashfield Market Access. This deal aims to support BioDelivery Sciences on managed markets and trade for Bunavail.
Meanwhile, BioDelivery Sciences and partner Endo International (ENDP) are conducting a phase III study on another candidate developed on the BEMA platform, BEMA buprenorphine, in opioid experienced patients. Top-line results from the study should be out by mid-2014. BioDelivery Sciences intends to file a new drug application (:NDA) for BEMA buprenorphine later this year or early next year.
We expect investor focus to remain on Bunavail’s approval status.
BioDelivery Sciences carries a Zacks Rank #3 (Hold). A better-ranked stock in the biotech sector is Alexion Pharmaceuticals, Inc. (ALXN) with a Zacks Rank #1 (Strong Buy). Quintiles also holds a Zacks Rank #1.