BioDelivery Sciences International, Inc.
) has inked a deal with
Quintiles Transnational Holdings Inc.
) for supporting the anticipated launch of BioDelivery Sciences'
Bunavail. The company is looking to get Bunavail approved as a
maintenance therapy for opioid dependence.
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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
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
) 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
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.
) with a Zacks Rank #1 (Strong Buy). Quintiles also holds a Zacks