ALIOF

Pipeline updates are highly awaited events in the pharma/biotech sector as they play an important role in deciding whether or not to invest in a particular company. These updates provide information on experimental drugs and at times give an insight into the commercial potential of the candidate once it is successfully developed and commercialized.

With the commencement of 2014, several companies have been providing an update on their pipelines as well as goals for the year. BioDelivery Sciences International, Inc. (BDSI) has important catalysts coming up this year with the database for a phase III study on its lead candidate, BEMA buprenorphine, expected to be locked soon.

BEMA buprenorphine is being developed for the treatment of moderate to severe chronic pain in opioid naive subjects and topline data from the phase III study should be out later this month/early next month.

BioDelivery Sciences has a licensing and development agreement with Endo Health Solutions, Inc. (ENDP) for BEMA buprenorphine. According to the agreement, BioDelivery Sciences will receive a milestone payment of $10 million from Endo once the database for the phase III study is locked.

Meanwhile, the database for a second phase III trial on BEMA buprenorphine (for opioid experienced patients) is scheduled to be locked by mid-2014. The company expects to file a New Drug Application (NDA) for the candidate in late 2014.

BioDelivery Sciences continues to work on its commercialization plans for Bunavail, which is currently under FDA review for maintenance treatment of opioid dependence. A response should be out by Jun 7, 2014. The re-launch of Onsolis (management of breakthrough pain in opioid tolerant patients with cancer) is slated for the second half of the year.

BioDelivery Sciences also said that it intends to commence a phase III study on clonidine topical gel in the first quarter for the treatment of painful diabetic neuropathy.

We expect investor focus to remain on the phase III BEMA buprenorphine data that should be out in the coming weeks.

BioDelivery Sciences carries a Zacks Rank#3 (Hold). Some better ranked stocks in the same sector include Actelion Ltd. (ALIOF) and Acceleron Pharma, Inc. (XLRN). While Actelion (ALIOF) is a Zacks Rank #1 (Strong Buy) stock, Acceleron Pharma (XLRN) is a Zacks Rank #2 (Buy) stock.

 
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