Updates on future business plans of a company and regular reviews on its achievements during a particular period of time 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 the pipeline, include news on filing of marketing applications, their acceptance by regulatory agencies and at times give an insight into the commercial potential of the candidate once it is successfully developed and commercialized.
Late last week, BioDelivery Sciences International, Inc. (BDSI) provided an update on its business operations and pipeline.
BioDelivery Sciences provided updates on two of its lead candidates containing buprenorphine for opioid dependence and pain management, respectively. The company confirmed that the U.S. Food and Drug Administration (:FDA) will provide a response on Bunavail’s approval status, for the maintenance treatment of opioid dependence by Jun 7. If approved, BioDelivery Sciences expects to launch Bunavail in the third quarter of 2014.
Meanwhile, BioDelivery Sciences and partner Endo (ENDP) are conducting a phase III study on BEMA buprenorphine in opioid experienced patients. Top-line results from this 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.
BioDelivery Sciences also intends to initiate two phase III studies on clonidine topical gel, licensed from Arcion Therapeutics in 2013, for the treatment of painful diabetic neuropathy. The company said that it will start enrolling patients for the first phase III study shortly. Interim data from the study should be out by the end of 2014. Having a fast-track designation, clonidine might be granted priority review by the FDA. The company intends to file an NDA for clonidine in 2016.
We expect investor focus to remain on Bunavail’s approval status.
BioDelivery Sciences carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the same sector include Alkermes plc (ALKS) and Alexion Pharmaceuticals, Inc. (ALXN). Both stocks carry a Zacks Rank #1 (Strong Buy).