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.
Late last week, BioDelivery Sciences International, Inc. (BDSI - Free Report) provided an update on its business operations and pipeline.
BioDelivery Sciences has an important regulatory event coming up with the U.S. Food and Drug Administration (FDA), which is expected to deliver a response regarding the approvability of Bunavail (buprenorphine and naloxone buccal film) for the maintenance treatment of opioid dependence by Jun 7.
If approved, the company expects to launch Bunavail towards the end of the third quarter of 2014. BioDelivery Sciences has an agreement with Quintiles for supporting the anticipated launch of BioDelivery Sciences’ Bunavail.
Meanwhile, BEMA Buprenorphine is in phase III studies for the treatment of moderate-to-severe chronic pain in patients (both opioid naive and opioid experienced) dependent on around-the-clock opioid therapy for an extended period of time. During the first quarter, BioDelivery Sciences and partner Endo International plc (ENDP - Free Report) announced positive top-line results from the study conducted in opioid naive patients.
Top-line results from the study conducted in opioid experienced patients should be out in early Jul 2014. The company intends to file a new drug application (NDA) for BEMA buprenorphine in this indication later this year or early next year.
BioDelivery Sciences is also conducting a phase III study (RHAPSODY) on clonidine topical gel for the treatment of pain associated with diabetic neuropathy. Interim data from this study is expected in the third quarter of 2014. BioDelivery Sciences intends to file a new drug application (NDA) for clonidine in 2016.
We expect near-term investor focus to remain on Bunavail’s approval status.
BioDelivery Sciences carries a Zacks Rank#3 (Hold). A better-ranked stock in the pharma sector is ANI Pharmaceuticals, Inc. (ANIP - Free Report) , carrying a Zacks Rank #1 (Strong Buy). Quintiles holds a Zacks Rank #2 (Buy).