BioDelivery Sciences (BDSI) has started making some noise again after a year of a relative flatline as discussions with the FDA were taking place to finalize the REMS issues regarding Onsolis in the United States.
A few weeks ago the company announced that Onsolis would be launched on the Canadian market during the current quarter, which expires at the end of September, and back in July BioDelivery announced the completion of a Phase III trial for BEMA Buprenorphine in the treatment of chronic pain.
The chronic pain indication could open up a lot of doors for the company and its BEMA drug delivery technology, which consists of a patch applied to the inner lining of the cheek from which a drug - in this case Buprenorphine - is absorbed. Onsolis targets breakthrough pain in cancer patients, but BEMA Bup would target a much broader scope of applications, should the results from this Phase III trial turn out positive.
With results expected within the next couple of weeks, BioDelivery is set to file a New Drug Application (NDA) in the first half of 2012.
In other positive news, it was announced on Tuesday morning that results from a Phase I trial testing the company's formulation of BEMA Buprenorphine/Naloxone in the treatment of opioid addiction turned out positive. These results will lead to a quick turnaround into another study and position BDSI for another NDA filing in late 2012, should the positive results of the early study be replicated in the follow-on.
Currently Suboxone is the treatment-of-choice in the United States for opioid dependence, and although other companies are developing competing treatments of their own for this indication, there's no reason not to believe that Bema Bup/Nal couldn't make a dent in the billion-dollar opioid-dependence market.
While these stories develop, BDSI's partner Meda has indicated that the Onsolis REMS issues in the US may be finalized later this year. With launches pending in both Canada and Europe, Onsolis might be ready to become a revenue factor within the next couple of quarters. Any such revenue spurt would help to offset some of the costs of developing the remainder of the pipeline while also potentially staving off any significant cash-raising events in the future.
BioDelivery is also developing BEMA Granisetron for nausea/vomiting and BEMA Triptan for migraines, but neither is expected to be a marketing factor over the near term.
Having treaded water for the past couple of years while the pipeline developed and REMS issues were resolved, 2012 could be the year that this company starts making some headway in the cancer and chronic pain market. Any movement on these fronts could start a string of momentum building as the rest of the pipeline develops, leaving BDSI still looking like a nice growth story down the road.
Looks like the worst might be behind this one.
Disclosure: Long BDSI.
