BioDelivery Sciences (BDSI) announced this week that the primary endpoint for its recently-completed Phase III BEMA Bup trial was missed, although some results were encouraging enough to spur the company to look towards conducting another efficacy trial that will run approximately nine months from its start date.

Dr. Andrew Finn, Executive Vice President of Product Development at BDSI, stated that, "We observed significant efficacy in the opioid experienced subset of patients and believe there is a clear pathway forward to determine the same in the opioid naive patients. We are also pleased to see that the product was well tolerated and that no unexpected side effects were seen. Our overall evaluation of the data in these two patient populations has given us valuable insight and confidence that we will use in commencing a new study."

Additional comments made by BioDelivery's President and CEO, Dr. Mark A. Sirgo, reiterate the positive belief of the company that BEMA Bup for the indication of chronic pain has not been derailed, just delayed.

BDSI has dropped to the three dollar mark of late, and it's possible that this latest delay will add some additional downward pressure.

As preparations for another trial gain traction, however, investors will be looking at other short and long term catalysts for the company.

Onsolis, a treatment for breatkthrough pain in cancer patients, is expected on the Canadian market this quarter, while negotiations with the FDA over the REMS issues relating to the product in the United States should be winding down.

A commercial launch that is quick to gain traction in Canada, combined with a positive resolution to the REMS issues in the US, could offset any negative sentiment that might result from the latest trial news, but for the time being investors could expect some short term volatility, as testified by the recent price drop.

BioDelivery and BEMA both continue to hold significant long term potential, in my opinion, but the best returns might still be a while away.

Keep an eye on comments from the company about its short and long term plans. It's possible BDSI and its technology could be scooped up by a larger pharma for a dirt cheap price.

Of note, BioDelivery's Onsolis partner is Meda.

Disclosure: Long BDSI.


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