@ Drug developer BDSI enters ‘transformational time,’ gets $10M milestone | SEBIO

Drug developer BDSI enters ‘transformational time,’ gets $10M milestone

Posted by on Jan 24, 2014

RALEIGH, N.C. – Drug developer BioDelivery Sciences International wrapped up the first of two Phase 3 drug trials, triggering a $10 million milestone payment from its partner.

The drug being tested is called BEMA buprenorphine and treats patients with chronic pain. BioDelivery (Nasdaq: BDSI) formed a partnership with Malvern-based Endo Pharmaceuticals Inc., a subsidiary of Endo Health Solutions Inc. (Nasdaq: ENDP), on this drug. The partnership calls for BioDelivery to finish development of the drug, while Endo will handle all commercialization.

Endo has now paid BioDelivery $55 million for the drug and could pay up to another $125 million, depending on how well the drug sells, if approved.

During development, drug companies test their drug against placebos in blind tests. For the trial to be considered successful, the patients who receive the active drug should report less pain.

The latest trial was in what are called “opioid-naïve subjects,” meaning patients have lesser pain and weren’t on a pain medication at the outset of the trial. In a trial running simultaneously, BioDelivery is testing the drug in “opioid-experienced patients” who have more severe pain and were on a pain medication at the outset of the trial.

BioDelivery CEO Mark Sirgo says the trial involving opioid-naive patients is more meaningful; because these patients aren’t as accustomed to pain medication and because their pain isn’t as severe, they are more susceptible to the placebo effect. Patients with more severe pain who have had pain medication prescribed for months or years can better tell the difference between an active drug and a placebo.

The partnership with Endo was pivotal in BioDelivery’s life as a company. Before that influx of cash from Endo, BioDelivery would likely have had to abandon development of this drug. Now, however, it is targeting a New Drug Application with the U.S. Food and Drug Administration later this year.

“It’s a transformational time for the company,” Sirgo said Friday. “If we stay on this course, this will be a very different company.”

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