Endo grabs BDSI's drug film chronic pain treatment through global license

BioDelivery Sciences International ($BDSI)'s dissolvable drug delivery film to treat chronic pain from inside the cheek is still under development and endured a recent clinical setback. But it's already going big time to the tune of as much as $180 million.

The Raleigh, NC, company has licensed BEMA Buprenorphine to Endo Pharmaceuticals ($ENDP), which will pay BDSI up to $180 million over time as the product reaches clinical, manufacturing, distribution, marketing and sales milestones. BDSI gets $30 million upfront, however. BDSI's good news comes a few months after the drug fared poorly in a Phase III placebo study, though the company cited enough positive evidence to proceed with late-stage testing.

BEMA Buprenorphine blends the opioid analgesic buprenorphine with BDSI's BioErodible MucoAdhesive (BEMA) drug delivery tech. A bioerodible polymer film about the size of a fingertip attaches to the inner lining of the cheek. The film then rapidly delivers its drug dose through the mucous membranes of the inner cheek, and completely dissolves in 15 to 30 minutes, according to the company, addressing a need for fast-delivered pain medication.

The Endo/BDSI pairing makes sense, considering Endo's market presence in the pain treatment space. Endo booked more than $425 million in branded pharmaceuticals sales in its fiscal 2011 third-quarter revenue reported in late October, much of which included pain drugs. BDSI CEO Mark Sirgo referred to BEMA Buprenorphine in a statement as his company's "most significant asset" and said Newark, DE-based Endo—as "one of the most highly regarded and recognized companies in the area of pain management"—is better equipped than most to bring the product to market.

Images courtesy of BDSI

BDSI has already had some success with Onsolis, its similar dissolvable polymer film and opioid analgesic (fentanyl), marketed by Meda Pharmaceuticals to treat persistent cancer-related pain in patients 18 and older. The product has generated substantial revenue for BDSI. But rival MonoSol Rx has accused BDSI of patent infringement with Onsolis and is seeking damages from the company, Meda and Aveva Drug Delivery Systems, which manufactures Onsolis. Could another patent lawsuit be in the cards for BEMA Buprenorphine?

Endo will handle global manufacturing, distribution, marketing and sales of BEMA Buprenorphine and tackle non-U.S. commercialization efforts either on its own or through regional partners. BDSI, on the other hand, will continue to conduct clinical studies leading up to its FDA new drug application and field interactions with regulators as the process advances. Both companies, however, will work together on planning and finalizing preparations for Phase III clinical trials and the regulatory strategy itself.

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