Endo, BDSI buoyed as PhIII pain drug success clears path to FDA

More than two years ago the pain specialist Endo Pharmaceuticals ($ENDP) stepped up with a $180 million deal to license rights to BEMA Buprenorphine, a pain therapy that had been repackaged using delivery tech from BioDelivery Sciences International ($BDSI), even though it had just failed the primary endpoint in a critical Phase III study. Today, Endo put out the word that its gamble had paid off, saying that a new Phase III trial hit the goal line on reduction in pain compared to a placebo, putting the treatment on a path to the FDA for a marketing decision.

BEMA--or BioErodable MucoAdhesive--technology relies on a dissolvable polymer from BDSI that is put on the inside of the cheek, delivering its dose through the mucous membranes in less than 30 minutes so patients can get a quick hit of pain relief from the buprenorphine in the package. 

The successful Phase III triggers a $10 million milestone for Raleigh, NC-based BDSI. The company's shares surged 15% on the news this morning.

Dr. Susan Hall

"We are highly encouraged by today's announced study results, which we believe are meaningful for appropriate patients requiring an opioid," said Dr. Susan Hall, Endo's Dublin-based executive vice president, chief scientific officer and global head of research and development and quality. "And we look forward to now focusing on our upcoming pre-NDA meeting this month with FDA followed by the preparation and submission of our NDA for BEMA buprenorphine as soon as possible."

Endo needs all the help it can get. The recent loss of patent protection on the pain patch Lidoderm triggered a tidal wave of red ink at the company as low-priced generics scooped up the market. Endo chief Rajiv De Silva responded by going on an M&A spree. A few weeks ago the company bought out the generics company DAVA Pharmaceuticals in a deal worth up to $600 million. And earlier it bought out Paladin Labs for $1.6 billion. The buyouts followed a restructuring a year ago that led to the loss of 700 jobs--a move that came soon after De Silva took the reins as one of its biggest investors scouted for someone to make a bid for the company.

Some analysts have estimated peak sales for this product at about $300 million. But there are a number of new products nearing the opioid market as a variety of developers from Teva ($TEVA) to Pfizer ($PFE) and Zogenix race ahead with new and improved treatments.

- here's the release