The investigational chronic pain treatment from BioDelivery Sciences International (NASDAQ:BDSI) that failed in a late-stage clinical trial now has a partner and a plan that salvages the drug program and infuses the biopharmaceutical company with cash at a critical time.
Endo Pharmaceuticals (NASDAQ:ENDP) has licensed pain treament candidate BEMA Buprenorphine in a deal that pays Raleigh, North Carolina-based BDSI $30 million up front and up to $150 million in milestones if the treatment hits clinical, regulatory and sales targets. Royalties on U.S. sales are in the mid- to upper teens. Endo gets a pain treatment candidate that could add to a drug portfolio that includes products such as Opana ER, Voltaren Gel and Liboderm.
“Endo is committed to serving as an integrated solutions provider for the development and commercialization of products focused on the management of pain,” Endo CEO Dave Holveck said in a statement.
BEMA Buprenorphine utilizes BDSI’s proprietary drug-delivery technology dubbed “BEMA,” short for BioErodible MucoAdhesive. The treatment is administered as a small piece of film that delivers the drug quickly as it dissolves on the inside of a patient’s cheek. The BEMA technology was used in developing and commercializing Onsolis, a treatment for breakthrough pain experienced by cancer patients. To date, Onsolis is BDSI’s only commercialized product.
After the 2009 regulatory approval of Onsolis, BDSI had identified BEMA Buprenorphine as the company’s lead product candidate. But in the fourth quarter of 2011, BEMA Buprenorphine’s prospects didn’t look so promising. BDSI announced phase 3 clinical trial results in late September showing that BEMA Buprenorphine did not perform better than a placebo. In conference calls, CEO Mark Sirgo tried to reassure analysts that the failure was due to an “exaggerated placebo effect” in patients who had never been treated with an opioid before. He said that an adjustment to the clinical trial would show statistical significance. Sirgo committed to conducting another phase 3 trial.
But paying for that trial posed a problem for the small drug developer, which so far draws scant revenue from a single commercialized product. In November, Sirgo said that BDSI had $15.1 million in cash, enough money to take the company through the second quarter of 2012. He estimated that more clinical work on BEMA Buprenorphine would cost up to $8 million. The best chance of taking BEMA Buprenorphine through another set of clinical studies was by finding a partner. BDSI found that partner in Chadds Ford, Pennsylvania-based Endo, who was attracted to another product candidate for the pain market that BDSI projects could generate $500 million in annual sales.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
The deal calls for Endo to handle manufacturing, distribution, marketing and sales of BEMA Buprenorphine worldwide. Endo will also handle commercialization of the product outside the United States on its own or through partnerships. The two companies will collaborate on the final phase 3 studies for BEMA Buprenorphine, which will be handled by BDSI up to the submission of a New Drug Application. Endo will file the NDA and work with the U.S. Food and Drug Administration.
“We could not be more pleased to enter into this significant partnership with a company that has the financial strength, market presence and focus in pain management as Endo,” Sirgo said.
