BioDelivery Sciences (BDSI) is getting $30 million up front in an agreement with Endo Pharmaceuticals covering BEMA Buprenorphine for the treatment of chronic pain. The drug utilizes BDSI's bioerodible muco-adhesive (BEMA) technology to deliver the opioid analgesic buprenorphine.
Under the exclusive, worldwide license and development arrangement, BDSI could receive another $95 million in potential milestone payments based on achievement of intellectual property, clinical development, and regulatory events; $55 million in potential sales milestones; and tiered, mid- to upper-teen royalties on U.S. net sales.
Both companies will collaborate on the planning and finalization of the Phase III development program and regulatory strategy for BEMA Buprenorphine for chronic pain. BDSI will maintain responsibility for the conduct of planned clinical studies leading up to the NDA submission. Endo will have the responsibility of submitting the NDA and managing the interactions with FDA. Endo will shoulder manufacturing, distribution, marketing, and sales of BEMA Buprenorphine on a worldwide basis.
"As we considered the ideal commercial partner for BDSI's most significant asset, we sought to balance the financial benefits of the transaction with a company that had a real need for a product with the potential of BEMA Buprenorphine along with solid experience and commitment to the pain category,” remarks Mark A. Sirgo, Pharm.D., president and CEO of BDSI. “Endo is one of the most highly regarded and recognized companies in the area of pain management, and they continue to demonstrate their ability to excel in this category.”
Dave Holveck, president and CEO of Endo, adds, “The addition of BEMA Buprenorphine will broaden Endo's portfolio of pain therapeutics, allowing us to offer an integrated suite of products that currently includes Opana ER, Voltaren Gel, and Lidoderm as well as a broad range of generic pain products.”