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BioDelivery Sciences (BDSI) and Endo (ENDP) Ink $180M Licensing and Development Agreement

BioDelivery Sciences International, a specialty pharmaceutical company focused on developing products in the areas of pain management and oncology supportive care, today announced it has signed a $180 million agreement with Endo Pharmaceuticals for worldwide exclusive rights to develop and commercialize BEMA Buprenorphine for the treatment of chronic pain.

BEMA Buprenorphine utilizes BioDelivery Sciences’ patented BioErodible MucoAdhesive (BEMA) technology to deliver the pain-reliving opiate drug.

Per the agreement, Endo will be responsible for the manufacturing, distribution, marketing and sales of BEMA Buprenorphine on a worldwide scale. Both companies will collaborate to organize the phase III clinical development program and regulatory strategy for BEMA Buprenorphine for chronic pain.

BioDelivery Sciences will be responsible for the conduct of planned clinical studies leading up to the submission of the New Drug Application (NDA), and Endo will pick up from there with the responsibility of submitting the NDA and managing the interactions with FDA.

The agreement is worth up to $180 million to BioDelivery Sciences if all milestones are met. Financial terms of the agreement include an upfront payment of $30 million; $95 million in commercial milestone payments based on achievement of pre-defined intellectual property, clinical development and regulatory events; $55 million in potential sales milestones upon achievement of designated sales levels; and a tiered mid to upper teen royalty on U.S. net sales of BEMA Buprenorphine.

Dr. Mark A. Sirgo, president and CEO of BioDelivery Sciences, praised Endo’s financial strength, market presence and focus in pain management.

Dave Holveck, president and CEO of Endo, noted BEMA Buprenorphine’s value to Endo’s product portfolio.

“Endo is committed to serving as an integrated solutions provider for the development and commercialization of products focused on the management of pain,” Holveck stated in the press release. “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. We look forward to working closely with BDSI on the development of this important asset.”

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