BioDelivery Sciences International, Inc. (BDSI), a specialty pharmaceutical company, has signed a worldwide license and development agreement with Endo Pharmaceuticals for the exclusive rights to develop and commercialize BEMA Buprenorphine for the treatment of chronic pain. BEMA Buprenorphine utilizes BDSI's patented and proven BioErodible MucoAdhesive (BEMA) technology to deliver the opioid analgesic buprenorphine.
In aggregate, the agreement is worth up to $180 million to BDSI if all milestones are met, which includes an upfront payment of $30 million, as well as intellectual property, development, regulatory and commercial milestone payments. Additionally, BDSI will receive a tiered mid to upper teen royalty on US net sales of BEMA Buprenorphine.
Financial terms of the agreement include: $30 million upfront payment to BDSI upon execution of the definitive agreement; $95 million in potential 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 Tiered, mid to upper teen royalty on US net sales
Under terms of the agreement, Endo will be responsible for the manufacturing, distribution, marketing and sales of BEMA Buprenorphine on a worldwide basis. Endo will commercialize BEMA Buprenorphine outside the US through its own efforts or through regional partnerships. Both companies will collaborate on the planning and finalization of the phase 3 clinical 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 submission of the New Drug Application (NDA). Endo will have the responsibility of submitting the NDA and managing the interactions with FDA.
"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," said Dr Mark A. Sirgo, president and chief executive officer of BDSI. "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. 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."
"Endo is committed to serving as an integrated solutions provider for the development and commercialization of products focused on the management of pain," said Dave Holveck, president and chief executive officer of Endo. "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."
BDSI is a specialty pharmaceutical company that is leveraging its novel and proprietary patented drug delivery technologies to develop and commercialize, either on its own or in partnerships with third parties, new applications of proven therapeutics.