BioDelivery Sciences International, Inc. (Nasdaq: BDSI) today announced the signing of a worldwide license and development agreement with Endo Pharmaceuticals (Nasdaq: ENDP) 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 U.S. 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 U.S. 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 U.S. 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.