BioDelivery Sciences International, Inc. (BDSI), a specialty pharmaceutical company, and Collegium Pharmaceutical, Inc. announced the signing of a licensing agreement under which BDSI is granting the exclusive rights to develop and commercialize Onsolis (fentanyl buccal soluble film) in the US to Collegium.

Onsolis is an opioid agonist indicated for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain.

Under terms of the agreement, Collegium will be responsible for the manufacturing, distribution, marketing and sales of Onsolis in the US.  Both companies will collaborate on the ongoing transfer of manufacturing, which includes submission of a Prior Approval Supplement (Supplement) to the US Food and Drug Administration (FDA). Upon approval of the Supplement, the New Drug Application (NDA) and manufacturing responsibility will be transferred to Collegium.

Financial terms of the agreement include:  $2.5 million upfront non-refundable payment, payable to BDSI within 30 days; Reimbursement for a pre-determined amount of the remaining expenses associated with the ongoing transfer of manufacturing of Onsolis; $4 million upon first commercial sale of Onsolis in the U.S;    Up to $17 million in potential payments based on achievement of performance and sales milestones;  Upper-teen percent royalties based on various annual U.S. net sales thresholds.

"We are very pleased to enter into this important partnership with a company that has a focus in the pain management area, through their recent FDA approval of Xtampza ER, an approved abuse-deterrent opioid and their commitment to the pain category," said Dr. Mark A. Sirgo, president and chief executive officer of BDSI.  "We believe there remains a significant need for novel delivery technologies for the treatment of breakthrough cancer pain, and we look forward to Onsolis potentially returning to the market by mid-2017."

"Onsolis is highly complementary to Xtampza ER as it allows us to leverage our commercial infrastructure. Many physicians treating patients with cancer-related persistent pain using extended-release oral opioids also need to manage breakthrough pain and can do this effectively with Transmucosal Immediate-Release Fentanyl. Adding this product to our portfolio contributes to our mission of supporting responsible opioid prescribing for patients requiring opioid pain therapies," said Michael Heffernan, chief executive officer of Collegium. "The timing of the potential Onsolis launch, expected in mid-2017, allows us to focus the commercial organization on the launch of Xtampza ER for at least the next 12 months."

In January 2015, BDSI entered into an assignment and revenue sharing agreement with Meda, under which Meda transferred the marketing authorizations for Onsolis for the United States and the right to seek marketing authorizations for Onsolis in Canada and Mexico back to BDSI.  Onsolis was originally licensed to and launched in the US by Meda.  Under the agreement, financial terms were established that enable Meda to share in the proceeds of any new North American partnership for Onsolis that may be executed by BDSI, and the completion of such a transaction by BDSI with Collegium required the execution of a definitive termination agreement between BDSI and Meda embodying those royalty-sharing terms and certain other provisions.  Meda continues to commercialize Onsolis (marketed under the brand name Breakyl) in the EU.

Onsolis is indicated for the management of breakthrough pain in cancer patients (BTPc), 18 years of age and older, who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain.

BioDelivery Sciences International, Inc. is a specialty pharmaceutical company with a focus in the areas of pain management and addiction medicine.  BDSI is utilizing its novel and proprietary BioErodible MucoAdhesive (BEMA) technology and other drug delivery technologies to develop and commercialize, either on its own or in partnership with third parties, new applications of proven therapies aimed at addressing important unmet medical needs.