BIODELIVERY SCIENCES INTERNATIONAL Inc. and Collegium Pharmaceutical Inc. signed a licensing agreement in which BDSI grants exclusive rights to develop and commercialize Onsolis (fentanyl buccal soluble film) in the U.S. 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 U.S. Both companies will collaborate on the ongoing transfer of manufacturing, which includes submission of a Prior Approval Supplement to FDA. Upon approval of the supplement, the New Drug Application 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.; and up to $17 million in potential payments based on achievement of performance and sales milestones.
