BioDelivery Sciences International (BDSI) has granted exclusive rights to develop and commercialize its pain drug Onsolis® (fentanyl buccal soluble film) in the U.S. to Collegium in a deal valued at up-to-$23.5 million-plus.
Onsolis is an opioid agonist indicated for 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.
Collegium has agreed to oversee the manufacturing, distribution, marketing, and sales of Onsolis in the U.S. Both companies agreed to collaborate on the ongoing transfer of manufacturing, which includes submission of a Prior Approval Supplement request to the FDA. Upon approval of the supplement, the NDA and manufacturing responsibility for Onsolis will be transferred to Collegium, the companies said.
BDSI has agreed to pay Collegium a $2.5 million upfront nonrefundable payment within 30 days, $4 million upon first commercial sale of Onsolis in the U.S., and up to $17 million in potential payments tied to achieving performance and sales milestones.
In addition, BDSI has also agreed to pay Collegium upper-teen percent royalties based on various annual U.S. net sales thresholds. BDSI said it will also reimburse Collegium for a predetermined amount of the remaining expenses associated with the ongoing transfer of manufacturing of Onsolis.
BDSI regained marketing authorizations for Onsolis for the U.S. in January 2015 from Meda, to which BDSI originally licensed rights to the pain drug in 2007. Two years later, the original formulation of Onsolis was launched in the U.S. by Meda following FDA approval.
In 2012, BDSI needed to change the product formulation after the FDA raised two appearance issues following an inspection of the manufacturing facility where Onsolis was produced.
Under the 2015 agreement, Meda can share in the proceeds of any new North American partnership for Onsolis that may be executed by BDSI. 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 other unspecified provisions. Meda continues to commercialize Onsolis (marketed under the brand name Breakyl in the E.U.).