BioDelivery Sciences will receive a $2.5 million milestone payment from Meda as a result of approval of the buccal film-based cancer pain treatment, BEMA Fentanyl, in Europe. Approval covers use of the drug for managing breakthrough cancer pain in opioid-tolerant adult patients. BioDelivery will separately receive another $2.5 million milestone once sales have started, plus double-digit sales royalties.
Approval in Europe has been achieved via the European decentralized procedure. Germany will act as the reference member state, and national marketing authorization approvals in individual EU countries are expected over the following months, the firms note. The drug will will be marketed in the EU as Breakyl (fentayl buccal film). It is already available commercially in the U.S. and Canada as Onsolis (fentanyl buccal soluble film).
Earlier this month BioDelivery inked a license and supply agreement with TTY Biopharm, which gives the latter exclusive rights to develop and commercialize BEMA Fentanyl in the Republic of China and Taiwan. BioDelivery received a $300,000 up-front fee and could earn another $1 million in milestone payments.
BEMA Fentanyl has been developed using BioDelivery’s buccal soluble film bioerodible mucoadhesive (BEMA) technology. Specialty pharmaceuticals firm MEDA has commercialization rights to the drug in North America and Europe.
BioDelivery is separately developing a BEMA Buprenorphine product for the treatment of acute and chronic pain conditions, including acute postoperative pain and chronic pain conditions such as low back, osteoarthritis, and neuropathic pain. Phase II trials are in progress. BioDelivery’s preclinical BEMA product pipeline includes a 5HT-3 antagonist for the treatmnet of nausea and vomiting, and a triptan product for the treatment of migraine.
The firm’s second platform technology for drug delivery is its Bioral® lipid encapsulation technology, designed to facilitate the oral delivery of drugs that would otherwise need to be administered intravenously. A Bioral formulation of amphotericin B is currently undergoing Phase II trials as a potential oral treatment for fungal infections. BioDelivery is separately working in collaboration with the Walter Reed Army Institute of Research to evaluate the use of Bioral in difficult-to-treat parasitic infections.
The Bioral technology has been developed in collaboration with the University of Albany and the University of New Jersey Medical and Dental School, both of which have granted BDSI® exclusive worldwide licenses under applicable patents.