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news.BioDelivery Sciences International has reported that Meda has submitted a dossier seeking approval to market Bema Fentanyl for the treatment of breakthrough pain in opioid tolerant cancer patients to the German Federal Institute for Drugs and Medical Devices.
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BioDelivery Sciences has received a $2.5 million milestone payment for completion of the clinical trial work supporting the dossier and expects to receive an additional milestone payment on approval, followed by revenues from a double digit royalty on net sales. Meda is BioDelivery’s commercialization partner for Bema Fentanyl in North America and Europe.
Mark Sirgo, president and CEO of BioDelivery Sciences, said: “This submission clearly reflects the priority Meda has placed on gaining approval for Bema Fentanyl both in Europe and in the US.”