The breakthrough cancer pain treatment developed by BioDelivery Sciences (NASDAQ:BDSI) International is making progress toward entering the European market, triggering a $2.5 milestone payment from BDSI’s drug partner Meda Pharmaceuticals.
The milestone was triggered by registration and pricing approval of the drug Breakyl in Europe. Raleigh, North Carolina-based BDSI is due another $2.5 million upon commercial launch, expected to occur in late 2012. Meda will be responsible for selling Breakyl in the European Union.
Breakyl is already commercialized in the United States under the name Onsolis. The product employs BDSI’s dissolvable film technology, which quickly delivers medication via a small disc placed on the inside of the cheek. Onsolis, designed for breakthrough cancer pain that does not respond to other pain treatment, quickly administers the painkiller fentanyl.
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The U.S. Food and Drug Administration approved Onsolis in 2009, though the product has experienced slow U.S. sales since. The FDA put the product under a Risk Evaluation and Mitigation Strategy, or REMS, which imposes stricter requirements of products that pose higher health risks or have the potential for drug abuse. BDSI has said that it was at a competitive disadvantage because fentanyl products commercialized before the FDA’s REMS requirement continued on the market without the same requirements.
A standard REMS applying to all fentanyl products is now in place, though BDSI has not been able to take advantage of it yet. BDSI postponed its Onsolis relaunch in March after the FDA expressed concerns about a color change in the product’s appearance over its two-year shelf life. The FDA said that the color change could confuse patients. BDSI said in its quarterly report that the company has been adjusting Onsolis’ formulation and that work is expected to be completed before the end of the second quarter. The company will then meet with the agency to discuss the changes and a review of the product. Until then, BDSI cannot offer any timeline for relaunching Onsolis in the United States.
The color change raised by the FDA is not expected to become an issue for the European launch of Breakyl. Breakyl will be made by a different manufacturer.
[Image from BioDelivery Sciences International]
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