BioDelivery Sciences Announces New Drug Submission In Canada For BEMA Fentanyl

Main Category: Cancer / Oncology
Also Included In: Regulatory Affairs / Drug Approvals;  Pain / Anesthetics
Article Date: 05 Oct 2009 - 4:00 PDT

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BioDelivery Sciences International, Inc. (Nasdaq: BDSI) announced the filing of a New Drug Submission (NDS) to Health Canada, the regulatory authority in Canada, for BEMA Fentanyl, also known as fentanyl buccal soluble film. BEMA Fentanyl is marketed in the U.S. as ONSOLIS, and the Canadian tradename is to be determined.

BEMA Fentanyl was submitted to Health Canada by Meda Valeant Pharma Canada Inc. BDSI's global commercial partner for BEMA Fentanyl, Meda AB, is engaged in a joint venture with Valeant Canada Limited to commercialize BEMA Fentanyl for the management of breakthrough cancer pain in opioid-tolerant patients.

"We are very pleased with the progress that Meda is making in expanding the availability of BEMA Fentanyl," said Dr. Mark A. Sirgo, President and Chief Executive Officer of BDSI. "We believe Meda's global presence and commitment to the product are playing an important role in growing the opportunity for BEMA Fentanyl."

In addition to approval from the U.S. FDA on July 16, 2009, BEMA Fentanyl is currently under regulatory review in the European Union with approval expected in 2010.

Under agreements with BDSI, Meda AB has the worldwide rights to commercialize and market BEMA Fentanyl, except in South Korea and Taiwan, the rights to which remain with BDSI.

Source
BioDelivery Sciences International

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