Health Canada approves BDSI's NDS for ONSOLIS

May 10 2010

BioDelivery Sciences International, Inc. (Nasdaq:BDSI) today announced the approval of a New Drug Submission (NDS) by Health Canada, the regulatory authority in Canada, for ONSOLIS (fentanyl buccal soluble film) in the management of breakthrough pain in opioid-tolerant adult patients with cancer. ONSOLIS is the first product approved in Canada for this indication.

“The regulatory approval of ONSOLIS in Canada represents the culmination of a great collaborative effort between BDSI, Meda, and Valeant”

ONSOLIS will be marketed in Canada by Meda Valeant Pharma Canada Inc., a joint venture between BDSI's commercial partner, Meda AB, and Valeant Canada Limited. ONSOLIS will be launched in the third quarter of this year.

"The regulatory approval of ONSOLIS in Canada represents the culmination of a great collaborative effort between BDSI, Meda, and Valeant," said Dr. Mark A. Sirgo, President and Chief Executive Officer of BioDelivery Sciences. "ONSOLIS provides an important new option to manage the potentially debilitating effects of breakthrough pain in opioid-tolerant individuals with cancer. As the first oral transmucosal fentanyl product in Canada, our commercial partners have the opportunity to establish and build an important new market for ONSOLIS."

Under the terms of its agreement with Meda, BioDelivery Sciences will receive a double-digit royalty on net sales.

In addition to approvals in the U.S. and Canada, ONSOLIS is currently under regulatory review in the European Union.