BioDelivery Sciences International, Inc.(BDSI), a specialty pharmaceutical company, and Purdue Pharma (Canada), a research-based pharmaceutical company, have signed an exclusive agreement for the licensing, distribution, marketing and sale of Belbuca (buprenorphine buccal film) in Canada.

Belbuca was recently approved by Health Canada for the management of pain severe enough to require daily, continuous, long-term treatment and that is opioid-responsive and for which alternative options are inadequate. Belbuca incorporates BDSI's BioErodible MucoAdhesive (BEMA) drug delivery technology and is the first and only long-acting opioid that uses novel buccal film technology to deliver buprenorphine for appropriate patients living with chronic pain.

According to the Canadian Pain Society, pain is the most common reason for seeking healthcare, with 1 in 5 Canadian adults suffering from chronic pain.

Dr. Mark A. Sirgo, president and CEO, BioDelivery Sciences International, Inc. commented: "We look forward to our partnership with Purdue Pharma (Canada) and expanding the reach of Belbuca to patients in Canada who are suffering from chronic pain.  We are particularly enthusiastic to be partnering with a company like Purdue given their long history and commitment to pain management as well as their expertise and strong presence in the Canadian pain market. The licensing of Belbuca in Canada is a very important step for BioDelivery Sciences in broadening access to Belbuca beyond the US and we look forward to the introduction of the product."

Dr. Craig Landau, president and CEO, Purdue Pharma (Canada) added: "Belbuca provides physicians another safe and effective treatment option, when used as indicated, for Canadian patients, deemed appropriate for treatment, who suffer from long-term, chronic pain. We believe the potential benefits of this buprenorphine-containing product are significant, and are enthusiastic at the opportunity to bring this therapeutic option to Canada. This agreement and the subsequent launch of Belbuca® underscores our commitment to pain patients and more broadly, to the field of pain management."

In return for the licensing and distribution rights to Belbuca in Canada, BioDelivery Sciences is eligible to receive upfront and potential milestones of up to $4.5 million CAD as well as royalties on net sales.

BioDelivery Sciences International, Inc. is a specialty pharmaceutical company with a focus in the areas of pain management and addiction medicine.  BDSI is utilizing its novel and proprietary BioErodible MucoAdhesive (BEMA) technology and other drug delivery technologies to develop and commercialize, either on its own or in partnership with third parties, new applications of proven therapies aimed at addressing important unmet medical needs.

Purdue Pharma (Canada) is a research-based pharmaceutical company with its headquarters, R&D operations and manufacturing located in Pickering, Ontario.