BioDelivery Sciences International, Inc. (BDSI) recently announced it has entered into a license and supply agreement with Kunwha Pharmaceutical Co., Ltd., for the exclusive rights to develop and commercialize BEMA Fentanyl (marketed as ONSOLIS in the US) in the Republic of Korea. The agreement results in potential milestone payments to BDSI of up to $1.275 million, which includes an up-front payment of $300,000. In addition, BDSI will receive an ongoing royalty based on net sales.

“We are very pleased to partner with Kunwha on the continued global commercialization of BEMA Fentanyl,” said Dr. Mark A. Sirgo, President and Chief Executive Officer of BDSI. “Kunwha has a long history in Korea and a strong market presence, as demonstrated by their sales force of 150 well-trained and experienced medical and sales representatives and is, we believe, ideally suited to address the specific needs of the Korean marketplace.”

Kunwha will be responsible for the regulatory filing of BEMA Fentanyl in South Korea as well as future commercialization in that territory. BEMA Fentanyl is approved in the US and Canada, under the trade name ONSOLIS, for the treatment of breakthrough pain in opioid-tolerant adult patients with cancer, and BDSI anticipates approval in the EU later this year. BEMA Fentanyl is licensed to Meda AB for all territories with the exception of Taiwan and South Korea.

BDSI is a specialty pharmaceutical company leveraging its novel and proprietary patented drug delivery technologies to develop and commercialize, either on its own or in partnerships with third parties, new applications of proven therapeutics. The company is focusing on developing products to meet unmet patient needs in the areas of pain management and oncology supportive care. BDSI’s pain franchise currently consists of two products utilizing the company’s patented BEMA buccal soluble film technology.