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news.BioDelivery Sciences International (BDSI) has entered into a license and supply agreement with Kunwha Pharmaceutical, for the exclusive rights to develop and commercialize BEMA Fentanyl (marketed as Onsolis in the US) in the Republic of Korea.
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Kunwha will be responsible for the regulatory filing of BEMA Fentanyl in South Korea as well as future commercialization in that territory.
The agreement results in potential milestone payments to BDSI of up to $1.2m, which includes an upfront payment of $300,000. In addition, BDSI will receive an ongoing royalty based on net sales.
BEMA Fentanyl, also known as fentanyl buccal soluble film, consists of a small, dissolvable, polymer disc, formulated with the opioid narcotic fentanyl for application to the buccal (inner lining of cheek) membranes.
It 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.
BDSI anticipates approval in the EU later this year. BEMA Fentanyl is licensed to Meda, a pharma company, for all territories with the exception of Taiwan and South Korea.
Mark Sirgo, president and CEO of BDSI, said: “We are very pleased to partner with Kunwha on the continued global commercialization of BEMA Fentanyl. 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.”
BDSI is a specialty pharmaceutical company that is 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.