Orexo AB has announced the approval of Abstral (fentanyl) sublingual tablets in Japan.
The product has been registered and will be sold by Kyowa Hakko Kirin Co., Ltd. Based on the agreement, the approval will trigger a milestone payment to Orexo. Kyowa Hakko Kirin and its subsidiaries have the rights for Abstral in all markets except the US, where the rights are held by Galena Biopharma, Inc. In Japan, Abstral will be distributed jointly by Kyowa Hakko Kirin and Hisamitsu Pharmaceutical Co., Inc. The two companies are well established in the field of treatment of cancer pain. Kyowa Hakko Kirin and Hisamitsu Pharmaceutical are jointly selling Fentos Tape (fentanyl citrate transdermal absorption product) since June 2010.
“With this approval, Abstral has now successfully been developed in the three major pharmaceutical markets in the world. The approval in Japan demonstrates again the capability of our organization as well as the value recognized by the regulatory authorities from new and advanced pharmaceutical sublingual formulations that improve treatment of patients. The approval in Japan is an exciting opportunity for Abstral and for Orexo and we are convinced that Kyowa Hakko Kirin is well positioned to successfully launch Abstral in Japan.” said Nikolaj Sørensen, President and CEO of Orexo.