Kyowa Hakko Kirin will be responsible for the approval process for the product in Japan. Under the terms of the agreement, KW-2246 will be jointly distributed by the two companies once the manufacturing and sales approval is obtained.
Each company will carry out independent product distribution and information provision/gathering activities under a one-brand, two-channel setup.
Torbjorn Bjerke, president and CEO of Orexo, said: “The preparation for a new-drug application for KW-2246 in Japan is one of the important steps in the international development of Orexo’s sublingual fentanyl product, in Europe launched under the brand Abstral. This agreement further strengthens the commitment we see from our partner Kyowa Hakko Kirin in the Japanese market.”