Orexo AB, an emerging specialty pharma company, announced that Kyowa Hakko Kirin Co., Ltd, a leading biopharmaceutical company, has launched Abstral in Japan. Abstral is a rapidly-disintegrating, sublingual (under the tongue) rapid acting formulation of fentanyl citrate, a well-established opioid, and is indicated for the management of breakthrough pain in cancer patients.

Kyowa Hakko Kirin (KHK) licensed the right for Abstral in Japan in 2003 and has completed a dedicated clinical development program for the product in the territory. Abstral will be jointly distributed by KHK and Hisamitsu Pharmaceutical Co., Inc. These companies are well established within the field of cancer pain and have collaborated since 2010. Orexo will receive a single digit royalty on net sales of Abstral in Japan.

The manufacturing and marketing approval of Abstral in Japan was received on September 20, 2013 ahead of expectations, and on November 19, 2013 Abstral was listed on the Japanese National Health Insurance Drug Price List.

Abstral is the leading fast-acting fentanyl product in Europe, where it achieved full year sales of EUR 41 million (SEK 380 million) in 2012. In the first nine months of 2013, sales exceeded EUR 39 million (SEK 360 million) corresponding to 29 percent growth versus prior year. Abstral is approved in the US, EU, Canadian and Japanese markets.

Orexo is an emerging specialty pharma company with commercial operations in the United States and R&D in Sweden developing improved treatments using proprietary drug delivery technology and commercial operations in the United States.

Kyowa Hakko Kirin is a leading biopharmaceutical company in Japan focusing on its core business area of oncology, nephrology and immunology/allergy.