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Kyowa Hakko submits Orexo's Abstral in Japan again

Under-the-tongue therapy for cancer pain ready for regulators with more clinical data
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Orexo's Japanese partner Kyowa Hakko has resubmitted Abstral, a sublingual fentanyl tablet, for marketing approval in Japan. The rapidly disintegrating tablet, developed by Orexo and also known as KW-2246, delivers the opioid drug under the tongue for the treatment of breakthrough cancer pain.

Abstral, which is already approved in the U.S., Europe and Canada, was originally submitted in Japan in February 2010, but this was withdrawn and further clinical trials carried out. The tablet will be marketed and sold jointly by Kyowa Hakko Kirin and Hisamitsu Pharmaceutical in Japan, and Orexo will get a milestone payment on product approval and single-digit royalties on sales. ProStrakan has rights to Abstral in Europe and North America.

In June 2010, Orexo signed a three-year, $585 million agreement with Ortho-McNeil-Janssen Pharmaceuticals and Janssen Pharmaceutica, part of Johnson & Johnson ($JNJ). However, the two companies ended the deal mutually earlier this year, resulting in the losses of up to 35 jobs at Orexo in a company restructure.

Orexo still has ongoing agreements with Meda, Novartis ($NVS) and Boehringer Ingelheim for a number of different projects, according to the company's website.

- read the press release

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