Tuesday, March 26, 2013

Kyowa Hakko Kirin receives approval for Dacarbazine (pheochromocytoma ) and Nouriast (Parkinson) and receives marketing rights for Onglyza (Diabetes) in Japan

Kyowa Hakko Kirin, has received approval for
1)  NOURIAST tablets 20 mg (nonproprietary name: istradefylline;), a novel antiparkinsonian agent, has been approved for manufacturing and marketing in Japan. NOURIAST is a selective adenosine A2A receptor antagonist for Parkinson's disease of which action site is clearly distinct from the existing agents acting on dopamine receptors or dopamine metabolism. In clinical trials in Japan, NOURIAST improved wearing-off phenomena and was well tolerated in Parkinson's disease patients treated with levodopa. Based on the clinical outcomes, Kyowa Hakko Kirin submitted an application for manufacturing and marketing approval on March 30, 2012. NOURIAST is authorized as the world's first antiparkinsonian agent of a first-in-class adenosine A2A receptor antagonist.

2) Otsuka Pharmaceutical Co., Ltd and Kyowa Hakko Kirin Co., Ltd. today announced that Otsuka has obtained marketing approval for Onglyza Tablets 2.5mg and 5mg(generic name: saxagliptin hydrate) to treat type 2 diabetes. Otsuka signed an agreement with Kyowa Hakko Kirin in June 2012, transferring to Kyowa Hakko Kirin the exclusive development and marketing rights for Onglyza® in Japan.
Otsuka Pharmaceutical is to transfer marketing rights in Japan for Onglyza® to Kyowa Hakko Kirin, based on the 2012 agreement signed by the two companies. Otsuka will receive ¥8.2 billion from Kyowa Hakko Kirin upon approval, in addition to the initial payment of ¥3.0 billion. Moreover, Otsuka will receive running royalties after the launch of the drug in proportion to its revenue.

3)Dacarbazine Injection 100 (generic name: dacarbazine), has been approved for the additional indication of pheochromocytoma by Japan's Ministry of Health, Labour and Welfare.According to international guides and overseas clinical practice guidelines, combination therapy of cyclophosphamide, vincristine and dacarbazine (“CVDtherapy”) is one choice for the treatment of pheochromocytoma. However, CVD therapy was not covered by the Japanese national health insurance system for the treat ment of pheochromocytoma

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