News Release


KIPRES Received Approvals for Additional Indication to Relieve Symptoms of Allergic Rhinitis

January 25, 2008

KYORIN Co., Ltd. announced today that its wholly owned subsidiary, KYORIN Pharmaceutical Co., Ltd. (Headquarter: Tokyo, President: Ikuo Ogihara) received today (i) approval of "Kipres® Tablets 10mg" (INN: montelukast sodium), leukotriene receptor antagonist and currently being marketed for the treatment of bronchial asthma, for an additional indication to relieve symptoms of allergic rhinitis in adults and (ii) marketing approval of new formulation "Kipres® Tablets 5mg" only for relief of symptoms of allergic rhinitis in adults.

Montelukast sodium has been developed by Merck & Co., Inc., Whitehouse Station, N.J., U.S.A., and KYORIN Pharmaceutical has been contributing to the asthma treatment through marketing products containing that compound as "Kipres® Tablets 10mg" for adults and "Kipres® Chewable Tablets 5mg" for pediatric patients aged 6 years and older since August 2001, and as "Kipres® Oral Granules 4mg" for pediatric patients aged 1 year and older but under 6 years since October 2007.

It is known that leukotriene is a major mediator in the pathologic condition of allergic rhinitis as well as bronchial asthma, and Merck & Co., Inc. had developed the montelukast sodium as allergic rhinitis
therapeutic drug since its mechanism of action could have potential to improve symptoms of not only bronchial asthma but also allergic rhinitis. Montelukast sodium is to date approved for relief of symptoms of seasonal allergic rhinitis in fifty countries and of perennial allergic rhinitis in thirteen countries, and has a wealth of usage experience overseas. Further, domestic clinical trials in Japan with montelukast sodium showed its beneficial effects on three major symptoms of allergic rhinitis; stuffy nose, runny nose and sneezing, by administering it once a day before bedtime.

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