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Press Release

December 25, 2012

Torii Pharmaceutical Co., Ltd.
Torii Files a New Drug Application for TO-194SL, a Sublingual Immunotherapy Drug for Japanese Cedar Pollinosis, in Japan
Torii Pharmaceutical Co., Ltd. (Torii) (TSE:4551) announced today that it has filed a New Drug Application for TO-194SL, a sublingual immunotherapy drug for Japanese cedar pollinosis, with the Japanese Ministry of Health, Labour and Welfare (MHLW).

According to a nationwide survey, about 20% of Japanese people have pollinosis, and about 70% of them have Japanese cedar pollinosis 1). At present, only injectable formulation of immunotherapy drugs are eligible for insurance coverage in Japan. However, they are not widely used because of concerns about the potential risk of rare but severe allergic reactions and the pain that patients suffer from after a subcutaneous injection.

TO-194SL is a different administration route drug from injection drugs of standardized Japanese cedar pollen extracts that we manufacture and market. We expect to be able to deliver a new treatment option for Japanese cedar pollinosis to the medical front.

Through providing immunotherapy drugs, Torii makes the efforts to improve the quality of life for allergy patients and meet the medical needs of healthcare professionals.

1) A FY 2010 MHLW-subsidized research program for prophylaxis/treatment of immunological allergic diseases, "Research for Correct Treatment of Pollinosis"

About Sublingual immunotherapy
During sublingual immunotherapy, the causative allergen is sublingually administered at a concentration/dose which is low at first and is increased gradually. When it reaches to a maximum level, the concentration/dose is administered daily as the maintenance dose to attenuate hypersensitivity to the allergen. Some foreign clinical reports show that sublingual immunotherapy achieves long term remission of allergic diseases.

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