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Press Release
December 25, 2015

Torii Pharmaceutical Co., Ltd.
Torii files a New Drug Application for TO-206, an Allergen Immunotherapy Tablet for Japanese Cedar Pollinosis
Torii Pharmaceutical Co., Ltd. (TSE:4551) announced today that it has filed a New Drug Application for TO-206, an allergen immunotherapy tablet for Japanese cedar pollinosis to the Japanese Ministry of Health, Labour and Welfare.

Torii has been pursuing clinical development of TO-206 which is expected improved convenience of use such as storage at room temperature as compared to“CEDARTOLEN® SUBLINGUAL DROP - Japanese Cedar Pollen”, a sublingual immunotherapy drug for Japanese cedar pollinosis, launched in October 2014.

Positive results were obtained from the Phase II/III clinical study of TO-206 in Japanese patients with Japanese cedar pollinosis, proving that sublingually administered TO-206 reduced symptoms of the Japanese cedar pollinosis. Furthermore, no specific finding was observed in safety.

Torii expects that expanded therapeutic option can contribute to the treatment of Japanese cedar pollinosis with TO-206 in addition to “CEDARTOLEN® SUBLINGUAL DROP - Japanese Cedar Pollen”. Furthermore, Torii expects to contribute to improve the quality of life of the patients with allergy, through marketing “MITICURE® House Dust Mite Sublingual Tablets” an allergen immunotherapy tablet for house dust mite-induced allergic rhinitis launched in December 2015, injectable products and diagnostic products.

Japanese cedar pollinosis

Japanese cedar pollinosis collectively refers to an allergic disease caused by Japanese cedar pollen. Patients with Japanese cedar pollinosis have excessive immunological reaction to Japanese cedar pollen and develop sneezing, nasal discharge, nasal occlusion, itchiness of the eyes, and runny eyes among other symptoms.
According to a nationwide survey, about 20% of Japanese people have pollinosis and about 70% of them have Japanese cedar pollinosis.
(A FY 2010 MHLW-subsidized research program for prophylaxis/treatment of immunological allergic diseases, "Research for Correct Treatment of Pollinosis")

Allergen immunotherapy

Allergen immunotherapy is a therapeutic method of administering the causative allergen of an allergic disease at a low dose at first and then an increased dose in order to reduce hypersensitivity to the allergen and has following characteristics.
●Alleviation of allergy symptoms and long-term remission are expected.
●Prior to commencement of treatment, a definitive diagnosis of causative allergen is necessary.
●Long-term treatment (3- 5 years) is required.
●Efficacy is expected on not all of the patients.

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