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Press Release
January 26, 2015

Torii Pharmaceutical Co., Ltd.
Torii files a New Drug Application for TO-203, an Allergen Immunotherapy Tablet for House Dust Mite Allergy
Torii Pharmaceutical Co., Ltd. (TSE:4551) announced today that it has filed a New Drug Application for TO-203, an allergen immunotherapy tablet for house dust mite allergy, for the indication of allergic rhinitis to the Japanese Ministry of Health, Labour and Welfare.
Torii holds the exclusive rights to develop and commercialize TO-203 in Japan, which were licensed from ALK-Abelló A/S in January 2011.

Allergen immunotherapy is a therapeutic method that the causative allergen of an allergic disease is administered initially at a low concentration and small amount of dose and then increased gradually in order to attenuate hypersensitivity to the allergen.

Positive results were obtained from the Phase II/III clinical study of TO-203 in Japanese patients with house dust mite-induced allergic rhinitis, proving that sublingually administered TO-203 reduced symptoms of the allergic rhinitis. Furthermore, no specific finding was observed in safety.

Torii expects that expanded therapeutic option for the treatment of house dust mite allergy can contribute to improve the quality of life of the patients with a sublingual tablet product (TO-203) in addition to an injectable product (TO-204) and a diagnostic product (TO-205) that received the approval of New Drug Application in Japan in December 2014.

About house dust mite-induced allergic rhinitis

House dust mite-induced allergic rhinitis is a disease accompanied by nasal symptoms such as sneezing, rhinorrhea, nasal congestion, and nasal itching due to an allergy to house dust mites.

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