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Press Release
November 26, 2015

Torii Pharmaceutical Co., Ltd.
Price Listing on the NHI Reimbursement List and Launch of “MITICURE® House Dust Mite
Sublingual Tablets” an Allergen Immunotherapy Tablet for House Dust Mite Allergy
Torii Pharmaceutical Co., Ltd. (TSE:4551) announced today that drug price of “MITICURE® House Dust Mite Sublingual Tablets” (“MITICURE” hereinafter), an allergen immunotherapy tablet for house dust mite allergy, was placed on the National Health Insurance reimbursement list as of today and would be launched in Japan on December 3, 2015. The New Drug Application for MITICURE was approved by the Japanese Ministry of Health, Labour and Welfare (MHLW) on September 28, 2015.

MITICURE, which is sublingual immunotherapy tablet, can be administered at home and can relieve patients from the pain associated with subcutaneous injection, compared to subcutaneous immunotherapy that has been performed in the past.
Positive results were obtained from the Phase II/III clinical study of MITICURE in Japanese patients with house dust mite-induced allergic rhinitis (12 - 64 years), proving that sublingually administered MITICURE reduced symptoms of the allergic rhinitis.

Torii expects that MITICURE will make a contribution as a new option for treating House dust mite-induced allergic rhinitis.

Torii is pursuing another Phase III clinical study of MITICURE in pediatric patients (5 - 11 years) that have high medical needs for the indication of house dust mite-induced allergic rhinitis.

This announcement does not lead Torii to a change of its financial outlook for the fiscal year ending December 2015.

Torii holds the exclusive rights to develop and commercialize MITICURE in Japan, which were licensed from ALK-Abelló A/S in January 2011.
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.

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.

Outline of MITICURE
Product Name: MITICURE® House Dust Mite Sublingual Tablets 3,300 JAU
MITICURE® House Dust Mite Sublingual Tablets 10,000 JAU
Indications: Hyposensitization therapy for allergic rhinitis induced by house dust mite antigens

Dosage and administration:

 The usual dose in adults and children aged ≥12 years is one tablet of MITICURE® House Dust Mite Sublingual Tablets 3,300 JAU once a day during the first week of treatment and one tablet of MITICURE® House Dust Mite Sublingual Tablets 10,000 JAU once a day from the second week. Patients should keep the tablet under the tongue for 1 minute and then swallow it. Patients should avoid gargling, eating, and drinking for 5 minutes after swallowing the tablet.
Approval conditions: Necessary measures should be taken for manufacturing and marketing so that this drug will be prescribed and used only by physicians with adequate knowledge and experience regarding sublingual immunotherapy, will be used only under the supervision of physicians and medical institutions that can manage and explain the risks, etc. of this drug, and will be dispensed at pharmacies only after the pertinent physicians and medical institutions have been confirmed.
Packages: MITICURE® House Dust Mite Sublingual Tablets 3,300 JAU
　　　7 tablets (7 tablets × 1 blister pack)
MITICURE® House Dust Mite Sublingual Tablets 10,000 JAU
　　　10 tablets (10 tablets × 1 blister pack), 100 tablets (10 tablets × 10 blister packs)
NHI drug price: MITICURE® House Dust Mite Sublingual Tablets 3,300 JAU: \ 66.40 per tablet
MITICURE® House Dust Mite Sublingual Tablets 10,000 JAU: \ 201.20 per tablet
Approval date: September 28, 2015
NHI pricing date: November 26, 2015
Launch date: December 3, 2015
Manufacturing
and distributor:		 Torii Pharmaceutical Co., Ltd.

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