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Press Release
September 28, 2015

Torii Pharmaceutical Co., Ltd.
New Drug Application Approval of “MITICURE® House Dust Mite Sublingual Tablets” an Allergen Immunotherapy Tablet for House Dust Mite Allergy in Japan
Torii Pharmaceutical Co., Ltd. (TSE:4551) announced today that the Japanese Ministry of Health, Labour and Welfare has approved the New Drug Application of “MITICURE® House Dust Mite Sublingual Tablets” (“MITICURE” hereinafter), an allergen immunotherapy tablet for house dust mite allergy, for the indication of allergic rhinitis.

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 expanded therapeutic option for the treatment of house dust mite allergy can contribute to improve the quality of life of the patients with MITICURE in addition to an injectable product and a diagnostic product that have launched in April 2015.

The timing of the launch of MITICURE will be announced as soon as a decision is made following the National Health Insurance price listing.

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.

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

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.

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