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September 2, 2014
| Torii Pharmaceutical Co., Ltd. |
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Torii announces Price Listing on the NHI Reimbursement List and Launch of “CEDARTOLEN® SUBLINGUAL DROP - Japanese Cedar Pollen” a Sublingual Immunotherapy Drug for Japanese Cedar Pollinosis |
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Torii Pharmaceutical Co., Ltd. (TSE:4551) announced today that drug price of “CEDARTOLEN® SUBLINGUAL DROP - Japanese Cedar Pollen” (“CEDARTOLEN” hereinafter), a sublingual immunotherapy drug for Japanese cedar pollinosis, was placed on the National Health Insurance reimbursement list as of today and will be launched in Japan on October 8, 2014. The New Drug Application for CEDARTOLEN was approved by the Japanese Ministry of Health, Labour and Welfare (MHLW) on January 17, 2014.
CEDARTOLEN, which is the first sublingual immunotherapy drug approved in Japan, 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.
Torii expects that CEDARTOLEN will make a contribution as a new option for treating Japanese cedar pollinosis.
The effects on business performance of this launch are expected to be minor in this fiscal year ending December 2014.
| About allergen immunotherapy |
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| Allergen immunotherapy is a therapeutic method that the causative allergen of an allergic disease is administered at a low concentration/dose at first and is increased gradually in order to attenuate hypersensitivity to the allergen and has following characteristics. |
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Alleviation of allergy symptoms and long-term remission are expected. |
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Prior to commencement of treatment, a definitive diagnosis of causative allergen is necessary. |
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Long-term treatment (3 – 5 years) is required. |
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Efficacy is expected on not all of the patients. |
| About CEDARTOLEN |
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Product Name: |
CEDARTOLEN® SUBLINGUAL DROP
- Japanese Cedar Pollen 200 JAU/mL bottle |
CEDARTOLEN® SUBLINGUAL DROP
- Japanese Cedar Pollen 2,000 JAU/mL bottle |
CEDARTOLEN® SUBLINGUAL DROP
- Japanese Cedar Pollen 2,000 JAU/mL pack |
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Indication: |
Japanese cedar pollinosis (Allergen immunotherapy) |
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Dosage and administration: |
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| 1.Period of updosing (1st - 2nd weeks) |
For adults and children over 12 years of age, the following doses will be administered sublingually once daily for 2 weeks after the initiation of administration. The solution should be retained for 2 minutes, and then swallowed. Gargling, eating, and drinking should be avoided for the next 5 minutes.
| 1st week of updosing |
2nd week of updosing |
CEDARTOLEN® SUBLINGUAL DROP
- Japanese Cedar Pollen 200 JAU/mL bottle |
CEDARTOLEN® SUBLINGUAL DROP
- Japanese Cedar Pollen 2,000 JAU/mL bottle |
| Day 1 |
0.2mL |
Day 1 |
0.2mL |
| Day 2 |
0.2mL |
Day 2 |
0.2mL |
| Day 3 |
0.4mL |
Day 3 |
0.4mL |
| Day 4 |
0.4mL |
Day 4 |
0.4mL |
| Day 5 |
0.6mL |
Day 5 |
0.6mL |
| Day 6 |
0.8mL |
Day 6 |
0.8mL |
| Day 7 |
1mL |
Day 7 |
1mL |
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| 2.Period of maintenance (3rd week and thereafter) |
| In the period of maintenance following the completion of the period of gradual increase, the full dose of CEDARTOLEN® SUBLINGUAL DROP - Japanese Cedar Pollen 2,000 JAU/mL pack (1 mL) will be administered sublingually once daily. The solution should be retained for 2 minutes, and then swallowed. Gargling, eating, and drinking should be avoided for the next 5 minutes. |
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Packages: |
Week 1: for period of updosing
CEDARTOLEN® SUBLINGUAL DROP
- Japanese Cedar Pollen 200 JAU/mL bottle
Bottle (PET container, 10 mL): 1 bottle (with a dispenser)
Week 2: for period of updosing
CEDARTOLEN® SUBLINGUAL DROP
- Japanese Cedar Pollen 2,000 JAU/mL bottle
Bottle (PET container, 10 mL): 1 bottle (with a dispenser)
From Week 3 onward: for period of maintenance
CEDARTOLEN® SUBLINGUAL DROP
- Japanese Cedar Pollen 2,000 JAU/mL pack
Divided packs (aluminum-laminated container, 1 mL): 14 packs (two 7-pack sheets)
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Storage condition: |
1. CEDARTOLEN should be stored in a cold place (2–8°C).
2. CEDARTOLEN should be kept out of reach of children.
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Approval conditions: |
Necessary measures should be taken for manufacturing and marketing so that this drug will be i) prescribed and used only by physicians with adequate knowledge and expertise regarding sublingual immunotherapy, ii) used only under the supervision of physicians and medical institutions that can manage and explain the risks, etc. of this drug, and iii) dispensed after pharmacies confirm the physicians and medical institutions meet the above requirements.
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Approval date: |
January 17, 2014 |
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NHI pricing date: |
September 2, 2014 |
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Launch date: |
October 8, 2014 |
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NHI drug price: |
CEDARTOLEN® SUBLINGUAL DROP
- Japanese Cedar Pollen 200 JAU/mL bottle : ¥421.10
CEDARTOLEN® SUBLINGUAL DROP
- Japanese Cedar Pollen 2,000 JAU/mL bottle : ¥1,006.60
CEDARTOLEN® SUBLINGUAL DROP
- Japanese Cedar Pollen 2,000 JAU/mL pack : ¥100.80
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| About development of TO-206, a sublingual immunotherapy tablet for Japanese cedar pollinosis |
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| Torii is pursuing clinical development of TO-206, a sublingual immunotherapy tablet for Japanese cedar pollinosis, which is expected improved convenience of use such as easier holding under the tongue and storage at room temperature as compared to CEDARTOLEN. Torii is undertaking a Phase II/III clinical study of TO-206 in Japan. |
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