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April 15, 2013

Launch of “Epadel T,” Japan’s First Switch-OTC Drug for Lifestyle-Related Diseases

Taisho Pharmaceutical Co., Ltd. (“Taisho Pharmaceutical”) [Head Office: Toshima-ku, Tokyo; President: Shigeru Uehara] has announced that it will launch “Epadel T” (Category 1 medicines), a treatment for improving abnormal triglyceride levels, on April 15. The drug marketing approval for “Epadel T” has been obtained by Mochida Pharmaceutical Co., Ltd. (“Mochida Pharmaceutical”) [Head Office: Shinjuku-ku, Tokyo; President: Naoyuki Mochida].

“Epadel T” was developed by converting the ethical drugs “Epadel” into an OTC drug, making it Japan’s first switch-OTC drug for lifestyle-related diseases. “Epadel” is a prescription pharmaceutical treatment for hyperlipidemia and arteriosclerosis obliterans that is manufactured and sold by Mochida Pharmaceutical. The active ingredient is EPA-E (Generic name: ethyl icosapentate). “Epadel T” contains 600 mg of EPA-E per packet, and is indicated for “the treatment of triglyceride levels that are in the borderline region, identified through health check-ups and other means.”

In the run-up to the nationwide launch of “Epadel T,” Taisho Pharmaceutical will conduct a survey on proper use in accordance with the instructions of the Ministry of Health, Labour and Welfare. This survey is designed to confirm whether or not pharmacists are able to determine customers suitable for taking this drug, and to provide proper guidance on drug administration, recommendations to see a doctor, and other services. During the survey period, “Epadel T” will be sold only at drugstores implementing the survey. Furthermore, Taisho Pharmaceutical will provide customers with the information they need to properly take “Epadel T.”

Mochida Pharmaceutical will continue to market the prescription pharmaceuticals “Epadel” for medical use.

[Product descriptions]

-Japan’s first switch-OTC drug for lifestyle-related diseases
-Administered to treat triglyceride levels that are in the borderline region, identified through health check-ups and other means.

[Product overview]

Product name: Epadel T
Category: Category 1 medicines
Suggested retail price: 42 packets ¥5,800 (Product ¥5,524 + Tax ¥276)
Ingredients: Each packet contains
Ethyl icosapentate·················600 mg
Indication: Treatment of triglyceride levels that are in the borderline region,* identified through health check-ups and other means.

*Borderline region: Refers to slightly elevated triglyceride levels (from 150 mg/dL to no more than 300 mg/dL) relative to the normal range, identified through health check-ups and other means.
Administration and dosage: Adminster the following dosage immediately after meals.
Age 20 and above Under 20
Single dose 1 packet Do not use
Daily dosage Three times a day
Date of launch: April 15, 2013