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July 6, 2010
OSAKA, Japan, July 6, 2010 --- Takeda Pharmaceutical Company Limited (“Takeda”) today announced that it launched “ROZEREM®” (generic name: Ramelteon) for treatment of insomnia, “METACT®” (generic name: Pioglitazone HCL / Metformin HCL) for treatment of type 2 diabetes and Actos® Orally Disintegrating Tablets (generic name: Pioglitazone HCL; Actos OD tablets) in Japan.
ROZEREM works by selectively targeting two melatonin receptors in the brain, MT1 and MT2. These receptors are located in the suprachiasmatic nucleus, the body’s ‘master clock’ that regulates circadian (24-hour) rhythms, including the sleep-wake cycle. By acting on these receptors, the body’s sleep-wake cycle is regulated and physiological sleep is promoted. It was approved by the U.S. Food and Drug Administration (FDA) in July 2005 as the first and only prescription sleep medication that is classified as a non-controlled substance, showing no evidence of abuse and dependence.
METACT is a fixed dose combination tablet of Actos with Metformin and the first fixed dose combination for treatment of type 2 diabetes approved in Japan. Actos OD tablets swiftly disintegrate in the oral cavity and can be taken easily without water. It is expected that these products will enable the patients to avoid missing a dose due to the greater ease of administration and improve Adherence[*], thereby allowing patients with type 2 diabetes to better control their blood glucose levels.
“The launch of ROZEREM will mark our full-scale entry into the Japanese Central Nervous System market, one of our core therapeutic areas,” said Yasuhiko Yamanaka, a member of the Board, Senior Vice President, Pharmaceutical Marketing Division of Takeda. “Recent research data have indicated that sleep disorders are associated with life style-related diseases. We aim to help more and more insomnia patients by providing sleep disorder specialists with relevant information and fully capitalizing on our strength: a solid presence in the life style-related disease area. Regarding diabetes, we expect that the addition of METACT and Actos OD tablets to our large line of products for treatment of diabetes will allow us to provide patients and healthcare professionals with better-tailored treatment options”.
The combined sales of these three products (at NHI price basis) are to be estimated several billion yen. Through the promotions of the six products, the above three plus previously launched NESINA, UNISIA and Vectibix, we are making a continued effort to solidify our leading market position in Japan by further enhancing our presence in the Metabolic & CV, Oncology and Central Nervous System therapeutic areas.
[*] Patients actively participate in the decision-making of treatment courses or policies, and the treatment is implemented and continued accordingly
<ROZEREM>
| Brand Name | ROZEREM® Tablets 8mg |
| Generic Name | Ramelteon |
| Dosage and Usage | ROZEREM is orally administered to adults once daily as Ramelteon 8mg at bedtime. |
| Indications | Improvement of difficulty in getting to sleep in insomnia |
| Product registration | Approved on April 16, 2010 |
| NHI Price | ¥82.60 (The Price includes tax and was listed on June 11, 2010) |
<METACT>
| Brand Name | METACT® Combination Tablets LD & HD |
| Generic Name | Pioglitazone HCL / Metformin HCL |
| Ingredients and Quantity | METACT Combination Tablets LD : It contains 15mg of Pioglitazone and 500mg of Metformin METACT Combination Tablets HD : It contains 30mg of Pioglitazone and 500mg of Metformin |
| Dosage and Usage | METACT is orally administered to adults once daily as Pioglitazone HCL / Metformin HCL, 15mg/500mg or 30mg/500mg after breakfast. |
| Indications | Type 2 Diabetes In patients appropriate to the treatment by concomitant therapy of Pioglitazone HCL and Metformin HCL. |
| Product registration | Approved on April 16, 2010 |
| NHI Price | METACT Combination Tablets LD ¥84.60 METACT Combination Tablets HD ¥158.00 (The Prices include tax and were listed on June 11, 2010) |
<Actos OD>
| Brand Name | Actos® OD tablets 15mg & 30mg | |
| Generic Name | Pioglitazone HCL | |
| Dosage and Usage | 1. | For patients undergoing diet and exercise therapy alone, or diet and exercise therapy in combination with sulfonylurea, alpha -glucosidase inhibitor or biguanide: Actos OD tablet is orally administered to adults once daily as Pioglitazone HCL, dose ranges from 15 to 30 mg, before or after breakfast. The dose should be adjusted depending on the sex, age and symptoms, within a range not exceeding 45 mg daily. |
| 2. | For patients undergoing diet and exercise therapy in combination with insulin: Actos OD tablet is orally administered to adults once daily as Pioglitazone HCL, dose ranges from 15 to 30 mg, before or after breakfast. The dose should be adjusted depending on the sex, age and symptoms, within a range not exceeding 30 mg daily. |
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| Indications | Type 2 Diabetes In patients insufficiently responsive to any one of the following therapies and suspected of having insulin resistance: |
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| 1. | Treatment by diet and exercise only I. In addition to treatment by diet and exercise, treatment by sulfonylurea II. In addition to treatment by diet and exercise, treatment by alpha-glucosidase inhibitor III. In addition to treatment by diet and exercise, treatment by biguanides |
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| 2. | In addition to treatment by diet and exercise, treatment by insulin | |
| Product registration | Approved on January 15, 2010 | |
| NHI Price | Actos OD tablet 15mg ¥84.60 Actos OD tablet 30mg ¥158.00 (The Prices include tax and were listed on May 28, 2010) |
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