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>April - June 2010
>Launches of "NESINA®" for treatment of type 2 diabetes, ...
April - June 2010
June 15, 2010
Takeda Pharmaceutical Company Limited
OSAKA, Japan, June 15, 2010 --- Takeda Pharmaceutical Company Limited (“Takeda”) today announced that it launched “NESINA®” (generic name: Alogliptin) for treatment of type 2 diabetes, “UNISIA®” (generic name: Candesartan Cilexetil / Amlodipine Besilate) for treatment of hypertension and “Vectibix®” (generic name: Panitumumab), anti-cancer agent.
NESINA is a dipeptidyl peptidase-IV (DPP-4) inhibitor and was created by Takeda San Diego, Inc., Takeda's wholly-owned subsidiary located in San Diego, California. It exhibits extremely high selectivity for DPP-4 inhibition and a once daily dosing with NESINA provides outstanding hypoglycemic benefits. As for indications, it is the only DPP-4 inhibitor that permits combination with alpha-glucosidase inhibitor, which is in common use in Japan.
UNISIA is a fixed dose combination tablet of Blopress® (generic name: Candesartan Cilexetil) and Amlodipine Besilate (generic name) and they are most prescribed Angiotensin Receptor Blocker (ARB) and Calcium Channel Blocker (CCB) respectively in Japan for treatment of hypertension. A once daily dosing with UNISIA provides outstanding anti-hypertensive benefits. In the guideline 2009 issued by The Japanese Society of Hypertension, the combination therapy of anti-hypertensive treatments is recommended, and the combination of ARB and CCB is one of such treatments in that guideline, being a logical one from the viewpoints of safety and efficacy, without affecting the efficacy of each medicine.
Vectibix was originally developed by Amgen Inc., located in Thousand Oaks, California, and Takeda Bio Development Center Limited[*], Takeda's wholly-owned subsidiary located in Tokyo, has been conducting the clinical development in Japan. It is an anti-EGFR human monoclonal antibody for treatment of advanced or recurrent colorectal cancer. It binds to epidermal growth factor receptor (EGFR), and suppresses tumor growth. It shows a low incidence of allergic reaction upon and also after administration.
“We are extremely delighted about the launches of these three products,” said Yasuhiko Yamanaka, a member of the board, senior vice president, Pharmaceutical Marketing Division of Takeda. “We expect that NESINA and UNISIA will help us to further drive our Metabolic & Cardiovascular franchise, where we currently have the edge. Our plan is to maximize the potential of our line in this strategic area. Having multiple drugs with different mechanisms of action will allow us to propose treatments that best match the conditions of individual patients. Meanwhile, through the promotion of Vectibix we wish to contribute to the treatment of colon cancer patients, thus making it a springboard for our full-fledged challenge to become a leader in the oncology area.”
The combined sales of these three products (at NHI price basis) are estimated around 10 billion yen. Takeda intends to make these three the future mainstay products that will drive its performance in Japan, by providing scientific information to as many healthcare professionals as possible.
[*]It is in charge of development of Takeda’ s oncology products in Japan
<NESINA>
| Brand Name | NESINA® Tablets 25mg, 12.5mg & 6.25mg |
| Generic Name | Alogliptin Benzoate |
| Dosage and Usage | NESINA is orally administered to adults once daily as Alogliptin 25mg. |
| Indications | Type 2 Diabetes In patients inadequately glycemic controlled by following treatments, 1. Treatment by diet and exercise only 2. In addition to treatment by diet and exercise, treatment by alpha-glucosidase inhibitor |
| Product registration | Approved on April 16, 2010 |
| NHI Price | NESINA Tablets 25mg ¥209.40 NESINA Tablets 12.5mg ¥112.20 NESINA Tablets 6.25mg ¥60.20 (The Prices include tax and were listed on June 11, 2010) |
<UNISIA>
| Brand Name | UNISIA® Combination Tablets LD & HD |
| Generic Name | Candesartan Cilexetil / Amlodipine Besilate |
| Ingredients and Quantity | UNISIA Combination Tablets LD : It contains 8mg of Candesartan Cilexetil and 2.5mg of Amlodipine UNISIA Combination Tablets HD : It contains 8mg of Candesartan Cilexetil and 5mg of Amlodipine |
| Dosage and Usage | UNISIA is orally administered to adults once daily as Candesartan Cilexetil / Amlodipine, 8mg/2.5mg or 8mg/5mg. It is not able to be used for the first line treatment of hypertension. |
| Indications | Hypertension |
| Product registration | Approved on April 16, 2010 |
| NHI Price | UNISIA Combination Tablets LD ¥150.30 UNISIA Combination Tablets HD ¥150.30 (The Prices include tax and were listed on June 11, 2010) |
<Vectibix>
| Brand Name | Vectibix® |
| Generic Name | Panitumumab (Genetical Recombination) |
| Dosage and Usage [*1] | The recommended dose of panitumumab (genetical recombination) is 6 mg/kg of body weight given once every 2 weeks over 60 minutes, as an intravenous drip infusion. Dose can be reduced based on patients’ conditions. |
| Indications [*2] | Unresectable, advanced or recurrent colorectal cancer with wild-type KRAS |
| Product registration | Approved on April 16, 2010 |
| NHI Price | ¥75,567 (The Price includes tax and were listed on June 11, 2010) |
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