April - June 2010
April 16, 2010
Takeda Pharmaceutical Company Limited
OSAKA, Japan, April 16, 2010 --- Takeda Pharmaceutical Company Limited (“Takeda”) today announced that New Drug Applications for five new products were approved on April 16 by the Japanese Ministry of Health, Labour and Welfare.
Five new products approved for commercial sale in Japan comprise three new medical entities; “NESINA®” for treatment of type 2 diabetes, “ROZEREM®” for treatment of insomnia and anti-cancer agent “Vectibix®”, and two fixed dose combinations; “METACT®” for treatment of type 2 diabetes and “UNISIA®” for treatment of hypertension, each of them contains two compounds with a different mechanism of action respectively.
Once launched, we expect that these products will provide patients and healthcare professionals with new treatment options. Through the sales of these new products, we are making continued effort to solidify our leading market position in Japan by further reinforcing our strong life-style related diseases franchise and enhancing our presence in the Central Nervous System and oncology therapeutic areas.
NESINA is a dipeptidyl peptidase-IV (DPP-4) inhibitor taken once daily, and was created by Takeda San Diego, Inc., Takeda's wholly-owned subsidiary located in San Diego, California
METACT is a fixed dose combination tablet of Actos® (generic name: pioglitazone HCL) with Metformin (generic name) and the first fixed dose combination for treatment of type 2 diabetes approved 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 and Calcium Channel Blocker respectively in Japan for treatment of hypertension.
ROZEREM was originally created by Takeda and is a melatonin receptor agonist whose mechanism of action is different from existing drugs for treatment of insomnia.
Vectibix was originally developed by Amgen Inc., located in Thousand Oaks, California, and Takeda Bio Development Center Limited*, Takeda's wholly-owned subsidiary, 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 is in charge of development of Takeda’ s oncology products in Japan
|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
|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.
|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.
|Brand Name||ROZEREM® Tablets 8mg|
|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|
|Generic Name||Panitumumab (Genetical Recombination)|
|Dosage and Usage||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||Unresectable, advanced or recurrent colorectal cancer with wild-type KRAS|
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