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News and Press Releases

November 7, 2006


duetact™ (pioglitazone HCl and glimepiride)Now Available in U.S. Pharmacies

New product offers ACTOS® (pioglitazone HCl) and glimepiride, two commonly used diabetes medications, in a single tablet; giving physicians and patients convenient dosing options


DEERFIELD, Ill., November 7, 2006 –Takeda Pharmaceuticals North America, Inc. announced that duetact™ (pioglitazone HCl and glimepiride), pronounced “duet act,” is now available by prescription in pharmacies across the United States for the treatment of type 2 diabetes.  To offer physicians greater flexibility in treating their patients’ needs, duetact will be available in two commonly used dosages of pioglitazone and glimepiride to be taken once daily — 30 mg/2 mg and 30 mg/4 mg.
 
Duetact combines ACTOS® (pioglitazone HCl) and glimepiride, two widely used diabetes medications with complementary actions, in a single tablet.  ACTOS directly targets insulin resistance, a condition where the body does not efficiently use the insulin it produces; and glimepiride, a sulfonylurea, acts primarily by increasing the amount of insulin produced by the pancreas. These medications work in combination to help patients with type 2 diabetes achieve and sustain blood glucose management. 

“People with type 2 diabetes often need multiple therapies to meet their blood sugar goals,” said Mark Booth, president of Takeda Pharmaceuticals North America, Inc.  “Takeda is pleased to now offer duetact, an effective and convenient combination tablet for people with type 2 diabetes.”

According to the American Diabetes Association, diabetes affects more than 20 million people in the U.S., and type 2 diabetes is the most common form of the disease. Both ACTOS and glimepiride are widely used medications in the treatment of type 2 diabetes, and both have a known safety profile. Combining these medications may provide patients with an easier way to take the two drugs, as diabetic patients are often prescribed multiple medications to help manage the disease.

About duetact™ (pioglitazone HCl and glimepiride)
Duetact, along with diet and exercise, helps improve blood sugar control in type 2 diabetes. Duetact is a combination of two drugs – pioglitazone hydrochloride and glimepiride.
Duetact may cause low blood sugar. Lightheadedness, dizziness, shakiness, or hunger may mean that your blood sugar is too low. Talk to your doctor if low blood sugar is a problem for you.
Duetact may cause fluid retention or swelling, which could lead to or worsen heart failure, so you should tell your doctor if you have a history of these conditions. If you experience an unusually rapid increase in weight, swelling, or shortness of breath while taking duetact, talk to your doctor immediately. Duetact is not recommended for patients with moderate to severe heart failure. 

Duetact is not recommended for patients with liver disease. Blood tests should be used to check for liver problems before starting and while taking duetact. Tell your doctor if you have liver disease, or if you experience unexplained tiredness, loss of appetite, stomach problems, dark urine, or yellowing of skin while taking duetact.

If you are nursing, do not take duetact. If you are pregnant or thinking about becoming pregnant, talk to your doctor before taking duetact. Duetact may increase your risk of becoming pregnant.
Some people in clinical trials experienced upper respiratory infections, weight gain, edema (swelling), hypoglycemia, and headache while taking the combination of drugs in duetact.
Your doctor should check your eyes regularly. Very rarely, some patients have experienced vision changes while taking pioglitazone, a component of duetact.

For Complete Prescribing Information for duetact or ACTOS, visit www.actos.com .

Takeda Pharmaceuticals North America, Inc.
Based in Deerfield, Ill., Takeda Pharmaceuticals North America, Inc., is a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan.  In the United States, Takeda currently markets oral diabetes, insomnia, cholesterol-lowering and gastroenterology treatments, and through the Takeda Global Research & Development Center, Inc., the company has a robust pipeline with compounds in development for diabetes, cardiovascular disease and other conditions.  Takeda is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products.  To learn more about the company and its products, visit
www.tpna.com .


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