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Takeda Launches ACTOSInfo.com to Provide Easily Accessible and Accurate Information Regarding ACTOS (pioglitazone HCl)

October 25, 2011

Online resource offers important facts about ACTOS for patients and health care professionals

DEERFIELD, Ill., October 25, 2011 – Takeda Pharmaceuticals North America, Inc. (“Takeda”) has launched a new website, ACTOSInfo.com, to provide patients and health care professionals (HCPs) with easily accessible and accurate information regarding ACTOS (pioglitazone HCl). This website was created in an effort to help clarify any questions surrounding ACTOS and bladder cancer. With nearly 26 million Americans with diabetes, 90 to 95 percent of whom have type 2 diabetes, a large portion of the population is impacted by any discussion around diabetes treatments. This new website includes frequently asked questions, current information about ACTOS, a printable resource for HCPs to provide to patients and general drug safety information.

“Patient safety and education is, and will always be, a top priority for Takeda, and we have therefore launched ACTOSInfo.com to address recent questions and ensure the public has access to reliable information about ACTOS,” said Doug Cole, president, Takeda Pharmaceuticals North America, Inc. “As a company, this responsibility to our patients begins before we bring a treatment to market and continues throughout the product lifecycle, as we continue to build the body of evidence surrounding our therapies. The extensive clinical research and twelve years of ACTOS patient experience reinforces Takeda’s confidence in ACTOS, along with diet and exercise, as an effective and appropriate treatment option for many adults living with type 2 diabetes, when used as labeled.”

Since its launch in 1999, Takeda has conducted extensive studies to evaluate the safety and tolerability of ACTOS. In the past twelve years, more than 100 million ACTOS prescriptions have been written globally, treating more than 10 million patients.

“To better understand the relationship between ACTOS and bladder cancer, Takeda is currently supporting a ten-year epidemiological study,” said Robert Spanheimer, M.D., vice president, medical and scientific affairs, Takeda Pharmaceuticals North America, Inc. “The longer a drug is available on the market and used by patients, the more it helps provide a higher and more detailed level of understanding of the product. Takeda is committed to ongoing research so that we can understand the full benefit and risk profiles for all of our products.”

Results of a five-year interim analysis from this ten-year study found that the use of ACTOS was associated with a statistically nonsignificant increase in the risk of bladder cancer overall. Compared to patients who had never been exposed to ACTOS (defined in the study as not having filled two ACTOS prescriptions within a sixth-month period), use of ACTOS therapy longer than 12 months was associated with an increased risk, which reached statistical significance after 24 months.

In other words, these results suggest an increase in risk from approximately 7 cases in 10,000 among patients who did not receive ACTOS, to approximately 10 cases in 10,000 among patients who had taken ACTOS for more than 12 months. The increase in three cases (10 minus 7) represents a 40 percent increase relative to the starting point of seven cases. This means there may be an increased risk of bladder cancer in patients taking ACTOS. This information is included in the current ACTOS label and Medication Guide. Takeda is committed to supporting this study through its conclusion and will report on the final results upon completion, with expected publication in 2013.

Takeda is the inventor and developer of ACTOS, which was launched commercially in the U.S. in 1999.

About Type 2 Diabetes
Type 2 diabetes is the most common form of diabetes and has reached epidemic proportions in the United States. Almost 26 million Americans currently live with diabetes, and at least 7 million are unaware that they have it. Type 2 diabetes is a progressive and chronic condition and patients should work with a health care professional to manage and monitor their disease. In addition to diet and exercise, patients often need to take medication in order to help manage glucose control. The global health care expenditures to treat and prevent diabetes and its complications were estimated at $376 billion in 2010. By 2030, this number is projected to exceed $490 billion.

About ACTOS (pioglitazone HCl)
ACTOS (pioglitazone HCl) is a prescription medication used with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes. ACTOS is not for patients with type 1 “juvenile” diabetes or diabetic ketoacidosis.

Important Safety Information

Warning: Heart Failure
ACTOS is not for everyone. ACTOS can cause or worsen heart failure. Heart failure means that the heart does not pump blood well enough. Patients should talk to their doctor immediately if they experience unusually fast weight gain, fluid retention (swelling), shortness of breath, or unusual tiredness. Certain patients with symptoms of heart failure should not start taking ACTOS. Patients should not take ACTOS if they have severe heart failure.

Patients should not take ACTOS if they are allergic to any of its ingredients.

ACTOS may cause liver problems. Patients should talk to their doctor immediately if they experience unexplained nausea, vomiting, stomach pain, unusual tiredness, loss of appetite, dark urine, or yellowing of the skin or eyes as these could be symptoms of liver damage.

Women are at higher risk of having broken bones (fractures) while taking ACTOS.

There may be an increased chance of having bladder cancer when taking ACTOS. Patients should not take ACTOS if they are receiving treatment for bladder cancer. Patients should talk to their doctor right away if they have blood or a red color in their urine, have an increased need to urinate, or have pain while urinating as these may be symptoms of bladder cancer.

When taking ACTOS with insulin or other anti-diabetic medications (especially sulfonylureas), hypoglycemia may occur. Lightheadedness, shakiness, dizziness, or hunger may mean that a patient’s blood sugar is too low. Patients should talk to their doctor if low blood sugar is a problem for them.

Some patients have experienced visual changes while taking ACTOS. If patients experience vision problems, they should consult their doctor immediately. Patients should have their eyes checked regularly.

If a patient is of childbearing age, but does not have regular monthly periods, she should talk to her doctor before taking ACTOS, as it could increase her chances of becoming pregnant.

The most common side effects of ACTOS include cold-like symptoms, headache, sinus infection, muscle pain, and sore throat.

Patients should tell their doctor about all the medicines, vitamins, and supplements they take. ACTOS and some other medicines can affect each other. Patients may need to have their doses of ACTOS or certain other medicines changed.

It is not known if ACTOS can harm an unborn, or nursing, baby. A patient should talk to her doctor if she is pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed.

Individuals are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see the accompanying Complete Prescribing Information, including warning about heart failure, and Medication Guide. Please visit www.ACTOS.com for more information.

Takeda Pharmaceuticals North America, Inc. and Takeda Global Research & Development Center, Inc.
Based in Deerfield, Ill., Takeda Pharmaceuticals North America, Inc. and Takeda Global Research & Development Center, Inc. are subsidiaries of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. The respective companies currently market oral diabetes, insomnia, rheumatology, gastroenterology, and cardiovascular treatments and seek to bring innovative products to patients through a pipeline that includes compounds in development for metabolic and cardiovascular disease, gastroenterology, neurology and other conditions. To learn more about these Takeda companies, visit www.tpna.com.

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Elissa J. Johnsen
Takeda Pharmaceuticals North America, Inc.
(224) 554-3185
[email protected]