More than 96 Percent of Claimants Opt-In to ACTOS Resolution Program; Takeda Expects Resolution to Become Effective Once Submission Review Completed; Takeda Stands Behind ACTOS

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Sep 11, 2015, 06:59 ET

DEERFIELD, Ill., Sept. 11, 2015 /PRNewswire/ -- Takeda Pharmaceutical Company Limited (TSE: 4502) and its wholly-owned subsidiary, Takeda Pharmaceuticals U.S.A., Inc. (collectively "Takeda"), today announced that more than 96 percent of eligible claimants have opted into the ACTOS (pioglitazone HCl) product liability resolution program that was announced on April 28, 2015. Takeda now is evaluating the submissions to determine whether they satisfy various criteria specified under terms of the resolution program. Takeda expects the resolution program to become effective upon completion of that review.

Per the resolution program, a 95 percent participation or greater triggers a $2.37 billion payment by Takeda into a settlement fund. However, that figure will rise to $2.4 billion if after a review of the claims submissions it is determined that 97 percent or more of them meet the settlement criteria. The settlement would not affect Takeda's ability to pay dividends.

Once the settlement is operative, the company also will have resolved seven of the nine previously tried ACTOS product liability cases, which have been in various stages of the appeals process. In Cooper v. Takeda, which was tried in Los Angeles, California, Takeda is appealing from a judgment against the company. In Triana and Cipriano v. Takeda, the plaintiffs are challenging through post-trial motions a judgment in favor of Takeda.

Takeda's decision to pursue this settlement does not change the company's continued commitment to ACTOS. ACTOS continues to be available as a treatment option in the U.S. and other countries. In fact, pioglitazone has been approved for use in 95 countries, including the U.S., Japan, several in Europe, Australia, Brazil, Canada and Russia, to highlight a few.

Takeda believes the company acted responsibly with regard to ACTOS, and firmly stands behind the substantial data confirming a positive benefit/risk profile for ACTOS. The data sets include a 10-year, prospective cohort study, conducted by the University of Pennsylvania and Division of Research at Kaiser Permanente Northern California, which showed no statistically significant increased risk of bladder cancer among patients ever exposed to pioglitazone, and the Pan European Multi-Database Bladder Cancer Risk Characterization Study, a large multi-database retrospective matched cohort study.

The settlement would reduce the uncertainties of complex litigation for the company and resolve a high percentage of the ACTOS product liability claims. The settlement would allow the company to fully focus on its mission of creating better health outcomes for people worldwide through innovation.

Indication for ACTOS
ACTOS (pioglitazone) is a prescription medicine used with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes. ACTOS is not for the treatment of type 1 "juvenile" diabetes or diabetic ketoacidosis (increased ketones in blood or urine).

Important Safety Information

WARNING: HEART FAILURE
ACTOS can cause or worsen heart failure. ACTOS can cause the body to keep extra fluid (fluid retention), which leads to swelling (edema) and weight gain. Extra body fluid can make some heart problems worse or lead to heart failure. Heart failure means the heart does not pump blood well enough. Patients should not take ACTOS if they have severe heart failure. If patients have heart failure with symptoms such as shortness of breath or swelling, even if these symptoms are not severe, ACTOS may not be right for them. Patients should call their doctor right away if they experience swelling or fluid retention (especially in the ankles or legs), shortness of breath or trouble breathing (especially when lying down), an unusually fast increase in weight, or unusual tiredness.

ACTOS may not be right for everyone. Serious side effects may happen to people taking ACTOS.

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

ACTOS may cause liver problems. Patients should call their doctor right away if they experience nausea, vomiting, stomach pain, unusual or unexplained 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 patients take ACTOS. Patients should not take ACTOS if they are receiving treatment for bladder cancer. Patients should tell their doctor right away if they have blood or a red color in the urine, have an increased need to urinate, or have pain while they urinate, as these may be symptoms of bladder cancer.

When taking ACTOS with insulin or other anti-diabetic medications (especially sulfonylureas), hypoglycemia (low blood sugar) 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, patients should consult their doctor immediately. Patients should have their eyes checked regularly.

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

It is not known if ACTOS can harm an unborn or nursing baby. Patients should talk to their doctor if they are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed.

Adverse Reactions
The most common side effects (>5%) of ACTOS include cold-like symptoms, headache, sinus infection, muscle pain, and sore throat.

Drug Interactions
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 dose of ACTOS or certain other medicines changed.

Patients 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 and Medication Guide for ACTOS.

About Takeda Pharmaceuticals U.S.A., Inc.
Based in Deerfield, Ill., Takeda Pharmaceuticals U.S.A., Inc. is a subsidiary of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. TPUSA markets oral diabetes, CNS, rheumatology and gastroenterology treatments. Its pipeline includes compounds for metabolic and cardiovascular disease, gastroenterology, neurology and other conditions. To learn more, visit www.takeda.us.

This press release contains forward-looking statements. Forward-looking statements include statements regarding Takeda's plans, outlook, strategies, results for the future, and other statements that are not descriptions of historical facts. Forward-looking statements may be identified by the use of forward-looking words such as "may," "believe," "will," "expect," "project," "estimate," "should," "anticipate," "plan," "assume," "continue," "seek," "pro forma," "potential," "target," "forecast," "guidance," "outlook" or "intend" or other similar words or expressions of the negative thereof. Forward-looking statements are based on estimates and assumptions made by management that are believed to be reasonable, though they are inherently uncertain and difficult to predict. Investors are cautioned not to unduly rely on such forward-looking statements.

Forward-looking statements involve risks and uncertainties that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking statements. Some of these risks and uncertainties include, but are not limited to, (1) the economic circumstances surrounding Takeda's business, including general economic conditions in Japan, the United States and worldwide; (2) competitive pressures and developments; (3) applicable laws and regulations; (4) the success or failure of product development programs; (5) actions of regulatory authorities and the timing thereof; (6) changes in exchange rates; (7) claims or concerns regarding the safety or efficacy of marketed products or product candidates in development; and (8) integration activities with acquired companies.

The forward-looking statements contained in this press release speak only as of the date of this press release, and Takeda undertakes no obligation to revise or update any forward-looking statements to reflect new information, future events or circumstances after the date of the forward-looking statement. If Takeda does update or correct one or more of these statements, investors and others should not conclude that Takeda will make additional updates or corrections.

SOURCE Takeda Pharmaceuticals