Takeda Responds to Verdict in Diabetes Drug Case

               Takeda Responds to Verdict in Diabetes Drug Case

PR Newswire

DEERFIELD, Ill., Sept. 26, 2013

DEERFIELD, Ill., Sept.26, 2013 /PRNewswire/ --Takeda Pharmaceuticals U.S.A.,
Inc. today announced that in the case of An, et al. v. Takeda, judgment was
entered in favor of the company. While the jury found that Takeda negligently
failed to adequately warn Mr. An's physician of the potential risk that ACTOS
(pioglitazone HCl) might cause bladder cancer, the jury also found that Mr. An
failed to exercise reasonable and ordinary care for his own health and safety.
As a result, judgment was entered in favor of Takeda, as required by Maryland

"We have empathy for Mr. An's family," said Kenneth D. Greisman, senior vice
president, general counsel, and secretary of Takeda Pharmaceuticals U.S.A.,
Inc. (Mr. An is deceased). "However, we believe we presented sufficient
evidence that his condition was not caused by ACTOS but rather resulted from
other risk factors such as his age and smoking history."

This is the second ACTOS case to go to trial. The judge in the first trial
granted Takeda's motion for judgment notwithstanding the verdict. In granting
the motion, the judge found that there was no reliable evidence that the
plaintiff's disease was caused by ACTOS. The company is confident in the
therapeutic benefits of ACTOS and its importance as a treatment for type 2

"Patient safety is a critical priority for Takeda," said Greisman. "We plan to
vigorously defend the company against future lawsuits."

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

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

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

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

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. and Takeda Global Research &
Development Center, Inc.

Based in Deerfield, Ill., Takeda Pharmaceuticals U.S.A., 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, andgastroenterology 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

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

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 U.S.A., Inc.

Website: http://www.takeda.us
Contact: Takeda Pharmaceuticals U.S.A., Inc., Sandy Rodriguez,
+1-773-592-7854, sandy.rodriguez@takeda.com
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