Takeda to Sell Non-Colcrys URL Pharma, Inc. Generic Business to Sun
DEERFIELD, Ill. and OSAKA, Japan, Dec. 17, 2012
DEERFIELD, Ill. andOSAKA, Japan, Dec. 17, 2012 /PRNewswire/ --Takeda
Pharmaceutical Company Limited (Takeda) announced today that Takeda's
wholly-owned subsidiary, Takeda Pharmaceuticals U.S.A., Inc. (TPUSA) has
entered into a definitive agreement with Caraco Pharmaceutical Laboratories,
Ltd. (Caraco), a wholly-owned subsidiary of Sun Pharmaceutical Industries Ltd
for the sale of the non-Colcrys (colchicine, USP) URL Pharma, Inc.* generic
With the acquisition of URL Pharma earlier this year, Takeda has become a
leader in gout therapy by adding Colcrys to its portfolio. Colcrys is the only
FDA-approved single-ingredient oral colchicine product available in the U.S.
Net sales for Colcrys totalled $155 million from June 1 to September 30, 2012.
Shortly after the acquisition of URL Pharma by Takeda's wholly-owned
subsidiary, Takeda America Holdings, Inc. (TAH) in June this year, TPUSA
successfully integrated all commercial and R&D activities associated with
Colcrys. As per the agreement with Caraco, TPUSA will retain ownership of
Colcrys and is exclusively responsible for the marketing and promotion of
Colcrys. Upon completion of the sale, the non-Colcrys assets of URL Pharma
will be owned and managed by Caraco. The deal is subject to satisfaction of
customary closing conditions, including applicable regulatory approvals.
"The addition of Colcrys has allowed Takeda to become a leader in gout, which
is part of our strategy to focus on best-in-class, innovative
pharmaceuticals," said Douglas Cole, president of TPUSA. "URL Pharma has many
great assets and Takeda was committed to finding a buyer for the remaining
business that would be dedicated to leveraging all that URL Pharma has to
The impact from this transaction on Takeda's fiscal 2012 consolidated
financial statements is limited, and Takeda does not find it necessary to
revise such forecasts at this point of time.
* Former privately-held Philadelphia-based pharmaceutical company acquired by
Takeda America Holdings, Inc. in June 2012.
Colcrys (colchicine, USP) is a prescription medicine used in adults for the
treatment of flares associated with gout when taken at the first sign of a
flare, as well as prevention of flares. Colcrys is not a pain medicine and it
should not be taken to treat pain from other causes. Colcrys^® is a trademark
of Takeda Pharmaceuticals U.S.A., Inc. registered with the U.S. Patent and
Trademark Office and used under license by Takeda Pharmaceuticals America,
Important Safety Information
Colcrys can cause serious side effects or death if levels of Colcrys are too
high in your body. Taking certain medicines with Colcrys can cause your level
of Colcrys to be too high, even at recommended doses, especially if you have
kidney or liver problems. Tell your healthcare provider about all your medical
conditions and all the medicines you take, including prescription and
non-prescription medicines, vitamins, and herbal supplements, and if you
consume grapefruit juice. Fatal overdoses, both accidental and intentional,
have been reported in adults and children who have ingested colchicine. Keep
Colcrys out of the reach of children. Colcrys can also cause serious muscle
problems and blood disorders even when taken as directed. You have a higher
chance for muscle problems if you are elderly, are taking certain other
medicines with Colcrys, or have kidney problems. Tell your healthcare provider
if you have any side effect that bothers you or that does not go away. The
most common side effects in people who have gout flares are diarrhea (23%) and
throat pain (3%).
For further information, please talk to your healthcare provider and see the
full Prescribing Information and Medication Guide.You are encouraged to report
negative side effects of prescription drugs to the FDA. Visit
www.fda.gov/medwatch, or call 1-800-FDA-1088.
About Takeda Pharmaceuticals U.S.A., Inc.
Based in Deerfield, Ill., Takeda Pharmaceuticals U.S.A., Inc. (TPUSA) is a
wholly-owned subsidiary of Takeda Pharmaceutical Company Limited, and is among
the top 15 pharmaceutical companies in the United States. TPUSA was founded in
1998 to accelerate Takeda's global expansion into the U.S. market. The company
currently markets oral diabetes, insomnia, rheumatology, gastroenterology and
cardiovascular treatments and seeks 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 Takeda, visit www.takeda.us.
About Takeda Pharmaceutical Company Limited
Located in Osaka, Japan, Takeda is a research-based global company with its
main focus on pharmaceuticals. As the largest pharmaceutical company in Japan
and one of the global leaders of the industry, Takeda is committed to strive
towards better health for patients worldwide through leading innovation in
medicine. Additional information about Takeda is available through its
corporate website, www.takeda.com.
This press release contains "forward-looking statements." Forward-looking
statements include all statements other than statements of historical fact,
including plans, strategies and expectations for the future, statements
regarding the expected timing of filings and approvals relating to the
transaction, the expected timing of the completion of the transaction, the
ability to complete the transaction or to satisfy the various closing
conditions, future revenues and profitability from or growth of Colcrys or any
assumptions underlying any of the foregoing. Statements made in the future
tense, and words such as "anticipate," "expect," "project," "continue,"
"believe," "plan," "estimate," "pro forma," "intend," "potential," "target,"
"forecast," "guidance," "outlook," "seek," "assume," "will," "may," "should,"
and similar expressions are intended to qualify as forward-looking statements.
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 and security holders are
cautioned not to place undue reliance on these 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: required regulatory approvals
for the transaction may not be obtained in a timely manner, if at all; the
conditions to closing of the transaction may not be satisfied; the transaction
may not be consummated; the anticipated benefits of the transaction may not be
realized; the transaction could disrupt relationships with employees,
licensees, customers and other business partners or governmental entities;
future sales of Colcrys could be adversely affected by competition or other
factors; and integration costs may exceed current expectations. In addition,
the combined business could be adversely affected by industry, economic or
political conditions outside of URL Pharma's or Takeda's control, including
general economic conditions in Japan, the United States and worldwide;
competitive pressures and developments; applicable laws and regulations; the
success or failure of product development programs; actions of regulatory
authorities and the timing thereof; changes in exchange rates; and claims or
concerns regarding the safety or efficacy of marketed products or product
candidates in development.
The forward-looking statements contained in this press release speak only as
of the date of this press release, and neither URL Pharma nor Takeda undertake
any 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 one or more of these statements is updated or
corrected, investors and others should not conclude that additional updates or
corrections will be made.
Takeda Pharmaceuticals U.S.A., Inc.
Elissa J. Johnsen
Takeda Pharmaceutical Company Limited
Corporate Communications Dept.
SOURCE Takeda Pharmaceutical Company Limited
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