Takeda Update Regarding Colcrys Litigation

PR59173

DEERFIELD, Ill. and OSAKA, Japan, Jan. 13, 2015 /PRN=KYODO JBN/ --

Takeda Pharmaceutical Company Limited ("Takeda") and its wholly-owned

subsidiary, Takeda Pharmaceuticals U.S.A., Inc. (TPUSA) stated today that TPUSA

will continue its patent infringement litigation against Hikma Pharmaceuticals

("Hikma") and its lawsuit against the U.S. Food and Drug Administration (FDA)

despite two recent court rulings that allowed Hikma to launch its colchicine

product.

"We remain committed to pursuing our patent infringement lawsuit against

Hikma," said Kenneth D. Greisman, senior vice president and general counsel,

Takeda Pharmaceuticals U.S.A., Inc. "We also believe that the FDA

inappropriately approved Hikma's product and we will continue to challenge that

approval."

On January 9, 2015, the United States Court of Appeals for the Federal Circuit

upheld an earlier decision by the United States District Court for the District

of Delaware that affirmed the denial of Takeda's request for a preliminary

injunction. The requested injunction would have prohibited the sale of Hikma's

colchicine product during the pendency of Takeda's patent infringement

litigation against Hikma. Colcrys(R) (colchicine, USP) is sold by TPUSA and is

protected by patents that extend through 2028 and 2029. A trial date in the

patent case has not been set.  

"Although the trial and appellate courts have not given Takeda preliminary

relief, we remain confident that after a trial, Takeda will prevail," Greisman

said.

Also on January 9, 2015, the United States District Court for the District of

Columbia denied Takeda's request to overturn the FDA approval of Hikma's

product. Takeda intends to appeal.

Gout affects more than 8 million Americans, and the prevalence is rising.

Colcrys is part of Takeda's gout treatment portfolio, and was launched

commercially in the U.S. in 2009. Colcrys is a prescription medicine and was

the first FDA-approved single-ingredient oral colchicine product available in

the U.S.

About Colcrys

Colcrys (colchicine, USP) 0.6 mg tablet is a prescription medicine used in

adults to prevent and treat gout flares. Colcrys is not a pain medicine and

should not be taken to treat pain related to other conditions. Colcrys(R) 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, Inc.

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, patients should speak with their healthcare provider

and see the complete Prescribing Information and Medication Guide (

http://general.takedapharm.com/content/file.aspx?applicationcode=6C7C39D8-5D09-453B-BF30-696A4AB88E62&FileTypeCode=colcrysPI&cacheRandomizer=a6b5e9c3-be34-4029-8e06-14849550caad

) for COLCRYS. 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.

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,"

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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 Pharmaceutical Company Limited

CONTACT: Takeda Pharmaceuticals U.S.A., Inc., Monica Gupta, +1-224-554-2021,

Monica.gupta@takeda.com, Takeda Pharmaceutical Company Limited, Corporate

Communications, Dept., +81-3-3278-2037