Deerfield, Ill., November 5, 2014 and Osaka, Japan, November 6, 2014 – Takeda Pharmaceutical Company Limited (“Takeda”) and its wholly-owned subsidiary, Takeda Pharmaceuticals U.S.A., Inc. stated today that the United States District Court for the District of Columbia, which is presiding in a lawsuit against the U.S. Food and Drug Administration (FDA), set an accelerated hearing to resolve the case.
On October 6, Takeda filed a lawsuit against the FDA for violation of the Administrative Procedure Act (APA) for its approval of the Hikma Pharmaceuticals (“Hikma”) and West-Ward Pharmaceuticals (“West-Ward”) colchicine product. The APA allows parties to challenge improper actions by government agencies, such as the FDA. A hearing in that case is scheduled for November 19 and a ruling is expected shortly thereafter.
On October 3, Takeda filed a separate patent infringement lawsuit against Hikma and West-Ward asserting their colchicine product infringes several Takeda patents applicable to Colcrys (colchicine, USP). Multiple patents applicable to Colcrys extend through 2028 and 2029. On November 4, the United States District Court for the District of Delaware denied Takeda’s request for a preliminary injunction in that lawsuit. However, Takeda has since filed an expedited appeal and the Court agreed to extend a previously issued temporary restraining order. As a result, Hikma and West-Ward are prohibited from marketing their colchicine product at this time.
“Takeda stands by its assertion that the FDA’s approval of Hikma’s colchicine product is legally impermissible. We also believe that we can prove patent infringement,” said Kenneth D. Greisman, senior vice president and general counsel, Takeda Pharmaceuticals U.S.A., Inc. “We have confidence in Colcrys and remain committed to pursuing our ongoing lawsuits against the FDA and Hikma.”
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-approved single-ingredient oral colchicine product available in the U.S.
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® 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
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," "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.