Deerfield, Ill., and Osaka, Japan, Dec. 17, 2012 – 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 business.
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 offer.”
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, 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, 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.