Addition of Colcrys (colchicine) to Takeda’s Gout Treatment Portfolio Will Immediately Contribute to Company’s Revenue
Deerfield, Ill., and Osaka, Japan, June 4, 2012 – Takeda Pharmaceutical Company Limited (Takeda) and its wholly owned subsidiary, Takeda Pharmaceuticals U.S.A., Inc. (TPUSA), jointly announced that Takeda’s wholly owned subsidiary, Takeda America Holdings, Inc., has completed its acquisition of URL Pharma, Inc. (URL Pharma) for an upfront payment of $800 million. The deal also includes an agreement for future performance-based contingent earn out payments. With the completion of the acquisition, TPUSA will begin the integration of URL Pharma and will immediately assume responsibility for the marketing and promotion of Colcrys (colchicine), URL Pharma’s leading product and an important therapy for the treatment and prevention of flares associated with gout. URL Pharma will be managed by Takeda Pharmaceuticals U.S.A., Inc., and report to Douglas Cole, president, Takeda Pharmaceuticals U.S.A., Inc.
The acquisition will result in an immediate increase in revenue with estimated FY 2012 net sales of more than $550 million, and continued growth of Colcrys sales is expected throughout the product’s lifecycle. The addition of Colcrys strengthens Takeda’s presence in the U.S. by increasing the company’s gout treatment portfolio to provide patients with more gout management options for acute and chronic aspects of the disease. Colcrys complements Takeda’s position in the gout marketplace with Uloric (febuxostat), used to lower blood uric acid levels in adults with gout.
“The acquisition of URL Pharma is a meaningful opportunity that delivers on our commitment to strengthen Takeda’s presence in the U.S. by adding products that amplify our expertise in primary care,” said Cole. “This commitment allows us to broaden our focus for patients by providing multiple therapeutic offerings for gout, which affects more than eight million Americans.”
Takeda will immediately assume responsibility for the marketing and promotion of Colcrys, the only FDA-approved single-ingredient oral colchicine product available in the U.S. Net sales for Colcrys in 2011 were more than $430 million. This acquisition is accretive to both GAAP and non-GAAP operating income immediately and provides a strong, profitable and long-term source of revenue that complements Takeda’s existing U.S. business.
The effect of acquisition of URL Pharma in the FY 2012 forecast
Financial impact for FY 2012 is estimated at approximately 44.0 billion yen in net sales and 5.0 billion yen in operating income on a GAAP basis after amortization costs derived from business combination accounting standards. However, the estimated amount based on business combination accounting standards may change as the final amount will be settled through the audit by our independent auditor within one year from the acquisition date (the exchange rate assumption for FY 2012 is US$1 = Yen 80).
Colcrys (colchicine) is a prescription medicine used in adults for the treatment and prevention of flares associated with gout when taken at the first sign of a flare. Colcrys is not a pain medicine and it should not be taken to treat pain related to other condition unless specifically prescribed for those conditions. Colcrys is a registered trademark of URL Pharma, 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, 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. Fatal overdoses, both accidental and intentional, have been reported in adults and children who have ingested Colcrys. 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, taking certain other medicines with Colcrys or have impaired kidney function. 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 and throat pain. For more information, refer to the patient Medication Guide. This information is not intended to replace discussions with a healthcare provider.
Please see the complete Prescribing Information and talk to your healthcare professional. 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.
Uloric (febuxostat) is a prescription medicine used to lower blood uric acid levels in adults with gout. Uloric is not for the treatment of high uric acid without a history of gout. Uloric is a registered trademark of Teijin Pharma Limited and used under license by Takeda Pharmaceuticals U.S.A., Inc.
Important Safety Information
Do not take Uloric if you are taking Azathioprine or Mercaptopurine. Your gout may flare up when you start taking Uloric; do not stop taking your Uloric even if you have a flare. Your healthcare provider may give you other medicines to help prevent your gout flares.
A small number of heart attacks, strokes, and heart-related deaths were seen in clinical studies. It is not certain that Uloric caused these events.
Tell your healthcare professional about liver or kidney problems or a history of heart disease or stroke. Your healthcare professional may do blood tests to check your liver function while you are taking Uloric. The most common side effects of Uloric are liver problems, nausea, gout flares, joint pain, and rash.
Please see the complete Prescribing Information and talk to your healthcare professional. 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.
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 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 Takeda, visit www.tpna.com.
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.