April - June 2012
April 11, 2012
Takeda Pharmaceutical Company Limited
URL Pharma, Inc.
Acquisition Expands U.S. Business, Leadership in Gout
Deerfield, Ill., Osaka, Japan, and PHILADELPHIA, April 11, 2012, – Takeda Pharmaceutical Company Limited (Takeda) and URL Pharma, Inc. (URL Pharma) jointly announced today that Takeda’s wholly-owned subsidiary, Takeda America Holdings, Inc. and URL Pharma have entered into a definitive agreement to acquire URL Pharma – a privately-held pharmaceutical company headquartered in Philadelphia, Pennsylvania, for an upfront payment of $800 million and future performance-based contingent earn out payments. Upon completion of the acquisition, URL Pharma will be managed by Takeda Pharmaceuticals U.S.A., Inc. The acquisition will contribute significantly to Takeda’s revenues, operating income, and free cash flow beginning in fiscal year (FY) 2013. Pending the satisfaction of customary closing conditions, the deal is expected to close within 60 days.
URL Pharma is a pharmaceutical company with 2011 calendar year revenues of nearly $600 million. Its leading product is Colcrys (colchicine) – used to treat and prevent gout flares. Net sales for Colcrys in calendar year 2011 were more than $430 million, and continued growth of Colcrys sales is expected through the product’s lifecycle.
“This acquisition expands Takeda’s gout treatment portfolio and leverages our expertise in primary care,” said Douglas Cole, president, Takeda Pharmaceuticals U.S.A., Inc. “Gout affects more than eight million Americans, and the prevalence of gout is rising. We are pleased to have URL Pharma’s Colcrys added to our product portfolio and look forward to further realizing our goal of helping patients by providing multiple treatment options to manage the symptoms of acute and chronic gout in the U.S.”
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 strengthens Takeda’s offerings in the U.S. pharmaceutical market by providing patients with more gout management options to treat and prevent gout flares and the high uric acid levels associated with the condition.
“URL Pharma is pleased to become a part of a leading research-based global pharmaceutical company,” said Richard H. Roberts, M.D., Ph.D., Chief Executive Officer, and Chairman of the Board, URL Pharma.
Takeda expects the acquisition of URL Pharma will:
The projected impact of this acquisition on Takeda’s consolidated financial statements will be reflected in Takeda’s fiscal 2012 outlook and Mid-Range Plan 2012-14, the outline of which will be announced on May 11, 2012.
Colcrys (colchicine, USP) is a prescription medicine used in adults to prevent gout flares and treat gout flares 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 conditions unless specifically prescribed for those conditions.
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.
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.
You may also report negative side effects to the manufacturer of Colcrys by calling
Uloric 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. Individual results may vary. Uloric® is a registered trademark of Teijin Pharma Limited and used under license by Takeda Pharmaceuticals U.S.A., Inc.
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.
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.takeda.us.
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.
URL Pharma, Inc., headquartered in Philadelphia, PA, is a leading specialty pharmaceutical company with fully integrated technology development, product development, manufacturing, and commercialization capabilities. After a long history of generic pharmaceutical research, development, and manufacturing, the Company has successfully transitioned to a technology-driven, specialty pharmaceutical business. The Company seeks to develop and commercialize scientifically and medically innovative products that address unmet medical needs for improvements in safety and efficacy. For additional information about the company, please visit www.urlpharma.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.