Takeda Completes Acquisition of URL Pharma, Inc.

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Overig advies 05/06/2012 09:36
Takeda Completes Acquisition of URL Pharma, Inc.
Addition of Colcrys® (colchicine) to Takeda’s Gout Treatment Portfolio Will Immediately Contribute to Company’s Revenue.
Deerfield, Ill., June 4, 2012 and Osaka, Japan, June 5, 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).

About Colcrys®
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.

About Uloric®
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



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