TOKYO, BRISTOL, Tenn., and JERUSALEM, Oct. 22 /PRNewswire/ -- Astellas Pharma Inc. , King Pharmaceuticals, Inc. and Teva Pharmaceutical Industries Ltd. today announced that US subsidiaries of Astellas, along with Item Development AB (“Item”) and King have executed settlement agreements with one of Teva’s subsidiaries on lawsuits filed in the United States against Teva’s subsidiaries regarding their submission of an abbreviated new drug application (“ANDA”) for a generic version of Adenoscan(R) (adenosine injection), a pharmacologic stress agent.
Two lawsuits were filed by Astellas US LLC and Astellas Pharma US, Inc. in the US District Court in Delaware on May 26, 2005 - one with co-plaintiff Item and the other with co-plaintiff King, respectively. Under the terms of the settlement agreement, Teva will be able to launch their generic version of Adenoscan pursuant to a license in September 2012, or earlier under certain conditions. Except as described, the terms of the settlement are confidential.
Subject to the Court’s approval, the cases will be dismissed and the patents remain in place including U.S. Patent No. 5,731,296, which expires in March 2015 and U.S. Patent No. 5,070,877, which expires in May 2009.
Adenoscan(R) (adenosine injection), licensed and sold by Astellas in the US, is a pharmacologic stress agent indicated as an adjunct to thallium-201 myocardial perfusion scintigraphy in patients unable to exercise adequately.
Astellas is the exclusive licensee of the U.S. use patents with regard to adenosine injection owned by King and Item and has marketed Adenoscan in the U.S. since 1995.
About Astellas
Astellas Pharma US, Inc., located in Deerfield, Illinois, is a U.S. affiliate of Tokyo-based Astellas Pharma Inc., Astellas is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. The organization is committed to becoming a global category leader in focused areas by combining outstanding R&D and marketing capabilities. In the US, Astellas markets products in the areas of Immunology, Urology, Anti-Infectives, Cardiovascular and Dermatology. For more information about Astellas Pharma US, Inc., please visit our website at www.astellas.com/us.
About King Pharmaceuticals
King, headquartered in Bristol, Tennessee, is a vertically integrated branded pharmaceutical company. King, an S&P 500 Index company, seeks to capitalize on opportunities in the pharmaceutical industry through the development, including through in-licensing arrangements and acquisitions, of novel branded prescription pharmaceutical products in attractive markets and the strategic acquisition of branded products that can benefit from focused promotion and marketing and life-cycle management.
About Teva
Teva Pharmaceutical Industries Ltd. , headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the leading generic pharmaceutical company. The company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients, as well as animal health pharmaceutical products. Over 75 percent of Teva’s sales are in North America and Europe.
Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act of 1995: This release contains forward-looking statements, which express the current beliefs and expectations of management. Such statements are based on management’s current beliefs and expectations and involve a number of known and unknown risks and uncertainties that could cause Teva’s future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to: Teva’s ability to successfully develop and commercialize additional pharmaceutical products, the introduction of competing generic equivalents, the extent to which Teva may obtain U.S. market exclusivity for certain of its new generic products and regulatory changes that may prevent Teva from utilizing exclusivity periods, competition from brand-name companies that are under increased pressure to counter generic products, or competitors that seek to delay the introduction of generic products, the impact of consolidation of our distributors and customers, potential liability for sales of generic products prior to a final resolution of outstanding patent litigation, including that relating to the generic versions of Allegra(R), Neurontin(R), Lotrel(R), and Famvir(R), the effects of competition on our innovative products, especially Copaxone(R) sales, the impact of pharmaceutical industry regulation and pending legislation that could affect the pharmaceutical industry, the difficulty of predicting U.S. Food and Drug Administration, European Medicines Agency and other regulatory authority approvals, the regulatory environment and changes in the health policies and structures of various countries, our ability to achieve expected results though our innovative R&D efforts, Teva’s ability to successfully identify, consummate and integrate acquisitions, potential exposure to product liability claims to the extent not covered by insurance, dependence on the effectiveness of our patents and other protections for innovative products, significant operations worldwide that may be adversely affected by terrorism, political or economical instability or major hostilities, supply interruptions or delays that could result from the complex manufacturing of our products and our global supply chain, environmental risks, fluctuations in currency, exchange and interest rates, and other factors that are discussed in Teva’s Annual Report on Form 20-F and its other filings with the U.S. Securities and Exchange Commission. Forward-looking statements speak only as of the date on which they are made and the Company undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
CONTACT: Maribeth Landwehr, Corporate Communications of Astellas US LLC,
+1-847-317-8988, Maribeth.landwehr@us.astellas.com; James Green, Corporate
Affairs of King Pharmaceuticals, Inc., +1-423-989-8125,
James.green@kingpharm.com; Dan Suesskind, Chief Financial Officer,
+972-2-941- 1717, George Barrett, Corp. Exec. V.P. - Global Pharmaceutical
Markets, Chief Executive Officer, Teva North America, +1-215-591-3030, or
Investor Relations: Liraz Kalif, +972-3-926-7281, or Kevin Mannix,
+1-215-591-8912, all of Teva Pharmaceutical Industries Ltd.
Web site: http://www.astellas.com/us/
