Adenoscan(R) Patent Lawsuits Settled
2007年10月22日 - 8:30PM
PRニュース・ワイアー (英語)
Astellas, King and Item finalize settlement agreement with Teva
TOKYO, BRISTOL, Tenn., and JERUSALEM, Oct. 22 /PRNewswire/ --
Astellas Pharma Inc. ("Astellas"; headquarters: Tokyo; President
and CEO: Masafumi Nogimori), King Pharmaceuticals, Inc. ("King";
NYSE: KG) and Teva Pharmaceutical Industries Ltd. ("Teva" Nasdaq:
TEVA) 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 http://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. (NASDAQ:TEVA),
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. DATASOURCE: Astellas Pharma US, Inc. CONTACT: Maribeth
Landwehr, Corporate Communications of Astellas US LLC,
+1-847-317-8988, ; James Green, Corporate Affairs of King
Pharmaceuticals, Inc., +1-423-989-8125, ; 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
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