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IVAX Wins Patent Case on Seretide - Advair - in UK
Business Wire, March 19, 2004
Business Editors/Health/Medical Writers
MIAMI--(BUSINESS WIRE)--March 19, 2004
IVAX Corporation (AMEX:IVX) (LSE:IVX.L) won a patent challenge case in the London High Court against GlaxoSmithKline's number one selling inhaled, combination asthma drug Seretide(R) (known in the U.S. as Advair(R)) with global sales of over $4 billion. Annual sales of Seretide in the UK are approximately $240 million.
IVAX along with fellow claimants Cipla Ltd. and Neolab Ltd., Generics (UK) Ltd. and Arrow Generics Ltd., succeeded on the grounds of "obviousness" maintaining that it was a well-known and standard practice to use both a beta-2 agonist and a corticosteroid together for simultaneous or sequential administration by inhalation in the treatment of respiratory disorders.
Mr. Justice Pumfrey, of the High Court, held that the patent was indeed obvious and in giving his judgment stated, "The claimants' case is in my view overwhelmingly strong."
GlaxoSmithKline may have data exclusivity claims on the product which run through 2008 and has stated that it is considering an appeal of the trial.
IVAX Corporation, headquartered in Miami, Florida, discovers, develops, manufactures, and markets branded and brand equivalent (generic) pharmaceuticals and veterinary products in the U.S. and internationally.
Copies of this and other news releases may be obtained free of charge from IVAX' website at http://www.ivax.com.
Except for the historical matters contained herein, statements in this press release are forward-looking and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that forward-looking statements involve risks and uncertainties which may affect the company's business and prospects, including the risks that GlaxoSmithKline may be successful in an appeal of the trial; the difficulty in predicting the timing and outcome of legal proceedings; the difficulty in predicting the timing of regulatory approvals; court and regulatory decisions on data exclusivity periods; GlaxoSmithKline's ability to enforce other patents on the drug or otherwise extend its exclusivity periods; the risks and uncertainties inherent generally in litigation; the impact of administrative or judicial agency's decisions on exclusivity periods; changing market conditions; the availability and cost of raw materials and other third party products; the impact of competitive products and pricing; and other risks and uncertainties based on economic, competitive, governmental, technological and other factors discussed in the Company's Annual Report on Form 10-K and its other filings with the Securities and Exchange Commission. Seretide(R) and Advair(R) are registered trademarks of GlaxoSmithKline.
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