Paxil - FDA Orange Book

GlaxoSmithKline PLC 01 July 2003 GSK asks FDA to remove three Paxil(R) patents from Orange Book LONDON, UK, 1 July 2003 -- GlaxoSmithKline plc announced today that it is requesting the U.S. Food and Drug Administration (FDA) to remove three patents related to the antidepressant Paxil(R) (paroxetine hydrochloride) from the register of pharmaceutical patents maintained by the FDA and known as the "Orange Book". The action follows the FDA's release on 12 June of new regulations concerning, among other matters, the listing of patents in the Orange Book. Although the new regulations do not specifically apply to patents already listed, FDA did provide new criteria for listing certain types of patents in the future. GSK is voluntarily seeking the delisting of three product-by-process patents -- U.S. Patent No. 6,172,233 ("the '233 patent"); U.S. Patent No. 6,080,759 and U.S. Patent No. 6,063,927 -- to proactively align with the new criteria. GSK's delisting does not affect the validity of these patents. The company continues to pursue patent infringement claims in litigation in Philadelphia against Apotex Corp. and other generic companies under these and other patents. No trial date has been set in the Philadelphia litigation. Delisting the '233 patent from the Orange Book removes the related Hatch-Waxman Act stay on final FDA approval of Apotex's abbreviated new drug application (ANDA) for paroxetine hydrochloride, although the litigation against Apotex continues. The Apotex stay was set to expire on 19 September 2003. Timing of the launch of generic Paxil(R) remains unclear; consequently GSK's published business performance earnings per share guidance for 2003 remains as previously stated.* S M Bicknell Company Secretary 1 July 2003 About GSK: GlaxoSmithKline, one of the world's leading research-based pharmaceutical and healthcare companies, is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For more information, please visit the company's web site at www.gsk.com. *Earnings Guidance The 2003 forecast is for high single digit percentage growth in business performance earnings per share as long as there is no generic competition to Paxil(R) in the U.S. Business performance, which is the primary measure used by management, is presented after excluding merger items, integration and restructuring costs and disposals of subsidiaries. Growth is at constant exchange rates. Cautionary statement regarding forward-looking statements Forward-looking statements involve inherent risk factors and uncertainties. The Group cautions investors that a number of important factors including those in this document could cause actual results to differ materially from those contained in any forward-looking statement. Such factors include, but are not limited to, those discussed under 'Risk Factors' in the Operating and Financial Review and Prospects in the Group's Annual Report on Form 20-F for 2002 filed with the US Securities and Exchange Commission. For further information, please contact: GSK Enquiries UK Media Martin Sutton 020 8047 5502 Chris Hunter-Ward 020 8047 5502 David Mawdsley 020 8047 5502 US Media Nancy Pekarek (215) 751 7709 Mary Anne Rhyne (919) 483 2839 Patricia Seif (215) 751 7709 European Analyst/Investor Duncan Learmouth 020 8047 5540 Philip Thomson 020 8047 5543 Anita Kidgell 020 8047 5542 US Analyst/Investor Frank Murdolo (215) 751 7002 Tom Curry (215) 751 5419 This information is provided by RNS The company news service from the London Stock Exchange

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