|
London, March 4, 2003 - GlaxoSmithKline (GSK) today announced that a federal judge for the United States District Court for the Northern District of Illinois (Chicago) has ruled in GSK's litigation with TorPharm Pharmaceuticals (a wholly owned subsidiary of Apotex) over GSK's anti-depressant drug, Paxil (paroxetine hydrochloride). The judge ruled that GSK's patent in the United States covering the hemihydrate form of Paxil is valid but not infringed by Apotex's product. The patent expires in 2006. GSK will appeal the ruling of non-infringement.
Although the judge did find it likely there would be some hemihydrate in Apotex' product, he found that GSK did not show hemihydrate would be present in sufficient amounts to infringe the patent under his claim interpretation. GSK disagrees with that claim interpretation.
The ruling by Judge Richard Posner on the hemihydrate patent represents one element of the current legal action between GSK and Apotex, which is seeking to market an anhydrate form of paroxetine hydrochloride. GSK is continuing to pursue litigation for infringement of other patents relating to Paxil against Apotex and other generic companies in the United States District Court for the Eastern District of Pennsylvania (Philadelphia). No trial date has been set. The last-to-expire 30-month stay against FDA approval of Apotex's product under Hatch Waxman law will expire on September 19, 2003.
Possible timing of a generic Paxil product remains unclear with the Philadelphia trial still pending and the Chicago decision now moving towards appeal. Consequently, GSK's published business performance earnings per share guidance for 2003 remains as previously stated.* If a generic launch of paroxetine hydrochloride became imminent, GSK would reassess this guidance.
Paxil was launched in the US in early 1993, and the first generic company, Apotex, sought marketing approval in 1998 - only 5 years after first launch.
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 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 (CER).
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 2001 filed with the US Securities and Exchange Commission.
| Enquiries |
| UK Media |
Martin Sutton
Siobhán Lavelle
David Mawdsley |
020 8047 5502
020 8047 5502
020 8047 5502 |
| US Media |
Nancy Pekarek
Mary Anne Rhyne
Patricia Seif |
(215) 751 7709
(919) 483 2839
(215) 751 7709 |
| European Analyst/Investor |
Duncan Learmouth
Philip Thomson
Anita Kidgell |
020 8047 5540
020 8047 5543
020 8047 5542 |
| US Analyst/Investor |
Frank Murdolo
Tom Curry |
(215) 751 7002
(215) 751 5419 |
|
