GlaxoSmithKline PLC
08 September 2003
Philadelphia & London, September 8, 2003
GSK STATEMENT
REGARDING LAUNCH OF GENERIC PAROXETINE HYDROCHLORIDE
GlaxoSmithKline (GSK) confirmed that a generic form of paroxetine hydrochloride
was launched by Apotex Corp. on Monday, September 8, 2003, triggering GSK's
license agreement with Par Pharmaceutical, Inc. Under the terms of the agreement
announced in April 2003, GSK will supply generic paroxetine hydrochloride
immediate-release tablets, manufactured by a GSK subsidiary, to Par for
distribution in the U.S. market.
GSK remains committed to Paxil CR, which now represents approximately 40% of new
Paxil prescriptions in the USA. Immediate release forms of Paxil, including the
generic products, are not substitutable for Paxil CR as a generic equivalent.
GSK is continuing to pursue litigation for infringement of patents relating to
the immediate release form of Paxil against Apotex and other generic companies
in Philadelphia. No trial date has been set for the Philadelphia litigation.
Separately, in March of this year a federal judge for the United States District
Court for the Northern District of Illinois (Chicago) 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 is appealing the
ruling of non-infringement. A date for the appeal court hearing has not been
set.
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.
SM Bicknell
Company Secretary
8th September 2003
GSK Inquiries
US Media inquiries: Nancy Pekarek (215) 751 7709
Mary Anne Rhyne (919) 483 2839
Patty Seif (215) 751 7709
UK Media inquiries: Martin Sutton 020 8047 5502
Chris Hunter-Ward 020 8047 5502
David Mawdsley 020 8047 5502
US Analyst/Investor inquiries: Frank Murdolo (215) 751 7002
Tom Curry (215) 751 5419
European Analyst/Investor Duncan Learmouth 020 8047 5540
inquiries: Philip Thomson 020 8047 5543
Anita Kidgell 020 8047 5542
This information is provided by RNS
The company news service from the London Stock Exchange
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