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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