GlaxoSmithKline PLC
23 May 2002
Federal District Court Rules in Augmentin Patent Trial
GSK TO APPEAL RULING
LONDON, May 23, 2002 -- GlaxoSmithKline (GSK) today announced that a federal
judge in the United States Federal District Court for the Eastern District of
Virginia has ruled in favour of Geneva Pharmaceuticals, Teva Pharmaceuticals and
Ranbaxy, declaring that three of GSK's US patents for its antibiotic Augmentin
are invalid. These three patents expire in June, July and December of 2002.
GSK continues to believe its patents covering Augmentin are valid. The Company
is appealing both this ruling and previous rulings from the same court on
Augmentin patents expiring in 2017 and 2018 to the Court of Appeals for the
Federal Circuit in Washington, D.C. A decision is expected within 12 to 18
months from the start of the appeal.
GSK is unable to assess the likelihood or timing of a generic version of
Augmentin entering the US market. If a generic version of Augmentin were to be
launched prior to the outcome of the appeal and GSK is successful in its appeal,
GSK would seek to recover damages for its lost profits.
In the absence of generic competition to Augmentin in the US, GSK's earnings
guidance is as previously stated: GSK expects business performance to deliver
earnings per share growth in the mid-teens in 2002 and low-teens or better in
2003. If generic competition were to occur prior to the resolution of the
appeal, it may have a material impact on the Company's earnings guidance for
2002 and 2003. If a generic Augmentin product were to be launched as early as
July 2002, the result would be a revised EPS growth forecast of around 10% in
2002 and high single digits in 2003.
GSK remains committed to its Augmentin range of products, including the
promotion of Augmentin ES, which the company launched last year for the
treatment of antibiotic resistant ear infections in children. Augmentin ES now
represents over 35% of Augmentin's total paediatric sales. Additionally, GSK has
filed an extra strength adult version, Augmentin XR, with the FDA and is hopeful
of a US launch by the end of 2002.
JP Garnier, Chief Executive Officer commented: "We are clearly disappointed with
the court's decision. We have provided this additional EPS guidance in order to
be clear on the impact should a generic Augmentin be launched before the appeal,
although I should emphasise that there is still no certainty whether this will
ultimately occur."
"Regardless of the potential impact of this decision, I want to stress that we
remain focussed on achieving the key goals that will deliver long-term growth
for GSK. These are to maximise the revenues from our key therapy areas,
continuously pursue opportunities for cost savings and efficiencies throughout
the business and build the best pipeline of new and important products in the
industry. Looking forward we expect to launch up to 11 new products during
2002-3. Beyond 2003, we expect our significant early stage pipeline will start
to deliver new products for GSK and we expect to file at least 13 major products
in the period 2003-5."
JP Garnier will host a teleconference to discuss the impact of the court
decision on Friday 24th May at 15.00 BST / 10:00 a.m. EDT. To access this call,
please telephone +44 (0)208 781 0597, quoting password GSK. To call from the US,
please telephone 1 888 806 9460, quoting password GSK. A recording of the
teleconference will be available shortly after the call. To access this call,
please dial +44 (0)208 288 4459, passcode 616952. To access the recording from
the US, please call 1 800 495 0250, passcode 616952.
Earnings forecasts continue to assume GSK successfully defends its intellectual
property surrounding Paxil in the US. Business performance earnings per share
growth is at constant exchange rates and excludes merger items, integration and
restructuring costs and disposals of subsidiaries.
Enquiries:
UK Media enquiries: Martin Sutton (020) 8047 5502
Alan Chandler (020) 8047 5502
US Media enquiries: Nancy Pekarek (215) 751 7709
Mary Anne Rhyne (919) 483 2839
Patty Seif (215) 751 7709
European Analyst/Investor enquiries: Duncan Learmouth (020) 8047 5540
Anita Kidgell (020) 8047 5542
Philip Thomson (020) 8047 5543
US Analyst/ Investor enquiries: Frank Murdolo (215) 751 7002
Tom Curry (215) 751 5419
Notes
Up to 11 products expected to be launched in 2002-3:
Vardenafil for erectile function
Avandamet for diabetes (Avandia + metformin)
Wellbutrin XL for depression
Augmentin XR for adult infections
Ariflo for COPD
Avolve for BPH
Bexxar for non-Hodgkin's lymphoma
Infanrix penta - paediatric vaccine (USA)
Lotronex for irritable bowel syndrome
Natrecor for congestive heart failure (Europe)
908 for HIV
At least 13 products expected to be filed in 2003-5:
Alvimopan for post-operative ileus
Avandia + sulphonylurea for diabetes
Ibandronate for osteoporosis (oral monthly and quarterly iv dosing)
Talnetant for urinary incontinence, schizophrenia and other indications
Vilazodone for depression
GW572016 for solid tumours
Carabersat for migraine prophylaxis
GW353162 for depression
S-1360 for HIV
4 new vaccines: MMRV; New Influenza; Meningitis A/C; Strep. pneumoniae
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.
This information is provided by RNS
The company news service from the London Stock Exchange
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