Shire Pharmaceuticals Group plc
Hampshire International Business Park,
Chineham, Basingstoke RG24 8EP UK
Tel +44 1256 894000 Fax +44 1256 894708
http://www.shire.com
7am GMT 2am ET
SHIRE RECEIVES APPROVABLE LETTER FROM FDA FOR FOSRENOL(R) POSITIVE
STEP FOR TREATMENT RELATED TO KIDNEY DISEASE IN THE UNITED STATES
Basingstoke, UK - 3 March 2003 - Shire Pharmaceuticals Group plc (LSE: SHP,
NASDAQ: SHPGY, TSX: SHQ) announces that it has received an approvable letter
from the U.S Food & Drug Administration (FDA) for FOSRENOL(R)(lanthanum
carbonate).
The approvable letter asks for additional data and analysis to address a number
of remaining questions. Shire is initiating a dialogue with the FDA to agree the
balance between pre and post approval commitments which will resolve the
questions. Shire will give further updates when it is in a position to be more
specific about the timing of approval and subsequent launch. Until that point,
Shire maintains its forecast of a US launch prior to the end of 2003.
Dr Wilson Totten, Group R&D Director of Shire, said: "This approvable letter is
excellent news. I am particularly pleased that the FDA was able to respond on
the ten month PDUFA* date. Shire has generated a very extensive data set for
FOSRENOL(R) and we are continuing to expand it. For dialysis patients treated
across the United States, FOSRENOL will be a welcome new and effective
alternative to current therapies."
FOSRENOL is a treatment for high phosphate levels in the blood, which occur in
patients undergoing dialysis as a result of chronic kidney failure. Estimates
show there are 269,000(1) dialysis patients in the United States. Even with a
low-phosphate diet, as many as 80% of dialysis patients develop
hyperphosphataemia(2) and need treatment with a phosphate binder, such as
FOSRENOL. If left untreated, hyperphosphataemia can lead to the bone disease
renal osteodystrophy, which causes bone pain, skeletal deformities, and can
result in fractures. Recent research also suggests that hyperphosphataemia is
associated with the development of cardiovascular disease, which accounts for
nearly 50% of all deaths in dialysis patients(3).
Submissions have also been made by Shire to gain marketing approval in Europe
and Canada, whilst development continues for Japan.
Shire has an exclusive worldwide license to develop, manufacture, use and sell
FOSRENOL under patents owned by AnorMED Inc
- ENDS -
FOR FURTHER INFORMATION PLEASE CONTACT:
GLOBAL (OUTSIDE US & CANADA)
Gordon Ngan - Investor Relations +44 1256 894 160
Jessica Mann - Media +44 1256 894 280
US & CANADA
Gordon Ngan - Investor Relations +44 1256 894 160
Michele Roy - Media +1 450 978 7938
REFERENCES:
* Prescription Drug User Fee Act
(1) US renal data system 2002 annual data report: Atlas of ESRD in US, National
Institutes of Health, National Institute of Diabetes and Digestive and Kidney
Diseases, Bethesda, Maryland, MD. 2002 page 44.
(2) Numbers of patients on dialysis broadly equates to patients with end stage
kidney disease. Source: Market Research, Insight International, Dec 01/Jan 02
(3) Davies MR, Hruska K. Pathophysiological mechanisms of vascular calcification
in end-stage renal disease. Kidney Int. 2001 Aug; 60(2): 472-9
NOTES TO EDITORS:
FOSRENOL(R) (Lanthanum carbonate) is a novel non-calcium, non-aluminium, potent
phosphate binder. It is available as a convenient chewable tablet to be taken at
mealtimes unlike existing treatments that must be taken with water. Patients on
dialysis need to restrict their fluid intake. FOSRENOL works by binding to
dietary phosphate throughout the GI tract forming a highly insoluble complex
that cannot pass through the stomach lining and into the blood stream. The
complex is eliminated from the body through the GI tract. As a result, overall
phosphate absorption from the diet is decreased significantly. Shire has
conducted an extensive clinical research programme for FOSRENOL involving almost
1700 patients, some of whom have been treated for 36 months or more.
SHIRE PHARMACEUTICALS GROUP PLC
Shire Pharmaceuticals Group plc (Shire) is a rapidly growing international
emerging pharmaceutical company with a strategic focus on four therapeutic areas
- - central nervous system disorders (CNS), gastro intestinal (GI), oncology, and
anti-infectives. Shire also has three platform technologies: advanced drug
delivery, lead optimisation for small molecules and Biologics. Shire's core
strategy is based on research and development combined with in-licensing and a
focus on eight key pharmaceutical markets.
For further information on Shire, please visit the Company's website:
www.shire.com
THE "SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT
OF 1995. Statements included herein that are not historical facts, are
forward-looking statements. Such forward-looking statements involve a number of
risks and uncertainties and are subject to change at any time. In the event such
risks or uncertainties materialise, Shire's results could be materially
affected. The risks and uncertainties include, but are not limited to, risks
associated with the inherent uncertainty of pharmaceutical research, product
development and commercialisation, patents, government regulation and approval,
including but not limited to the expected product approval date of lanthanum
carbonate (FOSRENOL(R)), the impact of competitive products, including but not
limited to the impact of same on Shire's ADHD franchise, and other risks and
uncertainties detailed from time to time in our filings, including the Annual
Report filed on Form 10-K by Shire with the Securities and Exchange Commission.