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
Shire
XAGRID(TM) (anagrelide hydrochloride) receives a positive opinion from the
European Committee for Proprietary Medicinal Products (CPMP)
Basingstoke, UK - 25 July, 2003- Shire Pharmaceuticals Group plc (LSE: SHP,
NASDAQ: SHPGY, TSX: SHQ) announces that it has received a positive opinion from
the CPMP for XAGRID(TM) (anagrelide hydrochloride) capsules to be used in the
treatment of essential thrombocythaemia (ET). The CPMP is the scientific
committee of the European Medicines Evaluation Agency (EMEA), and the CPMP
opinion will be ratified by the European Commission as part of the granting of
the pan-European marketing authorisation. Following the marketing approval,
pricing reimbursement negotiations will commence with individual national
authorities prior to launch.
XAGRID was granted European orphan drug status on 29 December 2000 for the
treatment of ET, thereby providing the product with up to ten years market
exclusivity in Europe from the date of marketing authorisation approval.
Essential thrombocythaemia is a chronic disorder of bone marrow, which is
associated with the increased production of blood platelets. Excessive platelet
production can result in abnormal blood clot formation and bleeding, thereby
increasing the risk of stroke, heart attack and gastrointestinal bleeding.
It is estimated by Shire that 40,000 patients suffering from ET across the
European Union member states would be eligible for treatment with XAGRID. There
is currently no other platelet-reducing treatment approved for the treatment of
ET across the whole EU.
The drug is already marketed by Shire in the US and a range of other territories
under the trademark AGRYLINTM. Sales of AGRYLIN in 2002 were $119.2 million, up
39% on 2001.
Says Dr Wilson Totten, Shire's Group R&D Director:
"XAGRID is a unique medicine for patients suffering from essential
thrombocythaemia as other currently marketed treatments can cause serious
side-effects by decreasing white or red blood cell counts. XAGRID is platelet
selective, targeting only those cells that develop into platelets. We welcome
the CPMP's opinion that XAGRID can have a beneficial role in helping these
patients across Europe."
1
For further information please contact:
Global (outside US and Canada)
Clea Rosenfeld - Investor Relations +44 1256 894 221
Jessica Mann - Media +44 1256 894 280
US & Canada
Gordon Ngan - Investor Relations +44 1256 894 160
Michele Roy - Media +1 450 978 7876
Notes to editors
o Shire acquired the worldwide rights to XAGRID/AGRYLIN from Bristol-Myers
Squibb in June 1999.
o The EMEA procedure included 15 European Communities countries, plus Iceland
and Norway.
o Orphan drug status for XAGRID has also been designated by the Japanese
Authorities, giving ten years' market exclusivity upon approval. The
product is currently in phase I trials in Japan
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), gastrointestinal (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 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, manufacturing and commercialisation, the impact of competitive
products, including, but not limited to, the impact on Shire's Attention Deficit
Hyperactivity Disorder (ADHD) franchise, patents, including but not limited to,
legal challenges relating to Shire's ADHD franchise, government regulation and
approval, including but not limited to the expected product approval date of
lanthanum carbonate (FOSRENOL(R)) and METHYPATCH(R), 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.
2