BASINGSTOKE, England, October 1 /PRNewswire/ --
- Not for Distribution to US Media
Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) the global specialty
biopharmaceutical company, confirms that it will act as an interested party
to the application to Appeal announced by Eisai against the High Court
judgment handed down by Judge Linda Dobbs on 10th August 2007.
Eisai has today applied to the Court of Appeal for permission to appeal
the recent High Court ruling on the process by which the National Institute
for Health and Clinical Excellence (NICE) reached its decision on the
cost-effectiveness of drugs in the early stages of Alzheimer's disease (AD).
Dr Ian Howe, Shire's Medical Director said: "Shire is continuing as an
interested party in the appeal against this judgment, and the NICE Guidance,
as we believe that NICE has acted unfairly. NICE failed to reveal a working
version of the cost-effectiveness model on which they based their decision
that the drugs are not cost-effective in the early stages of the disease, a
decision that excludes newly diagnosed patients with mild AD from NHS
support. This issue of procedural fairness will now be challenged through the
High Court."
Shire welcomed the Judicial Review's conclusion that NICE had acted
unlawfully by not taking enough account of the discriminatory nature of the
test [the MMSE] by which patients are assessed as being mild or moderate.
However, the revised guidance that NICE were forced to issue will, in
practice, only provide NHS support for a small percentage of newly diagnosed
patients.
Dr Howe continues: "We believe that all AD patients should have access to
these drugs on the NHS as they are effective at the early stages as well as
later stages of the disease. NICE agrees that these drugs, licensed for both
mild and moderate AD, are clinically effective."
The processes, including lack of transparency, used by NICE to reach its
decisions are not only being challenged in the High Court with regard to AD.
They are also being investigated by the House of Commons Health Select
Committee concerning the reasons for growing lack of confidence in NICE, the
decisions it makes, and the Appeal process against those decisions. The
Health Select Committee next takes evidence regarding NICE on 11th October
2007.
Note to Editors:
In the UK and Ireland, Shire markets REMINYL(R) (galantamine
hydrobromide) and REMINYL(R) XL (galantamine hydrobromide)
acetylcholinesterase inhibitors that are licensed for the symptomatic
treatment of mild and moderately severe dementia of the Alzheimer's type.
Shire plc
Shire's strategic goal is to become the leading specialty
biopharmaceutical company that focuses on meeting the needs of the specialist
physician. Shire focuses its business on attention deficit and hyperactivity
disorder (ADHD), human genetic therapies (HGT), gastrointestinal (GI) and
renal diseases. The structure is sufficiently flexible to allow Shire to
target new therapeutic areas to the extent opportunities arise through
acquisitions. Shire's in-licensing, merger and acquisition efforts are
focused on products in niche markets with strong intellectual property
protection either in the US or Europe. Shire believes that a carefully
selected portfolio of products with strategically aligned and relatively
small-scale sales forces will deliver strong results.
For further information on Shire, please visit the Company's website:
http://www.shire.com.
For further information please contact:
Shire
Jessica Mann
+44-1256-894-280
Public relations
Rhonda Smith
+44-1264-710428
+44-7887-714957
Shire PLC
