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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
Tuesday 29th October 2002 [08:00 GMT]
First long-term head to head study shows (COMPANY'S LOGO)
superiority of Reminyl(TM) over
donepezil in patients with
Alzheimer's Disease
29 October 2002, - At the 6th Congress of the European Federation of
Neurological Societies in Vienna, Shire Pharmaceuticals Group plc (LSE:
SHP,NASDAQ: SHPGY, TSE: SHQ) has today presented data with Janssen-Cilag Ltd
which shows that over one year, Reminyl (galantamine) has a superior treatment
profile compared to donepezil (Aricept (R)) when treating patients with
Alzheimer's Disease (AD). This is the first one-year head to head study of the
two drugs. Results of the long-term, rater-blinded, randomized study conducted
in the UK show that in two assessments of AD patients, those treated with
Reminyl had statistically superior scores on measures of cognition and attention
compared to those treated with donepezil.
Reminyl was shown to significantly improve a patient's attention within six
weeks of commencing treatment, using a validated computerised test for assessing
cognitive performance. These computerised assessments, by the independent
company, Cognitive Drug Research (CDR), measure a patient's reaction times and
showed that patients taking Reminyl significantly improved their choice reaction
times (CRT) compared to donepezil patients after only six weeks of treatment. At
52 weeks, Reminyl patients' CRT had been maintained at baseline levels. Patients
treated with donepezil had no significant changes in CRT throughout the study.
The improvements in attention, as measured by the computerised tests for
patients taking Reminyl, are thought to be due to its action on nicotinic
receptors. "Reminyl is different to other acetylcholinesterase inhibitors
(AChEIs) because it increases the levels of acetylcholine by two separate
mechanisms. As well as inhibiting acetylcholinesterase, it has also been shown
to enhance activity of nicotinic receptors," says Dr Roger Bullock of the
Kingshill Research Centre, Swindon. "Nicotinic receptors are known to be
important in
maintaining attention and concentration. These results demonstrate the
importance of Reminyl's dual mode of action."
Dr Bullock says: "Being able to improve a patient's ability to take part in
family events by increasing their attention and concentration adds an important,
but often neglected quality to the lives of both patients and their carers."
Patients treated with Reminyl were also more likely to improve or maintain their
level of dementia throughout the study compared with those patients taking
donepezil, as measured by the MMSE (Mini Mental State Examination) assessment
scale for AD. The MMSE, which measures cognition by testing functions such as,
memory, orientation and language, is the assessment scale recommended by the
National Institute for Clinical Excellence (NICE) and the one that most
clinicians use on a daily basis.
At 13 and 26 weeks, the MMSE score for Reminyl was significantly improved
compared with the baseline assessment. At 52 weeks, patients had been maintained
at their baseline score. Patients treated with donepezil only saw significant
improvement above baseline at the 13 week time point. At 26 weeks, their score
had returned to baseline values, whilst after 52 weeks, patients treated with
donepezil were statistically below their baseline scores. For those patients
less severely affected by AD, (those who fitted the NICE criteria for treatment
with AD drugs with a baseline MMSE score of 12-18 points), the results were even
more favourable for Reminyl. Reminyl was significantly superior to donepezil at
all time points measured throughout the 52 weeks study.
Reminyl was comparable to donepezil in terms of safety and tolerability, with
similar discontinuation rates during the study and similar numbers of patients
continuing on therapy after the end of the study.
The primary end point for the study was the Bristol Activities of Daily Living
(BrADL) rating scale, which measures a patient's ability to function. Patients
treated with Reminyl and donepezil performed equally well in this assessment.
This study confirms that Reminyl treated patients demonstrate an early
improvement in attention and sustained cognitive benefits.
- Ends -
For further information contact: Sue Welham, Nicky Chapple or Annabelle Lilly at
The Workhouse, tel: 020 8948 8388.
Reference:
1. Truyen L. et al. Poster presentation at 6th Congress of The European
Federation of Neurological Societies, Vienna, Austria, 29 October 2002.
Note to editors:
o Reminyl is indicated for the treatment of mild to moderate Alzheimer's
disease
o This study is a rater-blinded, randomised, comparative, parallel group
study of Reminyl compared with donepezil using a flexible dose design in
182 patients with moderate to severe Alzheimer's disease.
Reminyl was developed by Johnson & Johnson Pharmaceutical Research & Development
under a co-development and licensing agreement with UK-based Shire
Pharmaceuticals Group plc. Reminyl is marketed in the UK and Ireland by Shire
Pharmaceuticals Ltd. Outside of the UK and Ireland, Reminyl is marketed by
Janssen Pharmaceutica Products and Ortho-McNeil Pharmaceutical in the United
States, Janssen-Ortho in Canada and Janssen-Cilag elsewhere.
Shire Pharmaceuticals Group plc (Shire) is a rapidly growing international
specialty pharmaceutical company with a strategic focus on three therapeutic
areas - central nervous system disorders (CNS), oncology and anti-infectives.
Shire also has two platform technologies: advanced drug delivery 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 Janssen-Cilag companies, part of Johnson & Johnson (NYSE: JNJ)- one of the
most diversified healthcare companies - have a long track record in developing
and marketing treatments for central nervous system disorders, pain management,
fungal infections and gastrointestinal conditions. Leading products include
Eprex(R) (haematology), Risperdal(R) (psychiatry), Sporanox(R)
(dermatological/fungal infections), Durogesic(R) (management of chronic,
moderate to severe pain), Topamax(R) (neurology/epilepsy), Pariet(R)
(gastroenterology) and Reminyl(R) (Alzheimer's disease).
More information can be found at www.dementia.com or at www.janssen-cilag.com.
THE "SAFE HARBOUR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT
OF 1995. The statements in this press release 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 that
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, the impact of competitive products, patents,
government regulation and approval, and other risks and uncertainties detailed
from time to time in periodic reports produced by Shire, including the Annual
Report filed on Form 10K by Shire with the Securities and Exchange Commission.