Shire Pharmaceuticals Group plc and
Janssen Pharmaceutica today announce that ReminylTM
(galantamine), a new treatment for Alzheimer's disease, has successfully
completed the Mutual Recognition Procedure.
Thirteen EU countries, as well as Norway and Iceland, have mutually
agreed to recognize the early approval of ReminylTM by the Reference
Member State, Sweden. Switzerland also received approval in June, following a
separate application. ReminylTM will be available to doctors to prescribe
for their patients from the fourth quarter 2000, following completion, where
necessary, of certain administrative procedures.
ReminylTM is being developed by the Janssen Research Foundation and
Shire under a co-development and licensing agreement. ReminylTM will be
registered and marketed by Shire in the United Kingdom and Ireland under a
co-promotion agreement with Janssen-Cilag. Elsewhere in Europe, Janssen-Cilag
will market the product.
The European Summary of Product Characteristics (SmPC) indicates that
galantamine has a novel dual mechanism of action(7). Decreased levels of
acetylcholine, caused by the death of acetylcholine neurones, are known to be
related to the symptoms of Alzheimer's disease. In addition to preserving
levels of acetylcholine in the brain by blocking the action of the enzyme
acetylcholinesterase (which inactivates acetylcholine), laboratory research
suggests that galantamine may also act on the brain's nicotinic receptors.
The "modulation" of these receptors may lead to release of more
acetylcholine(1,2,3). Janssen Research Foundation is investigating the
clinical significance of this characteristic further.
Two Phase III studies published this month in Neurology showed that
treatment with ReminylTM significantly benefits the cognitive, functional
and behavioural symptoms of patients with mild to moderately severe
Alzheimer's disease. Moreover, cognitive and daily function were maintained
for 12 months(4,5). Adverse side effects experienced by study participants
were mostly gastrointestinal in nature and were reported as mild and
temporary. Side effects that were reported at least five percent more often
by patients taking galantamine as by those receiving placebo included nausea
and diarrhea (13% vs. 5% and 12% vs. 6% respectively).
Submissions seeking regulatory marketing approvals have also been made to
the regulatory health authorities in Canada, Australia, Poland, South Africa
and New Zealand during the second quarter of 1999 and to the US Food and Drug
Administration (FDA) at the end of September 1999. Marketing approvals in all
the aforementioned countries have not yet been received.
"We are proud to announce that ReminylTM has received approval in
Europe," said Dr. Alain Raoult, Vice President, Global Product Leader, CNS
R&D, Janssen Research Foundation. "We hope ReminylTM will improve the lives
of patients and caregivers affected by Alzheimer's disease."
"We are particularly pleased with the overall spectrum of effects of
ReminylTM covering behavioural symptoms and benefits to caregivers, in
addition to the traditional cognitive benefits," says Dr Wilson Totten, Group
R&D Director at Shire Pharmaceuticals Group plc.