Beerse, Belgium, 12 July 2000 -- Reminyl™ (galantamine), a new treatment for Alzheimer's disease, was granted marketing approval under the Mutual Recognition Procedure by thirteen European Union member states as well as Norway and Iceland.
The countries mutually agreed to recognise the March approval of Reminyl™ (galantamine) by the Reference Member State, Sweden. Switzerland also received approval in June, following a separate application.
Novel Dual Mode of Action
Research indicates that Reminyl™ (galantamine), unlike other Alzheimer's treatments currently available, has a dual mechanism of action. 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 has shown that Reminyl™ (galantamine) also appears to act on the brain's nicotinic receptors. The "modulation" of these receptors could lead to release of more acetylcholine. *1,2,3
Two phase III studies published this month in Neurology showed that treatment with Reminyl™ (galantamine) significantly improves cognition, global function and behavioural symptoms of Alzheimer's disease over a period of 1 year *4,5.
Reminyl™ (galantamine) is being developed by Janssen Pharmaceutica under a co-development agreement with UK-based Shire Pharmaceuticals Group plc.
"Reminyl™(galantamine) can improve patient's cognition including language and memory and preserves the ability to perform daily tasks. These improvements are crucial to physicians, patients and caregivers alike. We are hopeful that this approval will make this new option treatment option accessible to many more patients in need," said Dr Alain Raoult, Vice President, Global Product Leader, CNS R&D, Janssen Research Foundation.
*References:
1. Schrattenholz A et al. Agonist Responses of Neuronal Nicotinic Acetylcholine Receptors are Potentiated by a Novel Class of Allosterically Acting Ligands. Molecular Pharmacology. 1996; 49:1-6
2. Maelicke A. Nicotinic Receptors in the Central Nervous System. 6th International Conference on Alzheimer's Disease and Related Disorders. July 18, 1998; Amsterdam, The Netherlands
3. Vidal, C. Nicotinic Receptors in the Brain: Molecular Biology, Function, and Therapeutics. Molecular and Chemical Neuropathology. 1996;28:3-11
4. Raskind M.A., Peskind E.R, Wessel T, Yuan W and the Galantamine USA-1 Study Group. Galantamine in AD, A 6-month randomized, placebo-controlled trial with a 6-month extension. Neurology 2000; 54: 2261-2268
5. Tariot P.N, Soloman P.R, Morris J,C, Kershaw P, Lilienfeld S, Ding C and the Galantamine USA-10 Study Group. A 5-month, randomized, placebo-controlled trial of galantamine in AD. Neurology 2000; 54: 2269 - 2276
Notes to Editors:
Reminyl™ (galantamine) is being developed by the Janssen Research Foundation, under a co-development agreement with UK-based Shire Pharmaceuticals Group plc. A new drug application (NDA) was filed with the U.S. FDA in September 1999. Galantamine will be marketed under the trade name Reminyl™ by Janssen Pharmaceutica in the United States, by Janssen-Ortho in Canada and by Janssen-Cilag elsewhere -- with the exception of the United Kingdom and Ireland, where it will be registered and marketed by Shire under a co-promotion agreement with Janssen-Cilag UK.
Janssen Research Foundation, an affiliate of Janssen Pharmaceutica, is headquartered in Beerse, Belgium. Janssen-Cilag has operating companies in 32 countries, including the United States. A wholly owned subsidiary of Johnson & Johnson, it is a leader in central nervous system research. Other areas of research include anaesthesia, oncology and gastroenterology.
Shire Pharmaceuticals Group plc
Shire is an international specialty pharmaceutical company with a strategic focus on four therapeutic areas: central nervous system disorders, metabolic diseases, oncology and gastroenterology. The group has a sales and marketing infrastructure with a broad portfolio of products targeting the US, Canada, UK, Republic of Ireland, France, Germany, Italy and Spain, with plans to add Japan by 2004. Shire's global search and development expertise has already provided four marketed products, whilst the current pipeline of 14 projects includes one project in registration and nine projects post Phase II. Shire is actively searching to acquire further marketed products and development projects to enhance the potential for future growth, both organically and by acquisition.
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