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REMINYL ALZHEIMER'S TREATMENT GETS FIRST EU APPROVAL.

REMINYL (galantamine), a new symptomatic treatment for dementia of the Alzheimer's type, has received its first regulatory approval within the European Union from Sweden. Reminyl will subsequently be submitted through the EU Mutual Recognition Procedure to gain marketing approval in Europe.

Following successful approval, Reminyl will be registered and marketed by Shire in the United Kingdom and Ireland with a co-promotion agreement with Janssen-Cilag. Reminyl will be marketed in all remaining European countries by Janssen-Cilag. Reminyl is being developed by the Janssen Research Foundation and Shire under a co-development and licensing agreement.

Like other therapies currently on the market, Reminyl boosts the levels of acetylcholine in the brain by blocking the action of the enzyme acetylcholinesterase. However, unlike other therapies, research indicates that Reminyl has a second mechanism of action: it acts on nicotinic receptors in the brain. The "modulation" of these receptors is thought to increase the release of acetylcholine(1,2,3). An important feature of Alzheimer's disease is the progressive loss of cholinergic nerve cells, leading to a decline of critical chemical signals in the brain.

Submissions have also been made to the authorities in Canada, Australia, Switzerland, 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. Janssen-Cilag will market Reminyl on successful approval in all these countries, except the US where Janssen Pharmaceutica will be responsible for marketing.

"Alzheimer's disease is a devastating illness for patients and their families. We are proud to introduce Reminyl as an important new treatment for this disease," said Jack Grebb, Senior Vice President, Janssen Research Foundation.

"This first approval for Reminyl in Alzheimer's disease leads the way forward for the UK and other European markets and represents good news for everyone involved in providing care for people with Alzheimer's disease," commented Dr. Wilson Totten, Shire's Group R&D director.

Galantamine is being developed by the Janssen Research Foundation, under a co-development agreement with UK-based Shire Pharmaceuticals Group plc. If approved by regulatory authorities, galantamine will be marketed under the trade name Reminyl(R) by Janssen Pharmaceutica in the US and by Janssen-Cilag in most European countries. In the UK and Ireland, it will be registered and marketed by Shire under a co-promotion agreement with Janssen-Cilag.

Janssen-Cilag and Janssen Research Foundation

Janssen Pharmaceutica and Janssen Research Foundation, are headquartered in Beerse, Belgium, and have 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 focus include, anesthesia, oncology, gastroenterology and mycology.

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 and Italy, with plans to add other key markets in due course. Shire's global search and development expertise has already provided three marketed products, whilst the current pipeline of 12 projects includes one project in registration and a significant number 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.

For more information, call 212-704-8239.
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Comment:REMINYL ALZHEIMER'S TREATMENT GETS FIRST EU APPROVAL.
Publication:Worldwide Biotech
Geographic Code:4EUSW
Date:Apr 1, 2000
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