pointer from RS (thanks!), an old story for biotech, Stuart Lipton et al., and others. A big win.......
Memantine Ebixa® - approved for treatment of Alzheimers disease
Release number: 61 Release date: 20-02-2002
On the meeting of 20 February 2002 the Committee for Proprietary Medicinal Products (CPMP) recommended to the EU commission to approve memantine for the treatment of moderately severe to severe Alzheimers disease. Marketing authorisation covering the EU is expected late first half 2002, and Lundbeck will launch memantine under the brand name Ebixa® during the second half of 2002.
Ebixa® is the first in a new class of drugs for Alzheimers disease, NMDA receptor antagonists, demonstrating clinically significant efficacy in patients with moderately severe and severe Alzheimers disease. Ebixa® is expected to fulfil unmet needs within this group of patients - for whom no approved treatment has been available until now.
This is good news for the patients and their caregivers and I am convinced that many Alzheimer patients will benefit from this new drug, says Lundbecks head of R&D, Executive Vice President, Claus Braestrup. He continues saying for Lundbeck memantine represents a major milestone. We will now have an important innovative drug available within neurology, our new area of focus.
Alzheimers disease affects approximately 5 per cent of the population above 65 years and more than 20 per cent in the age group above 85. Currently less than 50 per cent of the people suffering from Alzheimer' disease are diagnosed correctly and of these only 10-30 per cent receive proper treatment. There are considerable variations between the countries.
Alzheimers disease is a neurodegenerative disease characterised by progressive cognitive impairment such as failing memory, reduced perception and language derangement, which ultimately leads to the patient not being able to look after himself. In later stages of the disease behavioural disturbances appear such as anxiety, confusion and anger.
Lundbeck has in-licensed memantine from Merz Pharma, a German research based pharmaceutical company. Lundbeck has acquired exclusive rights to a series of European markets as well as Canada, Australia and South Africa. Under a co-marketing agreement with Merz, Lundbeck has acquired semi-exclusive rights on the remaining markets worldwide exclusive of USA and Japan. Forest Laboratories, Inc holds the rights to the US market. For Japan memantine is under development by Merzs collaborating partner Suntory Ltd.
The content of this release will not influence the Lundbeck Group financial result for 2001, which will be presented on March 5, 2002, together with the companys financial expectations for the year 2002.
For further information please contact Hans Henrik Munch-Jensen, CFO, tel +45 36 30 15 11, ext. 2660 or Steen Juul Jensen, Director of Corporate Communication & Investor Relations, tel +45 36 30 13 11, ext. 3006. |
