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Hopes Rise for New Drug

LONDON (Reuters) - Ireland's Elan Corp and U.S. partner Wyeth plan to start final-stage clinical tests of a new antibody drug to fight Alzheimer's disease, offering new hope to patients and boosting shares in Elan.

Monday, May 21, 2007

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LONDON (Reuters) - Ireland's Elan Corp and U.S. partner Wyeth plan to start final-stage clinical tests of a new antibody drug to fight Alzheimer's disease, offering new hope to patients and boosting shares in Elan.

Bapineuzumab, also known as AAB-001, will begin phase III trials in treating patients with mild to moderate Alzheimer's in the second half of this year, once clinical trial design is finalised with regulatory agencies, the firms said on Monday.

The development is encouraging, since Alzheimer's research has been a graveyard of failed drugs, but the project remains high risk.

The decision to push ahead with phase III tests was reached taking into account the seriousness of the disease and a review of interim data from phase II studies, Elan and Wyeth said.

"No conclusion about the phase II study can be drawn until the study is completed and the final data are analysed and released in 2008," they added.

Despite the companies' caution, industry analysts said the decision to push ahead with late-stage testing suggested Elan and Wyeth had a promising new technology to tackle one of the world's most intractable diseases.

"This is a very positive development for both Elan and Wyeth, given that the acceleration of the drug into a phase III study was only going to be considered if the interim data showed a significant improvement in patient progress," Ian Hunter of Goodbody Stockbrokers said in a note.

Orla Hartford of NCB Stockbrokers said there was a possibility the new drug could be submitted for regulatory approval based on phase II data alone, if the results were good enough.

A filing based on phase II would increase the chance of the product's success to 60 percent from 25 percent and add around 50 percent to the stock's valuation, she added.

TOUGH DISEASE

Alzheimer's, which destroys memory and eventually leads to death, has been a focus of research for years but it is a very tough disease to fight and there are so far no very effective treatments.

Drugs approved since the 1990s, including Pfizer Inc. and Eisai Co. Ltd's market-leading Aricept, provide only modest symptomatic relief.

Elan and Wyeth's new drug could be the first disease-modifying treatment, making it a potential multibillion-dollar product -- if it works.

Bapineuzumab is a humanised monoclonal antibody designed to attack the A-beta peptide, which is one component of amyloid plaque that builds up in the brain and is thought to be responsible for damaging brain cells.

Elan and Wyeth are also working on a vaccine called ACC-001 designed to coax the body to make its own antibodies against A-beta peptide, which is in early-stage human trials.

An earlier experimental Alzheimer's vaccine from the two partners was abandoned in 2002 after it caused dangerous brain inflammation in some patients, although later research suggested it did help clear some brain-destroying plaques.

The World Health Organization estimates there are about 18 million people worldwide with Alzheimer's disease and this figure is projected to reach 34 million by 2025, due to ageing populations.

(Additional reporting by Paul Hoskins in Dublin)


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