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【drug-news】Alzheimer新药数据使Elan 股票大涨
By Ailish O'Hora
Tuesday April 08 2008
Shares in Elan finished yesterday up over 6pc at ?4.72 on the back of estimates that an Alzheimer's treatment co-developed by the Irish drugmaker and international giant Wyeth could notch up sales of over $13bn and surpass Pfizer's cholesterol treatment Lipitor to become the biggest drug of all-time.
According to a report in the influential Wall Street publication Barron's, healthcare investor Larry Feinberg, whose flagship healthcare hedge fund Oracle Investment Management has averaged 21pc over the past 18 years, said that the effect on Wyeth's shares could be a 50pc increase over the next year.
In early 2002, Wyeth was forced to halt an Alzheimer's vaccine trial after 18 out of 300 patients developed encephalitis. But the report stated that the two companies are sponsoring research aimed at neutralising the adverse reaction.
Wyeth researchers believe that what caused the brain swelling was the use of an "active" inoculation that mobilises the body's immune system to produce antibodies. So in 2005, they began testing a "passive" vaccine that supplies antibodies directly to fight senile plaques in the brain -- a characteristic feature of Alzheimer's Disease.
The US Federal Drug Administration (FDA) fast-tracked the study after patients seemed to show signs of mental improvement from even moderate doses of the drug. Results of the Phase II trial on 240 patients are due in June and there is also an ongoing Phase III trial, involving 4,100 people and costing an estimated $300m -- although it will probably be years before the treatment is fully tested and reviewed by regulators. Other biotechnology companies are also testing Alzheimer's treatments.
Elan is probably more famous for its multiple sclerosis treatment Tysabri which is also used to treat Crohn's disease.
Shares in Elan tumbled back in February when it emerged that Tysabri could cause significant liver damage in patients.
At the time, the US regulator, the Food and Drug Administration (FDA) announced that Elan and its US partner Biogen Idec had written to doctors to warn them of the danger.
Tysabri was taken off the market in 2005 shortly after its initial launch after three cases of a potentially fatal brain infection known as progressive multifocal leukoencephalopathy emerged.
The drug returned to the market in 2006 with limits after the FDA decided MS patients were willing to accept the risks in light of possible benefits. Hopes rise for Alzheimer's drug from Elan & Wyeth
By Ben Hirschler Monday, May. 21, 2007; 11:27 AM
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.
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作者:admin@医学,生命科学 2010-11-19 05:11
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