AstraZeneca: Stroke Drug Shows Promise
Posted on: Wednesday, 4 May 2005, 06:00 CDT
LONDON -- AstraZeneca PLC said Wednesday that its experimental drug designed to limit damage caused by strokes has proved effective by one measure in clinical trials.
AstraZeneca, Europe's third-largest drugmaker, said tests of the drug Cerovive showed that an improvement in post-stroke disabilities was significant compared to a placebo when measured using the so-called modified Rankin test, which examines mental function.
But the drugmaker added there was no significant improvement compared to a placebo when measured using a similar test by U.S. research body the National Institute of Health.
Analysts were cautiously optimistic about the trial results that involved 1,700 patients, pointing to the good reputation of the Rankin test and the enormous earnings potential from the drug.
Numis Securities said the data could be considered positive overall but not definitive and will require the completion of ongoing trials before any conclusions can be drawn.
AstraZeneca said that, depending on the final data results, it intends to go ahead with current plans to file regulatory submissions for Cerovive in the second half of 2006.
Analysts suggest that Cerovive, if approved by regulators, may generate more than $1 billion in sales, given the prevalence of strokes across North America and Western Europe, where it is the third-leading cause of death behind heart disease and cancer. Strokes also are the most common cause of long-term disability among adults in the United States.
Cerovive is designed to reduce the amount of brain damage by neutralizing chemicals released when the stroke destroys brain cells. The goal is to decrease memory loss, speech problems and other disabilities suffered by stroke survivors.
The drug is under license to AstraZeneca for development and marketing from California-based Pharmaceutical firm Renovis Inc. AstraZeneca will pay royalties to Renovis if the drug makes it to market.
AstraZeneca needs a strong pipeline of drugs following a series of setbacks. The company has struggled to regain investor confidence in recent months after it acknowledged that a trial showed that its lung cancer drug Iressa did not help patients live longer, U.S. authorities rejected its anticoagulant Exanta and its best-selling Crestor was hit by safety worries.
Cholesterol reducer Crestor is now regaining market share following a decision by the U.S. Food and Drug Administration in March to deny a petition by the Public Citizen's Health Research Group to remove it from the market. The FDA said the drug was safe and effective when used according the prescribing information.
Shares in AstraZeneca were up 0.2 percent at $44.63 in morning trading on the London Stock Exchange.
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Source: Associated Press/AP Online
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