http://www.nytimes.com/2006/10/27/business/27astra.html

 Astra Zeneca International
Research, manufacture and worldwide marketing of products in several therapeutic
classes. Includes drug profiles and patient information as well as links to
international subsidiaries and non-English ... 

www.astrazeneca.com . 10/25/2006 . Cached page 
AstraZeneca in the United States
AstraZeneca, one of the world's leading pharmaceutical companies providing
innovative prescription ... National Breast Cancer Awareness Month (NBCAM)
October is National Breast Cancer Awareness Month.

www.astrazeneca-us.com/default.asp . 10/26/2006 . Cached page 
 


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October 27, 2006
AstraZeneca Stroke Drug Fails in a Clinical Trial 
By ANDREW POLLACK
An experimental drug that AstraZeneca had hoped could protect the brain from the
damage caused by a stroke has failed in a large clinical trial, the company said
yesterday. 

The setback dashed the hopes not only of the drug's developers but also of
stroke specialists, who thought that success might at last be at hand after
countless past failures of such drugs. 

AstraZeneca, which sponsored the clinical trial, said yesterday that it would
halt development of the product, called NXY-059. 

Shares of AstraZeneca fell $4.99, or 7.5 percent, to $61.38, despite the
company's simultaneous announcement of a 33 percent increase in earnings per
share in the third quarter. 

Shares of Renovis, a small California biotechnology company that developed the
drug and had licensed it to AstraZeneca, lost more than 75 percent of their
value, plunging $10.77 to close at $3.43. Renovis has no other drugs in clinical
trials. 

Pharmaceutical companies and other medical researchers have tried for years to
develop so-called neuroprotectant drugs, created to help shield brain cells from
the damage caused by a stroke. 

But all those drugs have failed, in part because scientists lack knowledge of
what happens in the brain after a stroke and because animal tests do not always
predict what will happen in people. A paper published in March in the Annals of
Neurology said there had been 1,026 neuroprotectants tested so far, 114 in
people and 912 only in animals. 

Despite the long odds, hopes were riding on NXY-059, because last year it had
apparently achieved the first success ever in a late-stage clinical trial, when
it reduced disability in stroke patients as compared with a placebo. 

But the results of a second large trial, announced yesterday, showed no effect.
The trial involved 3,200 patients. 

"It's not an understatement to say we're shocked by the negative outcome," Corey
S. Goodman, the chief executive of Renovis, said in a conference call with
analysts. Mr. Goodman said he could not explain why the drug had seemed to work
in the first trial but not in the second. 

Dr. Justin A. Zivin, a professor of neuroscience at the University of
California, San Diego, who helped design the trial, said that in the first trial
the drug had been significantly better than a placebo by one scale used to
measure disability, but not by another one. "The results of the first trial were
marginal, and obviously the drug was just not sufficiently potent," he said. 

Still, "I think there was a real expectation," Dr. Zivin said. "I had thought it
would work, too. It's a big setback for the field, but it shouldn't be that the
whole field dies." 

There is one drug approved for stroke, Activase or tPA, from Genentech. It
breaks up the blood clots that cause most strokes. But it is given to only a
fraction of stroke victims because of restrictions on its use. 

The neuroprotectants like NXY-059 are designed to prevent damage over a wider
area of the brain. The drug traps free radicals - highly reactive molecules that
cause cell damage. 

AstraZeneca executives tried to put the failure in context. "Development of
drugs in the field of stroke is a very high risk endeavor," John Patterson, the
company's head of drug development, told analysts. 

Still, this is yet another setback for AstraZeneca. Earlier this year the
company dropped work on Exanta, a blood-thinning drug, and Galida, a diabetes
drug. 

AstraZeneca said its profit for the third quarter rose 29 percent to $1.59
billion, or $1.01 a share. That was up from $1.23 billion, or 76 cents a share,
a year earlier. Sales rose 13 percent to $6.52 billion. 

Sales of Crestor, its anticholesterol pill, rose 62 percent to $536 million.
Sales of the heartburn drug Nexium rose 13 percent to $1.28 billion. 

The company also said yesterday that it had received subpoenas from regulators
in California and Alaska seeking information about its marketing of Seroquel, a
drug for schizophrenia and bipolar disorder. Sales of that drug rose 19 percent
in the third quarter to $848 million. 

AstraZeneca also said the Securities and Exchange Commission had begun an
informal inquiry about payments made to doctors and government officials in
certain countries outside the United States. It did not identify the countries. 



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