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Re: DewDiligence post# 5101

Wednesday, 11/24/2004 12:38:31 PM

Wednesday, November 24, 2004 12:38:31 PM

Post# of 257323
I hedged today with Jan 45s.

Company News

UPDATE 1-Astra to release Iressa survival data by year-end
Wed Nov 24, 2004 11:32 AM ET
(Updates with shares, further details)
By Ben Hirschler, European Pharmaceuticals Correspondent

LONDON, Nov 24 (Reuters) - AstraZeneca Plc (AZN.L: Quote, Profile, Research) aims to release results of a clinical study on the survival benefits of its lung-cancer drug Iressa before the end of the year, a company executive said on Wednesday.

Conclusive proof that Iressa helps patients live longer would give the Anglo-Swedish group important ammunition in a marketing battle with rival medicine Tarceva, which was approved in the United States last week.

Industry analysts had not expected the findings from the study to be published until around February or March next year.

But drug development head Martin Nicklasson, speaking at a media reception, said the clinical trial -- involving more than 1,200 patients -- had already seen enough "events", or patient deaths, to reach a statistically significant conclusion. The data is now being analysed.

Iressa has already been approved in the United States and Japan on the basis of studies showing it can shrink tumours.

However, the drug has yet to show outright survival benefits, putting it at a disadvantage to Tarceva, which was developed by OSI Pharmaceuticals Inc (OSIP.O: Quote, Profile, Research) , Genentech Inc (DNA.N: Quote, Profile, Research) and Roche Holding AG (ROG.VX: Quote, Profile, Research) .

Tarceva extended patients' life expectancy by a third in clinical trials, and AstraZeneca has said in the past it expects its product to demonstrate similar benefits.

Positive results for Iressa would be a rare piece of good news for AstraZeneca, after U.S. regulators rejected its anticoagluant pill Exanta last month and a Food and Drug Administration official last week questioned the safety of cholesterol fighter Crestor.

Shares in Europe's third largest drugmaker were 1.7 percent lower at 21.08 pounds by 1600 GMT, as a downgrade from Smith Barney and a decision by Capital Group to cut its holding to 14.78 percent from 15.89 percent weighed on sentiment.

Both Iressa and Tarceva are pills belonging to a new class of drugs that block the epidermal growth factor signal which promotes tumour cell growth.

Analysts believe they should both eventually generate annual sales of more than $1 billion and the two products are being studied in a number of different cancers.

For now, their use is confined to treating patients with advanced non-small cell lung cancer who have failed to respond to treatment with conventional chemotherapy.

Lung cancer is the most common form of cancer, accounting for 1.2 million cases a year worldwide, and non-small cell lung cancer accounts for almost 80 percent of all types of lung cancer.




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