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AstraZeneca Announces IRESSA Drug Fails Lung Cancer Trial

December 17th, 2004 – InvestorIdeas.com – On Friday morning, following issuance of a statement that their drug IRESSA failed to significantly prolong survival in patients with lung cancer, the share price of healthcare company AstraZeneca dropped by 8.7%.

Upon release of this news, share prices of OSI Pharmaceuticals (OSIP) and Genentech (DNA), marketers of rival lung cancer drug Tarceva, increased significantly.

OSI jumped nearly 43 percent, or $20.16, to $67.26 per share, while Genentech gained 5.7 percent, or $2.77, to $51.26 per share.

In their statement, AstraZeneca announced that the initial analysis of the primary endpoint of Study 709, IRESSA Survival Evaluation in Lung cancer (ISEL) with 1692 patients had been conducted, and showed that IRESSA failed to significantly prolong survival in comparison to placebo in the overall population, or in patients with adenocarcinoma.

The study showed that there was a statistically significant improvement in tumor shrinkage, which did not translate into a statistically significant survival benefit. Prospective subgroup analyses suggested survival benefits in patients of Oriental origin and in patients who never smoked.

"The trial was well designed, the data are robust and there is no methodological explanation for these findings,” said Professor Nick Thatcher, Principal Investigator for the ISEL study. “Full results from ISEL will be presented in the first half of 2005."

AstraZeneca is now actively consulting with Regulatory Authorities to determine the impact of these data and intends to honor a commitment to continue to supply IRESSA to any patient receiving the drug who, in consultation with their physician, wishes to continue treatment. Patients currently being prescribed IRESSA should continue to take their medication and should consult their physician about their ongoing treatment at the first opportunity.

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