Meanhwile, Iressa looking wobbly a day before its ODAC meeting.
>>WASHINGTON (Reuters) - A review of AstraZeneca's (London:AZN.L - News) cancer drug Iressa raises "several bothersome issues," including treatment response and the eligibility of patients in clinical trials, according to a Food and Drug Administration report released on Monday.
The staff review said the FDA medical officer "defers making a final recommendation on approval until after" a Tuesday meeting of an agency advisory committee.
AstraZeneca shares, which have lost more than half their value since April, hit a new 2 1/2-year low following release of the FDA documents before paring losses to close 3.8 percent lower at 18.73 pounds in London.
"This is bad news big time for AstraZeneca," said Navid Malik, industry analyst at Williams de Broe in London, who rates AstraZeneca a sell.
"I don't think we will see Iressa getting to the market in the U.S., and you've got to have some doubts about what the interpretation will be in the EU, where the drug is coming up for review as well," he added.
AstraZeneca is seeking U.S. approval of Iressa for treating patients with advanced lung cancer who have failed other therapies. The preliminary FDA staff analysis said AstraZeneca trials showed Iressa "has a favorable safety profile for the intended patient population."
Analysts had already slashed sales forecasts for Iressa following the drug's failure in combination therapy trials last month. The product has been approved and launched in Japan, but overall sales are now expected to fall well short of the initially hoped-for $1 billion a year.
Lehman Brothers estimates peak sales at a modest $325 million, a small sum for AstraZeneca, which had 2001 sales of $16.5 billion.
Analyst Andrew Pendrill of ABM AMRO said the design of its clinical trials meant it was always going to be tricky for AstraZeneca to prove its case.
"The absence of a demonstrated survival benefit may make it hard for the FDA to approve Iressa," he said. "However, Iressa does offer low side effects and appears to offer patients a more tolerable therapy, improving quality of life in patients who have failed to respond to all other therapy," he added.<<
snip
Cheers, Tuck |
