said Thursday it expects to submit by mid-July additional information to U.S. drug regulators for its cancer-fighting drug Zevalin.
But the San Diego biopharmaceutical firm stopped short of predicting when its new drug, used to treat non-Hodgkins lymphoma, would get the green light from the
U.S. Food and Drug Administration
Last month, IDEC
acknowledged that Zevalin's approval was being delayed because the FDA was requesting additional information. Last week, IDEC says it received a "complete review letter" from the FDA and is now in the process of compiling the requested data.
On a conference call with analysts Thursday afternoon, IDEC executives expressed confidence that the work could be completed by mid-July and will not require any new or additional Zevalin testing. Once the information is sent back to the FDA, it is up to the agency to schedule IDEC for an advisory committee meeting that will get the ball rolling on Zevalin's final approval.
And that is where IDEC's control over the situation ends. The company has already missed the cutoff for a June advisory committee meeting, and now must hope to get put on the schedule for meetings in the fall. That decision is made by the FDA, which has been taking a
go-slow approach to the drug approval process.
The FDA is taking an even closer look at Zevalin because it's an entirely new type of drug -- an antibody that attacks cancerous cells using a radioactive isotope. Biotech rival
is also developing a similar drug, dubbed Bexxar, and has been hit with the same FDA delay problems.
The most optimistic estimates have Zevalin approval slated for the late fourth quarter of this year, or early in 2002. At its peak, Zevalin sales could reach between $300 million and $400 million.
Shares in IDEC closed Thursday down $1.38, or 2.5%, to $52.81.
Interested in drilling deeper on biotech?
here for a special one-day conference to hear the most knowledgeable financial experts in the biotech sector discuss the winning technologies, most promising treatments and best investment opportunities.