IDEC Sees the Light at the End of the Zevalin Tunnel
By Adam Feuerstein [TSC]
Staff Reporter
5/10/01 6:32 PM ET
IDEC Pharmaceuticals (IDPH:Nasdaq - news) 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 Corixa (CRXA:Nasdaq - news) 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. |
