Zevalin Approved for NHL; What About Bexxar?

[Guest guest]

Corixa rival Idec Pharmaceuticals gets OK for cancer drug

By Luke Timmerman

Seattle Times business reporter

Idec Pharmaceuticals won regulatory approval yesterday for a new

cancer drug that could widen its advantage over its competitor,

Corixa.

The U.S. Food and Drug Administration (FDA) approved Zevalin, the

first in a new class of drugs for the fifth-most-common form of

cancer in the U.S., non-Hodgkin's lymphoma.

The announcement came sooner than most analysts were expecting,

because Idec has spent months trying to iron out manufacturing

problems to the FDA's satisfaction.

The news came after markets closed, and Idec's shares soared $3.71 to

$59.72, a 6.6 percent gain, in after-hours trading. Corixa gained 25

cents in after-hours trading to close at $11.03 a share.

Corixa, meanwhile, has had a frustrating few months. The Seattle

biotech company has been pushing to get approval for its competing

drug, Bexxar, but it hasn't been able to schedule a hearing because

the FDA says it is too swamped.

Corixa Chief Executive Steve Gillis has said publicly he's still

planning that Bexxar will get approved this year. It's critical that

the company deliver, because Bexxar represents Corixa's first shot at

getting a drug on the market, and if it makes millions, it could

energize research Corixa has going in 15 other drugs.

But if Idec uses its head start to strengthen its grip on the market,

analysts say Corixa could get squeezed.

" With Idec getting approval, they'll be the first to the market, and

obviously they will have the lead, " said Elise Wang, an analyst with

Salomon Barney.

Wang said she's predicting $38 million in sales for Zevalin this

year, but some analysts are expecting as much as $50 million to $100

million. Idec says it will get its drug on the market in 30 to 60

days.

Corixa spokesman Jim DeNike said there is room for two treatments.

" We can't speculate about whether the launch of a commercial product

will create a sustainable edge for Idec, " DeNike said. " We think

cancer patients will benefit from having two different radiotherapies

on the market. "

Zevalin and Bexxar work in similar ways. Both use antibodies packed

with radiation to zero in on and kill tumor cells.

Both drugs are being aimed at patients who have failed with

conventional chemotherapy.

Idec declined to comment about its competitor, but Corixa is quick to

point out differences.

Patients who take Bexxar get a dose tailored specifically to how

advanced his or her tumors are, designed to maximize effectiveness

and reduce the risk of underdosing or overdosing. Zevalin adjusts its

dose based on a patient's size, not tumors.

DeNike added that Bexxar's radiation comes in the form of Iodine-131,

which has been used for 50 years to treat Grave's disease and thyroid

cancer. Zevalin's radioactive component, Yttrium-90, is being

approved now for the first time.

Heyward, a biotech analyst with Ragen MacKenzie, said Bexxar

appears to be more effective and to have fewer side effects than

Zevalin. He said it's important that Bexxar not fall too far behind,

and that it needs a marketing edge.

" You have to make sure there's language in the label that makes your

drug look more effective and safe, " Heyward said.