UPDATE 2-Antigenics says EU may not OK kidney cancer vaccine

Wed Oct 21, 2009 12:24pm EDT

* Says was informed the decision at an oral meeting

* To evaluate options, including appealing the decision

* Says too early to tell impact on possible partnership

* Shares fall as much as 43 pct (Recasts, adds company comments; updates share movement)

BANGALORE, Oct 21 (Reuters) - Drug developer Antigenics Inc (AGEN.O) said European health regulators are likely to turn down its application to market a kidney cancer vaccine, sending its shares down 43 percent.

The company said the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has verbally informed it to expect a negative opinion on the marketing authorization application for Oncophage (vitespen) in early-stage, localized renal cell carcinoma.

The product works by tuning the body's defenses to attack only the cancer cells, and would have been the first therapeutic cancer vaccine to receive a marketing licence in the European Union if approved.

It is too early to say what, if any, the impact would be on a partnership that the company is looking for in Europe, Antigenics spokesperson Brad Miles told Reuters.

"The plan is to identify and work with a partner for Europe. Nothing has changed. It has not changed from yesterday," Miles said.

The company said it would evaluate options, including an appeal of the decision, once the CHMP formally decides on the vaccine for kidney cancer patients.

But it is too early for the company to say if shelving the product is one of the options that it would consider following the CHMP information, Miles said.

"Antigenics believes clinically relevant benefits were demonstrated with Oncophage in both recurrence-free survival and overall survival endpoints and that this benefit has persisted for nearly five years," it said in a statement.

Oncophage, which had received orphan drug designation from the European Medicines Agency for kidney cancer, got fast track and orphan drug designations from the U.S. Food and Drug Administration for both kidney cancer and metastatic melanoma.

Shares of the company were down 40 percent at $1.25 in midday trade Wednesday on Nasdaq. The stock, which had tripled in value over the last six months, touched a low of $1.20 in morning trade. (Reporting by Vidya L Nathan in Bangalore; Editing by Maju Samuel and Gopakumar Warrier)

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