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Biotech / Medical : MEDX ... anybody following?
MEDX 31.15-0.3%Nov 3 1:15 PM EST

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From: Icebrg6/4/2008 11:09:13 AM
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Medarex shares fall on concerns over melanoma data
Associated Press 06.02.08, 7:31 PM ET
NEW YORK -

Shares of biotechnology company Medarex Inc. fell Monday after analysts expressed concerns over the company's late-stage melanoma drug candidate ipilimumab.

Shares fell 63 cents, or 7.2 percent, to $8.08.

BMO Capital Markets analyst Jason Zhang said he does not believe data supports claims made by Medarex during a presentation Sunday at the American Society of Clinical Oncology meeting on ipilimumab, which is being developed in partnership with Bristol-Myers Squibb Co. Those claims include increased effectiveness when ipilimumab is combined with the drug dacarbazine, compared with ipilimumab alone, and prolonged survival benefits.

"There is no randomized data with a chemotherapy control supporting ipilimumab's survival-prolonging abilities," he wrote in a note to clients. Zhang has a "Market Perform" rating on shares.

Data from the company's mid-stage study in advanced melanoma showed that patients treated with ipilimumab and dacarbazine had a median overall survival of 449 days compared with 351 days in patients given ipilimumab alone. The results, however, were not statistically significant.

Jefferies & Co. analyst Eun Yang added that most experts are not optimistic on combining ipilimumab with dacarbazine since the two drugs could act against each other. However, she maintained her "Buy" rating and $11 price target on Medarex shares, citing its pipeline and antibody development.

Goldman Sachs analyst Meg Malloy, who has a "Neutral" rating on shares, said she's awaiting data from an ongoing late-stage study of ipilimumab as a first-line melanoma treatment. The company is expected to provide an update on timelines for the program in the third quarter.

In April, Medarex and Bristol-Myers said they would delay submitting an application to the Food and Drug Administration beyond this year in order to gain additional survival data.

Also Monday, Medarex announced interim results from a Phase 1/2 trial of ipilimumab alone and in combination with radiation in patients with aggressive castration-resistant prostate cancer. The drug proved to be generally well-tolerated, with 21 percent of the 33 patients showing a decline in levels of prostate-specific antigen serum, a tumor marker, of over 50 percent for an average of 4.8 months.
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