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Biotech / Medical : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?


To: Czechsinthemail who wrote (6420)5/23/2002 4:24:53 PM
From: Biomaven  Respond to of 52153
 
Here's Feuerstein's piece that gives some details:

FDA Panel Approves Biogen's Psoriasis Drug

By Adam Feuerstein
Staff Reporter
05/23/2002 04:00 PM EDT

Biogen (BGEN:Nasdaq - news - commentary - research - analysis) and the entire biotech sector received a nice boost Thursday afternoon after an advisory panel to the Food and Drug Administration recommended approval of the company's experimental psoriasis drug Amevive.

The vote of the Dermatologic and Ophthalmic Drugs Advisory Committee was 8-2 in favor of Amevive's approval. In short, panel members were impressed with Amevive's benefit as a new and novel treatment for the painful, scaly skin lesions that can make psoriasis such a debilitating disease. And maybe more importantly, the panel wasn't as concerned with the risks linked to the drug's well-publicized safety issues.


The panel's positive recommendation will now be forwarded to the full FDA, which is expected to rule on Amevive's approval by August.

The good news delivered to Biogen on Thursday afternoon should also provide a nice boost to the embattled biotech sector, which is in desperate need of a hug after a long string of drug disappointments. Biotech observers believe the thumbs up from the FDA advisory panel should be a positive signal that the risk-averse agency is willing to approve first-in-class drugs -- even those with some hair on them.

The Amex Biotechnology Index started ripping around 2 p.m. EDT as the FDA panel neared a vote and it became clear that the Amevive decision would be positive. The index is up TK% in recent Thursday trading.

Amevive is a new biologic drug that attacks psoriasis by suppressing a certain type of T lymphocyte, or immunity-boosting T-cells, responsible for triggering the outbreak of skin lesions. (Psoriasis looks like a skin ailment, but it's actually classified as an autoimmune disease.) But T-cell suppression also raised fears that psoriasis patients could be more susceptible to infections, even cancer.

Several Wall Street fund managers watching today's FDA advisory panel meeting say Biogen did an excellent job of answering questions and presenting data that allayed fears about Amevive's T-cell suppression. The rather nasty side effects of existing psoriasis treatments like methotrexate, which can cause liver problems when used for long periods of time, also bolstered Biogen's case.

The panel members, ultimately, decided to lean in favor of Amevive's benefits, rather than dwell on its risks.

Biogen shares were halted today, but closed Wednesday at $40.36.


Peter