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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: Icebrg	6/17/2008 9:56:57 AM
	of 2240

Bright Prospects for J&J Psoriasis Drug Posted by Shirley S. Wang [HEALTH BLOG WSJ’s blog on health and the business of health.] Industry watchers are predicting good things for J&J’s experimental psoriasis drug ustekinumab. (Sorry about the hard-to-say generic name; we haven’t yet heard what the brand name is.) The drug will be vetted tomorrow by a panel of FDA advisers, and the briefing documents for the meeting were published online late last week. Studies show the drug works and looks safe, the FDA documents suggest. But the agency wants the panel to weigh in on whether there’s a need for more data to see if the drug raises risk of cancer in the long-term. The drug targets the immune system in order to reduce inflammation. Anti-TNF drugs, another class of medicines used sometimes for psoriasis, also target the immune system. They already carry a warning about a potential cancer risk. Although the human studies of ustekinumab submitted to the FDA don’t show heightened risk of cancer in humans, there was an association in animal studies. “Although the occurrence of malignancies were comparable to placebo in clinical trials for ustekinumab, the risk of malignancies with immunosuppressive therapy is theoretically possible,” J&J spokesman Michael Parks wrote in an e-mail to the Health Blog. “Though not observed in our relatively large clinical trial safety database, we plan to monitor such risks through a comprehensive Risk Manangement Plan that will be presented to the Committee on Tuesday.” Wall Street analysts don’t seem to think that the potential risk will be a big problem. Merrill Lynch analyst Michael Jüngling puts an approval date in September or October. Bruce Nudell at UBS also thinks approval is likely, though he and others suggest the FDA may require J&J to conduct a “robust” (read: expensive) post-approval study. The drug’s label may also reflect the potential cancer risk, Nudell says, and the agency may require it to be injected by a medical professional, rather than by the patient. blogs.wsj.com

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