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Biotech / Medical : Ligand (LGND) Breakout! -- Ignore unavailable to you. Want to Upgrade?

To: jayhawk969 who wrote (21858)	6/4/1998 9:56:00 PM
From: Henry Niman	Respond to of 32384

Virtually all Biotechs without earnings are placed in the speculative risk category. BARS came out with an extensive (8 page) report on the ONTAK approval. They maintain their BUY rec and expect near term revenue from the deal. Here's their summary: NEWS: Ligand's Ontak drug received the endorsement of the FDA's Oncologic Drugs Advisory Committee to treat cutaneous T-cell lymphoma (CTCL). The advisory committee voted unanimously (14-0) that "an overall response rate of 30% and a complete response rate of 10% is reasonably likely to predict clinical benefit in patients with CTCL who have failed one or more systemic therapies." In the second major vote, the panel again voted unanimously that the adverse events (constitutional symptoms, hypotension, vascular leak syndrome, increased infections rates, etc.) were acceptable given the response rates and duration of responses. The remaining questions posed to the panel by the FDA and much of the discussion during the day concentrated on the proposed labeling of the drug and additional studies necessary after FDA approval. These concerns centered around the requirement that patients be CD25 receptor positive in the Phase III trial and the need for additional studies in patients without this receptor to IL-2. Additionally, the panel members felt that the label should include a range of doses but that further studies were necessary to characterize the benefit of higher doses. Overall, the meeting went smoothly, and we expect the FDA to approve this drug by year-end 1998. In our opinion, this positive meeting for Ontak is a complete validation of Ligand's strategy to buy Seragen as this acquisition is very likely to lead to a near-term revenue opportunity for Ligand.