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

To: shasta23 who wrote (18816)	4/7/1998 2:44:00 PM
From: Peter Singleton	Read Replies (1) \| Respond to of 32384

fyi, CTCL competition SuperGen <SUPG.O> secures orphan drug designation SAN RAMON, Calif., April 6 (Reuters) - SuperGen Inc said Monday it received Orphan Drug Designation from the U.S. Food and Drug Administration for Nipent in cutaneous T-cell lymphoma (CTCL). SuperGen said in a statement that it plans to submit a Supplemental New Drug Application to market Nipent to treat CTCL by the end of 1998. SuperGen already markets Nipent in the U.S. for hairy cell leukemia, and has received Orphan Drug Designation in the area of chronic lymphocytic leukemia. Orphan drugs receive a seven-year period of exclusivity from the date they are cleared by the FDA. The company said that data from several studies show Nipent used as a single chemotherapeutic agent has produced clinically significant response rates in patients with CTCL. "This is the first step in extending Nipent beyond its initial indication and into new markets that could eventually total in excess of $200 million," Chief Executive Dr. Joseph Rubinfeld said. "There are significantly more patients with CTCL than there are with hairy cell leukemia," Rubinfeld said. "Under allowance by the FDA, we will actively distribute appropriate independent clinical information about Nipent and CTCL to physicians." 14:31 04-06-98