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Biotech / Medical : Guilford (GLFD) - Steadily Rising

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To: DAVID HU who wrote (4)	6/25/1996 3:38:00 PM
From: DAVID HU	of 496

Great News for GLFD. NEW YORK, June 25 (Reuter) - Guilford Pharmaceuticals Inc will meet with the U.S. Food and Drug Administration in coming weeks in hopes of gaining approval for its Gliadel Wafer brain cancer treatment for use in all surgeries, rather than only in follow-up interventions, a senior executive said on Tuesday. Earlier this month an FDA advisory panel recommended the treatment be approved for use in recurrent brain cancer but not in initial surgery. The FDA usually follows advisory panel recommendations but is not bound to them. Guilford executives will discuss Gliadel with FDA officials in coming weeks, said Nicholas Landekic, Guilford vice president of business development. "We'd like a claim that would include all surgeries," Landekic said in an interview. "We'll see what the FDA says." He said it was "pretty safe to assume" an FDA decision on Gliadel will come by the end of the year. Gliadel is a biodegradable polymer wafer, several of which are implanted in the cavity created after a brain tumor is removed. The wafers slowly erode releasing an anti-cancer drug. The FDA often approves drugs for relatively narrow uses, then broadens their labels as further studies are done. Hambrecht and Quist analyst Alex Zisson said in a recent report that he expected surgeons to use Gliadel Wafers off label in primary surgeries if the FDA follows the narrower advisory panel recommendation. Guilford's stock hit a 52-week high of 37-3/4 on June 14 after the company reported it signed pact with Rhone-Poulenc Rorer Inc to market Gliadel. But the stock tumbled later that day after news of the panel meeting emerged. Analysts attributed the selloff to the panel recommendation for narrower use of the product and also profit taking in the stock. Landekic also noted a recent general downturn in biotech shares. It was off 1/8 at 25-1/4 on Tuesday. -- R. Jacobsen, 212-859-1733

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