Intergel

From: KathFindlay (klfindlay@adhesions.org.uk)
Fri Oct 26 21:10:34 2001


LifeCore says FDA agrees to Intergel approval

CHASKA, Minn., Oct 5 (Reuters) - LifeCore Biomedical Inc. (NasdaqNM: LCBM <http://finance.yahoo.com/q?s=lcbm&d=t> - news <http://biz.yahoo.com/n/l/lcbm.html> ), a manufacturer of surgical devices, said on Friday a U.S. Food and Drug Administration official has agreed with a dispute resolution panel's recommendation to approve the company's surgical gel for women, a product regulators rejected last year. The decision by David Feigal, head of the FDA's Center for Devices and Radiological Health, means the product, called Gynecare Intergel, will be cleared for marketing in the United States once labeling and a summary of safety and effectiveness are finalized, the company said in a statement. Shares in Lifecore initially jumped to their highest price since January 2000 on the news. They were last trading $1.29, or 10 percent, higher at $13.69 on the Nasdaq. Chaska, Minnesota-based Lifecore said it anticipated the product would be available in the United States in early 2002. The company said the product has been in research and development since 1989. The initial pivotal human clinical trial, which was the source of the scientific dispute that brought the product before the Medical Devices Dispute Resolution Panel, began in March 1996. The premarket approval application, which included that clinical trial data was filed with the FDA in March 1999 and formally accepted for expedited review in May 1999. The company told the dispute resolution panel that Intergel could safely reduce the rate and severity of post-surgical adhesions that can cause pain and infertility for women after gynecological surgery. Adhesions are fibrous bands of scar tissue that bind together normally separate anatomical areas. The product has been marketed in some foreign markets since 1998 by Lifecore's global marketing partner, Gynecare, the women's healthcare division of Ethicon Inc., a Johnson & Johnson Company (NYSE: JNJ <http://finance.yahoo.com/q?s=jnj&d=t> - news <http://biz.yahoo.com/n/j/jnj.html> ).


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