Mixed Reaction To Genzyme's Seprafilm

Genzyme gained a recommendation for approval in the USA to market its hyaluronic acid-based bioresorbable membrane, Seprafilm, for the reduction of postoperative adhesions. The Food and Drug Administration panel recommended approval of Seprafilm in the two indications studied in clinical trials - in abdominal and gynecological surgery - but did not agree to a broader indication.

Seprafilm has been on the market in the Netherlands since November 1995, and was cleared for marketing in the European Union in February. It is already marketed in the UK and Sweden, and has also been approved in Canada and Singapore. The company filed for approval of a companion product, Sepracoat, in January.

Despite the favorable panel verdict, some analysts said the company had not clearly demonstrated the value of preventing adhesions and will have to struggle to create a market for Seprafilm. According to a Reuters report, Bear Sterns' David Molowa said that "they've shown that it works, that it prevents adhesions, but the question is what does that mean for the patients?"