Genzyme Corp.'s premarket approval (PMA) applicationfor Seprafilm Bioresorbable Membrane will get expeditedreview by the FDA, the Cambridge, Mass. company saidMonday.
Seprafilm, also called HAL-F, is a synthetic membranederived from hyaluronic acid, a natural polysaccharidemodified to slow deterioration. It is being developed toprevent adhesions following abdominal and gynecologicsurgeries. Expedited review means the PMA will begiven priority over non-expedited applications.
Genzyme said no products currently address post-operative adhesions. The market for such productsexceeds $400 million annually, it said. Earlier this year,Genzyme's president and CEO Henri Termeer said thatthe HAL products could become his company's premierproducts, double the company's revenues and changeGenzyme by boosting it into the hospital market.
Genzyme released general results in January of a pivotalSeprafilm trial for abdominal surgeries. Companyofficials, while not detailing specifics, said the product"in many cases prevented adhesion altogether and forthose who developed adhesions they were significantlyreduced." (See BioWorld Today, Jan. 26, 1995, p. 1.) Itsaid all results were highly statistically significant.
Clinical investigators will present full details of theresults at the American College of Surgeons meeting inNew Orleans on Oct. 24. Genzyme is waiting until resultsfrom gynecologic studies are in before filing a PMA, saidCaren Arnstein, director of corporate communications forGenzyme.
The pivotal gynecologic study involves 124 patients at 12sites. General results from that study are expected to beannounced within a month, Arnstein said, and presentedlater at an appropriate scientific forum.
Results from another product in the HAL line, Sepracoat(also called HAL-C), are expected to be released inSeptember. That product, a coating solution designed toprevent adhesions, also is being tested in gynecologicsurgeries.
Adhesions are fibrous tissue that form where internaltissues have been traumatized during surgery. At the site,tissues that should remain apart during the healingprocess fuse together, potentially leading to pain andmore serious conditions and complications.
Another company developing adhesion control productsis Gliatech Inc., of Cleveland. Its Adcon-L is asemisynthetic carbohydrate polymeric gel designed toprevent excessive scarring after lumbar surgery. Adcon-T/N is being developed to prevent adhesions followingtendon and peripheral nerve surgeries. Gliatech is seekingapproval of the product throughout Europe, where pivotalstudies have been completed, and said pivotal studies inthe U.S. would start this quarter.
Genzyme also has filed for product approval in Europe.Its stock (NASDAQ:GENZ) closed at $58.50 Monday, up$2.50 per share. n
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