Genzyme Corp. released what it said Thursday werestatistically significant results of its Sepracoat coatingsolution for postoperative adhesions, and said it will file apremarket approval (PMA) application by the end of theyear.
Analysis from the 362-patient trial in gynecologicsurgical procedures showed Sepracoat patients had fewernewly formed adhesions by two measures: a lowerproportion of adhesion sites, and a larger percentage ofpatients who had no adhesions at all.
Similarly positive results were released last month for thecompany's Seprafilm bioresorbable membrane, whichalso involved use in gynecologic surgeries. An earlierstudy in abdominal surgeries also showed statisticalsignificance. The company has said it plans to file a PMAthis month for Seprafilm. Both will get expedited reviewby the FDA.
Genzyme, of Cambridge, Mass., currently is underregistration. It is trying to raise more than $100 millionthrough the sale of 2.5 million shares.
The company can't comment publicly on certain issuesdue to the registration, but has said the market for theadhesion products exceeds $400 million, and maybe $1billion, per year.
Caren Arnstein, Genzyme's director of corporatecommunications, said prices have not been set forSepracoat and Seprafilm. But, she said, "We have said wehave a goal of setting a price that will allow this to beused routinely, as a standard of care in every surgicalprocedure. One of the things we're using for a pricingguideline is we're expecting to add an average of 1 or 2percent to the cost of surgery to cover Sepracoat orSeprafilm."
Postoperative adhesions can cause intestinal obstruction,infertility and chronic pain.
Both Sepracoat and Seprafilm are made from hyaluronicacid. Sepracoat is intended for use in indirect surgicaltraumas _ such as tissue drying or handling _ and isdesigned to lubricate and protect tissue surfaces withineither the thoracic or peritoneal cavity. In the pivotal trial,some of the patients had Sepracoat applied to the entireperitoneal cavity immediately after they were opened, andevery hour in the surgery. The control group received abuffered saline solution as a placebo.
Six weeks after surgery, surgeons used laparoscopy tofind newly formed adhesions at 23 previously designatedsites in the peritoneal cavity.
Safety studies previously were done of Sepracoat in othersurgeries, so Genzyme's PMA will be for broaderindications, including use with gynecologic, abdominaland cardiovascular procedures.
The complementary product, Seprafilm, is intended foruse in direct surgical traumas, such as at the incision site.The synthetic membrane acts as a temporary barrierbetween tissue surfaces, and is applied to the area oftrauma before the patient is closed.
Specific numbers from Sepracoat and Seprafilm trials arebeing held pending presentation at scientific forums.
Genzyme's stock (NASDAQ:GENZ) gained $2.25 pershare on Thursday's news, closing at $52.25. It hasdropped, however, since its closing price of $60 on Sept.13, 1995, when the company proposed its public offeringand released Seprafilm results. (See BioWorld Today,Sept. 14, 1995, p. 1.) n
-- Jim Shrine
(c) 1997 American Health Consultants. All rights reserved.