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GENZYME'S SEPRACOAT 'SAFE AND EFFECTIVE' IN REDUCING ADHESIONS IN CLINICAL STUDY

PHILADELPHIA, March 22 /PRNewswire/ -- Surgery patients treated with Genzyme Corp. General Division's (Nasdaq: GENZ) Sepracoat(TM) coating solution had 23 percent fewer sites involved in "de novo," or newly formed, adhesions and were nearly three times more likely to be completely free of de novo adhesions than patients in a control group, according to data from a multi-center pivotal clinical study presented in Philadelphia today at a meeting of the Society for Gynecologic Investigation.

Adhesions in patients treated with Sepracoat were, on average, 38 percent less severe and 42 percent less extensive than those in the control group. All of these differences were statistically significant.

"As a tissue precoating, Sepracoat was shown in this study to be safe and effective in the reduction of de novo adhesion formation," said Michael Diamond, M.D., professor of obstetrics and gynecology at Wayne State University, Detroit, who made the presentation today. "This unique surgical approach may be combined with other methods to provide a significant breakthrough in the reduction of overall postoperative adhesion development."

In a separate in-depth survey of 13 gynecologic surgeons on their perceptions about the problem of adhesions, Diamond and other researchers found that reducing adhesions by 10 percent or more was thought to increase the likelihood of pregnancy and reduce the incidence of chronic pelvic pain, Diamond said in an interview.

Separately, the U.S. Food and Drug Administration recently notified Genzyme that its premarket approval application (PMA) for Sepracoat "is sufficiently complete to permit a substantive review and is, therefore, suitable for filing." Last August, Genzyme was notified that the FDA would expedite its review of the company's PMA for Sepracoat.

The FDA decision regarding the filing of the PMA triggers the in- depth evaluation of safety and effectiveness that the company believes will lead to approval to market Sepracoat in the United States. Genzyme estimates that, if approved by the FDA, Sepracoat could prove useful in approximately 5 million operations annually in the United States.

Additionally, the European inspection of Genzyme's manufacturing facilities and product files for Sepracoat has been successfully completed. This is the final step toward attaining the Approval of Conformity Certificate (CE Mark), which will indicate that the product meets quality standards necessary for marketing in the European Community.

Adhesions are internal scar tissues that often develop after surgery, joining tissues and organs that normally are separate. They can make subsequent surgeries more difficult to perform and more dangerous for the patient. They may lead to serious complications, such as chronic pain and intestinal obstruction. Adhesions also create complications that can result in infertility in women.

Tissue injury that causes adhesions results from two categories of trauma: intentional, direct trauma, such as incision, and unintentional, indirect trauma from tissue drying or handling. Physical barriers, such as Seprafilm, offer surgeons a method of preventing adhesions to tissues that have obviously and directly been injured during surgery. Sepracoat is the only product designed to reduce adhesion formation that results from indirect trauma. It is intended for use in abdominal, pelvic, and cardio-thoracic surgery.

"Given this study's extensive evaluation of adhesions in 23 different locations throughout the abdominal and pelvic cavity, we are particularly pleased to see no new adhesions at all in some patients," said Henri A. Termeer, Genzyme's chairman and chief executive officer. "That's not a result we expected. We anticipate that surgeons will often use Sepracoat and Seprafilm together as a system to maximize reduction of adhesion formation that results from both indirect and direct surgical trauma."

In the pivotal clinical trial, 17 surgeons at 23 medical centers performed myomectomies and other open gynecologic surgical procedures on 245 evaluable patients. Some patients were randomly selected to receive a 0.4-percent solution of Sepracoat, which the surgeon applied to the entire peritoneal cavity immediately after opening the patient and periodically during the procedure. The other patients received a placebo of buffered saline solution.

During follow-up procedures approximately six weeks after surgery, the surgeons used laparoscopes to look for the presence of de novo adhesions at 23 previously designated sites in the peritoneal cavity. De novo adhesions are those that occur at sites not previously involved in adhesions.

Excluded from the analysis were sites that had sustained direct trauma during the surgery and sites that had been involved in adhesions from previous operations. The surgeons graded each of the sites with respect to four levels of extent and four levels of severity.

The data showed that 23 percent of the available sites had adhesions in the Sepracoat group, compared to 30 percent of the available sites in the control group, a statistically significant 23- percent difference (P = 0.004).

The study also revealed statistically significant differences in the number of patients who were free from de novo adhesions and in the extent and severity of de novo adhesions.

In the Sepracoat group, 13.1 percent of patients were free from de novo adhesions, while only 4.6 percent of patients in the control group had no de novo adhesions (P = 0.018).

Adhesions in patients treated with Sepracoat had an average severity score of 0.20 compared with the control group's average score of 0.32 (P = 0.026). Sepracoat patients had an average extent score of 0.11, while the control group's average extent score was 0.19 (P = 0.014).

A review of adverse events and clinical laboratory tests did not reveal any consequential problems attributable to Sepracoat, demonstrating the product's safety in this study.

One of the world's top five biotechnology companies, Cambridge, Mass.-based Genzyme focuses on developing innovative products and services for major unmet medical needs. The company's General Division markets Ceredase(R) and Cerezyme(R) replacement enzymes for the treatment of Gaucher disease. It also develops and markets surgical and diagnostic products, genetic diagnostic services, and pharmaceuticals.

NOTE: Genzyme's releases are on the World Wide Web at http://www.prnewswire.com and PR Newswire's fax-on-demand service at 1-800-758-5804, ext. 104284.
 -0- 3/22/96


/CONTACT: Cheryl Greenhouse of Genzyme, 617-252-7570/

(GENZ)

CO: Genzyme Corp. ST: Massachusetts, Pennsylvania IN: MTC SU: PDT

SB -- NEF016 -- 3482 03/22/96 14:45 EST
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