Clinical study: Genzyme's HAL-F reduced incidence, extent of adhesions.

CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Jan. 25, 1995 -- In a multi-center pivotal clinical study, HAL-F bioresorbable membrane, a surgical product being developed by Genzyme Corp.'s general division (NASDAQ:GENZ), significantly reduced the incidence and extent of adhesions following abdominal surgery.

Based on these findings, Genzyme will file for approval to market HAL-F in the United States and is already filing in Europe. The company plans to launch the product in selected European countries before receiving U.S. marketing approval.

"The results exceeded our expectations. They are highly significant both statistically and clinically," said Henri A. Termeer, Genzyme's chairman and chief executive officer. "When this product receives regulatory approval, I expect it will have a substantial impact on surgical practice throughout the world, and it will change Genzyme in a very positive and fundamental way."

Adhesions are fibrous tissues that often form where internal tissues have been traumatized during the normal course of surgery. At the site of damage, tissues that normally should remain separate during the healing process may join together.

Small bowel obstruction from adhesions is a major cause of long-term surgery-related illness following abdominal operations. According to several studies, between 64 percent and 79 percent of hospital admissions for small bowel obstruction are due to postoperative adhesions. Such bowel obstruction often requires a second operation to divide or lyse the adhesions. These subsequent operations carry additional costs and risks, and adhesions often reform because of tissue injury caused by the lysis procedure.

A 1993 study estimated $1.2 billion in annual expenses in the United States, not including outpatient and indirect costs, due to hospitalizations associated with removal of lower abdominal adhesions. Another study estimated that the cost per patient in 1993 for treatment of intestinal adhesions was more than $22,000, with an average hospital stay of 11 days.

HAL-F membrane provides a physical barrier between damaged tissue surfaces to prevent them from forming adhesions. This product may be useful in the estimated 2 million abdominal operations performed annually in the United States that present the highest risk from adhesions. It may also be useful in other open surgical procedures.

The randomized, blinded study involved 183 patients who underwent a standardized major abdominal surgery at 11 medical centers. Approximately one-half of the patients were randomly selected to receive sheets of HAL-F membrane that the surgeon placed between the incision and underlying tissue. The rest of the patients underwent surgery without receiving HAL-F. At scheduled follow-up surgery, surgeons who did not know which patients had received HAL-F looked for and evaluated adhesions. The primary endpoints of the trial were the number and extent of adhesions to the incision line.

The study revealed HAL-F had not only limited the extent of adhesions but also prevented adhesions in many cases. The clinical investigators will publicly release details of the study after the results have been presented at a scientific meeting and peer-reviewed for publication in a scientific journal.

The principal component of HAL-F membrane is hyaluronic acid, a polysaccharide found naturally in a wide range of human tissues. In making HAL-F, the company chemically modifies hyaluronic acid to extend its life in the body. The resulting compound is then formed into a film. Since the body degrades and absorbs HAL-F, no follow-up surgery is needed to remove the membrane.

Genzyme has strong patent protection for HAL-F. Two U.S. patents have been issued covering compositions of matter and methods of production.

A second pivotal study of HAL-F -- this one in gynecological surgery -- is nearing completion. At mid-year, Genzyme will include the results of the gynecological study with those of the abdominal study in a pre-market approval application to the U.S. Food and Drug Administration.

Regulatory filings are under way in Europe. European applications for devices are generally approved more quickly than in the United States. Genzyme has applied to the FDA for approval to export HAL-F to Europe as soon as the company receives approval to market the product there.

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Cambridge, Mass.-based Genzyme, one of the top five biotechnology companies in terms of sales, focuses on developing innovative products and services for major unmet human health care needs. The company's general division markets proprietary therapeutic and diagnostic products, genetic testing services, and bulk pharmaceuticals and fine chemicals. The Genzyme Tissue Repair division (NASDAQ: GENZL) is a leading developer of biologically active products for treatment of severe burns, chronic skin ulcers, cartilage damage, and multiple sclerosis.

CONTACT: Genzyme Corp.

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