Data presented Friday showed Genzyme Corp.'s Sepracoat resultedin statistically significant reductions in newly formed adhesionsamong those undergoing gynecological surgeries.
Genzyme, of Cambridge, Mass., already has a premarket approvalapplication on file with the FDA for Sepracoat, a hyaluronic-basedsolution applied before and during surgery to reduce adhesionsformed by indirect trauma. While the 245-patient study involved onlygynecological procedures, the company is seeking approval ofSepracoat in abdominal, pelvic and cardio-thoracic surgeries.
The data, presented Friday in Philadelphia at a meeting of the Societyfor Gynecologic Investigation, showed Sepra-coat-treated patientshad 23 percent fewer sites involved in newly formed adhesions andwere nearly three times more likely to be completely free of thoseadhesions. Adhesions were 38 percent less severe and 42 percent lessextensive in the Sepracoat group.
A related product, Seprafilm _ which is a bioresorbable membranedesigned to act as a barrier to prevent adhesions to tissues injuredduring surgery _ is being reviewed today by the FDA's General andPlastic Surgery Devices Panel of the Medical Devices AdvisoryCommittee.
Sepracoat results came from 23 medical centers where patients wererandomly selected to receive a 0.4 percent solution of Sepracoatapplied to the peritoneal cavity immediately after opening and duringthe procedure, or a buffered saline solution as placebo. After sixweeks surgeons looked for new adhesions at 23 preselected sites.
Twenty-three percent of sites in the Sepracoat group had adhesionsvs. 30 percent in the control group (p=0.004). In the Sepracoat group13.1 percent were free from newly formed adhesions compared to 4.6percent in the control group (p=0.018). No safety concerns werereported.
The rights to Sepracoat, Seprafilm and products behind them are heldby a partnership established in 1989 that raised $36.8 million to fundearly development of the anti-adhesives. In January Genzyme offered$93 million in stock for return of those rights, one of the optionsGenzyme had for acquiring the products. Two independent directorsof the general partner must approve the offer, then two-thirds of thelimited partners would have to affirm it.
The offer is still being negotiated, said Genzyme spokeswomanCheryl Greenhouse.
Genzyme's stock (NASDAQ:GENZ) gained 88 cents per shareFriday to close at $63.50. n
-- Jim Shrine
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