The question seems to be not whether Genzyme Corp.'sHAL products work but how often surgeons will use theanti-adhesives.
Genzyme today will present results of a second trial ofSeprafilm that again showed the product reduced thenumber and extent of post-surgical adhesions. Thecompany in October filed a premarket approvalapplication with the FDA to market Seprafilm for use inabdominal and gynecologic surgeries.
Results being presented in Brussels, Belgium, at ameeting of the European Society for GynecologicalEndoscopy, show use of the bioresorbable membraneresulted in 37 percent fewer adhesions to the uteruscompared to those in an untreated control group. InOctober investigators reported abdominal surgery datashowing 51 percent of Seprafilm-treated patients did notdevelop adhesions, while only 6 percent of untreatedpatients did not develop adhesions.
The gynecologic data included a number of parameters inwhich statistically significant results were achieved.
The pivotal trial used data from 127 women whounderwent myomectomies, an alternative to hysterectomythat involves removal of benign muscular tumors fromthe wall of the uterus. About half those undergoing thesurgery received Seprafilm, a membrane derived fromhyaluronic acid, which was wrapped around the entireuterus.
Follow-up procedures involved use of laparoscopes toassess adhesions to the uterus, which can contribute toinfertility.
On an adhesion severity scale, in which 3 represents themost severe adhesion, the Seprafilm group had a score of1.94 compared to 2.43 in the untreated controls. Also,Seprafilm patients had 50 percent fewer adhesions on theanterior surface of the uterus and 21 percent feweradhesions on the posterior surface.
While the study was not designed to assess adhesions tothe fallopian tubes and ovaries, since Seprafilm was notplaced there, the proportion of patients with no adhesionsfrom the posterior uterus to the tubes or ovariesnevertheless was 56 percent greater in the Seprafilmgroup.
"That was a real bonus in the gynecologic trial," saidStephen Push, vice president, corporate communications,for Cambridge, Mass.-based Genzyme. "That's the verytype of adhesion that's often associated with infertility.
"We're extremely pleased with the results," Push said."To have two very different types of surgery _ both verychallenging models _ and show statistically significantresults on multiple parameters in both was reallyoutstanding."
Genzyme isn't predicting when the FDA will reach adecision on the Seprafilm application, but it is planningfor the best, or worst.
"We're prepared for an early approval," Push said, addingthat sales forces are being hired in the U.S. and Europe."We don't want to be caught unprepared if we get a quickreview." But in terms of revenue projections, Genzyme isassuming a lengthy review time.
The product already is being sold in the Netherlands,where marketing results should be available in the secondquarter next year, Push said.
"We have plans for expanding manufacturing capacity asneeded, and we're learning in the Netherlands whatmarketing approaches work best," he said.
Genzyme has said Seprafilm and related anti-adhesionproducts could be its biggest seller. The companyestimated the initial market opportunity in the U.S. tocomprise about 3.1 million high-risk gynecologic andabdominal surgeries.
Push said the price for Seprafilm likely will be 1 to 2percent of the cost of surgery, or $200 to $400 inGenzyme's model.
"We think that will not create a major impediment topeople trying it out," Push said. "If we show we canprevent some repeat operations, it should be a win-winsituation."
Results of the trial were released after the market closedThursday. Genzyme's stock (NASDAQ:GENZ) gained13 cents on the day to close at $67.38. n
-- Jim Shrine
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