By Frances Bishopp
Based on the results of a European clinical trial, the FDA has accepted Gliatech Inc.'s premarket approval application for Adcon-L, a semisynthetic polymeric gel designed to act as a barrier against postsurgical peridural fibrosis and adhesions following lumbar surgery. If approved, Adcon-L would be Gliatech's first commercial product in the U.S.
The gel was evaluated in a multicenter pivotal trial involving 267 evaluable patients of nine European academic medical centers. Results of this study, Rodney Dausch, chief financial officer at Gliatech, told BioWorld Today, demonstrated that Adcon-L significantly reduced the incidence of peridural fibrosis and improved patient outcome by reducing the incidence of postoperative activity-related pain by as much as 44 percent.
Approximately 420,000 lumbar disc surgeries are performed annually in the U.S. and recurrent postoperative pain can occur in up to 50 percent of patients following surgery. Five to 10 percent of these patients will undergo a second disc operation. Adhesions from the first surgery make reoperation difficult and complicated.
Adcon-L is a proprietary resorbable gel which provides a physical barrier to adhesions between the spinal cord and nerve roots and the surrounding muscle and bone. The gel is applied directly to the surgery site immediately before wound closure.
"This gel, which is classified by the FDA as a medical device, mimics a natural barrier called the basal lamina barrier," Dausch explained. "It is absorbed into the body in about four weeks."
Adcon-L and Adcon-T/N, another adhesion control product for Gliatech, have both received European Union regulatory approval and are being sold in all major countries in the EU, as well as Australia and New Zealand. Adcon-T/N is used to inhibit surgical adhesions around tendons and peripheral nerves.
Gliatech, of Cleveland, currently is conducting U.S. clinical trials of Adcon-L in approximately 350 patients, Dausch said.
Sales of the product in Europe, Dausch said, have gone very well with increasing sales every quarter. "We have met our projections," he said.
Mike Zupon, vice president of product development at Gliatech, said Gliatech can't speculate on how long the FDA approval process will take, but, the company hopes to do a market launch sometime in 1998.
If approved by the FDA, Adcon-L joins another commercial anti-adhesion product by Genzyme Corp., of Cambridge, Mass. known at Seprafilm, a synthetic membrane derived from hyaluronic acid, a natural polysaccharide modified to slow deterioration. Seprafilm is used to prevent adhesions following abdominal and gynecologic surgeries and is applied to the area of trauma just before the surgeon closes the patient. It turns into a gel within two days, is absorbed by the body within seven days and is excreted from the body within 28 days. No follow-up surgery is needed to remove the membrane.
"No other company has products that are designed for general use in the back area," Dausch said.
Analyst David Crossen, of Montgomery Securities, of San Francisco, said the PMA acceptance is an important event for Gliatech because the U.S. market is a critical market for the company.
"My estimate is about $1 million in European sales in 1996," Crossen said, "going to about $4.1 million in sales in 1997, which is a nice ramp, but doesn't get you to a meaningful level."
"It is important for them to get into the U.S. market as soon as possible," Crossen said, "because this is product that is sold to surgeons and surgeons are always a little slow in adopting to a new therapy."
"I see them reaching profitability in 1998," Crossen said.
Gliatech has approximately $17.5 million. Gliatech's stock (NASDAQ:GLIA) closed Thursday at $13.625, up $0.625. *