Gliatech Inc., whose stock has soared about 60 percent in the last twoweeks, received European Union (EU) approval of its secondadhesion control product to prevent post-surgical scarring _ acondition causing pain, motion impairment and other complications.
Gliatech's Adcon (short for adhesion control) devices aresemisynthetic carbohydrate polymeric gels designed to act as barriersagainst formation of internal scars and adhesions following surgery.
Adcon-L, which received EU approval in 1995, is designed for usewith lumbar disc surgery. The product approved Tuesday, Adcon-T/N, is targeted for surgeries involving tendons and peripheralnerves.
Gliatech, of Cleveland, will begin pivotal clinical trials in the U.S.this year for both Adcon products. It expects to apply for FDAapproval of Adcon-L in early 1997.
Rodney Dausch, Gliatech's chief financial officer, said Adcon-L andAdcon-T/N will be marketed for use with all surgeries in the targetedindications. About 1 million tendon and peripheral nerve operationsand 800,000 lumbar surgeries are conducted each year worldwide.
Gliatech's researchers discovered the carbohydrate used in Adconthrough their research into glial cells, which the company also isstudying to develop treatments for Alzheimer's disease. Glial cellsmake up about half of the cells in the central nervous system and arebelieved to regulate growth, differentiation and function of neurons,the other half of the nervous system's cellular composition.
Dausch said the Adcon products, which are biodegradable in about30 days, guard against adhesions by preventing fibroblasts frommigrating to surgically traumatized areas.
Genzyme Corp., of Cambridge, Mass., is developing competingproducts _ Seprafilm and Sepracoat _ derived from hyaluronicacid, a natural lubricant in connective tissues of the joints.Genzyme's devices keep separate tissues damaged during surgery,preventing them from fusing.
Genzyme targeted abdominal and pelvic surgeries for its firstindications for the products. Seprafilm, a biodegradable membrane, isapproved in Europe and has been submitted to the FDA forclearance. Applications for approval of Sepracoat, a coating solution,have been filed in Europe and the U.S. Genzyme also is developing agel, called Sepragel.
Gliatech said additional Adcon products will target abdominal, pelvicand cardiac surgeries.
Gliatech's stock (NASDAQ:GLIA) closed Tuesday down 50 cents to$16.12.
Since Jan. 29, 1996, when the company announced an expansion ofits Alzheimer's disease drug collaboration with JanssenPharmaceutica N.V., of Beerse, Belgium, Gliatech's shares havejumped $6.12 from $10.
Janssen is a subsidiary of Johnson & Johnson, of New Brunswick,N.J. n
-- Charles Craig
(c) 1997 American Health Consultants. All rights reserved.