Biomatrix Inc. said Monday it received Europeanapprovals for two products, Synvisc and Hylaform, whichare derived from hyaluronan, a viscoelastic substance,and are used respectively to treat osteoarthritis of the kneeand facial wrinkles.

Endre Balazs, CEO and chief scientific officer forBiomatrix, estimated the European markets for the twoproducts at a combined $400 million with Synviscaccounting for most of the potential sales.

Both Synvisc and Hyalform are made from hyaluronan,which is a naturally occurring lubricant, shock absorberand structure stabilizer in human tissues. Synvisc isinjected into knee joints to supplement synovial fluid,whose protective properties are reduced by osteoarthritis.Hylaform, a viscoelastic gel, is used for smoothing facialwrinkles and scars. Both products, classified as devices,are under review by the FDA.

In addition to getting European approval for Synvisc,Biomatrix, of Ridgefield, N.J., also reacquired marketingrights for most of Europe from Basel, Switzerland-basedRoche Holdings Ltd.

Balazs said Biomatrix received $3 million from Roche toend the marketing collaboration, which was formed bySyntex Pharmaceuticals International Ltd., of Palo Alto,Calif., in 1994 prior to its acquisition by Roche. Syntexpaid about $6.5 million for the licensing rights andBiomatrix will retain those funds. Roche, which owns asmall percentage of Biomatrix, will continue to sellSynvisc in Sweden where it was launched in June 1995.Roche also has distribution rights in South Africa.

Biomatrix has marketing agreements for Synvisc inCanada with Rhone-Poulenc Rorer Inc., of Collegeville,Pa., and in Italy with Recordati Industria Chimca eFarmaceutica S.p.A., of Milan.

Based on sales of other viscosupplementation products,Biomatrix said the potential market for Synvisc could beas much as $1 million per 1 million people or $380million in 19 European countries.

Balazs said Biomatrix is in negotiations with severalcompanies to market Synvisc in Europe. He also istalking with firms to distribute Hylaform, which isexpected to compete with collagen products. Biomatrixsaid European sales of collagen in 1994 were estimated at$20 million. European distribution agreements forSynvisc and Hylaform are expected to be signed by thefirst quarter of 1996.

Biomatrix (NASDAQ:BIOX) closed Monday at $12.37,down 12 cents. n

-- Charles Craig

(c) 1997 American Health Consultants. All rights reserved.