Biomatrix Inc. said Tuesday it filed a premarket approval applicationwith the FDA for Synvisc hylan polymer for the treatment ofosteoarthritis. The Ridgefield, N.J., company already markets theproduct in Canada, and has regulatory submissions pending in Swedenand Great Britain.Synvisc is a chemically modified version of the naturally occurringbiomaterial hyaluronan, found in most body tissue and some bacterialcapsules. It is injected into the affected arthritic joint, replacingabnormally-low elastoviscous fluid. It acts as a physical entity, notchemically, which is why it's classified as a device rather than a drug.Standard therapy involves a series of three injections _ one per week_ into the infected joint, costing about $150, Endre Balazs, CEO andchief scientific officer for Biomatrix, told BioWorld.Biomatrix's product is intended only for the knee.Balazs said he expects an FDA response in 18 to 24 months, and saidits too early to say how much of the osteoarthritis market Synviscwould capture from current medications, most notably anti-inflammatories and analgesics. He said osteoarthritis affects nearly 1percent of the population, with 60 percent of those having osteoarthritisof the knee."The filing of the PMA represents a major achievement for thecompany and marks further progress toward the globalcommercialization of Synvisc for viscosupplementation, a newtherapeutic modality for the management of osteoarthritis," saidBalazs, a co-founder of Biomatrix and inventor of the proprietary hylanpolymer.Sales for 1994 in Canada are projected at $1.2 million, a figure thatwould be higher except the government and some insurers have not yetdeclared Synvisc reimbursable. Balazs said the product's cost would bereimbursed in the U.S. and Europe.The PMA application to the FDA included data from 100 preclinicalstudies and seven (three pivotal, four supportive) clinical studiesinvolving about 500 patients. Biomatrix is marketing itself in Canadathrough subsidiary Biomatrix Medical Canada in Quebec, where theproduct is manufactured.Balazs said Biomatrix hasn't decided whether to seek a marketingpartner in the U.S.But he said the company is negotiating to expand its agreement inEurope with Syntex Pharmaceuticals International Ltd., which hasmarketing exclusivity in France, Britain, Scandinavia and Ireland. That10-year deal is worth up to $6 million to Biomatrix, as well as apercentage of net sales.Biomatrix (NASDAQ:BIOX) stock was up 25 cents Tuesday, closingat $6.25.
-- Jim Shrine
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