Biomatrix Inc. said Tuesday that an initial review of its premarketapproval (PMA) application for Synvisc was completed, and theapplication is suitable for filing with the FDA.Synvisc, already approved in Canada for osteoarthritis, is a chemicallymodified version of the naturally occurring biomaterial hyaluronan,found in most body tissue and some bacterial capsules. It is injectedinto the knee, replacing abnormally low elastoviscous fluid, with thegoal of relieving pain and improving joint function. Synvisc isclassified as a device because it acts as a physical entity, notchemically.Biomatrix filed its PMA in late May. Endre Balazs, CEO and chiefscientific officer for the Ridgefield, N.J., company, told BioWorld hedoesn't expect to hear back from the FDA for at least six months."We passed through the first hurdle," Balazs said. "A lot ofapplications are not accepted at this stage or are asked for furtherinformation. It couldn't be better at this point."Biomatrix markets the product itself in Canada through subsidiaryBiomatrix Medical Canada in Quebec, where Synvisc is manufactured.Biomatrix has granted Syntex Pharmaceuticals International Ltd.marketing rights in most of Europe. No decision has been made on howmarketing would be handled in the U.S., Balazs said.New drug applications have been filed for Synvisc in Great Britain andSweden, and Biomatrix plans to file in France by the end of the year,Balazs said. The first of the three countries to approve the product thenwould be used to gain approvals in the rest of Europe, he said.Biomatrix's product is intended only for osteoarthritis of the knee,which Balazs said makes up 60 percent of the osteoarthritis market. Hewould not speculate on what share of the market he might get fromcurrent medications, most notably anti-inflammatories and analgesics.But he said "pain relief was observed to some degree for roughly 80percent" of those tested in clinical trials.The PMA application included data from 100 preclinical studies andseven clinical trials involving about 500 patients.Synvisc is injected in the affected arthritic joint to supplement andrestore the lubricating and protecting properties of synovial fluid,which is compromised due to osteoarthritis. Standard therapy involvesa series of three injections, once per week, costing about $150, Balazssaid.Biomatrix (NASDAQ:BIOX) stock gained 17 percent (75 cents)Tuesday, closing at $5.25 per share. n
-- Jim Shrine
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