By Randall Osborne
Having signed a marketing deal with Bristol-Myers Squibb Co. worth up to $23 million, Anika Therapeutics Inc. submitted a premarket approval application to the FDA for Orthovisc, an injectable form of hyaluronic acid (HA) to treat osteoarthritis of the knee.
In support of the application, Anika, of Woburn, Mass., used data from Phase III trials completed in June 1997 at 10 centers with 266 patients in the U.S., showing Orthovisc safe and effective.
The drug, made of naturally derived HA, provides lubrication and cushioning for the knee, emulating the viscoelastic properties of HA in the synovial fluid of healthy joints.
Anika completed the distribution and marketing deal last month with Zimmer Inc., a subsidiary of New York-based Bristol-Myers, covering the U.S., Canada and select Asia-Pacific markets. Another agreement was signed in October with Grupo Ferrer Internacional SA, of Barcelona, Spain, which will distribute Orthovisc in that country and Portugal.
Orthovisc is approved for sale in Europe, Canada and Turkey. Registrations have been filed to market the drug in Australia and New Zealand.
Osteoarthritis of various types afflicts more than 16 million people in the U.S. The condition is characterized by joint pain, stiffness and loss of mobility.
Similar Products Already On Market
Two other HA drugs for treating osteoarthritis of the knee already are on the market. Biomatrix Inc., of Ridgefield, N.J., won approval from the FDA in August for Synvisc, which is marketed by Wyeth-Ayerst Laboratories, a division of Madison, N.J.-based American Home Products. (See BioWorld Today, Aug. 14, 1997, p. 1.)
The other drug, Hyalgan, is distributed by Sanofi Pharmaceuticals Inc., of New York, and OrthoLogic Corp., of Phoenix. The drug is licensed from Fidia Pharmaceutical, of Padua, Italy.
Sean Moran, CFO of Anika, said Orthovisc has a higher molecular weight than Hyalgan, which means increased viscosity.
Hyalgan's treatment regimen calls for five injections, Moran said. "We did our studies [with Orthovisc] with three injections per course of treatment," he said. Orthovisc is injected into the joint space three times over a two-week period, to supplement viscosity of the joint and relieve pain.
Synvisc also is a three-injection treatment, Moran said. Orthovisc's performance in relation to Synvisc has not been measured, he added, but physicians may prefer the natural product.
"We haven't done any comparative studies," Moran said. "When we get to the marketplace, we'll see."
Anika's stock (NASDAQ:ANIK) closed Monday at $8.437, down $0.187. The company filed its application with the FDA on Dec. 31, and its shares that day closed at $9.313, up $1.063, an 11 percent rise. *