By Jim Shrine

Anika Therapeutics Inc. got FDA approval to begin a Phase III trial of Orthovisc, about five months after the agency determined the prior study was not sufficient to demonstrate effectiveness.

The study will test the hyaluronic-acid formulation¿s ability to treat osteoarthritis of the knee. The primary endpoint is reduction of pain, which was one of four endpoints in the first study.

Sean Moran, chief financial officer at Woburn, Mass.-based Anika, said Orthovisc was effective in the previous study, when patients with pain in both knees were excluded.

¿In this study, we¿re taking that into account in the clinical design,¿ he said. ¿The other thing that is different is we have a single endpoint ¿ the WOMAC pain score.¿ He said the FDA agreed that would be sufficient for the filing of a pre-market approval (PMA) application.

The first study had four primary endpoints: physician and patient global assessment scores; pain upon standing; and pain after walking 50 feet. Anika filed a PMA based on that study at the end of 1997; the FDA responded in October that it was not sufficient.

Orthovisc is partnered with Zimmer Inc., a subsidiary of New York-based Bristol-Myers Squibb Co., which has rights in the U.S., Canada, Asia-Pacific markets, Europe and Latin America. Anika still can achieve about $20.5 million in regulatory and sales milestones from that deal. Upon approval, Anika would manufacture product and sell it to Zimmer.

Study Could Finish In Early 2000

The new study will enroll up to 350 patients at 20 sites in the U.S. and Canada. The prospective, double-blind, randomized study will compared Orthovisc to a saline control. Patients will get three intra-articular injections over two weeks, and then be followed for six months.

¿We¿re going to try to do this as quickly as we can,¿ Moran said, adding that the study could be completed sometime early in 2000.

The FDA will allow the company to file a modular PMA, Moran said, which is expected to expedite the process. That means that all parts of the PMA other than the trial results can be filed before the study is completed.

Orthovisc is a high molecular weight, highly purified, naturally derived form of hyaluronic acid (HA). It is designed to coat, lubricate and protect joint tissues, providing the viscoelastic and cushioning properties of natural HA found in the synovial fluid of healthy joints, the company said.

Zimmer already is selling the product in Canada and much of Europe. Other partners are selling Orthovisc in Spain, Portugal, Turkey and Israel.

Anika¿s stock (NASDAQ:ANIK) gained $18.74 cents Monday, to close at $5 per share.

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