WOBURN, Mass.--(BW HealthWire)--August 19, 1999--Anika Therapeutics, Inc. (Nasdaq:ANIK) today said it has completed patient enrollment in its Phase III clinical study for ORTHOVISC(R) sodium hyaluronate, a treatment for osteoarthritis of the knee.
Anika commenced its Phase III study in April 1999 after receiving Investigational Device Exemption approval from the U.S. Food and Drug Administration. The prospective, randomized, double-blind study has been designed to assess the safety and effectiveness of ORTHOVISC in comparison to a saline control. More than 375 patients have been enrolled in the study and provided a treatment regimen consisting of three intra-articular injections of ORTHOVISC or saline over a two-week interval with a six-month follow-up period. The study is being conducted in 22 centers in the United States and Canada with both orthopedic surgeons and rheumatologists.
The primary endpoint used to measure the effectiveness of ORTHOVISC will be a reduction in pain based on the WOMAC (Western Ontario McMaster University) Pain Index, a respected and validated measurement methodology that was used as a secondary endpoint in the first clinical study.
"We are pleased to have completed patient enrollment according to our clinical timetable," said J. Melville Engle, Anika chairman, president and chief executive officer. "Timely completion of this study is a major corporate objective for Anika ."
A world leader in knee and hip replacements, Zimmer, Inc. (subsidiary of Bristol-Myers Squibb) is Anika's major marketing partner for ORTHOVISC. Zimmer launched ORTHOVISC throughout most of the major markets in Europe in February 1999 and has sold the product in Canada since 1998. ORTHOVISC also is approved for sale and is marketed in Turkey by Biomeks Pharmaceuticals, in Israel by Rafa Laboratories and in Spain by Grupo Ferrer Internacional.
A high molecular weight, highly purified, naturally derived form of hyaluronic acid (HA), ORTHOVISC is designed to emulate the viscoelastic and cushioning properties of natural HA found in the synovial fluid of healthy joints. ORTHOVISC coats, lubricates and provides shock absorption protection to joint tissues. The product is injected into the knee joint space three times over a two-week period intending to provide viscosupplementation and pain relief.
Anika Therapeutics, Inc. develops manufactures and commercializes therapeutic products and devices intended to promote the repair, protection and healing of bone, cartilage and soft tissue. These products are based on hyaluronic acid, a naturally occurring, biocompatible polymer found throughout the body. In addition to ORTHOVISC (not for sale in U.S), Anika markets HYVISC(R) in the U.S. for the treatment of equine osteoarthritis through Boehringer Ingelheim Vetmedica, Inc. and manufactures AMVISC(R) and AMVISC(R) Plus, z highly viscous HA products used as viscoelastic supplements during ophthalmic surgery, for worldwide marketing and distribution by Bausch & Lomb Surgical. Therapies currently under development include INCERT(R), a family of HA products designed to prevent post-surgical adhesions. Anika is also collaborating with Orquest, Inc. to manufacture Ossigel(R), an injectable formulation of basic fibroblast growth factor combined with HA designed to accelerate the healing of bone fractures.
The statements made in this press release which are not historical facts are forward-looking statements within the meaning of Section 27A of the Securities Exchange Act of 1933 and Section 21E of the Securities Exchange Act of 1934. The Company's actual results could differ materially from those set forth in the forward-looking statements as a result of a number of factors. In particular, there E can be no assurance that the clinical trial results will produce data supporting the efficacy of ORTHOVISC. Even if the Company is able to successfully complete the clinical trial and the results thereof support the efficacy of ORTHOVISC, there can be no assurance that the Company will receive FDA or other regulatory approval of ORTHOVISC, or that such approval will be obtained in a timely manner or without the need for additional clinical trials. In addition, there can be no assurance that any delay in receiving any such approval will not adversely affect the Company's competitive position. Certain other factors that might cause the Company's actual results to differ materially from those in the forward-looking statements include those factors set forth under the heading "Risk Factors and Certain Factors Affecting Future Op åerating Results" in the Company's 10-K filed with the Securities and Exchange Commission on March 31, 1999 as well as those listed in the Company's other SEC filings.