Anika Therapeutics (Anika) has received approval from Health Canada for Monovisc, its single injection viscosupplement, for the treatment of osteoarthritis of the knee.
Anika expects to launch Monovisc this month through its long-term Orthovisc distribution partner in Canada, Rivex Pharma, the specialty drug distribution division of Aurora, and Ontario-based Helix BioPharma.
Bill Chick, VP, Product Distribution for Helix BioPharma, said: “We are very pleased to be the exclusive distributor of Monovisc in the Canadian market and will begin aggressively marketing it immediately. We believe that both patients and physicians stand to benefit from Monovisc’s unique features: patients will welcome fewer office visits and lower treatment costs, while physicians will appreciate the simplicity of the single-injection regimen.”
Charles Sherwood, president and CEO at Anika, said: “Health Canada approval marks an important next step as we continue to expand the geographic reach of our novel osteoarthritis treatment therapy and establish Monovisc as the premier single-injection product on the market worldwide. We are successfully moving forward on our goal of achieving FDA approval for Monovisc in the US. The initial PMA modules have been submitted to the FDA and are currently under review. We expect to submit the final module containing the clinical study data prior to year-end 2009. We are confident that MONOVISC will be as well received in North America as it has been in Europe.”