Anika Therapeutics, Inc. (Anika), has received Health Canada approval for MONOVISC for the treatment of osteoarthritis of the knee. This single injection viscosupplement is planned to be launched this month through the company's long-term ORTHOVISC distribution partner in Canada, Rivex Pharma Inc., Ontario-based Helix BioPharma Corp. MONOVISC was marketed in the European Union since the second quarter of 2008.
“We are very pleased to be the exclusive distributor of MONOVISC in the Canadian market and will begin aggressively marketing it immediately,” said Bill Chick, VP Product Distribution for Helix BioPharma Corp. “We believe that both patients and physicians stand to benefit from MONOVISC’s unique features such as patients will welcome fewer office visits and lower treatment costs, while physicians will appreciate the simplicity of the single-injection regimen.”
“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,” said Charles H. Sherwood, Ph.D., Anika’s President and Chief Executive Officer. “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.”
The Company previously announced that it has completed the clinical segment of the US pivotal trial for MONOVISC, and is focused on completing the retreatment study for MONOVISC, which is designed to demonstrate the safety and benefit of repeat injections.
MONOVISC is Anika’s next-generation HA-based therapy for treating osteoarthritis that features enhanced durability in a safe, easy-to-use, single injection regimen. MONOVISC is made from highly purified, non-animal, natural hyaluronan. Hyaluronan occurs naturally throughout the body, especially in articular cartilage, synovial fluid in joints and in the skin.