After receiving FDA premarket approval (PMA) in February for Monovisc, Anika Therapeutics, Inc. announced in mid-April the first commercial sale of the product by its commercial partner, DePuy Synthes Mitek Sports Medicine.
Under a license agreement with Mitek, Anika is to receive a milestone payment of $5 million upon first commercial sale of the product in the market. The agreement also calls for potential additional payments contingent on achieving certain performance and sales threshold milestones, in addition to product transfer and royalty fees. Anika has marketed Monovisc internationally since 2008. The product is currently sold in a variety of territories, including Canada, the UK and several countries in the Middle East, Europe and Asia.
“The U.S. market for viscosupplementation therapy is experiencing double digit growth annually, ” said Anika’s President and CEO Charles Sherwood, Ph.D. when FDA approval was announced in February.
The product is indicated for the treatment of pain in osteoarthritis of the knee for patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics.
According to the company, Monovisc is a single injection supplement to synovial fluid of the osteoarthritic joint and is the first FDA approved single injection product with hyaluronic acid (HA) from a non-animal source. It is comprised of a sterile, clear, biocompatible, resorbable, viscoelastic fluid composed of partially cross-linked sodium hyaluronate (NaHA) in phosphate buffered saline.
Clinical Synopsis
The company said FDA approval was based on safety and effectiveness data from a randomized, controlled, double-blind multi-center pivotal U.S. clinical study encompassing a total of 369 patients at 31 centers in the U.S. and Canada suffering from OA of the knee. The objective of the study was to assess the safety and effectiveness of Monovisc for the treatment of joint pain. Patients were randomized to either Monovisc or control (saline injection) and were evaluated for improvement in pain as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at follow-up assessments out to 26 weeks. The primary effectiveness analysis compared the proportion of Monovisc patients achieving a greater improvement from baseline in WOMAC pain score versus control through 12 weeks. The safety analysis showed the product had an extremely low rate of adverse events and there were no serious adverse events associated with the product.
Patent Lawsuit Dismissed
In March 2014, the company announced the dismissal of a patent infringement lawsuit by Genzyme Corporation against the company over the product.
