Monovisc, a single injection supplement to synovial fluid of an osteoarthritic joint, and made by Anika Therapeutics, Inc., has received approval of its FDA premarket application (PMA).
The company announcement on February 25, 2014, said the product will be marketed in the U.S. by DePuy Synthes, Mitek Sport Medicine, under a licensing agreement. Anika will receive a milestone payment of $5 million when the first commercial sale is made. There will be more potential payments contingent on achieving certain performance and sales thresholds.
Monovisc is used to treat pain and improve joint mobility in patients suffering from osteoarthritis of the knee. The product, according to the company, 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.
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 President and CEO Charles H. Sherwood, Ph.D. “We are moving forward rapidly with Mitek Sports Medicine to capitalize on the strengths of our viscosupplementation portfolio.” He added that the commercial introduction of the product in the U.S. is planned to take place in conjunction with the annual meeting of the American Academy of Orthopedic Surgeons to be held in New Orleans, March 11 to 15, 2014.
Product Summary
Monovisc, according to the company, is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and to simple analgesics (e.g. acetaminophen). It is a sterile, non-pyrogenic, viscoelastic solution of hyaluronan contained in a single-use syringe. The product consists of high molecular weight, ultra-pure natural hyaluronan, a complex sugar of the glycosaminoglycan family. The hyaluronan is derived from bacterial cells and is cross-linked with a proprietary cross-linker. The product was designed to deliver a comparable HA dose to Anika’s three-injection viscosupplement, Orthovisc, in a single 4 mL intra-articular injection.
Clinical Synopsis
The FDA approval is 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 US 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 Monovisc had an extremely low rate of adverse events. There were no serious adverse events associated with the product.
The company’s stock price jumped over 50% on the news.
