Anika Therapeutics receives marketing approval from FDA for MONOVISC injection

Anika Therapeutics, Inc. (NASDAQ:ANIK) today announced it has received marketing approval for MONOVISC® from the U.S. Food and Drug Administration (FDA). MONOVISC is a single injection supplement to synovial fluid of the osteoarthritic joint, used to treat pain and improve joint mobility in patients suffering from osteoarthritis (OA) of the knee. MONOVISC is the first FDA approved single injection product with 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.

MONOVISC will be marketed in the U.S. by DePuy Synthes, Mitek Sports Medicine (Mitek), a leading orthopedic sports medicine company. Under the license agreement with Mitek, Anika will receive a milestone payment of $5 million upon first commercial sale of MONOVISC 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 U.K. and several countries in the Middle East, Europe and Asia.

"The U.S. market for viscosupplementation therapy is experiencing double digit growth annually. With FDA approval of MONOVISC, we can be better positioned with our single and multi-injection products to meet the varying needs of physicians and patients," said Charles H. Sherwood, Ph.D., President and Chief Executive Officer "We are moving forward rapidly with Mitek Sports Medicine to capitalize on the strengths of our viscosupplementation portfolio. Commercial introduction for MONOVISC 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 is indicated for the treatment of pain in 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. MONOVISC 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. MONOVISC was designed to deliver a comparable HA dose to Anika's three-injection viscosupplement, ORTHOVISC, in the convenience of a single 4 mL intra-articular injection.

Clinical Synopsis

The FDA approval of MONOVISC 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 MONOVISC.

SOURCE Anika Therapeutics, Inc.

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