Anika Therapeutics (ANIK) has received marketing approval for MONOVISC from the US Food and Drug Administration (FDA) for the treatment of patients suffering from osteoarthritis (OA) of the knee.
MONOVISC is a single injection supplement to synovial fluid of the osteoarthritic joint, indicated to treat pain and improve joint mobility in these patients who have failed to respond adequately to conservative non-pharmacologic therapy and to simple analgesics.
It includes a sterile, clear, biocompatible, resorbable, viscoelastic solution composed of partially cross-linked sodium hyaluronate (NaHA) in phosphate buffered saline.
The vaccine consists of high molecular weight, ultra-pure natural hyaluronan, which 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 the company's three-injection viscosupplement, Orthovisc, in the convenience of a single 4ml intra-articular injection.
In the US, MONOVISC will be marketed by DePuy Synthes, Mitek Sports Medicine (Mitek), a leading orthopedic sports medicine company.
Under the license deal with Mitek, Anika will receive a milestone payment of $5m upon first commercial sale of the product in the market.
The deal also calls for potential additional payments contingent on achieving certain performance and sales threshold milestones, in addition to product transfer and royalty fees.
MONOVISC is currently sold in several territories, including Canada, the UK and many countries in the Middle East, Europe and Asia.
Anika Therapeutics president and CEO Charles Sherwood said the US 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," Sherwood said.
"We are moving forward rapidly with Mitek Sports Medicine to capitalize on the strengths of our viscosupplementation portfolio.
"Commercial introduction for MONOVISC in the US 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."
