Anika Therapeutics, Inc. (Nasdaq: ANIK), a leader in products for tissue protection, healing and repair, based on hyaluronic acid ("HA") technology, today announced the first U.S. commercial sale of Monovisc® by its commercial partner, DePuy Synthes Mitek Sports Medicine, a leading orthopedic sports medicine company.
Monovisc received marketing approval from the U.S. Food and Drug Administration ("FDA") in February 2014. It is indicated for the treatment of pain in osteoarthritis of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and to simple analgesics, such as acetaminophen. It is a sterile, non-pyrogenic, viscoelastic solution of hyaluronan, and is the first FDA-approved single-injection product with HA from a non-animal source.
Anika has marketed Monovisc internationally since 2008, with total treatments exceeding 230,000 since inception. In addition to the United States, the product is currently sold in Canada, the United Kingdom and a growing number of countries in the Middle East, Europe and Asia. The U.S. commercial introduction of Monovisc took place in March 2014 at the annual meeting of the American Academy of Orthopedic Surgeons in New Orleans. As a result of the first commercial sale in the U.S., and under the terms of its license agreement with DePuy Synthes Mitek Sports Medicine, Anika will receive a $5 million milestone payment. In addition to product transfer and royalty fees, the license agreement contains potential additional payments contingent on achieving certain performance and sales threshold milestones.
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