Anika Therapeutics' MONOVISC gains FDA marketing approval

BEDFORD, Mass.—Anika Therapeutics, Inc. has announced the receipt of marketing approval for MONOVISC from the U.S. Food and Drug Administration (FDA). The drug is a single injection supplement to the synovial fluid of an osteoarthritic joint, meant for the treatment of pain and to improve joint mobility in individuals afflicted with osteoarthritis of the knee. The drug is indicated for patients who have failed to see an adequate response to non-pharmacologic therapy and/or standard analgesics such as acetominophen.

The drug consists of a sterile, clear, biocompatible, resorbable, viscoelastic fluid composed of partially cross-linked sodium hyaluronate (NaHA) in phosphate buffered saline. MONOVISC is the first FDA-approved single injection product with hyaluronate from a non-animal source, as it features 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 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,” Charles H. Sherwood, Ph.D., president and CEO of Anika Therapeutics, said in a press release. “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.”

DePuy Synthes Mitek Sports Medicine, a division of DePuy Orthopaedics, Inc., will be marketing MONOVISC in the United States; Anika has marketed the product internationally since 2008. Per the companies’ license agreement, Mitek will pay Anika a milestone payment of $5 million upon the first commercial sale of the drug in the market. Anika will also be eligible for potential additional payments if certain performance and sales threshold milestones are met, as well as product transfer and royalty fees.

More than 5 percent of the global population suffers from osteoarthritis of the knee, including some 10 million Americans, making it the most common joint disease. Osteoarthritis is characterized by the degradation of cartilage in the knees. As the cartilage breaks down, the bones of the knee are no longer properly cushioned and begin to rub against each other, leading to pain and loss of movement. In addition, it is thought that degradation changes in the synovial fluid—which lubricates the knee and facilitates movement—of the joint also plays a role in the disease.

The current standards of therapy for osteoarthritis consist of analgesics, non-steroidal anti-inflammatory drugs, viscosupplementation and intra-articular steroids. For those that fail to respond to such treatments, surgery is also an option.

SOURCE: Anika Therapeutics press release