BEDFORD, Mass.--(BUSINESS WIRE)--Anika Therapeutics, Inc., (NASDAQ: ANIK), a global, integrated orthopedics medicines company specializing in therapeutics based on its proprietary hyaluronic acid “HA” technology, today announced that it received CE Mark approval for CINGAL® as a medical device to treat pain associated with osteoarthritis of the knee. CINGAL is the first and only commercially-available combination viscosupplement, formulated with the Company’s proprietary cross-linked sodium hyaluronate (currently marketed as the single-injection viscosupplement MONOVISC®) and triamcinolone hexacetonide, a well-established, FDA-approved steroid to treat inflammation. CINGAL is Anika’s third-generation viscosupplement, following the company’s ORTHOVISC® and MONOVISC® products, to treat pain associated with osteoarthritis of the knee.

“The European approval of CINGAL marks an important milestone for Anika as it advances our global expansion strategy, provides a platform for us to demonstrate our commercialization capabilities, and most importantly, reinforces the product’s tremendous clinical value to people struggling with the debilitating symptoms of osteoarthritis,” said Charles H. Sherwood, Ph.D., President and Chief Executive Officer. “We look forward to working with our distribution partners to commence our European launch in the coming months, while remaining steadfast in our commitment to collaborate with the FDA to bring this important treatment to the millions of Americans coping with chronic knee pain.”

Anika recently announced plans to strengthen its global commercialization capabilities, and the company will support key aspects of the European launch, which will be executed through a network of existing and new commercial partnerships. The Company previously achieved approval of CINGAL in Canada, and is currently working with its distribution partner to finalize the commercial launch of the product in the second quarter of 2016. Anika also continues to vigorously pursue regulatory approval of the product in the U.S.
“The availability of CINGAL is welcome news for millions of Europeans living with osteoarthritis-related knee pain due to a lack of effective, long-lasting, non-surgical treatment options,” said Prof. Laszlo Hangody, MD, Ph.D., DSc., Clinical Professor at the Semmelweis Medical School Budapest, former President of the Hungarian Orthopedic Society, and global principal investigator for the CINGAL Phase III program. “CINGAL combines two proven, approved therapies for pain and inflammation into a single injection treatment that has been shown to provide immediate pain relief that lasts for 6 months, reduce stiffness, and improve function. For knee pain sufferers, the availability of CINGAL not only translates to postponing an invasive and costly knee replacement surgery, but also to enabling these individuals to resume their normal lifestyle prior to the onset of chronic pain.”

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