Anika’s CINGAL Receives CE Mark

Anika Therapeutics, Inc. has announced that it received CE Mark approval for CINGAL as a medical device to treat pain associated with osteoarthritis (OA) of the knee. CINGAL is comprised of Anika’s proprietary cross-linked sodium hyaluronate (HA–currently marketed as the single-injection viscosupplement MONOVISC) and triamcinolone hexacetonide, an FDA-approved steroid for inflammation.

“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 President and CEO Charles H. Sherwood, Ph.D., in the March 28, 2016 news release. “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.”

“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, M.D., 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.”

Asked about distribution plans, Dr. Sherwood told OTW, “With approvals in Europe and Canada in hand, we plan to market CINGAL via a strong network of existing and new commercial partners. We expect product launches in Canada and Europe during the second quarter of 2016. This partnership model will be utilized for other targeted key international markets as well. We also recently announced plans to strengthen our global commercialization presence. Our plans in the United States are to establish direct commercialization capabilities for CINGAL and additional office-based orthopedic products. The direct access to the market will provide Anika better control of the distribution and will provide us a sales and marketing channel for a portfolio of orthopedic products. Anika continues to vigorously pursue regulatory approval of the product in the U.S., and looks forward to making this safe and efficacious product available to patients at home.”

“This approval is supported by a strong clinical profile showing statistically significant pain relief at 1 week and continuing through 26 weeks with no diminishing effect. Current HA-only products typically do not provide clinically relevant pain relief for at least several weeks after injection.”

“CINGAL will provide health care providers with an effective therapy across a broad range of patients. OA patients who typically receive steroid injections can now benefit from the steroid in CINGAL and gain the added benefit of the longer lasting cushioning and lubrication effects of HA.”