Anika Therapeutics Announces Health Canada Approval of CINGAL® for the Treatment of Pain Associated with Osteoarthritis of the Knee
Achieves First Approval for Innovative Therapy Combining Hyaluronic Acid Technology with FDA-Approved Steroid
"We are very pleased to announce the first regulatory approval for our breakthrough, next generation viscosupplement, CINGAL," said Charles H. Sherwood, Ph.D., President and Chief Executive Officer. "In its pivotal clinical study, CINGAL has demonstrated an ability to provide immediate and long-lasting pain relief for those affected by osteoarthritis of the knee. The availability of CINGAL allows us to extend the proven benefits of MONOVISC to a broader range of patients across the spectrum of osteoarthritis management. We look forward to advancing CINGAL through regulatory channels globally and improving the lives of millions of people worldwide struggling with the debilitating symptoms of osteoarthritis."
CINGAL is Anika Therapeutics' third-generation viscosupplementation
product, adding to the Company's strong product portfolio for the
treatment of joint pain associated with OA. Anika already maintains a
market leadership position in
About Osteoarthritis of the Knee
Greater than 5% of the world's population is afflicted by OA of the knee, making it the most common joint disease. Most commonly affecting middle-aged and older people, OA can range from very mild to very severe. Risk factors include being overweight, joint injury, muscle weakness, having other forms of arthritis, and heredity.
OA of the knee is characterized by the breakdown of cartilage, the part of the joint that cushions the ends of bones, which causes bones to rub against each other, and results in pain and loss of movement. Degradation changes in the synovial fluid contained in the joint may also play a role in OA. Synovial fluid, which mostly consists of hyaluronan, lubricates the joint and is needed to facilitate movement of the joint.
Standard treatment modalities that seek to relieve pain, improve mobility and increase range of motion include analgesics, nonsteroidal anti-inflammatory drug (NSAIDS), viscosupplementation, and intra-articular steroids. Should these approaches become insufficient or fail, some patients may become surgical candidates. Viscosupplementation represents an effective, safe, convenient, and non-surgical therapeutic alternative or adjunct to physical therapy, medication or surgery.
The statements made in the second paragraph of this press release,
which are not statements of historical fact, are forward-looking
statements within the meaning of Section 27A of the Securities Act of
1933, as amended, and Section 21E of the Securities Exchange Act of
1934, as amended. These statements include, but are not limited to,
those relating to the global regulatory progress of CINGAL and the
Company's leadership position in the viscosupplementation market. These
statements are based upon the current beliefs and expectations of the
Company's management and are subject to significant risks,
uncertainties, and other factors. The Company's actual results could
differ materially from any anticipated future results, performance, or
achievements described in the forward-looking statements as a result of
a number of factors including (i) the Company's ability to successfully
commence and/or complete clinical trials of its products, including for
HYALOFAST or for expanded indications of the Company's MONOVISC product,
on a timely basis or at all; (ii) the Company's ability to obtain
pre-clinical or clinical data to support domestic and international
pre-market approval applications or 510(k) applications, or to timely
file and receive
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