Anika Therapeutics Announces Canadian Launch of CINGAL for the Treatment of Pain Associated with Osteoarthritis of the Knee

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 the commercial launch of CINGAL®, its third-generation viscosupplement, in Canada. CINGAL received Health Canada approval in October 2015 to treat pain associated with osteoarthritis of the knee.

CINGAL will be marketed and sold in Canada by Pendopharm, a division of Pharmascience Inc., a Quebec-based pharmaceutical company that commercializes nearly 300 products in Canada and across the globe. Under terms of the current commercialization agreement between the companies, Anika will supply CINGAL to Pendopharm for sale in the Canadian market, where Pendopharm is also Anika’s sole commercialization partner for its ORTHOVISC® and MONOVISC® products.

“CINGAL represents a significant major advancement among viscosupplements, and we’re excited that Canadians with knee pain can now access a new and more effective treatment option,” said Charles H. Sherwood, Ph.D., President and Chief Executive Officer. “We are pleased to expand our partnership with Pendopharm to accelerate demand for CINGAL by leveraging their established physician networks and distribution channels, which led to the commercial successes of ORTHOVISC and MONOVISC in Canada.”

Viscosupplements are injected by a licensed medical professional into the knee to replenish the joint’s natural cushioning that depletes with age and degenerative orthopedic diseases, causing pain. CINGAL is the first and only approved viscosupplement that combines triamcinolone hexacetonide, a well-established, FDA-approved steroid to treat inflammation, with sodium hyaluronate, the active “cushioning” ingredient in the Company’s best-selling viscosupplements, ORTHOVISC and MONOVISC. CINGAL received regulatory approval in Europe earlier this month, and it is under regulatory review in the United States.

“Chronic knee pain caused by osteoarthritis diminishes a patient’s quality of life by limiting their ability to participate in routine activities such as walking, climbing stairs and even getting a good night’s sleep,” said Dr. Robert McCormack, M.D., Orthopedic Surgeon and Chief Medical Officer for Team Canada. “Viscosupplements and steroid injections are safe and commonly-used treatments to provide long-term pain management that can help patients with knee pain restore function and stave off invasive interventions such as knee replacement surgery. CINGAL combines the benefits of viscosupplements and steroids in a single injection to help patients achieve sustained pain relief for up to 26 weeks.”

About Anika Therapeutics, Inc.

Anika Therapeutics, Inc. (NASDAQ: ANIK) is a global, integrated orthopedics medicines company based in Bedford, Mass. Anika is committed to improving the lives of patients with degenerative orthopedic diseases and traumatic conditions by providing clinically meaningful therapeutic pain management solutions along the continuum of care, from palliative care to regenerative medicine. The Company has over two decades of expertise developing, manufacturing and commercializing more than 20 products, in markets across the globe, based on its proprietary hyaluronic acid (HA) technology. Anika’s orthopedic medicine portfolio is comprised of marketed (ORTHOVISC and MONOVISC) and pipeline (CINGAL and HYALOFAST® in the U.S.) products to alleviate pain and restore joint function by replenishing depleted HA and aiding cartilage repair and regeneration. For more information about Anika, please visit http://www.anikatherapeutics.com.

About Pendopharm

Pendopharm is a division of Pharmascience Inc., a Canadian privately-owned company. Established in 1983, Pharmascience Inc. is the largest pharmaceutical company in Quebec, Canada with a highly-skilled workforce of 1,600 people. It commercializes nearly 300 products, including branded prescription, OTC and BTC products, as well as generic products, in Canada and with its affiliates and distributors in Europe, Asia, the Middle East,Africa and Oceania.

Strategically committed to growth, Pendopharm is actively engaged in licensing, partnering, developing, and marketing specialty prescription medicines as well as consumer brands.

Forward-Looking Statements

The statements made in the second, third, and fifth paragraphs 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 effectiveness of, the commercialization of, and the demand for CINGAL inCanada. 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 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, 510(k) applications, or new drug applications, or to timely file and receive FDA or other regulatory approvals or clearances of its products; (iii) that such approvals will not be obtained in a timely manner or without the need for additional clinical trials, other testing or regulatory submissions, as applicable; (iv) the Company’s research and product development efforts and their relative success, including whether we have any meaningful sales of any new products resulting from such efforts; (v) the cost effectiveness and efficiency of the Company’s clinical studies, manufacturing operations, and production planning; (vi) the strength of the economies in which the Company operates or will be operating, as well as the political stability of any of those geographic areas; (vii) future determinations by the Company to allocate resources to products and in directions not presently contemplated; (viii) the Company’s and its partner’s ability to successfully commercialize its products, in the U.S. and abroad; (ix) the Company’s ability to provide an adequate and timely supply of its products to its customers; and (x) the Company’s ability to achieve its growth targets. Additional factors and risks are described in the Company’s periodic reports filed with the Securities and Exchange Commission, and they are available on the SEC’s website at www.sec.gov. Forward-looking statements are made based on information available to the Company on the date of this press release, and the Company assumes no obligation to update the information contained in this press release.

For Investor Inquiries:
Anika Therapeutics, Inc.
Sylvia Cheung, 781-457-9000
Chief Financial Officer
For Media Inquiries:
Pure Communications
Susan Heins, 864-286-9597

Source: Anika Therapeutics, Inc.

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Josh Sandberg

Josh Sandberg is the President and CEO of Ortho Spine Partners and sits on several company and industry related Boards. He also is the Creator and Editor of OrthoSpineNews.

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