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Anika Announces European Commercial Launch of CINGAL for the Treatment of Pain Associated with Osteoarthritis

June 01, 2016

 

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 the European Union. CINGAL, which will be initially available in Hungary, Czech Republic, Poland, Germany, and Italy, received CE Mark approval in March 2016 to treat pain associated with osteoarthritis. CINGAL will be marketed and sold in Europe by a network of experienced commercial partners under the terms of their respective commercialization agreements.

“The launch of CINGAL in Europe marks an important milestone in our global expansion, which is a key part of our overall growth strategy. It strengthens our footprint in the European Union, and allows us access to additional international viscosupplementation markets,” said Charles H. Sherwood, Ph.D., President and Chief Executive Officer. “For the millions of Europeans living with osteoarthritis pain, CINGAL offers a safe, non-opioid, long-term pain management option that can help restore day-to-day function and preserve normal quality of life.”

CINGAL is the first and only viscosupplement approved for use in the European Union 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®. Viscosupplements are injected by a licensed medical professional into synovial joints to replenish the natural cushioning within joints that depletes with age and degenerative orthopedic diseases, causing pain. In addition to Europe, CINGAL is available in Canada, and the Company continues to vigorously pursue regulatory approval of the product in the U.S.

“With the global population aging at an unprecedented rate, we are seeing a marked increase in chronic, degenerative diseases such as osteoarthritis, that require safe, long-term, non-surgical management,” said Prof. Laszlo Hangody, MD, Ph.D., DSc., Clinical Professor at the Debrecen Medical School and Senior Consultant in the Orthopaedic Department at Uzsoki Hospital, Budapest, Hungary. “CINGAL combines two tried, tested, and proven treatments into a single injection that can provide patients up to six months of pain relief, while avoiding the harsh side effects associated with the daily use of oral pain medications and staving off invasive joint replacement surgery. As the Principle Investigator for the highly successful CINGAL 13-01 clinical trial, I am very pleased that patients across Europe will now have access to CINGAL.”

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.

Forward-Looking Statements

The statements made in the second and third 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 Company’s global expansion and overall growth strategy and the U.S. regulatory status of Cingal. 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 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.

Contacts

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

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Josh Sandberg

Josh Sandberg is the President of Ortho Spine Partners and Partner for The De Angelis Group. He also serves as Co-Founder and Editor of OrthoSpineNews.

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