Anika Therapeutics Announces Decision to Proceed with CINGAL Premarket Review Through FDA's Center for Drug Evaluation and Research BEDFORD, Mass.--(BUSINESS WIRE)

Therapeutics Announces Decision to Proceed with CINGAL Premarket Review

Through FDA's Center for Drug Evaluation and Research

BEDFORD, Mass.--(BUSINESS WIRE)--December 9, 2015--Anika Therapeutics,

Inc., (NASDAQ: ANIK), a global, integrated orthopedics medicines company

specializing in therapeutics based on its proprietary hyaluronic acid

technology, today announced that the U.S. Food & Drug Administration's

(FDA) Office of Combination Products has assigned CINGAL to the Center

for Drug Evaluation and Research (CDER) as the lead center for premarket

CINGAL is the first combination viscosupplement formulated with Anika's

proprietary cross-linked sodium hyaluronate (currently marketed as the

single-injection viscosupplement MONOVISC ) and triamcinolone

hexacetonide, an FDA-approved steroid to treat inflammation. Earlier

this year, Anika announced positive results from its CINGAL 13-01 and

13-02 studies, demonstrating the efficacy and safety of a single

injection of CINGAL for treatment of pain caused by osteoarthritis (OA)

of the knee, as well as the safety of a repeat injection.

"While we strongly disagree with the FDA's decision, as our position of

CINGAL's device-lead classification is supported by both regulations and

scientific data, we intend to proceed expeditiously to move CINGAL

through regulatory review," said Dr. Charles H. Sherwood, President and

Chief Executive Officer of Anika Therapeutics. "We have already been in

contact with CDER to start the NDA process, and are confident that the

definitive results from two clinical studies provide the essential

foundation for marketing approval of CINGAL."

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 the United States and a growing presence

internationally, with its multi-injection product, ORTHOVISC , and its

single-injection product, MONOVISC. CINGAL was approved in Canada as a

medical device to treat pain associated with OA of the knee, and is

under review in the E.U.

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 third and fourth 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 U.S. and 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 FDA or other regulatory

approvals or clearances of its products; (iii) that such approvals,

including for CINGAL, 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 operate 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; (x) the

Company's ability to continue to successfully manage Anika Therapeutics

S.r.l.'s business; and (xi) the Company's ability to achieve its growth

Anika Therapeutics, Inc.

Christopher Ranjitkar,

IR & Corporate Communications Manager