Anika Therapeutics Announces First U.S. Commercial Sale of Monovisc®

  Anika Therapeutics Announces First U.S. Commercial Sale of Monovisc®

  Company’s Commercial Partner, DePuy Synthes Mitek Sports Medicine, Records
 First Commercial Sale of Single-Injection Treatment for Osteoarthritis Knee
                                     Pain

Business Wire

BEDFORD, Mass. -- April 15, 2014

Anika Therapeutics, Inc. (Nasdaq: ANIK), a leader in products for tissue
protection, healing and repair, based on hyaluronic acid (“HA”) technology,
today announced the first U.S. commercial sale of Monovisc^® by its commercial
partner, DePuy Synthes Mitek Sports Medicine*, a leading orthopedic sports
medicine company.

Monovisc received marketing approval from the U.S. Food and Drug
Administration (“FDA”) in February 2014. It is indicated for the treatment of
pain in osteoarthritis of the knee in patients who have failed to respond
adequately to conservative non-pharmacologic therapy and to simple analgesics,
such as acetaminophen. It is a sterile, non-pyrogenic, viscoelastic solution
of hyaluronan, and is the first FDA-approved single-injection product with HA
from a non-animal source.

Anika has marketed Monovisc internationally since 2008, with total treatments
exceeding 230,000 since inception. In addition to the United States, the
product is currently sold in Canada, the United Kingdom and a growing number
of countries in the Middle East, Europe and Asia. The U.S. commercial
introduction of Monovisc took place in March 2014 at the annual meeting of the
American Academy of Orthopedic Surgeons in New Orleans. As a result of the
first commercial sale in the U.S., and under the terms of its license
agreement with DePuy Synthes Mitek Sports Medicine, Anika will receive a $5
million milestone payment. In addition to product transfer and royalty fees,
the license agreement contains potential additional payments contingent on
achieving certain performance and sales threshold milestones.

About Anika Therapeutics, Inc.

Headquartered in Bedford, Mass., Anika Therapeutics, Inc. develops,
manufactures and commercializes therapeutic products for tissue protection,
healing, and repair. These products are based on hyaluronic acid (HA), a
naturally occurring, biocompatible polymer found throughout the body. Anika’s
products range from orthopedic/joint health solutions led by Orthovisc^® and
Monovisc^®, treatments for osteoarthritis of the knee; to surgical aids in the
anti-adhesion and ophthalmic fields. The company also offers aesthetic dermal
fillers for the correction of facial wrinkles. Anika’s Italian subsidiary,
Anika Therapeutics S.r.l., provides complementary HA products in
orthopedic/joint health and anti-adhesion, as well as therapeutics in areas
such as advanced wound treatment and ear, nose and throat care. Its
regenerative technology advances Anika’s vision to offer therapeutic products
and medical solutions that go beyond pain relief to protect and restore
damaged tissue.

The statements made in 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 (i) the successful commercialization of
Monovisc, (ii) the achievement of performance and sales threshold milestones
relating to Monovisc under the license agreement with its U.S. commercial
partner, and (iii) the future receipt of product transfer and royalty fees
relating to Monovisc. 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, obtain
pre-clinical or clinical data to support domestic and international pre-market
approval applications or 510(k) applications, or timely file and receive FDA
or other regulatory approvals or clearances of its products, or 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; (ii) the company's research and product development efforts and
their relative success, including whether the company has any meaningful sales
of any new products resulting from such efforts; (iii) the cost effectiveness
and efficiency of the company’s clinical studies, manufacturing operations and
production planning; (iv) 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; (v) future determinations by the company to allocate
resources to products and in directions not presently contemplated, (vi) the
company and its partner’s ability to launch Monovisc in the U.S.; (vii) the
company’s ability to provide an adequate and timely supply of its products to
its customers; (viii) the company’s ability to successfully manage its Anika
S.r.l.’s business; and (ix) the company’s ability to achieve its stated growth
targets. Certain other factors that might cause the company's actual results
to differ materially from those in the forward-looking statements include
those set forth under the headings "Business," "Risk Factors" and
"Management's Discussion and Analysis of Financial Condition and Results of
Operations" in the company's Annual Report on Form 10-K for the year ended
December 31, 2013, as well as those described in the company's other press
releases and SEC filings.

* DePuy Synthes Mitek Sports Medicine is a division of DePuy Orthopaedics,
Inc.

Contact:

Anika Therapeutics, Inc.
Charles H. Sherwood, Ph.D., President and CEO, 781-457-9000
or
Sylvia Cheung, CFO, 781-457-9000
 
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