Anika Therapeutics Announces Dismissal of MONOVISC® U.S. Patent Infringement Lawsuit

  Anika Therapeutics Announces Dismissal of MONOVISC® U.S. Patent Infringement
  Lawsuit

Business Wire

BEDFORD, Mass. -- March 13, 2014

Anika Therapeutics, Inc. (Nasdaq: ANIK), a leader in products for tissue
protection, healing and repair, based on hyaluronic acid (“HA”) technology,
today announced that Genzyme Corporation (plaintiff) and Anika Therapeutics,
Inc. (defendant) filed a joint motion with the United States District Court
for the District of Massachusetts to lift a stay and dismiss a patent
infringement lawsuit concerning MONOVISC. MONOVISC, a single-injection
treatment for osteoarthritis pain of the knee, received FDA PMA approval in
February 2014. The court granted the parties’ motion and issued an order
dismissing the litigation with prejudice on March 10, 2014. This final and
unappealable order resolves the parties’ dispute and is another important
milestone toward commercialization of the product in the United States.

MONOVISC is marketed in the U.S. by DePuy Synthes, Mitek Sports Medicine
(“Mitek”). Under the license agreement with Mitek, Anika will receive a
milestone payment of $17.5 million upon an irrevocable resolution of the
Genzyme litigation allowing Mitek and Anika to make, use, and sell MONOVISC
without infringing the Genzyme intellectual property. The agreement also calls
for potential additional payments contingent on achieving certain performance
and sales threshold milestones, in addition to product transfer and royalty
fees.

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^®, a
treatment 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 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 commercialization of MONOVISC, (ii)
the achievement of performance and sales threshold milestones relating to
MONOVISC, and (iii) the milestone related to the resolution of the Genzyme
litigation. 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 our 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’s ability to launch Monovisc in the U.S.; (vii) the company’s ability
to provide an adequate and timely supply of its ophthalmic, Orthovisc and
other products to its customers, (viii) our ability to successfully manage and
turnaround 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, 2012, as well as those described
in the company's other press releases and SEC filings.

Contact:

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