Full Press Release Details
Therapeutics Announces Dismissal of MONOVISC
U.S. Patent Infringement Lawsuit
BEDFORD, Mass.--(BUSINESS WIRE)--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
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
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.
Anika Therapeutics, Inc.
Charles H. Sherwood, Ph.D.,