Full Press Release Details
Therapeutics Comments on Patent Litigation
BEDFORD, Mass.--(BUSINESS WIRE)--April 26, 2011--Anika Therapeutics,
Inc. (Nasdaq: ANIK), a leader in products for tissue protection,
healing and repair, based on hyaluronic acid ("HA") technology,
announced today that Genzyme Corporation has amended its original patent
infringement lawsuit with respect to MonoviscTM, Anika's
single-injection treatment for osteoarthritis of the knee, to include a
newly issued patent. Genzyme also filed an additional complaint in the
United States District Court for the District of Massachusetts on April
26, 2011 that relates to the new patent and which asserts the same
claims. Anika intends to continue to vigorously defend the lawsuits and
the Monovisc product franchise.
About Anika Therapeutics, Inc.
Headquartered in Bedford, Mass., Anika Therapeutics, Inc. develops,
manufactures and commercializes therapeutic products for tissue
protection, healing, repair and regeneration. 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 ophthalmic and
anti-adhesion 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 new areas such as advanced
wound treatment and ear, nose and throat care. Anika S.r.l.'s
regenerative tissue technology advances Anika's vision to offer
therapeutic products 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 and Section 21E of the
Securities Exchange Act of 1934, including, without limitation,
statements that may be identified by words such as "expectations,"
"remains," "focus," "expected," "prospective," "expanding," "building,"
"continue," "progress," "plan," "efforts," "hope," "believe,"
"objectives," "opportunities," "will," "seek," "expect" and other
expressions which are predictions of or indicate future events and trends
do not constitute historical matters and identify forward-looking
statements. These statements also include those relating to: (i)
the Company's intent to vigorously defend the Genzyme
Corporation lawsuits and the Monovisc product franchise. 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 clinical data to support a pre-market approval
application or timely file and receive FDA or other regulatory approvals
of its products, or that such approvals will not be obtained in a timely
manner or without the need for additional clinical trials; (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 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, or
(vi) the Company's ability to launch Monovisc in the U.S., if at all.
Any delay in receiving any regulatory approvals may adversely affect
the Company's competitive position. Even if regulatory approvals
are obtained, there is a risk that meaningful sales of the products may
not be achieved. There is also a risk that (i) the Company's
existing distributors or customers will not continue to place orders at
historical levels or that any of them will seek to modify or terminate
existing arrangements, (ii) the Company's efforts to enter into
long-term marketing and distribution arrangements, including with new
international distributors for Orthovisc and Monovisc, will not be
successful, (iii) new distribution arrangements will not result in
meaningful sales of the Company's products, (iv) the Company's
distributors will be unable to achieve performance and sales threshold
milestones in its distribution agreements, (v) competitive products will
adversely impact the Company's product sales, (vi) the estimated size(s)
of the markets which the Company has targeted its products will fail to
be achieved, (vii) lack of adequate coverage and reimbursement provided
by governments and other third party payers for our products and
services could have a material adverse effect on our results of
operations, or (viii) increased sales of the Company's products,
including Hyvisc, Orthovisc, or its ophthalmic products, will not
continue or sales will decrease or not reach historical sales levels, or
even if such increases occur that such increases will improve gross
margins, any of which may have a material adverse effect on the
Company's business and operations. 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,
2010, as well as those described in the Company's other press releases
Anika Therapeutics, Inc.
Charles H. Sherwood, Ph.D.,
Kevin W. Quinlan, CFO, 781-457-9000