FDA Approves MONOVISC®, A New Single Injection Treatment for Treatment of Pain Due to Osteoarthritis of the Knee

  FDA Approves MONOVISC®, A New Single Injection Treatment for Treatment of
  Pain Due to Osteoarthritis of the Knee

Business Wire

BEDFORD, Mass. -- February 25, 2014

Anika Therapeutics, Inc. (NASDAQ:ANIK) today announced it has received
marketing approval for MONOVISC^® from the U.S. Food and Drug Administration
(FDA). MONOVISC is a single injection supplement to synovial fluid of the
osteoarthritic joint, used to treat pain and improve joint mobility in
patients suffering from osteoarthritis (OA) of the knee. MONOVISC is the first
FDA approved single injection product with HA from a non-animal source. It is
comprised of a sterile, clear, biocompatible, resorbable, viscoelastic fluid
composed of partially cross-linked sodium hyaluronate (NaHA) in phosphate
buffered saline.

MONOVISC will be marketed in the U.S. by DePuy Synthes, Mitek Sports Medicine
(Mitek), a leading orthopedic sports medicine company. Under the license
agreement with Mitek, Anika will receive a milestone payment of $5 million
upon first commercial sale of MONOVISC in the market. 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. Anika has marketed MONOVISC internationally since 2008. The product is
currently sold in a variety of territories, including Canada, the U.K. and
several countries in the Middle East, Europe and Asia.

“The U.S. market for viscosupplementation therapy is experiencing double digit
growth annually. With FDA approval of MONOVISC, we can be better positioned
with our single and multi-injection products to meet the varying needs of
physicians and patients,” said Charles H. Sherwood, Ph.D., President and Chief
Executive Officer “We are moving forward rapidly with Mitek Sports Medicine to
capitalize on the strengths of our viscosupplementation portfolio. Commercial
introduction for MONOVISC in the U.S. is planned to take place in conjunction
with the annual meeting of the American Academy of Orthopedic Surgeons to be
held in New Orleans, March 11 to 15, 2014.”

Product Summary

MONOVISC is indicated for the treatment of pain in OA of the knee in patients
who have failed to respond adequately to conservative non-pharmacologic
therapy and to simple analgesics (e.g. acetaminophen). It is a sterile,
non-pyrogenic, viscoelastic solution of hyaluronan contained in a single-use
syringe. MONOVISC consists of high molecular weight, ultra-pure natural
hyaluronan, a complex sugar of the glycosaminoglycan family. The hyaluronan is
derived from bacterial cells and is cross-linked with a proprietary
cross-linker. MONOVISC was designed to deliver a comparable HA dose to Anika’s
three-injection viscosupplement, ORTHOVISC, in the convenience of a single 4
mL intra-articular injection.

Clinical Synopsis

The FDA approval of MONOVISC is based on safety and effectiveness data from a
randomized, controlled, double-blind multi-center pivotal U.S. clinical study
encompassing a total of 369 patients at 31 centers in the US and Canada
suffering from OA of the knee. The objective of the study was to assess the
safety and effectiveness of MONOVISC for the treatment of joint pain. Patients
were randomized to either MONOVISC or control (saline injection) and were
evaluated for improvement in pain as measured by the Western Ontario and
McMaster Universities Osteoarthritis Index (WOMAC) at follow-up assessments
out to 26 weeks. The primary effectiveness analysis compared the proportion of
MONOVISC patients achieving a greater improvement from baseline in WOMAC pain
score versus control through 12 weeks. The safety analysis showed MONOVISC had
an extremely low rate of adverse events. There were no serious adverse events
associated with MONOVISC.

About Osteoarthritis of the Knee

Greater than 5% of the world’s population is afflicted by osteoarthritis of
the knee, making it the most common joint disease. Most commonly affecting
middle-aged and older people, OA can range from very mild to very severe. Risk
factors include being overweight, joint injury, muscle weakness, having other
forms of arthritis and heredity. Approximately 10 million Americans currently
suffer from OA of the knee and that number is expected to increase.

OA of the knee is characterized by the breakdown of cartilage, the part of the
joint that cushions the ends of bones, causing bones to rub against each
other, resulting in pain and loss of movement. Degradation changes in the
synovial fluid contained in the joint may also play a role in OA. Synovial
fluid, which mostly consists of hyaluronan, lubricates the joint and is needed
to facilitate movement of the joint.

Standard treatment modalities that seek to relieve pain, improve mobility and
increase range of motion include analgesics, nonsteroidal anti-inflammatory
drug (NSAIDS), viscosupplementation and intra-articular steroids. Should these
approaches become insufficient or fail, some patients may become surgical
candidates. Viscosupplementation represents an effective, safe, convenient,
and non-surgical therapeutic alternative or adjunct to physical therapy,
medication or surgery.

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

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 pain due to 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 tissue technology advances Anika’s vision to offer therapeutic
products 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 company and its partner’s ability to
commercialize Monovisc in the U.S., (ii) our ability to capitalize on the
strengths of our viscosupplementation portfolio, (iii) our ongoing initiatives
to improve performance across the business, (iv) our efforts and ability to
strengthen and expand our international Orthobiologics distribution network,
(v) the company’s plans to continue to drive efficiencies in operations and
manufacturing, (vi) the prospects for the company’s product pipeline,
including regenerative product development, (vii) bringing Cingal to market,
and (viii) expectations for future growth and profitability improvement in the
quarters ahead. 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) application, 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 provide an adequate and timely supply of its products to
its customers, (vii) our ability to successfully manage Anika S.r.l.’s
business, and (viii) 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 Sherwood, Ph.D., CEO, 781-457-9000
or
Sylvia Cheung, CFO, 781-457-9000
 
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