FOR IMMEDIATE RELEASE
FDA Approves ORTHOVISC for Treating
Osteoarthritis of the Knee; Anika
to Receive $20 Million Milestone Payment
from U.S. Marketing Partner
WOBURN, Mass.--(BUSINESS WIRE)--Feb.
5, 2004--Anika Therapeutics, Inc.
(Nasdaq:ANIK) today announced it received
marketing approval from the U.S. Food
and Drug Administration (FDA) for
ORTHOVISC(R), a highly purified, high
molecular weight form of hyaluronic
acid for treating pain in patients
suffering from osteoarthritis (OA)
of the knee.
As recently announced, ORTHOVISC(R)
will be marketed in the U.S. by Ortho
Biotech Products, L.P. Under its marketing
and distribution agreement with Ortho
Biotech, Anika will receive a milestone
payment for FDA approval of $20 million
during the first quarter of 2004.
The agreement also calls for potential
additional payments contingent on
achieving performance and sales threshold
milestones, in addition to royalty
and transfer fees.
"Receiving FDA approval for
ORTHOVISC is a major milestone for
Anika Therapeutics," said Chief
Executive Officer Charles H. Sherwood,
Ph.D. "Given the strength of
our safety and efficacy data from
the ORTHOVISC clinical trials, we
believe there is a significant opportunity
to penetrate the U.S. market for viscosupplementation
therapy for the treatment of pain
from osteoarthritis of the knee."
Sherwood noted that the current estimated
annual U.S. market for viscosupplementation
therapy is approximately $350 million.
The U.S. commercial launch for ORTHOVISC
is expected to take place in conjunction
with the annual meeting of the American
Academy of Orthopaedic Surgeons to
be held in San Francisco March 10-14,
2004. Designed to relieve pain and
stiffness and improve joint mobility,
ORTHOVISC has been marketed internationally
since 1996, and currently is sold
in Canada and various European and
Middle Eastern nations.
ORTHOVISC 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,
such as acetaminophen. It is a sterile,
non-pyrogenic, clear, viscoelastic
solution of hyaluronan contained in
a single-use syringe. ORTHOVISC consists
of high molecular weight, ultra-pure
natural hyaluronan dissolved in physiological
saline. A natural complex sugar of
the glycosaminoglycan family, hyaluronan
is a high molecular weight polysaccharide
composed of repeating disaccharide
units of sodium glucuronate and N-acetylglucosamine.
The hyaluronan is extracted from rooster
combs. ORTHOVISC is injected into
the knee joint in a series of intra-articular
injections one week apart.
The FDA approval of ORTHOVISC is based
on integrated effectiveness data from
two randomized, controlled, double-blind
multi-center Phase III U.S. clinical
studies encompassing a total of 458
patients suffering from OA of the
knee. Safety data from a third U.S.
trial were also included in the FDA
The objective of the studies was
to assess the effectiveness of ORTHOVISC
for the treatment of joint pain. Patients
were divided into three and four ORTHOVISC
injection regimen groups and two control
groups: arthrocentesis and saline
injection. Patients were evaluated
for improvement in pain as measured
by the Western Ontario and McMaster
Universities Osteoarthritis Index
(WOMAC) at four follow-up assessments
over weeks 7 through 22 of the studies.
The primary effectiveness analysis
compared the proportion of ORTHOVISC
patients achieving a greater improvement
from baseline in WOMAC pain score
versus controls. Patients in both
groups experienced a statistically
significant improvement as measured
by change in WOMAC pain scores. An
integrated safety analysis, which
included 562 patients treated with
ORTHOVISC, had an extremely low rate
of adverse events. There were no serious
adverse events associated with ORTHOVISC.
About Osteoarthritis (OA) of the
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
About Anika Therapeutics
Headquartered in Woburn, Mass., Anika Therapeutics,
develops, manufactures and commercializes therapeutic
products and devices intended to promote the repair,
protection and healing of bone, cartilage and soft tissue.
These products are based on hyaluronic acid (HA), a
naturally occurring, biocompatible polymer found throughout
the body's joints. In addition to ORTHOVISC®, Anika
markets HYVISC® in the U.S. for the treatment of
equine osteoarthritis through Boehringer Ingelheim Vetmedica,
Inc. and manufactures AMVISC® and AMVISC® Plus,
HA viscoelastic products for ophthalmic surgery, for
Bausch & Lomb. It also produces STAARVISCTM-II for
distribution by STAAR Surgical Company and ShellgelTM
for Cytosol Ophthalmics, Inc.
Anika Therapeutics, Inc.
Pondel Parsons & Wilkinson
Susan Klein, (508) 358-4315
Robert Whetstone, (310) 207-9300
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 "designed," "believe,"
"will," "expect," "look forward,"
"expand" and other expressions which are predictions
of or indicate future events and trends and which do
not constitute historical matters identify forward-looking
statements, including without limitation statements
regarding the Company's expectations and beliefs with
respect to growth in Canadian sales of ORTHOVISC or
the Canadian osteoarthritis market or Rivex's ability
to market and distribute ORTHOVISC. These statements
are based upon the current beliefs and expectations
of the Company's management and are subject to significant
risks and uncertainties. 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 the risk that (i) Rivex's aggressive
marketing efforts do not result in meaningful sales
in Canada, (ii) enactment of adverse government regulation,
(iii) competitive pressures among hyaluronic acid viscoelastic
products may increase significantly and have an effect
on pricing, or (iv) the strength of the Canadian economy.
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 Certain Factors Affecting Future Operating Results"
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, 2001, as well as those described in the Company's
other press releases and SEC filings.