Press Release
<p>HEAD-TO-HEAD STUDY SHOWS EUFLEXXA™ HAS GREATER TOLERABILITY COMPARED TO SYNVISC<sup><sup>®</sup></sup> FOR OSTEOARTHRITIS KNEE PAIN</p>
<p><strong>CONTACT:</strong> Tara Fisher <strong>FOR IMMEDIATE RELEASE</strong><br/>
Kovak-Likly Communications<br/>
203-762-8833, tfisher@klcpr.com </p>
<p><strong>HEAD-TO-HEAD STUDY SHOWS EUFLEXXA™ HAS GREATER TOLERABILITY COMPARED TO SYNVISC<sup>®</sup> FOR OSTEOARTHRITIS KNEE PAIN</strong><br/>
<strong>Significantly More Patients Symptom-Free, Lower Incidence of Joint Effusions</strong> </p>
<p>Suffern, NY – February 13, 2006 – An important head-to-head study has demonstrated the
efficacy and greater tolerability of EUFLEXXA™ (highly purified hyaluronan) compared to Synvisc<sup>®</sup>*,
an avian-derived hyaluronan and the leading hyaluronic acid (HA) product in its class for the
treatment of osteoarthritis (OA) knee pain.1 In the 12-week trial of 321 patients, EUFLEXXA™
showed statistically significant advantages over Synvisc: more patients treated with EUFLEXXA™
were symptom-free (p=0.038), there was a lower incidence of joint effusion (p=0.0015), fewer
patients required supplemental simple analgesics (p=0.013), and more patients reported being
“very satisfied” (p=0.03). The study was published in the February 2006 issue of <i>Osteoarthritis
and Cartilage</i>. </p>
<p>EUFLEXXA™ is the first and only hyaluronic acid (HA) approved in the U.S. for the treatment
of the pain of knee osteoarthritis that is not derived from an avian source** (chicken or
rooster combs). This eliminates the risk of related reactions.2,3 EUFLEXXA™ is a three-injection
treatment regimen indicated for patients who have failed to respond adequately to conservative
non-pharmacologic therapy and simple analgesics. The goal of HA therapy is to reduce pain and
improve physical function by replenishing the HA in human synovial fluid (fluid in joints). In
OA, this fluid becomes thinner, leading to a decrease in elasticity and viscosity. </p>
<p>“This study shows that EUFLEXXA™ offers better symptom-free relief from OA pain over a 12-week
period than the market-leading HA therapy with less use of simple analgesics,” said Wayne Anderson,
President, Ferring Pharmaceuticals Inc. “For the growing number of Americans who live with the pain
caused by knee osteoarthritis, this study demonstrates the greater tolerability of EUFLEXXA™
compared to the leading therapy in its class.” </p>
<p><strong>About the Study</strong><br/>
In a prospective, multicenter, randomized, double-blind controlled trial, 321 patients
with confirmed knee osteoarthritis were randomized to treatment with either EUFLEXXA™ (n=160)
or Synvisc (n=161). The Western Ontario McMaster Universities Osteoarthritis (WOMAC) Index
pain subscale was the primary efficacy measure. Both products were administered as a course
of three weekly injections, with follow-up evaluations at weeks 3, 6 and 12. Both treatment
groups experienced statistically significant improvements from baseline (p=0.0001). </p>
<p>EUFLEXXA™ (WOMAC pain score = 29.8 mm (-61.6%)) was shown to be comparable in efficacy to Synvisc (WOMAC
pain score = 28.8 mm (-54.9%)).1 At the study endpoint, 63% of patients treated with EUFLEXXA™
were symptom-free compared with 52% of those treated with Synvisc (p=0.038), as determined by a
VAS (100-mm visual analog scale) score of <20 for the average of the five WOMAC pain questions. <sup>1</sup> </p>
<p>EUFLEXXA™ also showed a significant advantage over Synvisc in the number of joint effusions
(p=0.0015), patients requiring supplemental simple analgesics (p=0.013), and patient satisfaction
(p=0.03). For patient satisfaction, 50% of EUFLEXXA™ patients were ‘very satisfied’ with treatment
results compared to 37% for the Synvisc group. A subanalysis performed on patients with unilateral
OA found that only 49% of patients treated with EUFLEXXA™ used supplemental simple analgesics compared
to 82% of those treated with Synvisc (p=0.001). <sup>1</sup> </p>
<p><strong>About EUFLEXXA™</strong><br/>
EUFLEXXA™ (1% sodium hyaluronate) is the <b>first and only</b> non-avian-derived hyaluronic acid
approved in the U.S. for the treatment of pain caused by knee osteoarthritis. The process
used to manufacture EUFLEXXA™ results in ultra-high-purity HA with properties similar to the HA in
healthy human synovial fluid. EUFLEXXA™ is also free of chemical cross-linking, which minimizes the
risk of related reactions.<sup>2-7</sup> </p>
<p>EUFLEXXA™ received approval from the U.S. Food and Drug Administration (FDA) on December
3, 2004, and became available to the public on November 8, 2005. For more information,
visit www.EUFLEXXA.com. </p>
<p><strong>About Hyaluronic Acid</strong><br/>
HA is a viscous, elastic liquid that is naturally found in many tissues of the body and in
high concentrations in joint cartilage and synovial fluid. Within a joint, HA is essential to water
balance, viscosity, lubrication and the structure of cartilage.<sup>8</sup> In cartilage, HA binds to other
molecules, helping it withstand weight-bearing force and movement of the joint. Inside the knee
joint, HA provides a cushion to protect the joint from mechanical damage and acts as both
a shock-absorbing fluid and regulator of water and metabolites. </p>
<p><strong>Osteoarthritis and the General Population</strong><br/>
The Arthritis Foundation estimates that 66 million Americans
are affected by arthritis, half of whom are unaware of available treatments, and that
the disease costs the U.S. economy more than $86.2 billion annually. The Foundation
also estimates that 21 million American adults suffer from osteoarthritis.<sup>9</sup> Osteoarthritis,
a form of arthritis, affects certain parts of the body, most commonly the knee. Over time,
articular cartilage in the knee loses elasticity and becomes worn. As a result, the bony
surfaces of the joint can grind together and eventually wear the cartilage away entirely.
This leads to symptoms of pain, stiffness and impaired joint movement. There are a wide range
of treatment options for the pain of knee OA, including behavior modification, drug therapy,
injections within the joint and knee replacement surgery. </p>
<p>Non-steroidal anti-inflammatory drugs (NSAIDs) are common first-line pharmacologic treatments
for knee pain relief. Serious side effects and risks (i.e. potentially life-threatening stomach
bleeding and kidney disease) have been associated with such treatments. The effectiveness of
different treatments varies from person-to-person and with the severity of the condition.
Treatment options are generally a shared decision between the patient and his/her physician
with total knee replacement surgery usually sought as the last option. </p>
<p>About Ferring Pharmaceuticals Inc.
Ferring Pharmaceuticals Inc., part of the Ferring Group, is a privately owned,
international pharmaceutical company. Ferring’s line of orthopaedic and urology
products includes EUFLEXXA™, hyaluronic acid for the treatment of pain from
osteoarthritis of the knee and degarelix for prostate cancer (Phase III). </p>
<p>Ferring also markets MENOPUR<sup>®</sup> (menotropins for injection, USP), BRAVELLE<sup>®</sup>
(urofollitropin for injection, purified), REPRONEX<sup>®</sup> (menotropins for injection, USP) and
NOVAREL<sup>®</sup> (chorionic gonadotropin for injection, USP) in the U.S. to infertility specialists and
their patients. Ferring offers the Q·CAP™, the first and only needle-free reconstitution device, for use with its fertility treatments. </p>
<p>Other products include ACTHREL<sup>®</sup> (corticorelin ovine triflutate for injection) for the
differential diagnosis of Cushing’s syndrome and generic desmopressin acetate in injectable
and rhinal tube forms for the treatment of diabetes insipidus and primary nocturnal enuresis. </p>
<p># # #<br/>
* Synvisc is a registered trademark of Genzyme Corporation.<br/>
** Derived through bacterial fermentation </p>
EUFLEXXA (1% sodium hyaluronate) is used to relieve knee pain due to osteoarthritis. It is used in people who do not get enough relief from simple pain medications such as acetaminophen or from exercise and physical therapy.
Important Safety Information
You should not receive this product if you have had any previous allergic reaction to EUFLEXXA or hyaluronan products. You should not have an injection into the knee if you have a knee joint infection or if you have skin disease or infection around the injection site.
EUFLEXXA is only for injection into the knee performed by a qualified doctor. After you receive this injection you may need to avoid activities such as jogging, tennis, heavy lifting, or standing on your feet for a long time (more than one hour). The safety and effectiveness of repeat treatment cycles of EUFLEXXA have not been established. The safety and effectiveness of EUFLEXXA have not been shown in people under 18 years of age.
Side effects sometimes seen when EUFLEXXA is injected into the knee joint were pain, swelling, skin irritation, and tenderness and these were generally mild and did not last long.
Please see Full Prescribing Information.
Please see Important Information for Patients.
PLEASE CONSULT WITH YOUR DOCTOR, OR OTHER QUALIFIED HEALTH CARE PROFESSIONAL BEFORE USING ANY PRODUCT DISCUSSED WITHIN THIS WEB SITE.
This website is intended only for US residents.
Euflexxa® is a registered trademark of Ferring Pharmaceuticals Inc.
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