Press Release
<p>FERRING PHARMACEUTICALS ANNOUNCES LAUNCH OF EUFLEXXA™ FOR OSTEOARTHRITIS KNEE PAIN</p>
<p><strong>Contact:</strong> Kelly Laban <strong>FOR IMMEDIATE RELEASE</strong><br/>
Kovak-Likly Communications<br/>
(203) 762-8833 x15 or KLaban@KLCpr.com </p>
<p>Ferring Pharmaceuticals launches EUFLEXXA™
(highly purified hyaluronan), a new treatment for the pain
caused by knee osteoarthritis that provides proven safety
and efficacy with more patients symptom-free at the end of
a 12-week study period than the leading therapy in its
class.*<br/>
<i>*Osteoarthritis and Cartilage; in press.</i> </p>
<p><strong>FERRING PHARMACEUTICALS ANNOUNCES LAUNCH OF EUFLEXXA™ FOR OSTEOARTHRITIS KNEE PAIN</strong><br/>
<strong>More Patients Treated with EUFLEXXA™ Symptom-Free at End of 12-Week Study Than Those Treated With the Leading Therapy in its Class</strong> </p>
<p>Suffern, NY – November 14, 2005 – Ferring Pharmaceuticals Inc. announced today the launch
of EUFLEXXA™ (highly purified hyaluronan) for the treatment of pain caused by knee
osteoarthritis (OA). It is the first and only non-avian* derived hyaluronic acid (HA) indicated for
a three-injection treatment regimen for patients who have failed to respond adequately to
conservative non-pharmacologic therapy and simple analgesics. At the end of a 12-week study,
significantly more patients treated with EUFLEXXA™ were symptom-free (p=0.038) than those
treated with Synvisc**, the leading HA product in its class.<sub>1</sub> </p>
<p>“EUFLEXXA™ is a new treatment option that can help millions of people who live with
painful knees,” said Wayne C. Anderson, president, Ferring Pharmaceuticals. “It is proven to
offer better drug-free symptom relief over a 12-week period than the current leading HA therapy.
Additonally, it offers proven safety and efficacy with significantly fewer joint effusions and less
use of simple analgesics than Synvisc. Not surprisingly, patients reported higher satisfaction
with EUFLEXXA™.” </p>
<p><strong>Clinical Advantages</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).
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.<sub>1</sub><br/>
EUFLEXXA™ also showed a significant advantage over Synvisc in the number of
patients requiring supplemental simple analgesics (p=0.013), joint effusion (p=0.0015) 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).<sub>1</sub> </p>
<p><strong>About EUFLEXXA™</strong><br/>
EUFLEXXA™ is the first and only non-avian derived hyaluronic acid approved in the
U.S. for the treatment of pain caused by knee osteoarthritis. Since it is not derived from an
avian source (chicken or rooster combs), the risk of related reactions is eliminated.2,3 In
addition, the process used to manufacture EUFLEXXA™ results in ultra-high-purity HA with
properties similar to the HA in human synovial fluid. EUFLEXXA™ is also free of chemical crosslinking
which minimizes the risk of related reactions.<sub>2-7</sub> </p>
<p>EUFLEXXA™ received approval from the U.S. Food and Drug Administration (FDA) on
December 3, 2004, and is also approved in Israel and the European Union. Ferring acquired
the product in July 2005 as part of its acquisition of the global biologics manufacturing business
of Savient Pharmaceuticals, Inc. </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.8 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.9 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 knee OA, including behavior
modification, drug therapy, injections within the joint and knee replacement surgery.
Non-steroidal anti-inflammatory drugs (NSAIDs) are common first-line pharmacologic
treatments for knee pain relief. Serious side effects and risks (ie. 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><strong>About Ferring Pharmaceuticals Inc.</strong><br/>
Ferring Pharmaceuticals Inc., part of the Ferring Group, is a privately owned,
international pharmaceutical company. Ferring’s line of orthopaedic and urology products
include 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.
The Ferring Group specializes in the research, development and commercialization of
compounds in general and pediatric endocrinology, urology, gastroenterology,
obstetrics/gynecology and infertility. For more information, visit www.FerringUSA.com. </p>
<p># # #<br/>
* Derived through bacterial fermentation<br/>
** Synvisc is a registered trademark of Genzyme Corporation. </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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