Wednesday August 13 8:10 AM EDT
Company Press Release
Innovative New Treatment for Osteoarthritis of the Knee Receives FDA
Clearance
RADNOR, Penn.--(BUSINESS WIRE)--Aug. 13, 1997--
Breakthrough technology closely simulates the normal properties
of shock-absorbing joint fluid
Synvisc(R), a unique new treatment for pain due to osteoarthritis of the knee, has been cleared for marketing by the U.S. Food
and Drug Administration, Wyeth-Ayerst Laboratories, a division of American Home Products Corp. (NYSE:AHP), and
Biomatrix Inc. (NASDAQ:BIOX) announced today.
Synvisc(R), a non-pharmacological therapy derived from natural hyaluronan, represents an innovation in the treatment of
osteoarthritis (OA). Synvisc(R) was developed by Biomatrix to have physical properties comparable to those of healthy joint
(synovial) fluid. This new medical technology, viscosupplementation, represents the first new treatment modality for OA to be
introduced in 25 years.
Osteoarthritis, one of the leading causes of disability for Americans over age 50, leads to changes in hyaluronan, a natural
substance that helps provide the fluid within the joint with elasticity and viscosity. The goal of viscosupplementation is to
supplement and restore the natural elastic and viscous properties of the synovial joint fluid. Synvisc(R) is composed of modified
hyaluronan molecules called hylans, which are uniquely engineered to possess elasticity and viscosity comparable to healthy
young synovial fluid.
Synvisc(R) is used to relieve osteoarthritic knee pain in patients who do not get adequate relief from simple painkillers or from
exercise and physical therapy.
``Synvisc(R) helps meet a critical need in the treatment of osteoarthritis. It offers patients an advanced therapy that works
directly within the knee joint to address the pain and loss of function that drives patients to seek medical treatment,'' said
Charles Weiss, MD, chairman, Department of Orthopedic and Rehabilitative Medicine, Mt. Sinai Hospital, Miami, and Clinical
Professor of Orthopedic Surgery, University of Miami School of Medicine. ``In clinical use, a course of treatment consisting of
three injections has provided pain relief in some patients for up to six months or more.''
Robert Essner, president of Wyeth-Ayerst Laboratories, stated, ``The groundbreaking technology and exceptional clinical
results make Synvisc an important therapeutic advance in the treatment of osteoarthritis. As a leader in marketing arthritis
therapies, Wyeth-Ayerst Laboratories is well positioned to successfully introduce Synvisc(R) in the U.S.''
``I am extremely pleased that after three decades of research, development, and global clinical trials, Synvisc(R), a new therapy
for osteoarthritis of the knee, will soon be available in the U.S.,'' said Dr. Endres Balazs, co-founder, chief executive officer,
and chief scientific officer of Biomatrix Inc. ``Synvisc(R), an elastoviscous medical device developed by Biomatrix,
accomplished my goal of designing a product with physical properties comparable to those of healthy synovial fluid.''
Osteoarthritis is by far the most common form of arthritis. According to figures from the Centers for Disease Control and
Prevention, 15% of the U.S. population (37.9 million Americans) had arthritis in 1990, and nearly 3% (7.0 million Americans)
had arthritis as a major or contributing cause of activity limitation. The prevalence of osteoarthritis will increase as baby
boomers approach their mature years with the expectation of maintaining their active lifestyle. By 2020, the number of persons
with arthritis is expected to increase by 57% (to 59.4 million Americans). Activity limitation associated with arthritis is expected
to increase by 66% (to 11.6 million Americans).
Mild to moderate transient local reactions consisting mostly of knee pain and swelling at the site of injection have been
observed in clinical studies of Synvisc(R). Rare systemic adverse events have been reported that did not recur with repeat
injections in the same patients. Joint infections have been reported rarely. No cases of anaphylaxis or anaphylactoid reaction
have been reported.
About Wyeth-Ayerst Laboratories
Wyeth-Ayerst Laboratories is a major research-oriented pharmaceutical company with leading products in the areas of
women's health care, cardiovascular, and metabolic disease therapies, central nervous system drugs, anti-inflammatory agents,
vaccines, and generic pharmaceuticals. American Home Products is one of the world's largest research-based pharmaceutical
and health care products companies. It is a leader in the discovery, development, manufacturing and marketing of prescription
drugs and over-the-counter medications. It is also a leader in vaccines, biotechnology, agricultural products, animal health care
and medical devices.
About Biomatrix Inc.
Biomatrix Inc., headquartered in Ridgefield, N.J., is an international biomedical company that develops, manufactures and
commercializes viscoelastic products made from proprietary biological polymers called hylans, used in therapeutic medical
applications and in skin care products. Biomatrix Inc. currently markets Synvisc(R) in Canada and in Europe through
distribution agreements and direct sales. Wyeth-Ayerst Laboratories is the exclusive distributor of Synvisc(R) in the United
States. Synvisc(R) is a registered trademark of Biomatrix Inc.
The statements in this press release that are not historical facts are forward-looking statements that involve risks and
uncertainties including, without limitation, risks associated with the inherent uncertainty of pharmaceutical research, product
development and commercialization, the impact of competitive products, and patent and other risks and uncertainties, including
those detailed from time to time in AHP's and Biomatrix's periodic reports including quarterly reports on Form 10-Q and the
annual report on Form 10-K, filed with the Securities and Exchange Commission. Actual results may differ from the
forward-looking statements. |
