Centocor, Inc. Submits Application to FDA Requesting Approval of Golimumab for the Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis
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Extensive Clinical Development Program Investigating Golimumab in the Treatment of These Diseases Serves as Basis for the Application HORSHAM, Pa., June 27
HORSHAM, Pa., June 27 /PRNewswire/ -- Centocor, Inc. announced today that
a Biologics License Application (BLA) has been submitted to the U.S. Food and
Drug Administration (FDA) requesting the approval of golimumab (CNTO 148) as a
monthly subcutaneous treatment for adults with active forms of rheumatoid
arthritis, psoriatic arthritis and ankylosing spondylitis. Golimumab,
Centocor's next-generation human anti-TNF-alpha monoclonal antibody, is being
studied as an every four week subcutaneous injection and is also being studied
as an intravenous (IV) infusion therapy. In February 2008, Centocor submitted
a Marketing Authorization Application (MAA) to the European Medicines Agency
(EMEA) requesting the approval of golimumab as a monthly subcutaneous
treatment for the same indications.
"This submission marks a major milestone in the clinical development
program of golimumab, and we look forward to working with the FDA to bring
golimumab to market," said Jerome A. Boscia, M.D., senior vice president,
Clinical R&D, Centocor, Inc. "We remain focused on our commitment to
innovation in the field of biomedicines, to addressing the ongoing needs of
patients living with these debilitating diseases and to physicians in need of
additional therapeutic options to effectively treat their patients."
Five pivotal Phase 3 trials support the BLA, which include the GOlimumab
Before Employing methotrexate as the First-line Option in the treatment of
Rheumatoid arthritis of Early onset (GO-BEFORE) study; the GOlimumab FOR
subjects With Active RA Despite MTX (GO-FORWARD) study; and A Multicenter,
Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Human
Anti-TNF-alpha Monoclonal Antibody, Administered Subcutaneously in Subjects
with Active Rheumatoid Arthritis and Previously Treated with Biologic
Anti-TNF-alpha Agent(s) (GO-AFTER) study were recently presented at the
European League Against Rheumatism Annual Congress. In November 2007, primary
endpoint study findings from the Golimumab - A Randomized Evaluation of Safety
and Efficacy in Subjects with Psoriatic Arthritis Using a Human Anti-TNF
Monoclonal Antibody (GO-REVEAL) trial and the Golimumab - A Randomized Study
in Ankylosing Spondylitis Subjects of a Novel Anti-TNF mAB Injection (SC)
Given Every Four Weeks (GO-RAISE) trial were reported at the American College
of Rheumatology Annual Scientific Meeting.
About Rheumatoid Arthritis
Rheumatoid arthritis (RA) is a chronic and debilitating disease that
affects approximately 1.3 million people in the United States and more than
three million people in Europe. Signs and symptoms of RA include pain,
stiffness and motion restriction in multiple joints. Because RA is a
progressive disease, it can cause permanent joint deformity and severe
disability if not diagnosed early or if initial treatment is delayed. RA can
occur at any age, but is most common in adults 30-50 years old and is
two-to-three times more prevalent in women than in men. The cause of RA is
unknown, although genetic factors may contribute to the disease.
About Psoriatic Arthritis
Psoriatic arthritis is a chronic inflammatory arthropathy manifesting with
joint pain and swelling that can lead to joint destruction and debilitation.
It is frequently associated with inflamed, scaly, red patches of skin
psoriasis and psoriasis nail involvement. Symptoms may include stiffness and
tenderness of the joints and surrounding tissue and reduced range of motion.
Joints of the hands, wrists, knees, ankles, feet, lower back and neck are
commonly affected. Psoriasis affects an estimated two to three percent of the
world's population, and approximately one out of three patients affected by
psoriasis may develop psoriatic arthritis. Both men and women are equally
affected by psoriatic arthritis, most commonly between the ages 30 and 50, in
the peak of their productive years.
About Ankylosing Spondylitis
Ankylosing spondylitis (AS) is a painful and progressive form of spinal
arthritis and symptoms of inflammatory back pain often first present in people
before age 35. It typically begins in the late teens and early twenties and
in severe cases may result in fusing spinal vertebrae and may cause structural
damage to hips and other joints. Often misdiagnosed as "just back pain" or
undifferentiated arthritis, AS is a systemic inflammatory disease that, in
addition to its effect on the spine, can affect internal organs, peripheral
joints and vision. The Arthritis Research Campaign estimates that on the
European continent, AS prevalence ranges from 0.2 to 1 percent of the entire
population. The Spondylitis Association of America estimates that between
350,000 and one million people in the U.S. suffer from ankylosing spondylitis.
About Golimumab
Golimumab, Centocor, Inc.'s next-generation human anti-tumor necrosis
factor (TNF)-alpha monoclonal antibody, is currently in the most comprehensive
Phase 3 development program to date for an anti-TNF-alpha biologic therapy.
With ongoing studies for the treatment of rheumatoid arthritis, psoriatic
arthritis and ankylosing spondylitis, golimumab is being studied as an every
four week subcutaneous injection and an intravenous (IV) infusion therapy.
Golimumab targets and neutralizes both the soluble and membrane-bound forms of
TNF-alpha.
Centocor discovered golimumab and has exclusive marketing rights to the
product in the United States. Pending regulatory approval, Schering-Plough
will assume exclusive marketing rights outside the United States except in
Japan, Indonesia and Taiwan where golimumab will be co-marketed by Mitsubishi
Tanabe Pharma Corporation and Janssen Pharmaceutical Kabushiki Kaisha; Hong
Kong, where golimumab will be exclusively marketed by Janssen-Cilag; and China
where golimumab will be exclusively marketed by Xian-Janssen.
About Centocor, Inc.
Centocor is harnessing the power of world-leading research and
biomanufacturing to deliver innovative biomedicines that transform patients'
lives. Centocor has already brought innovation to the treatment of adult and
pediatric Crohn's disease, rheumatoid arthritis, ankylosing spondylitis,
psoriatic arthritis, ulcerative colitis and psoriasis.
The world leader in monoclonal antibody production and technology,
Centocor has brought critical biologic therapies to patients suffering from
debilitating immune disorders. Centocor is a wholly-owned subsidiary of
Johnson & Johnson.
CENTOCOR DISCLOSURE NOTICE: This press release contains "forward-looking
statements" as defined in the Private Securities Litigation Reform Act of
1995. These statements are based on current expectations of future events.
If underlying assumptions prove inaccurate or unknown risks or uncertainties
materialize, actual results could vary materially from Centocor's expectations
and projections. Risks and uncertainties include general industry conditions
and competition; economic conditions, such as interest rate and currency
exchange rate fluctuations; technological advances and patents attained by
competitors; challenges inherent in new product development, including
obtaining regulatory approvals; domestic and foreign health care reforms and
governmental laws and regulations; and trends toward health care cost
containment. A further list and description of these risks, uncertainties and
other factors can be found in Exhibit 99 of Johnson & Johnson's Annual Report
on Form 10-K for the fiscal year ended December 30, 2007. Copies of this Form
10-K, as well as subsequent filings, are available online at www.sec.gov,
www.jnj.com or on request from Johnson & Johnson. Centocor does not undertake
to update any forward-looking statements as a result of new information or
future events or developments.
SOURCE Centocor, Inc.
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PR Newswire. All rights reserved.
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