Centocor, Inc. announced
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 sec, jnj 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.
Centocor, Inc.
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