Canadian Approval Is World's First Regulatory Approval for SIMPONI
HORSHAM, Pa. and KENILWORTH, N.J., April 13 /PRNewswire-FirstCall/
Centocor Ortho Biotech Inc. and Schering-Plough Corporation (NYSE: SGP) today
announced that Health Canada has granted approval of SIMPONI (TM) (golimumab)
as a once-monthly, subcutaneous therapy for the treatment of moderately to
severely active rheumatoid arthritis (RA), active psoriatic arthritis (PsA)
and active ankylosing spondylitis (AS). With this approval in Canada,
SIMPONI, in combination with methotrexate (MTX), is indicated for reducing the
signs and symptoms in adult patients with moderately to severely active RA;
reducing signs and symptoms in adult patients with moderately to severely
active PsA, alone or in combination with MTX; and reducing signs and symptoms
in adult patients with active AS who have had an inadequate response to
conventional therapies. SIMPONI is the first biologic therapy to be approved
concurrently in three distinct rheumatologic diseases. Schering-Plough
anticipates that the medication will become available in Canada in the second
half of 2009.
"This first approval marks a major milestone in the clinical development
program for SIMPONI," said Jerome A. Boscia, M.D., senior vice president,
Clinical R&D, Centocor Research & Development, Inc. "More importantly, the
approval of SIMPONI expands the therapeutic options for physicians and offers
patients an effective new medication that can be self-administered once
monthly."
"This is the first approval for SIMPONI, one of the five stars in our
late-stage pipeline," said Thomas P. Koestler, Ph.D., executive vice
president, Schering-Plough Corporation and president, Schering-Plough Research
Institute. "Offering once-monthly subcutaneous dosing, SIMPONI will provide
an important and convenient new treatment option to rheumatologists and their
patients. SIMPONI expands our leading immunology franchise in meeting the
needs of the rheumatology community."
Centocor Ortho Biotech Inc. developed and discovered SIMPONI and has
exclusive marketing rights to the product in the United States. Following
regulatory approvals, Schering-Plough will assume exclusive marketing rights
outside the United States except in Japan, Indonesia and Taiwan, where SIMPONI
will be co-marketed by Mitsubishi Tanabe Pharma Corporation and Janssen
Pharmaceutical Kabushiki Kaisha; Hong Kong, where SIMPONI will be exclusively
marketed by Janssen-Cilag; and China, where SIMPONI will be exclusively
marketed by Xian-Janssen.
In March 2008, Centocor Ortho Biotech Inc. and Schering-Plough Corporation
announced that a Marketing Authorization Application (MAA) had been submitted
to the European Medicines Agency (EMEA) requesting the approval of golimumab
as a monthly subcutaneous treatment for adults with RA, PsA and AS.
In June 2008, Centocor Ortho Biotech Inc. announced that a Biologics
License Application (BLA) had been submitted to the U.S. Food and Drug
Administration (FDA) requesting the approval of golimumab as a monthly
subcutaneous treatment for adults with active forms of RA, PsA and AS.
The approval of SIMPONI in Canada is based on data from five pivotal
clinical trials: GO-BEFORE, GO-FORWARD, GO-AFTER, GO-REVEAL and GO-RAISE. Each
trial found SIMPONI to be effective in reducing the signs and symptoms of RA,
PsA and AS.
About Rheumatoid Arthritis
RA is a chronic and debilitating disease that affects approximately 4
million people in Canada. Signs and symptoms of RA include pain, stiffness and
motion restriction in multiple joints. Because RA is a progressive disease,
over time it can cause permanent joint deformity and severe disability. 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
over time. 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 is a painful and progressive form of spinal
arthritis, and symptoms of inflammatory back pain often first present in
people under the age of 35 years. It typically begins in the late teens and
early twenties, and in severe cases can result in fusing of the spinal
vertebrae and cause structural damage to hips and other joints. Often
misdiagnosed as "just back pain" or undifferentiated arthritis, ankylosing
spondylitis is a systemic inflammatory disease that, in addition to its effect
on the spine, can affect internal organs, peripheral joints and vision.
About SIMPONI
SIMPONI is a human monoclonal antibody that targets and neutralizes excess
TNF-alpha, a protein that when overproduced in the body due to chronic
inflammatory diseases can cause inflammation and damage to bones, cartilage
and tissue. The first once-monthly subcutaneous anti-TNF-alpha therapy,
SIMPONI is approved in Canada for the treatment of moderately to severely
active rheumatoid arthritis, active psoriatic arthritis and active ankylosing
spondylitis, and is available either through the SIMPONI SmartJect auto
injector or a prefilled syringe. SIMPONI is also being studied as an
intravenous infusion therapy for the treatment of rheumatoid arthritis.
In Canada, SIMPONI is approved for:
-- In combination with methotrexate (MTX), reducing signs and symptoms in
adult patients with moderately to severely active rheumatoid arthritis.
-- Reducing signs and symptoms in adult patients with moderately to
severely active psoriatic arthritis, alone or in combination with MTX.
SIMPONI can be used in combination with MTX in patients who do not
respond adequately to MTX alone.
-- Reducing signs and symptoms in adult patients with active ankylosing
spondylitis who have had an inadequate response to conventional
therapies.
Important Safety Information
SIMPONI is contraindicated in patients with severe infections such as
sepsis, tuberculosis and opportunistic infections and in patients who are
hypersensitive to golimumab, latex or any of the excipients. Serious
infections, including sepsis, pneumonia, tuberculosis, invasive fungal and
other opportunistic infections have been observed with the use of TNF
antagonists including SIMPONI. Some of these infections have been fatal.
SIMPONI should not be given to patients with a clinically important, active
infection (chronic or localized). Caution should be exercised when
considering the use of SIMPONI in patients with a chronic infection or a
history of recurrent infection. Patients should be monitored for signs and
symptoms of infection while on or after treatment with SIMPONI. If a patient
develops a serious infection or sepsis, SIMPONI therapy should be
discontinued. Patients should be advised of and avoid exposure to potential
risk factors for infection as appropriate. For patients who have resided in
or traveled to regions where invasive fungal infections such as
histoplasmosis, coccidioidomycosis, or blastomycosis are endemic, the benefits
and risks of SIMPONI treatment should be carefully considered before
initiation of SIMPONI therapy. Patients must be evaluated for the risk of
tuberculosis, including latent tuberculosis, prior to initiation of SIMPONI.
Treatment of latent tuberculosis infection should be initiated prior to
therapy with SIMPONI. Antituberculosis therapy prior to initiating SIMPONI
should also be considered in patients who have several or highly significant
risk factors for tuberculosis infection and have a negative test for latent
tuberculosis. Patients receiving SIMPONI should be monitored closely for
signs and symptoms of active tuberculosis during and after treatment,
including patients who tested negative for latent tuberculosis infections.
The use of TNF blocking agents has been associated with reactivation of
hepatitis B virus in patients who are chronic carriers of the virus. Chronic
carriers of hepatitis B should be appropriately evaluated and monitored prior
to the initiation of, during treatment with, and for several months following
discontinuation of SIMPONI.
Lymphomas have been observed in patients treated with TNF blocking agents,
including SIMPONI. The incidence of non-lymphoma malignancies was similar to
controls, and lymphoma is seen more often than in the general population. The
potential role of TNF-blocking therapy in the development of malignancies is
not known. Caution should be exercised when considering TNF-blocking therapy
for patients with a history of malignancy or when considering continuing
treatment in patients who develop malignancy.
Worsening congestive heart failure (CHF) and new onset CHF have been
reported with TNF blockers. Cases of CHF in patients with known cardiovascular
risk factors have been observed with SIMPONI. SIMPONI should be used with
caution in patients with heart failure and should be discontinued if new or
worsening symptoms of heart failure appear. TNF-blocking agents, including
SIMPONI, have been associated in rare cases with demyelinating disease. The
benefits and risks of anti-TNF treatment should be carefully considered before
initiation of SIMPONI therapy in patients with pre-existing or recent onset of
demyelinating disorders. Treatment with SIMPONI may result in the formation
of auto-antibodies and, rarely, in the development of a lupus-like syndrome.
Women of childbearing potential must use adequate contraception to prevent
pregnancy and continue its use for at least 6 months after the last SIMPONI
treatment.
The most common adverse drug reaction reported from clinical trials was
upper respiratory tract infection (7.2 percent of SIMPONI-treated patients
compared with 5.8 percent in control-treated patients). In controlled Phase 3
trials through Week 16 in RA, PsA and AS, 5.8 percent of SIMPONI treated
patients had injection site reactions compared with 2.2 percent in
control-treated patients. The majority of the injection site reactions were
mild and moderate, and the most frequent manifestation was injection site
erythema.
About Centocor Ortho Biotech Inc.
Centocor Ortho Biotech Inc. redefines the standard of care in immunology,
nephrology, and oncology. The company was created when Ortho Biotech Inc.
merged into Centocor, Inc., and Centocor, Inc. was renamed Centocor Ortho
Biotech Inc. Built upon a pioneering history, Centocor Ortho Biotech Inc.
harnesses innovations in large-molecule and small-molecule research to create
important new therapeutic options. Beyond its innovative medicines, Centocor
Ortho Biotech is at the forefront of developing education and public policy
initiatives to ensure patients and their families, caregivers, advocates, and
healthcare professionals have access to the latest treatment information,
support services, and quality care. Centocor Ortho Biotech is a wholly-owned
subsidiary of Johnson & Johnson.
(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 Ortho Biotech Inc. and/or Johnson &
Johnson'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 28,
2008. 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.
Neither Centocor Ortho Biotech Inc. nor Johnson & Johnson undertake to update
any forward-looking statements as a result of new information or future events
or developments.)
About Schering-Plough
Schering-Plough is an innovation-driven, science-centered global health
care company. Through its own biopharmaceutical research and collaborations
with partners, Schering-Plough creates therapies that help save and improve
lives around the world. The company applies its research-and-development
platform to human prescription and consumer products as well as to animal
health products. Schering-Plough's vision is to "Earn Trust, Every Day" with
the doctors, patients, customers and other stakeholders served by its
colleagues around the world. The company is based in Kenilworth, N.J., and
its Web site is www.schering-plough.com.
SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press release
includes certain "forward-looking statements" within the meaning of the
Private Securities Litigation Reform Act of 1995, including statements
relating to the potential market for SIMPONI.
Forward-looking statements relate to expectations or forecasts of future
events. Schering-Plough does not assume the obligation to update any
forward-looking statement. Many factors could cause actual results to differ
materially from Schering-Plough's forward-looking statements, including market
forces, economic factors, product availability, patent and other intellectual
property protection, current and future branded, generic or over-the-counter
competition, the regulatory process, and any developments following regulatory
approval, among other uncertainties. For further details about these and
other factors that may impact the forward-looking statements, see
Schering-Plough's Securities and Exchange Commission filings, including Item
1A. "Risk Factors" in Schering-Plough's 2008 10-K, filed February 27, 2009.
SIMPONI (TM) is the trademark of Centocor Ortho Biotech Inc. used under
license by Schering-Plough Canada Inc.
