SCHERING-PLOUGH 
By Canadian Approval Is World's First Regulatory Approval for SIMPONI
"This first approval marks a major milestone in the clinical development
program for SIMPONI," said
"This is the first approval for SIMPONI, one of the five stars in our
late-stage pipeline," said
Centocor Ortho Biotech Inc. developed and discovered SIMPONI and has
exclusive marketing rights to the product in
In
In
The approval of SIMPONI in
About Rheumatoid Arthritis
RA is a chronic and debilitating disease that affects approximately 4
million people in
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
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
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
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
SIMPONI (TM) is the trademark of Centocor Ortho Biotech Inc. used under license by Schering-Plough Canada Inc.
SOURCE Centocor Ortho Biotech Inc.; Schering-Plough Corporation
