New SIMPONI(TM) Data Show Long-Term Efficacy in Treatment of Rheumatoid Arthritis

Mon Oct 19, 2009 8:05am EDT

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New SIMPONI(TM) Data Show Long-Term Efficacy in Treatment of Rheumatoid
Arthritis
Patients with Active Rheumatoid Arthritis Receiving SIMPONI Demonstrated
Sustained Improvements in Signs and Symptoms Through One Year

PHILADELPHIA, Oct. 19 /PRNewswire/ -- New long-term data from two pivotal,
Phase 3 clinical trials showed that patients with active rheumatoid arthritis
(RA) receiving SIMPONI(TM) (golimumab) every four weeks achieved sustained
improvements in signs and symptoms and physical function response through one
year.  These new data were presented today at the 2009 American College of
Rheumatology (ACR) Annual Scientific Meeting.


"New data demonstrate sustained efficacy of golimumab dosed every four weeks
in patients with RA who were previously treated with anti-TNF agents," said
Dr. Jonathan Kay, Professor of Medicine and Director of Clinical Research in
the Rheumatology Division at the University of Massachusetts Medical School in
Worcester, Massachusetts and lead study investigator.


Findings from the GOlimumab After Former anti-TNF Therapy Evaluated in RA
(GO-AFTER) study demonstrated that patients with RA previously treated with
adalimumab, etanercept or infliximab responded to, and maintained response to,
SIMPONI through one year.  At week 52, 63 percent of patients receiving
SIMPONI 50 mg achieved at least a 20 percent improvement in arthritis signs
and symptoms as measured by American College of Rheumatology (ACR 20)
response, and 41 percent achieved a 50 percent improvement in arthritis signs
and symptoms as measured by ACR 50 response.


SIMPONI-treated patients who had discontinued previous anti-TNF treatment for
any reason sustained improvements in physical function, as measured by the
Health Assessment Questionnaire (HAQ).  At week 52, patients receiving SIMPONI
50 mg maintained a clinically relevant improvement (decrease in HAQ score of
at least 0.25) from baseline. Similar results were previously reported at week
24.  HAQ assesses the degree of difficulty a person has in accomplishing tasks
in eight functional areas (dressing, arising, eating, walking, hygiene,
reaching, gripping and other activities of daily living). The data also showed
that 81 percent and 61 percent of patients receiving SIMPONI 50 mg reported
improvements from baseline in the number of tender and swollen joints,
respectively.


Results from the GOlimumab FOR subjects With Active RA Despite Methotrexate
(GO-FORWARD) study showed the efficacy of SIMPONI in patients with active RA
despite prior treatment with methotrexate.  At week 52, 64 percent of patients
taking SIMPONI 50 mg plus methotrexate achieved ACR 20 response, and 25
percent achieved a 70 percent improvement in arthritis signs and symptoms as
measured by ACR 70 response.  There was no clear evidence of improved ACR
response with the higher SIMPONI dose group (100 mg). Importantly,
investigators also reported that 48 percent of patients receiving SIMPONI 50
mg plus methotrexate achieved a low level of disease activity as measured by
Disease Activity Score 28 (DAS 28) C-reactive protein (CRP) <2.6, which
measures tender and swollen joints, inflammation and overall disease activity
including measurement of serum CRP levels.


"These data show that patients receiving golimumab, a once-monthly anti-TNF
therapy, sustained clinical response through one year," said Dr. Mark
Genovese, Division Co-Chief of Immunology and Rheumatology at Stanford
University and study investigator.


In April 2009, the U.S. Food and Drug Administration (FDA) and Health Canada
approved SIMPONI 50 mg as a once-monthly subcutaneous injection for the
treatment of moderately to severely active RA, active psoriatic arthritis
(PsA) and active ankylosing spondylitis.  In October   2009, the European
Commission approved SIMPONI as a once-monthly, subcutaneous injection for the
treatment of moderate to severe, active RA, active and progressive PsA and
severe, active ankylosing spondylitis.


About the GO-AFTER Trial
GO-AFTER is the first placebo-controlled, double-blind, Phase 3 registration
trial that demonstrates the efficacy and safety of an anti-TNF-alpha agent in
patients previously treated with other anti-TNFs.  The trial included patients
with active RA of 8.65 years mean duration. Discontinuation of previous
anti-TNF-alpha therapy was to occur at least eight to 12 weeks prior to
enrollment in the study.  At baseline, 66 percent of patients were receiving
methotrexate; five percent and eight percent of patients were receiving
sulfasalazine and hydroxychloroquine, respectively.  Patients continued to
receive stable doses of methotrexate, sulfasalazine and/or hydroxychloroquine
if receiving them at baseline.  At week 16, patients with less than a 20
percent improvement in tender and swollen joint counts were entered into a
double-blinded early escape.  Those who did not achieve ACR 20 response at
week 16 while taking placebo were given SIMPONI 50 mg every four weeks.  Those
who qualified for early escape and had been taking SIMPONI 50 mg were given
SIMPONI 100 mg and those who had been receiving SIMPONI 100 mg continued to
receive that dosing.


At least one adverse event was reported in 76 percent of patients receiving
SIMPONI 50 mg or SIMPONI 100 mg with 13 and eight percent of patients,
respectively, experiencing a serious adverse event.  Serious infections were
reported in four percent of patients receiving SIMPONI 50 mg and three percent
of patients taking SIMPONI 100 mg, and injection site reactions were reported
in one percent and two percent of patients, respectively.


About the GO-FORWARD Trial
GO-FORWARD, a Phase 3, multi-center clinical trial, includes adult patients
with active RA and more than four tender and swollen joints, despite
methotrexate therapy.  Patients were randomly assigned to receive SIMPONI (50
or 100 mg) plus methotrexate, SIMPONI 100 mg plus placebo or placebo plus
methotrexate at weeks 0, 4, 8, 12, 16 and 20.  At week 16, patients with at
least a 20 percent response (ACR 20) were entered into an early escape and
patients who had been receiving placebo plus methotrexate received SIMPONI 50
mg plus methotrexate; methotrexate was added to the SIMPONI 100 mg with
placebo group, the group receiving SIMPONI 50 mg plus methotrexate was given
SIMPONI 100 mg and the SIMPONI 100 mg plus methotrexate group was not changed.
 The patients continued receiving treatment through 52 weeks.


Serious adverse events were reported in 11, 17, 14 and 18 percent of patients
in each group, respectively, and two, six, two and eight percent of patients,
in each group respectively, experienced a serious infection.  From week 24
through week 52, nine serious infections were reported; three in patients
receiving SIMPONI 50 mg plus methotrexate, four in patients receiving SIMPONI
100 mg plus placebo and two in patients taking SIMPONI 100 mg plus
methotrexate.  There were also four malignancies reported between week 24 and
week 52; two patients receiving SIMPONI 50 mg plus methotrexate were diagnosed
with squamous and basal cell cancer and breast cancer, respectively, and two
patients receiving SIMPONI 100 mg plus methotrexate were diagnosed with basal
cell cancer and breast cancer, respectively.


About Rheumatoid Arthritis
Rheumatoid arthritis is characterized by persistent and progressive joint
inflammation, causing pain, stiffness and functional disability.  The
Arthritis Foundation estimates that approximately 1.3 million people in the
United States are affected by RA.  For more information, visit the Arthritis
Foundation.


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 for the treatment of RA, PsA and ankylosing spondylitis in
the United States, Europe and Canada, and is available either through the
SIMPONI SmartJect autoinjector or a prefilled syringe. For more information
about SIMPONI, visit www.SIMPONI.com.


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.  Centocor Ortho Biotech, Janssen-Cilag and Xian-Janssen are
wholly owned subsidiaries of Johnson & Johnson.


Important Safety Information 
SIMPONI is a prescription medicine. SIMPONI can lower your ability to fight
infections. There are reports of serious infections caused by bacteria, fungi,
or viruses that have spread throughout the body, including tuberculosis (TB)
and histoplasmosis. Some of these infections have been fatal. Your doctor will
test you for TB before starting SIMPONI and will monitor you for signs of TB
during treatment. Tell your doctor if you have been in close contact with
people with TB.  Tell your doctor if you have been in a region (such as the
Ohio and Mississippi River Valleys and the Southwest) where certain fungal
infections like histoplasmosis or coccidioidomycosis are common.  


You should not start SIMPONI if you have any kind of infection.  Tell your
doctor if you are prone to or have a history of infections or have diabetes. 
You should also tell your doctor if you are currently being treated for an
infection or if you have or develop any signs of an infection such as:
    --  fever, sweat, or chills
    --  muscle aches
    --  cough
    --  shortness of breath
    --  blood in phlegm
    --  weight loss
    --  warm, red, or painful skin or sores on your body
    --  diarrhea or stomach pain
    --  burning when you urinate or urinate more than normal

    --  feel very tired



Tell your doctor about all the medications you take or if you are scheduled to
or recently received a vaccine.


Reactivation of hepatitis B virus has been reported in patients who are
carriers of this virus and are taking TNF blocker medicines, such as SIMPONI. 
Some of these cases have been fatal.  Your doctor may do blood tests before
and after you start treatment with SIMPONI.  Tell your doctor if you know or
think you may be a carrier of hepatitis B virus or if you experience signs of
hepatitis B infection, such as:
    --  feel very tired
    --  skin or eyes look yellow
    --  little or no appetite
    --  vomiting
    --  muscle aches
    --  dark urine
    --  clay-colored bowel movements
    --  fevers
    --  chills
    --  stomach discomfort

    --  skin rash



If you take SIMPONI or other TNF blockers, your risk for developing lymphoma
or other cancers may increase. You should tell your doctor if you have had or
develop lymphoma or other cancers.


Heart failure can occur or get worse in people who use TNF blockers like
SIMPONI.  Your doctor will monitor you closely if you have heart failure. 
Tell your doctor right away if you get new or worsening symptoms of heart
failure like shortness of breath or swelling of your lower legs or feet.


Rarely, people using TNF blockers can have nervous system problems such as
multiple sclerosis.  Tell your doctor right away if you have symptoms like
vision changes, weakness in your arms or legs, or numbness or tingling in any
part of your body.


Liver problems can happen in people using TNF blockers.  Contact your doctor
immediately if you develop symptoms such as feeling very tired, skin or eyes
look yellow, poor appetite or vomiting, or pain on the right side of your
stomach.


Low blood counts have been seen with people using TNF blockers.  If this
occurs, your body may not make enough blood cells to help fight infections or
help stop bleeding. Your doctor will check your blood counts before and during
treatment.  Tell your doctor if you have signs such as fever, bruising,
bleeding easily, or paleness.


Rarely, people using TNF blockers have developed lupus-like symptoms.  Tell
your doctor if you have any symptoms such as a rash on your cheeks or other
parts of the body, sensitivity to the sun, new joint or muscle pain, becoming
very tired, chest pain or shortness of breath, swelling of the feet, ankles,
and/or legs.


Tell your doctor if you are allergic to rubber or latex. The needle cover
contains dry natural rubber.


Tell your doctor if you have any symptoms of an allergic reaction while taking
SIMPONI such as hives, swollen face, breathing trouble, or chest pain. Common
side effects of SIMPONI include: upper respiratory tract infection, nausea,
abnormal liver tests, redness at site of injection, high blood pressure,
bronchitis, dizziness, sinus infection, flu, runny nose, fever, cold sores,
numbness or tingling.


You are encouraged to report negative side effects of prescription drugs to
the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. 


The Full Prescribing Information and Medication Guide for SIMPONI will be
available at www.SIMPONI.com.


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.  For more information about Centocor Ortho
Biotech, visit www.CentocorOrthoBiotech.com .  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 healthcare
reforms and governmental laws and regulations; and trends toward healthcare
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 website
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 Part II, Item 1A. "Risk Factors" in the
Company's second quarter 2009 10-Q, filed July 24, 2009.




SOURCE  Centocor Ortho Biotech Inc.

Media, Centocor Ortho Biotech Inc., Brian Kenney, +1-215-325-2107, mobile:
+1-215-620-0111; or Investors: Johnson & Johnson, Tina Pinto, +1-732-524-2034;
or Media, Schering-Plough, Catherine Cantone, +1-908-298-3944, or mobile:
+1-908-327-3013; or Investors: Schering-Plough, Janet Barth or Joe Romanelli,
+1-908-298-7436
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