Phase 3 Data Show Intravenous Golimumab Inhibited Radiographic Progression in Patients with Active Rheumatoid Arthritis

Phase 3 Data Show Intravenous Golimumab Inhibited Radiographic Progression in
                  Patients with Active Rheumatoid Arthritis

Patients Receiving Intravenous Golimumab Showed Significant Improvements in
Signs and Symptoms of Rheumatoid Arthritis through One Year According to New
Study Findings

PR Newswire

WASHINGTON, Nov. 12, 2012

WASHINGTON, Nov. 12, 2012 /PRNewswire/ -- New Phase 3 findings from a Janssen
Research & Development, LLC (Janssen)-sponsored study showed treatment with
the investigational intravenous (I.V.) therapy golimumab, a tumor necrosis
factor (TNF) inhibitor, significantly inhibited radiographic progression in
patients with active moderate to severe rheumatoid arthritis (RA) despite
treatment with methotrexate. Analysis ofstudy patients' X-rays showed
significant inhibition of the progression of structural damage at week 24 in
greater proportions of patients receiving I.V. golimumab plus methotrexate
compared with patients receiving placebo plus methotrexate. The inhibition of
structural damage progression was maintained in patients randomized to I.V.
golimumab through week 52, and inhibition of structural damage progression was
observed at week 52 in patients receiving placebo who crossed over to I.V.
golimumab at week 24. Treatment with I.V. golimumab plus methotrexate also
led to improvements in signs and symptoms and disease activity with nearly 60
percent of patients achieving at least a 20 percent improvement in the
American College of Rheumatology (ACR 20) score at week 14, the study's
primary endpoint, and nearly two-thirds of patients achieving that response at
week 52. These data are being presented at the 2012 Annual Meeting of the
American College of Rheumatology.

In September, Janssen announced the submission of a Biologics License
Application (BLA) to the U.S. Food and Drug Administration (FDA) requesting
approval of I.V. golimumab in combination with methotrexate for the treatment
of adults with moderately to severely active RA. Golimumab is currently
marketed as SIMPONI^® (golimumab), a subcutaneous injection approved by the
United States Food and Drug Administration (FDA) for the treatment of
moderately to severely active RA with the medicine methotrexate, active
psoriatic arthritis alone or with the medicine methotrexate and active
ankylosing spondylitis.

"These Phase 3 data show treatment with intravenous golimumab plus
methotrexate induced and maintained improvements in the signs and symptoms of
rheumatoid arthritis, and inhibited the progression of structural damage.
Such findings are encouraging for rheumatologists and patients," said Rene
Westhovens, M.D., Ph.D., Professor at the Department of Rheumatology, KU
Leuven, Belgium, and study investigator."Through week 52, intravenously
administered golimumab showed a consistent benefit-to-risk profile compared
with previously reported week 24 data."

In the Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Trial
of Golimumab, an Anti-TNF-alpha Monoclonal Antibody, Administered
Intravenously, in Subjects with Active Rheumatoid Arthritis Despite
Methotrexate Therapy (GO-FURTHER), patients were randomized to receive I.V.
golimumab 2 mg/kg or placebo, via a 30-minute infusion, plus methotrexate at
weeks 0, 4 and then every 8 weeks. Non-responders to placebo at week 16 were
crossed over to receive I.V. golimumab, and all remaining patients receiving
placebo crossed over at week 24. Radiographic progression was assessed by the
change from baseline in van der Heijde-Sharp (vdH-S) scores, an X-ray measure
of joint destruction, including joint erosion and joint space narrowing in
which higher scores indicate greater structural damage. At week 24, patients
receiving I.V. golimumab had a mean change (+/- standard deviation) in total
vdH-S score of 0.03 (+/-1.90) from baseline, compared with a mean change of
1.09 (+/- 3.19) in the placebo group (P < 0.001). At week 52, patients who
received the 52-week regimen of I.V. golimumab had a mean change of 0.13 (+/-
3.11) from baseline, compared with a mean change of 1.22 (+/- 3.98) in
patients who crossed over from placebo to I.V. golimumab during the trial (P <
0.001). Patients randomized to I.V. golimumab and those in the crossover
group had a mean change in total vdH-S score of 0.15 (+/- 1.83) and 0.12 (+/-
2.44), respectively, from week 24 to 52, supporting inhibition of structural
damage progression in all patients receiving I.V. golimumab.

Significant proportions of patients receiving I.V. golimumab also demonstrated
improvements in signs and symptoms compared with patients receiving placebo
according to ACR scores, European League Against Rheumatism (EULAR)/Disease
Activity Score (DAS) 28 C-reactive protein (CRP) response criteria and Health
Assessment Questionnaire (HAQ) disability scores at weeks 14 and 24. A
majority of those patients who achieved ACR 20, ACR 50, ACR 70 and EULAR/DAS
28 CRP good/moderate response by week 24 maintained response through week 52
(82 percent of ACR20 responders; 71.7 percent of ACR 50 responders; 60.9
percent of ACR 70 responders; 80 percent demonstrating DAS28-CRP good/moderate
response). The EULAR/DAS 28 CRP is a measure of disease activity in patients
with RA that is calculated by assessing the number of tender and swollen
joints (among a total of 28), serum CRP level (indicator of inflammation), and
the patient's assessment of global health.

Through week 52 of the GO-FURTHER trial, the safety profile of I.V. golimumab
remained consistent with previously reported week 24 data. Through week 24,
adverse events (AEs) occurred in 53 percent of patients receiving I.V.
golimumab and 49 percent of patients receiving placebo, and serious AEs were
reported in more I.V. golimumab-treated patients (4 percent) than
placebo-treated patients (2 percent). Rates of AEs and serious AEs at week 52
among patients receiving I.V. golimumab were 65 percent and 9 percent,
respectively. There were no serious opportunistic infections through week 52
of the study. One case of tuberculosis and one death, a myocardial infarction
secondary to community-acquired pneumonia, were reported in the I.V. golimumab
group. Through week 52, the proportions of infusions and patients with
infusion reactions were 0.7 percent and 3.6 percent, respectively, (versus 1.1
percent and 3.5 percent at week 24, respectively).

About GO-FURTHER
The GO-FURTHER trial is a Phase 3, international multicenter, double-blind,
placebo-controlled study including 592 adults with RA designed to compare ACR
20 response at week 14 in patients receiving an I.V. golimumab infusion plus
methotrexate compared with patients receiving placebo infusions plus
methotrexate. The trial included patients diagnosed with active RA who had at
least six tender and six swollen joints and who had been receiving background
methotrexate for at least three months. Patients were randomized 2:1 to
receive a 30 (+/- 10) minute I.V. infusion of golimumab 2 mg/kg or placebo
plus methotrexate at weeks 0, 4, and then every eight weeks. The primary
endpoint of the study was ACR 20 at week 14. At week 16, patients receiving
placebo with less than 10 percent improvement in combined swollen and tender
joint counts were entered into early escape to receive I.V. golimumab 2 mg/kg
at week 16 and week 20. All patients receiving placebo crossed over to I.V.
golimumab at week 24. Radiographs of the hands and feet were taken at
baseline, week 24 (week 16 for early escape participants) and week 52 and were
scored using the modified vdHS score. Week 24 results from the
Janssen-sponsored study were presented earlier this year at the 2012 EULAR
Annual Congress and also appeared in the Annals of the Rheumatic Diseases.

About Rheumatoid Arthritis
Rheumatoid Arthritis is a chronic, systemic inflammatory condition that is
often characterized by symptoms that include pain, stiffness and inflammation,
and in some cases, joint destruction and disability. It is estimated that 1.5
million Americans^^[1] and more than 23.5 million people worldwide^^[2] are
affected by the condition, for which there is no cure.

About SIMPONI
SIMPONI is a human monoclonal antibodythat 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. SIMPONI is approved in 57 countries for adult rheumatologic
indications, including the United States where SIMPONI received FDA approval
in April 2009 for the treatment of moderately to severely active rheumatoid
arthritis (RA) with the medicine methotrexate, active psoriatic arthritis
alone or with the medicine methotrexate and active ankylosing spondylitis.
SIMPONI is available either through the SmartJect^® autoinjector or a
prefilled syringe as a subcutaneously administered injection. For more
information about SIMPONI, visit www.SIMPONI.com.

Applications requesting approval of SIMPONI as a subcutaneously administered
anti-TNF-alpha therapy for the treatment of adult patients with moderately to
severely active ulcerative colitis have been submitted in Europe and the U.S.

In addition, applications requesting approval of I.V. golimumab for the
treatment of adults with moderately to severely active RA have been submitted
in the U.S. and Europe.

Janssen Biotech, Inc. discovered and developed SIMPONI and markets the product
in the United States. Janssen pharmaceutical companies market SIMPONI ^ in
Canada, Central and South America, the Middle East, Africa and Asia Pacific.

In Japan, Indonesia and Taiwan, Janssen Biotech, Inc. licenses distribution
rights to SIMPONI to Mitsubishi Tanabe Pharma Corporation and has retained
co-marketing rights in those countries. In Europe, Russia and Turkey, Janssen
Biotech, Inc. licenses distribution rights to SIMPONI to Schering-Plough
(Ireland) Company, a subsidiary of Merck & Co., Inc.

The U.S. full prescribing information for SIMPONI can be accessed at the
following link:
http://www.simponi.com/sites/default/files/pdf/prescribing-information.pdf.

For further information about SIMPONI outside of the United States, please
consult the relevant official product information applicable to that country
location

Important Safety Information About SIMPONI Subcutaneous Formulation
SIMPONI^®  (golimumab) 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,
HIV or a weak immune system. 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:

  ofever, sweat, or chills
  omuscle aches
  ocough
  oshortness of breath
  oblood in phlegm
  oweight loss
  owarm, red, or painful skin or sores on your body
  odiarrhea or stomach pain
  oburning when you urinate or urinate more than normal
  ofeel very tired

Unusual cancers have been reported in children and teenage patients taking
TNF-blocker medicines. For children and adults taking TNF blockers, including
SIMPONI^®, the chances for getting lymphoma or other cancers may increase. You
should tell your doctor if you have had or develop lymphoma or other cancers.

Tell your doctor about all the medications you take including ORENCIA
(abatacept), KINERET (anakinra), ACTEMRA (tocilizumab), RITUXAN (rituximab),
or another TNF blocker, or if you are scheduled to or recently received a
vaccine. People taking SIMPONI^® should not receive live vaccines.

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 should 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:

  ofeel very tired
  odark urine
  oskin or eyes look yellow
  olittle or no appetite
  ovomiting
  omuscle aches
  oclay-colored bowel movements
  ofevers
  ochills
  ostomach discomfort
  oskin rash

Heart failure can occur or get worse in people who use TNF blockers, including
SIMPONI^®. Your doctor will closely monitor you 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, including SIMPONI^®, can have nervous
system problems such as multiple sclerosis or Guillain-Barre syndrome. 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.

Serious liver problems can happen in people using TNF blockers, including
SIMPONI^®. 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, including
SIMPONI^®. 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.

New or worse psoriasis symptoms may occur. Tell your doctor if you develop red
scaly patches or raised bumps that are filled with pus.

Tell your doctor if you are pregnant, planning to become pregnant or are
breastfeeding or have a baby and were using SIMPONI^® during pregnancy. Tell
your baby's doctor before your baby receives any vaccine because of an
increased risk of infection for up to 6 months after birth.

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, chest pain. Some
reactions can be serious and life-threatening.

Common side effects of SIMPONI^® include: upper respiratory tract infection,
reaction at site of injection, and viral infections.

Please read the Medication Guide for SIMPONI^® and discuss any questions you
have with your doctor.

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

The U.S. full prescribing information for SIMPONI^® can be accessed at the
following link:
http://www.simponi.com/sites/default/files/pdf/prescribing-information.pdf.

About Janssen Research & Development, LLC
At Janssen Research & Development, LLC, we are united and energized by one
mission—to discover and develop innovative medicines that ease patients'
suffering, and solve the most important unmet medical needs of our time. As
one of the Janssen Pharmaceutical Companies of Johnson & Johnson, our strategy
is to identify the biggest unmet medical needs and match them with the best
science, internal or external, to find solutions for patients worldwide. We
leverage our world-class discovery and development expertise, and operational
excellence, to bring innovative, effective treatments in oncology, immunology,
neuroscience, infectious diseases and vaccines, and cardiovascular and
metabolic diseases. For more information on Janssen R&D, visit
http://www.janssenrnd.com/.

[1] Centers for Disease Control and Prevention. Arthritis-Related Statistics.
http://www.cdc.gov/arthritis/data_statistics/arthritis_related_stats.htm.
Accessed November 10, 2012.

[2] World Health Organization. The global burden of disease: 2004 update.
Geneva: WHO Press, 2008.
http://www.who.int/healthinfo/global_burden_disease/GBD_report_2004update_full.pdf.
Accessed November 10, 2012.

SOURCE Janssen Research & Development, LLC

Website: http://www.janssenrnd.com
Contact: Media: Brian Kenney, +1-215-628-7010, +1-215-620-0111 (mobile);
Investor: Louise Mehrotra, Johnson & Johnson, +1-732-524-6491; Stan
Panasewicz, Johnson & Johnson, +1-732-524-2524
 
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