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SIMPONI® ARIA™ (golimumab) For Infusion Receives FDA Approval For Treatment Of Moderately To Severely Active Rheumatoid



SIMPONI® ARIA™ (golimumab) For Infusion Receives FDA Approval For Treatment Of
              Moderately To Severely Active Rheumatoid Arthritis

First Anti-TNF Infusion Therapy Approved in More Than a Decade for Patients
Living with Moderately to Severely Active Rheumatoid Arthritis

PR Newswire

HORSHAM, Pa., July 18, 2013

HORSHAM, Pa., July 18, 2013 /PRNewswire/ -- Janssen Biotech, Inc. announced
today the U.S. Food and Drug Administration (FDA) approval of SIMPONI^®
ARIA^TM (golimumab) for infusion for the treatment of adults with moderately
to severely active rheumatoid arthritis (RA) in combination with
 methotrexate.  SIMPONI ARIA, the only fully-human anti-tumor necrosis factor
(TNF)-alpha infusible therapy, has been shown to significantly improve signs
and symptoms and physical function, and inhibit the progression of structural
damage.  The SIMPONI ARIA dose regimen is 2 mg/kg given as an intravenous
infusion at weeks 0 and 4, then every 8 weeks thereafter. The infusion is
given over a 30-minute period, providing a short infusion time for patients.
Approximately 1.3 million people in the United States are living with RA,[i] 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.[ii]

"Phase 3 data showed treatment with SIMPONI ARIA plus methotrexate
significantly improved signs and symptoms and physical function at week 24,
and inhibited the progression of structural damage in patients with moderate
to severe RA at week 24 and 52," said Sergio Schwartzman*, MD, Director,
Inflammatory Arthritis Center, Hospital for Special Surgery, Associate
Professor, Weill Cornell Medical College, and advisory board member.  "The
approval of SIMPONI ARIA offers rheumatologists a new anti-TNF infusible
treatment for patients who demonstrate an inadequate response to methotrexate;
having treatment options remains critical for us to continue to meet the needs
of our patients."

The approval is supported by findings from the Phase 3 Trial of Golimumab, an
Anti-TNF-alpha Monoclonal Antibody, Administered Intravenously, in Subjects
with Active Rheumatoid Arthritis Despite Methotrexate Therapy (GO-FURTHER)
trial, which evaluated 592 patients diagnosed with moderately to severely
active RA who had at least six tender and six swollen joints at screening and
baseline, had elevated C-reactive protein (CRP) levels at screening and who
had been receiving background methotrexate for at least three months. Results
from the trial revealed 59 percent (n = 231/395) of patients receiving
treatment with SIMPONI ARIA plus methotrexate versus 25 percent of patients
receiving placebo plus methotrexate (n = 49/197) (a difference with 95 percent
CI 25.9, 41.4) experienced significant improvements in signs and symptoms at
week 14, as demonstrated by at least 20 percent improvement in American
College of Rheumatology criteria (ACR 20), the study's primary endpoint.  A
higher proportion of patients receiving SIMPONI ARIA plus methotrexate
achieved at least a 50 percent improvement in ACR criteria (ACR 50) compared
with patients receiving placebo plus methotrexate at week 14 (30 percent
versus 9 percent, respectively, a difference with 95 percent CI 15.3, 27.2).
 Significant improvements in ACR 20 were observed as early as week 2, after a
single SIMPONI ARIA infusion, as 33 percent of patients achieved an ACR 20
response versus 12 percent of patients receiving placebo.  Radiographic
progression of the hands and feet were 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 SIMPONI
ARIA plus methotrexate had a mean change in total vdH-S score of 0.03 from
baseline, compared with a mean change of 1.09 in the placebo plus methotrexate
group (P<0.001). At week 52, the mean change in total vdH-S score from
baseline was 0.13 in SIMPONI ARIA treated patients versus 1.20 in placebo
patients who crossed over to SIMPONI ARIA at either week 16 or 24.  

"SIMPONI ARIA demonstrated a compelling efficacy profile in the treatment of
moderately to severely active rheumatoid arthritis in the GO-FURTHER study,"
said Jerome A. Boscia, M.D., Vice President, Head of Immunology Development,
Janssen Research & Development, LLC. "The approval of SIMPONI ARIA represents
our commitment to bringing forward new therapeutic options for patients living
with immunological diseases, including potentially disabling diseases like
rheumatoid arthritis."

"As leaders in rheumatology, we're proud to expand our treatment portfolio by
making an anti-TNF infusible medicine like SIMPONI ARIA available to
patients," said Rob Bazemore, President, Janssen Biotech, Inc.  "Treatment
with SIMPONI ARIA provides a different infusion experience; patients can now
receive this form of treatment administration with an anti-TNF therapy via a
short infusion time of 30 minutes with a dosing regimen of every 8 weeks."

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 moderately to
severely active RA who had at least six tender and six swollen joints at
screening and baseline, had elevated CRP levels at screening and who had been
receiving background methotrexate for at least 3 months. Patients were
randomized 2:1 to receive a 30 (+/- 10) minute I.V. infusion of golimumab 2
mg/kg or placebo at weeks 0, 4, and then every 8 weeks; in both treatment
arms, methotrexate was taken.  The primary endpoint of the study was the
proportion of ACR 20 responders at week 14.  At week 16, patients receiving
placebo with less than 10 percent improvement in combined swollen and tender
joint counts from baseline qualified for early escape and received I.V.
golimumab 2 mg/kg infusions at week 16 and week 20 and every 8 weeks
subsequent; patients receiving golimumab who qualified for early escape
remained on their golimumab therapy.  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 regardless
of whether they had been randomized to placebo or golimumab) and week 52, and
were scored using the van der Heijde-Sharp (vdH-S) score. 

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). In the controlled phase of the
trial through Week 24, infections were observed in 27 percent of SIMPONI
ARIA-treated patients compared with 24 percent of placebo-treated patients,
and serious infections were observed in 0.9 percent of SIMPONI ARIA-treated
patients and 0.0 percent of placebo-treated patients. One case of tuberculosis
and one death, a myocardial infarction secondary to community-acquired
pneumonia, were reported in the I.V. golimumab group. In addition, one death
was reported among placebo-treated patients through week 24. Through week 24,
the proportions of infusions with infusion reactions were 1.1 percent and 0.2
percent, respectively.

For more information regarding the safety profile for SIMPONI ARIA, please see
"Important Safety Information" below.

About Rheumatoid Arthritis

Rheumatoid arthritis (RA) 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^[ii]. It is
estimated that 1.3 million Americans^[i] and more than 23.5 million people
worldwide^^[iii] are affected by the condition, for which there is no cure.

About SIMPONI® ARIA™ (golimumab) for infusion

SIMPONI ARIA is an infusible, fully human anti-TNF monoclonal antibody that
targets both soluble and transmembrane bioactive forms of 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.  By binding with
and blocking TNF-alpha, SIMPONI ARIA helps control inflammation. SIMPONI ARIA
also helps to inhibit the progression of further joint damage.  SIMPONI ARIA
is approved for the treatment of adult patients with moderately to severely
active rheumatoid arthritis (RA) with the medicine methotrexate.  More
information about SIMPONI ARIA will be available soon at www.SimponiARIA.com.

Please see SIMPONI ARIA U.S. full Prescribing Information and Medication
Guide.

Janssen Biotech, Inc. discovered and developed SIMPONI ARIA.  

Important Safety Information

SIMPONI^® ARIA™ (golimumab) is a prescription medicine. SIMPONI^® ARIA™ 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^® ARIA™ and will closely 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 receive SIMPONI^® ARIA™  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:

 

  o fever, sweat, or chills
  o muscle aches
  o cough
  o shortness of breath
  o blood in phlegm
  o weight loss
  o warm, red, or painful skin or sores on your body
  o diarrhea or stomach pain
  o burning when you urinate or urinate more than normal
  o feel very tired

Unusual cancers have been reported in children and teenage patients taking TNF
blocker medicines. For children and adults receiving TNF blockers, including
SIMPONI^® ARIA™, 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.

Some people treated with SIMPONI^® ARIA™  developed skin cancer. Tell your
doctor if any changes in the appearance of your skin or growths on your skin
occur during or after your treatment with SIMPONI^® ARIA™. Your doctor should
periodically examine your skin, especially if you have a history of skin
cancer.

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 receiving SIMPONI^® ARIA™  should not receive live vaccines.

Reactivation of hepatitis B virus has been reported in patients who are
carriers of this virus and are receiving TNF-blocker medicines, such as
SIMPONI^® ARIA™. Some of these cases have been fatal. Your doctor should do
blood tests before and after you start treatment with SIMPONI^® ARIA™. 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:

 

  o feel very tired
  o clay-colored bowel movements
  o dark urine
  o fevers
  o skin or eyes look yellow
  o little or no appetite
  o vomiting
  o muscle aches
  o chills
  o  stomach discomfort
  o skin rash

Heart failure can occur or get worse in people who use TNF blockers, including
SIMPONI^® ARIA™. 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, swelling of your lower legs or feet,
or sudden weight gain.

Rarely, people using TNF blockers, including SIMPONI^® ARIA™, 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^® ARIA™. 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^® ARIA™. 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.

Tell your doctor if you have any symptoms of an allergic reaction while
receiving SIMPONI^® ARIA™ such as hives, swollen face, breathing trouble, or
chest pain. Some reactions can be serious and life-threatening.

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 or
legs.

Tell your doctor if you have psoriasis.

Tell your doctor if you are pregnant, planning to become pregnant or are
breastfeeding or have a baby and received SIMPONI^® ARIA™ 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.

The most common side effects of SIMPONI^® ARIA™ include: upper respiratory
infection, viral infections, bronchitis, high blood pressure, and rash.

Please read the full Prescribing Information and Medication Guide  for
SIMPONI^® ARIA™ and discuss any questions you have with your doctor.

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.

About Janssen Biotech, Inc.

Janssen Biotech, Inc. redefines the standard of care in immunology, oncology,
urology and nephrology. Built upon a rich legacy  of  innovative firsts,
Janssen Biotech has delivered on the promise of new treatments and ways to
improve the health of individuals with serious disease. Beyond its innovative
medicines, Janssen Biotech is at the forefront of developing education and
public policy initiatives to ensure patients and their families, caregivers,
advocates and health care professionals have access to the latest treatment
information, support services and quality care. For more information on
Janssen Biotech, Inc. or its products, visit www.janssenbiotech.com.

Janssen Biotech is one of the Janssen Pharmaceutical Companies of Johnson &
Johnson which are dedicated to addressing and solving some of the most
important unmet medical needs in oncology, immunology, neuroscience,
infectious diseases and vaccines, and cardiovascular and metabolic diseases.
Driven by our commitment to patients, we work together to bring innovative
ideas, products, services and solutions to people throughout the world. Follow
us on Twitter at www.twitter.com/JanssenUS.

*Dr. Schwartzman was not associated with the SIMPONI^® ARIA^TM clinical trials
and was not compensated for any media work. He has been a paid consultant to
Janssen Biotech, Inc.

References

[i] Arthritis Foundation. Who gets rheumatoid arthritis? Available at:
http://www.arthritis.org/who-gets-rheumatoid-arthritis.php. Accessed April 22,
2013.

[ii] Arthritis Foundation. What is rheumatoid arthritis? Available at:
http://www.arthritis.org/types-what-is-rheumatoid-arthritis.php. Accessed
April 22, 2013.

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

 

SOURCE Janssen Biotech, Inc.

Contact: Media Contacts: Megan Farina, Office: 215-325-6861, Mobile:
610-724-1079, or Brian Kenney, Office: 215-628-7010, Mobile: 215-620-0111, or
Investor Contacts: Louise Mehrota, Johnson & Johnson, Office: 732-524-6491, or
Stan Panasewicz, Johnson & Johnson, Office: 732-524-2524
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