Janssen Submits Applications Requesting Approval Of STELARA® In U.S. And
Europe For Treatment Of Active Psoriatic Arthritis
HORSHAM, Pennsylvania and LEIDEN, Netherlands, Dec. 6, 2012
HORSHAM, Pennsylvania and LEIDEN, Netherlands, Dec. 6, 2012 /PRNewswire/ --
Janssen Biotech, Inc. and Janssen Biologics B.V. announced today the
submission of a supplemental Biologics License Application (sBLA) to the
United States Food and Drug Administration (FDA) and a Type II Variation to
the European Medicines Agency (EMA) requesting approval of STELARA®
(ustekinumab) for the treatment of adult patients with active psoriatic
arthritis. It is estimated that more than two million people in the U.S.
and approximately 4.2 million people across Europe,, are living with
psoriatic arthritis, a chronic autoimmune disease characterized by both joint
inflammation and psoriasis skin lesions, for which there is no cure.
"We are pleased to present applications to health authorities in the U.S. and
Europe seeking approval of STELARA for the treatment of active psoriatic
arthritis, a chronic, debilitating immune-mediated inflammatory disease," said
Jerome A. Boscia, M.D., Vice President, Head of Immunology Development,
Janssen Research & Development, LLC. "The efficacy and safety of STELARA, an
anti–interleukin-12/23 antibody, have been evaluated in a large Phase 3
clinical development program for the treatment of active psoriatic arthritis,
a disease for which tumor necrosis factor inhibitors are currently the only
approved biologic therapies, and additional therapeutic options are needed."
The applications are supported by findings from P hase 3 Multicenter, Randomi
s ed, Double-blind, Placebo-controlled trials of U stekinumab, a Fully Human
anti–IL-12/23p40 M onoclonal Antibody, Ad m inistered Subcutaneously, i n
Subjects with Active Psoriatic Ar t hritis (PSUMMIT I and PSUMMIT II), which
evaluated the efficacy and safety of subcutaneously administered STELARA 45 mg
or 90 mg at weeks 0, 4 and then every 12 weeks. The trials included patients
diagnosed with active psoriatic arthritis who had at least five tender and
five swollen joints and C-reactive protein (CRP) levels of at least 0.3 mg/dL
in spite of previous treatment with conventional therapy. PSUMMIT II also
included patients with previous exposure to tumor necrosis factor (TNF)
inhibitors. The primary endpoints for both studies were the proportion of
patients demonstrating at least a 20 percent improvement in arthritis signs
and symptoms [American College of Rheumatology (ACR) 20] at week 24. Secondary
endpoints at week 24 included in the submissions were: improvements in Health
Assessment Questionnaire Disability Index (HAQ-DI) scores, a 50 or 70 percent
improvement in arthritis signs and symptoms (ACR 50 or ACR 70), and at least a
75 percent improvement in psoriatic skin lesions as measured by the Psoriasis
Area Severity Index (PASI 75) in patients with at least three percent body
surface area involvement at baseline.
Data from the Janssen Research & Development–sponsored PSUMMIT I and PSUMMIT
II studies were recently presented at the 2012 Annual Meeting of the American
College of Rheumatology.
About Psoriatic Arthritis Psoriatic arthritis is a chronic immune-mediated
inflammatory disease characterized by both joint inflammation and the skin
lesions associated with psoriasis that affects as many as 37 million people
worldwide. While estimates of the prevalence of psoriatic arthritis among
people living with psoriasis vary, up to 30 percent may develop inflammatory
arthritis. Though the exact cause of psoriatic arthritis is unknown, genes,
the immune system and environmental factors are all believed to play a role in
the onset of the disease.
About STELARA STELARA, a human interleukin (IL)-12 and IL-23 antagonist, is
currently approved in 69 countries for the treatment of moderate to severe
plaque psoriasis. IL-12 and IL-23 are naturally occurring proteins that are
believed to play a role in immune-mediated inflammatory diseases, including
psoriasis and psoriatic arthritis.
In the U.S., STELARA is approved for the treatment of adult patients (18 years
or older) with moderate to severe plaque psoriasis who are candidates for
phototherapy or systemic therapy.
In the EU, STELARA is approved for the treatment of moderate to severe plaque
psoriasis in adults who failed to respond to, or who have a contraindication
to, or are intolerant to other systemic therapies including ciclosporin,
methotrexate and PUVA (psoralen plus UVA).
STELARA is not recommended for use in children and adolescents below age 18
due to a lack of data on safety and efficacy.
In addition to the Phase 3 clinical development program in psoriatic
arthritis, STELARA is in Phase 3 development for the treatment of moderately
to severely active Crohn's disease.
Janssen Biotech, Inc. discovered STELARA and has exclusive marketing rights to
the product in the United States. The Janssen pharmaceutical companies
maintain exclusive worldwide marketing rights to STELARA.
For more information about STELARA in the U.S., visit www.STELARAinfo.com .
For further information about STELARA outside of the U.S., please consult the
relevant official product information applicable to that country location.
Important Safety Information (U.S.) STELARA ® is a prescription medicine that
affects your immune system. STELARA ® can increase your chance of having
serious side effects including:
Serious Infections STELARA ® may lower your ability to fight infections and
may increase your risk of infections. While taking STELARA ® , some people
have serious infections, which may require hospitalization, including
tuberculosis (TB), and infections caused by bacteria, fungi, or viruses.
*Your doctor should check you for TB before starting STELARA ® and watch
you closely for signs and symptoms of TB during treatment with STELARA ® .
*If your doctor feels that you are at risk for TB, you may be treated for
TB before and during treatment with STELARA ® .
You should not start taking STELARA ® if you have any kind of infection unless
your doctor says it is okay.
Before starting STELARA ® , tell your doctor if you think you have an
infection or have symptoms of an infection such as:
*fever, sweats, or chills
*shortness of breath
*blood in your phlegm
*warm, red, or painful skin or sores on your body
*diarrhea or stomach pain
*burning when you urinate or urinate more often than normal
*feel very tired
*are being treated for an infection
*get a lot of infections or have infections that keep coming back
*have TB, or have been in close contact with someone who has TB
After starting STELARA ® , call your doctor right away if you have any
symptoms of an infection (see above).
STELARA ® can make you more likely to get infections or make an infection that
you have worse. People who have a genetic problem where the body does not make
any of the proteins interleukin 12 (IL-12) and interleukin 23 (IL-23) are at a
higher risk for certain serious infections that can spread throughout the body
and cause death. It is not known if people who take STELARA ® will get any of
these infections because of the effects of STELARA ® on these proteins.
Cancer STELARA ® may decrease the activity of your immune system and increase
your risk for certain types of cancer. Tell your doctor if you have ever had
any type of cancer.
Reversible posterior leukoencephalopathy syndrome (RPLS) RPLS is a rare
condition that affects the brain and can cause death. The cause of RPLS is not
known. If RPLS is found early and treated, most people recover. Tell your
doctor right away if you have any new or worsening medical problems including:
headache, seizures, confusion, and vision problems.
Serious Allergic Reactions Serious allergic reactions can occur. Get medical
help right away if you have any symptoms such as: feeling faint, swelling of
your face, eyelids, tongue, or throat, trouble breathing, throat or chest
tightness, or skin rash.
Before receiving STELARA®, tell your doctor if you:
*have any of the conditions or symptoms listed above for serious
infections, cancer, or RPLS
*have recently received or are scheduled to receive an immunization
(vaccine). People who take STELARA ® should not receive live vaccines.
Tell your doctor if anyone in your house needs a vaccine. The viruses used
in some types of vaccines can spread to people with a weakened immune
system, and can cause serious problems. You should not receive the BCG
vaccine during the one year before taking STELARA® or one year after you
stop taking STELARA® . Non-live vaccinations received while taking STELARA
® may not fully protect you from disease.
*are receiving or have received allergy shots, especially for serious
*ever had an allergic reaction to STELARA®
*receive phototherapy for your psoriasis
*have any other medical conditions
*are pregnant or plan to become pregnant. It is not known if STELARA ®
will harm your unborn baby. You and your doctor should decide if you will
take STELARA ® .
*are breast-feeding or plan to breast-feed. It is thought that STELARA ®
passes into your breast milk. You should not breast-feed while taking
STELARA ® without first talking to your doctor.
Tell your doctor about all the medicines you take, including prescription and
non-prescription medicines, vitamins, and herbal supplements . Especially tell
your doctor if you take:
*other medicines that affect your immune system
*certain medicines that can affect how your liver breaks down other
Common side effects of STELARA® include: upper respiratory infections,
headache, and tiredness
These are not all of the side effects with STELARA ® . Tell your doctor about
any side effect that bothers you or does not go away. Ask your doctor or
pharmacist for more information.
Please read the Medication Guide for STELARA® 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.
The U.S. full prescribing information for STELARA® can be accessed at the
following link: http://www.stelarainfo.com/pdf/PrescribingInformation.pdf .
Important Safety Information (EU)  Ustekinumab is a selective
immunosuppressant and may have the potential to increase the risk of
infections and reactivate latent infections. Serious infections have been
observed in patients receiving STELARA in clinical trials. Do not start
STELARA during an active infection. If a serious infection develops, monitor
patients carefully and stop STELARA until the infection resolves. Patients
should be evaluated for tuberculosis (TB) infection prior to initiating
treatment with STELARA.
Ustekinumab is a selective immunosuppressant. Immunosuppressive agents have
the potential to increase the risk of malignancy. Malignancies have been
observed in patients receiving ustekinumab in clinical trials. Caution should
be exercised when considering the use of STELARA in patients with a history of
malignancy or when considering continuing treatment in patients who develop a
Serious allergic reactions have been reported in the post-marketing setting,
in some cases several days after treatment. Anaphylaxis and angioedema have
occurred. If an anaphylactic or other serious allergic reaction occurs,
administration of STELARA should be discontinued immediately and appropriate
It is recommended that live viral or live bacterial vaccines (such as Bacillus
of Calmette and Guerin [BCG]) should not be given concurrently with STELARA.
No overall differences in efficacy or safety in patients age 65 and older who
received STELARA were observed compared to younger patients. Because there is
a higher incidence of infections in the elderly population in general, caution
should be used in treating the elderly.
Special Warnings and Precautions for Use  Concomitant immunosuppressive
therapy: Caution should be exercised when considering concomitant use of other
immunosuppressants and ustekinumab or when transitioning from other
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
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 .
About Janssen Biologics B.V. Janssen Biologics B.V., based in Leiden, The
Netherlands, maintains a leading position in the biotechnology industry
developing and producing medicines through biopharmaceutical processes. As one
of the Janssen Pharmaceutical Companies of Johnson & Johnson, we remain
committed to delivering important biological medicines in the fight against
heart, vascular and infectious diseases, and immunological diseases such as
rheumatoid arthritis, Crohn's disease, ulcerative colitis and psoriasis. For
more information on Janssen Biologics, visit
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
(This press release contains "forward-looking statements" as defined in the
Private Securities Litigation Reform Act of 1995. The reader is cautioned not
to rely on these forward-looking statements. 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 the expectations and projections of Janssen Biotech,
Inc., Janssen Biologics B.V., Janssen Research & Development, LLC and/or
Johnson & Johnson. Risks and uncertainties include, but are not limited to,
general industry conditions and competition; economic factors, such as
interest rate and currency exchange rate fluctuations; technological advances,
new products and patents attained by competitors; challenges inherent in new
product development, including obtaining regulatory approvals; challenges to
patents; product efficacy or safety concerns resulting in product recalls or
regulatory action; changes in behavior and spending patterns or financial
distress of purchasers of health care products and services; changes to
governmental laws and regulations and domestic and foreign health care
reforms; trends toward health care cost containment; and increased scrutiny of
the health care industry by government agencies. 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 January 1, 2012. 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. Janssen Biotech, Inc., Janssen Biologics B.V., Janssen
Research & Development, LLC and Johnson & Johnson do not undertake to update
any forward-looking statements as a result of new information or future events
 About Psoriasis: Statistics. National Psoriasis Foundation.
http://www.psoriasis.org/learn_statistics . Accessed December 6, 2012. 
Augustin M, Herberger K, Hintzen S, et al. Prevalence of skin lesions and need
for treatment in a cohort of 90880 workers. Br J Dermatol.
2011;165(4):865-873.  Parisi R, Symmons DP, Griffiths CE, Ashcroft DM, on
behalf of the Identification and Management of Psoriasis and Associated
ComorbidiTy (IMPACT) project team. Global epidemiology of psoriasis: a
systematic review of incidence and prevalence. J Invest Dermatol. 2012 Sep 27
[Epub ahead of print].  Ortonne JP, Prinz JC. Alefacept: a novel and
selective biologic agent for the treatment of chronic plaque psoriasis. Eur J
Dermatol. 2004;14:41-45.  About Psoriatic Arthritis. National Psoriasis
Foundation. http://www.psoriasis.org/psoriaticarthrits . Accessed December 6,
2012.  Ustekinumab European Summary of Product Characteristics. March 2012.
Contact: Media Contact: Brian Kenney, Office: +1-215-628-7010, Mobile:
+1-215-620-0111; Investor Contacts: Louise Mehrotra, Johnson & Johnson,
Office: +1-732-524-6491, or Stan Panasewicz, Johnson & Johnson, Office:
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