SIMPONI(R)* (golimumab) Receives Health Canada Approval for Ulcerative Colitis

SIMPONI(R)* (golimumab) Receives Health Canada Approval for Ulcerative Colitis 
First and Only Subcutaneous Biologic Treatment Approved to Reduce Signs and 
Symptoms, Achieve Sustained Clinical Remission and Improve Appearance of the 
Mucosa During Induction 
TORONTO, Sept. 24, 2013 /CNW/ - Janssen Inc. announced today that Health 
Canada has approved SIMPONI(®) (golimumab) for the treatment of moderately to 
severely active ulcerative colitis (UC). SIMPONI(®) is the first and only 
subcutaneously administered anti-tumor necrosis factor (TNF)-alpha therapy 
approved in Canada to reduce signs and symptoms, induce clinical remission, 
achieve sustained clinical remission in induction responders and improve 
endoscopic appearance of the mucosa during induction in adult patients with 
moderately to severely active UC who have had an inadequate response to 
conventional therapy.(1) 
"This approval is an important advance in the treatment of ulcerative colitis. 
In clinical studies, golimumab was shown to induce rapid and continuous 
clinical response in symptom control, which may help to optimize patient 
outcomes," said Dr. Brian Feagan, Professor of Medicine and Epidemiology and 
Biostatistics at the Western University in London, Ontario, and an expert in 
the field of inflammatory bowel disease. "In addition, self-administered 
subcutaneous delivery provides some physicians and patients with an option to 
tailor treatment based on individual circumstances." 
Ulcerative colitis is a chronic inflammatory bowel disease (IBD) marked by 
ulcers in the lining of the colon.(2)Canada has among the highest incidence 
of people with IBD, including Crohn's disease and UC, in the world. It is 
estimated that there are over 230,000 individuals living with IBD in Canada, 
including over 100,000 people living with UC.(2) Symptoms of UC may include: 
bloody diarrhea, mild fever, abdominal pains and cramps, fatigue, loss of 
appetite, weight loss, and pain and swelling in the joints.(2) UC can have a 
range of implications for people's quality of life, including a negative 
psycho-social impact and a substantial personal burden.(2) 
The approval is supported by data from the Program of Ulcerative Colitis 
Research Studies Utilizing an Investigational Treatment (PURSUIT) clinical 
trials, evaluating patients with moderately to severely active UC who had 
previously failed or were intolerant to conventional treatments. For the 
treatment of UC, the SIMPONI(®) dose regimen consists of 200 mg 
subcutaneously injected at week 0, followed by 100 mg at week 2 and then 50 mg 
every 4 weeks, thereafter.The maintenance dose of 100 mg every 4 weeks can 
be considered at the discretion of the treating physician. A significantly 
greater proportion of patients who received SIMPONI(®) 200 mg/100 mg achieved 
clinical response, clinical remission and improvement of the endoscopic 
appearance of the mucosa at week 6 compared with patients receiving placebo. 
Those patients who responded during induction were randomized into the 
maintenance study where they were assessed every four weeks for clinical 
response. The proportion of patients who maintained clinical response through 
week 54 was significantly greater in the SIMPONI(®) 50 mg group and 100 mg 
group compared with the placebo group.Additionally, the proportions of 
patients who were in continuous clinical response and maintained sustained 
remission (in remission at both weeks 30 and 54), and those who demonstrated 
sustained improvement of endoscopic appearance of the mucosa at both weeks 30 
and 54 were significantly greater in the SIMPONI(®) 100 mg group compared 
with the placebo group. 
"Effective treatment options are vital disease management tools for Canadians 
who are living with ulcerative colitis," said Gail Attara, President and CEO, 
Gastrointestinal Society. "Ensuring that these treatments are accessible to 
those who will likely have a vast health benefit from them is also of 
paramount importance." 
Canadians living with UC and prescribed treatment with SIMPONI(®) will 
receive instruction and support from the BioAdvance(®*) Network of clinics, 
located in centres across Canada, or through home injection services delivered 
by BioAdvance(® )nurses. 
About PURSUIT
The Program of Ulcerative Colitis Research Studies Utilizing an 
Investigational Treatment (PURSUIT) included Phase 3 multicenter, randomized, 
double-blind, placebo-controlled studies designed to evaluate the safety and 
efficacy of subcutaneous induction and every-four-week maintenance regimens of 
SIMPONI(®) in adults with moderately to severely active UC. All trial 
patients had failed to respond to or tolerate treatment with 6-mercaptopurine 
(6-MP), azathioprine (AZA), corticosteroids and/or 5-aminosalicylate (5-ASA), 
or were corticosteroid dependent. Study participants were naïve to treatment 
with TNF inhibitors and had a baseline Mayo score between 6 and 12 and 
endoscopic subscore of 2 or more. The Mayo score is a 12-point clinical 
assessment and colonoscopy-based measure of disease activity, which assesses 
improvement in symptoms based on rectal bleeding, endoscopic findings, stool 
frequency and a physician's global assessment. 
The PURSUIT-Induction trial had an adaptive design with a Phase 2 dose-finding 
portion followed by a Phase 3 dose-confirming component. The primary endpoint 
was clinical response at week 6. Secondary endpoints at week 6 included 
clinical remission and improved endoscopic appearance of the mucosa during 
induction. Overall, 1,065 patients were treated in the study; 761 of these 
patients were randomized into the Phase 3 component of the study. 
Patients responding to induction treatment with SIMPONI(®) were eligible to 
be randomized in the Phase 3 PURSUIT-Maintenance study. The primary endpoint 
in this study was maintenance of clinical response through week 54, and 
secondary endpoints included clinical remission and improvement of endoscopic 
appearance of the mucosa at both weeks 30 and 54. 
In both studies, clinical response, clinical remission and improvement of 
endoscopic appearance of the mucosa were defined based on the Mayo score, 
which consists of four subscores:stool frequency, rectal bleeding, findings 
of endoscopy, and physician's global assessment.Each subscore is rated on a 
scale from 0 to 3, indicating normal (0) to severe (3) activity.The Mayo 
score is the sum of the four subscores.Clinical response was defined as a 
decrease from week 0 of induction in the Mayo score of ≥ 30% and ≥ 3 
points, accompanied by a decrease in the rectal bleeding subscore of ≥ 1 or 
rectal bleeding subscore of 0 or 1.Clinical remission was defined as a Mayo 
score ≤ 2 points, with no individual subscore >1.Improvement of endoscopic 
appearance of the mucosa was defined as a Mayo endoscopy subscore of 0 (normal 
or inactive disease) or 1 (erythema, decreased vascular pattern, mild 
friability). 
The safety results of SIMPONI(®) observed in the PURSUIT studies were 
consistent with the known safety profile of SIMPONI(®) in labeled 
rheumatologic indications. 
About SIMPONI(®) (golimumab)
First approved by Health Canada in April 2009, SIMPONI(®), in combination 
with methotrexate, is also indicated for reducing signs and symptoms and 
improving physical function in adult patients with moderately to severely 
active rheumatoid arthritis (RA), as well as inhibiting the progression of 
structural damage in adult patients with moderately to severely active RA who 
had not previously been treated with methotrexate. SIMPONI(®) is also 
approved for reducing signs and symptoms, inhibiting the progression of 
structural damage and improving physical function in adult patients with 
moderately to severely active psoriatic arthritis, as well as reducing signs 
and symptoms in adult patients with active ankylosing spondylitis who have had 
an inadequate response to conventional therapies.(1) 
SIMPONI(®) can lower the body's ability to fight infections. Serious 
infections, including sepsis, tuberculosis, legionellosis (a serious form of 
bacterial pneumonia), listeriosis (an infection that usually develops after 
eating food contaminated by the bacteria listeria) and opportunistic 
infections (such as systemic fungal and bacterial infections) have been 
reported in patients receiving SIMPONI(®) and other similar medicines, and in 
some cases have been fatal. 
Please refer to the SIMPONI(®) Product Monograph for additional safety 
information, including information regarding malignancies, congestive heart 
failure, neurologic events and hematologic warnings, and for complete 
prescribing information( )available at www.janssen.ca. 
About Janssen Inc.
As a member of the Janssen Pharmaceutical Companies, Janssen Inc. is dedicated 
to addressing and solving the most important unmet medical needs in pain 
management, psychiatry, oncology, immunology, psoriasis, virology, anemia, 
attention deficit hyperactivity disorder, gastroenterology and women's health. 
Driven by our commitment to the passionate pursuit of science for the benefit 
of patients, we work together to bring innovative ideas, products and services 
to patients around the world. 
*All trademark rights used under license. 
References: 
(1) SIMPONI(®) Product Monograph, Janssen Inc., 2013. Available at 
www.janssen.ca.
(2) "The Impact of Inflammatory Bowel Disease (IBD) in Canada - 2012 Final 
Report and Recommendations," Crohn's and Colitis Foundation of Canada, 
accessed May 3, 2013, 
http://www.isupportibd.ca/pdf/ccfc-ibd-impact-report-2012.pdf 
 

SOURCE  Janssen Inc. 
or to arrange an interview, please contact: 
Jennifer McCormack Janssen Inc. 416-449-9444 jmccorm3@its.jnj.com 
Laine Jaremey GCI Group 416-486-7224 laine.jaremey@gcicanada.com 
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CO: Janssen Inc.
ST: Ontario
NI: MTC  
-0- Sep/24/2013 11:00 GMT
 
 
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