STELARA(R)* AWARDED PRIX GALIEN CANADA 2010 - INNOVATIVE PRODUCT AWARD

TORONTO, Nov. 17 /CNW/ - Janssen-Ortho Inc. announced today that STELARA(R) (ustekinumab) has been awarded the prestigious 2010 Prix Galien Canada Innovative Product Award. The Prix Galien is the most prestigious award in the field of Canadian pharmaceutical research and innovation. Referred to as the Nobel Prize of pharmaceutical research, it recognizes the efforts and achievements of pharmaceutical research and development.

Approved first in the world by Health Canada in December 2008 for the treatment of adults with chronic moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, STELARA(R) is a first-in-class human monoclonal antibody that selectively targets two cytokines, interleukin-12 (IL-12) and interleukin-23 (IL-23), naturally occurring proteins that are believed to play a role in the development of psoriasis.

"Close to half of the clinical trial patients for STELARA(R) came from Canada, making this achievement particularly meaningful to Canadians," said Dr. Kim Papp, dermatologist and study investigator. "STELARA(R) is an exciting and innovative advancement in the management of psoriasis. The high level of efficacy observed with STELARA(R) and the maintenance dosing schedule of every twelve weeks is what makes this a welcome new therapeutic option for psoriasis patients."

The Prix Galien is given annually to an individual or a team for making a significant contribution to the diagnosis, prevention and treatment of illnesses. Prix Galien was first established in 1970 by French pharmacist Roland Mehl and was inaugurated in Canada in 1994 making this the first North American country to recognize the efforts and achievements of pharmaceutical research and development. The members of the independent Jury of the Prix Galien Canada are among the most eminent Canadian experts in pharmacy, pharmacology and medicine.

"Janssen-Ortho Inc. is committed to offering innovative products that make a difference in the lives of Canadians," said Chris Halyk, President, Janssen-Ortho Inc. "It is a tremendous honor to have STELARA(R) recognized with the Prix Galien Canada Innovative Product Award."

    
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    (1) All trademark rights used under license


    About Psoriasis
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Affecting more than one million Canadian adults, psoriasis is a chronic, immune-mediated disease that results from the overproduction of skin cells, resulting in their accumulation on the surface of the skin, which causes red, scaly plaques that may bleed. The severity ranges from minor localized patches to complete body coverage and can have a profound impact on a person's quality of life.

    
    About STELARA(R) (ustekinumab)
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STELARA(R) is a first-in-class, human, monoclonal antibody approved first in the world by Health Canada in December 2008 for the treatment of psoriasis. A selective immunomodulating agent, STELARA(R) is indicated for the treatment of adult patients with chronic moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy(1).

STELARA(R) works by targeting and regulating the activity of cytokines interleukin-12 (IL-12) and interleukin-23 (IL-23)(2). These cytokines are naturally occurring proteins that are important in regulating immune responses, and are thought to be associated with immune-mediated inflammatory disorders, including plaque psoriasis(3).

Centocor Ortho Biotech Inc. discovered and developed STELARA(R) and has exclusive marketing rights to the product in the United States. Janssen-Ortho Inc. has exclusive marketing rights in Canada for the treatment of chronic moderate to severe plaque psoriasis.

    
    STELARA(R) Clinical Trials
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STELARA(R) was studied in two pivotal phase 3 clinical trials. The trials demonstrated that the majority of patients with moderate to severe plaque psoriasis who received STELARA(R) sustained, clinically significant improvement in their disease severity. At week 12, the primary endpoint of both studies, 66 percent to 76 per cent of patients who received just two doses of STELARA(R), 45 mg or 90 mg, respectively, at weeks 0 and 4, achieved PASI 75 (75 per cent improvement on the Psoriasis Activity and Severity Index) compared with 3 to 4 per cent of patients receiving placebo (p(less than)0.001). Long-term results from these studies through 76 weeks were published in The Lancet in May 2008.

Most recently, findings from an international, Phase 3 clinical study comparing the efficacy and safety of STELARA(R) (ustekinumab) with Enbrel(+) (etanercept) in the treatment of moderate to severe plaque psoriasis showed a significantly higher clinical response with both doses of STELARA(R) than etanercept over a 12-week period. The first-of-its-kind head-to-head study comparing two biologic agents for plaque psoriasis also shows the efficacy of STELARA(R) among patients in the study who failed to respond to etanercept. The international study included 18 Canadian sites. Findings from this study have been published in the January issue of The New England Journal of Medicine.

    
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    (+) etanercept is a product of Amgen Canada, Inc., and Wyeth Canada.


    Safety Information
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STELARA(R) is a prescription medicine that affects the immune system. The most common adverse reactions ((greater than)10%) in controlled and uncontrolled portions of the psoriasis clinical studies with STELARA(R) were nasopharyngitis and upper respiratory tract infection. Most were considered to be mild and did not necessitate drug discontinuation.

STELARA(R) has not been studied in patients with a history of malignancy. Caution should be exercised when considering the use of STELARA(R) in patients with a history of malignancy or when considering continuing treatment in patients who develop a malignancy.

STELARA(R) is a selective immunomodulator and may have the potential to increase the risk of infections and reactivate latent infections. Caution should be exercised when considering the use of STELARA(R) in patients with a chronic infection or a history of recurrent infection. If a patient develops a serious infection, they should be closely monitored and STELARA(R) should not be administered until the infection resolves.

Prior to initiating treatment with STELARA(R), patients should be evaluated for tuberculosis infection. STELARA(R) should not be given to patients with active tuberculosis.

    
    About Janssen-Ortho Inc.
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Janssen-Ortho Inc. is a healthcare company committed to providing Canadians with innovative treatment options that enhance and improve life. Headquartered in Toronto, the company offers a broad range of medications used in psychiatry, dementia, attention deficit hyperactivity disorder, psoriasis, pain management, women's health, infectious disease, anemia, oncology, and virology.

    
    References
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    (1) STELARA product monograph - June 18, 2010.
    (2) STELARA product monograph - June 18, 2010.
    (3) Kikly K, Liu L, Na S, Sedgwick J. The IL-23TH (17) axis: therapeutic
targets for autoimmune inflammation. Curr Opin Immunol. 2006;18:670-675
    

For further information: or to arrange an interview, please contact: Collin Matanowitsch, MSLCanada, [phone], [email protected]; Suzanne Frost, Janssen-Ortho Inc., [phone], [email protected]