New Treatment for Hepatitis C Approved by Health Canada Priority Review Gives Physicians and Patients an Effective and Tolerable Treatment Choice

GALEXOS™* is the first treatment for chronic hepatitis C to be approved for once-daily use in combination with pegylated interferon and ribavirin

TORONTO, Nov. 20, 2013 /CNW/ - Janssen Inc. announced today that Health Canada has approved GALEXOS™ (simeprevir) for the treatment of chronic hepatitis C (CHC) genotype 1 infection, in combination with peginterferon alfa and ribavirin in adults with compensated liver disease, including cirrhosis, who are treatment-naïve or who have failed previous interferon therapy (pegylated or non-pegylated) with ribavirin.1 GALEXOS™ was approved following Priority Review and is the first treatment for chronic hepatitis C to be approved for once-daily administration with pegylated interferon and ribavirin in Canada.2

GALEXOS™ is a protease inhibitor that works by blocking the protease enzyme that enables the hepatitis C virus (HCV) to replicate in host cells.3 GALEXOS™ is administered by oral capsule, once daily for 12 weeks in combination with pegylated interferon and ribavirin, followed by pegylated interferon and ribavirin alone for an additional 12 or 36 weeks.4

"Patients with hepatitis C and their physicians need new, more tolerable treatment options for this complex and difficult-to-treat disease," said Dr. Morris Sherman**, Associate Professor of Medicine at the University of Toronto. "Data from clinical trials have shown that in combination with pegylated interferon and ribavirin, GALEXOS™ can give patients, even those who have failed previous treatment with pegylated interferon and ribavirin, a chance to cure the disease with a manageable side-effect profile."

Chronic hepatitis C, caused by HCV, is a blood-borne infectious disease that attacks the liver. Left untreated, it can cause significant damage, including liver failure, cirrhosis and cancer.5 People with HCV often have no symptoms and can live for decades without feeling sick. When symptoms do appear, it is often during the later stages of infection, when irreversible liver damage may have already occurred.6 Unlike many other viral infections, HCV is curable - effective treatment can eradicate the virus, halting the progression of the disease.7

The approval of GALEXOS™ in Canada is based on four pivotal studies of patients with CHC genotype 1 infection: in treatment-naïve patients (QUEST-1 and QUEST-2); in patients who have relapsed after prior treatment with pegylated interferon and ribavirin (PROMISE); and, in patients who were prior non-responders to pegylated interferon and ribavirin (ASPIRE).

Results from a pooled analysis of QUEST-1 and QUEST-2 demonstrated that 80 per cent of treatment-naïve patients in the group receiving GALEXOSTM achieved sustained virologic response 12 weeks after the end of treatment (SVR12), compared with 50 per cent of patients in the placebo groups. In PROMISE, 80 per cent of prior-relapser patients in the GALEXOSTM arm of the study achieved SVR12 compared with 37 per cent of patients in the placebo group. Results from ASPIRE demonstrated that use of GALEXOSTM led to sustained virologic response 24 weeks after the end of treatment (SVR24) in 62 per cent of prior partial responder patients and 58 per cent of prior null-responder patients compared with 6 per cent and 15 per cent of prior partial and null-responder patients in the placebo groups, respectively.8

"Each new generation of hepatitis C therapy is improving the treatment options for patients, making them more effective, tolerable and easier to use," said Gary Fagan, President of the Canadian Liver Foundation. "In order to prevent patients from developing the severe complications of hepatitis C, including cirrhosis and liver cancer, it is vital that we have the widest range of options to treat patients as early as possible to give them the best chance for recovery."

About GALEXOS™
GALEXOS™ is a NS3/4A protease inhibitor jointly developed by Janssen R&D Ireland and Medivir AB. It is indicated in Canada for the treatment of chronic hepatitis C (CHC) genotype 1 infection, in combination with peginterferon alfa and ribavirin in adults with compensated liver disease, including cirrhosis, who are treatment-naïve or who have failed previous interferon therapy (pegylated or non-pegylated) with ribavirin. GALEXOS™ is administered once-daily by 150mg capsule for 12 weeks in combination with pegylated interferon and ribavirin, followed by pegylated interferon and ribavirin alone for an additional 12 or 36 weeks.9

GALEXOS™ was generally well-tolerated. The most common side effects seen with GALEXOS™ in the phase III clinical trials were itch, rash, sun sensitivity, increased bilirubin in the blood and constipation.10

GALEXOS™ met the Health Canada criteria for Priority Review. For a drug to receive priority or accelerated review in Canada, it must show effective treatment of a serious, life-threatening or severely debilitating disease or condition for which no drug is presently marketed in Canada.  Or, it must show a significant increase in efficacy and/or decrease in risk so that the overall benefit/risk profile is improved over existing therapies for a disease that is not adequately managed by a drug already marketed in Canada.11

About HCV
More than 250,000 Canadians are living with HCV, with thousands of new cases diagnosed each year;12 however, the actual number of Canadians with the disease is likely much higher than 250,000 because 35 per cent of those who have HCV don't know it.13 Hepatitis C virus causes more lost years of life and illness than any other infectious disease in Ontario (and likely Canada).14,15 Combined with the indirect costs of HCV, the financial burden of the disease in Canada is estimated at $500 million annually.16

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 trademarks used under license.

**Dr. Sherman was not compensated for any media work. He has been a paid consultant to Janssen Inc.

References:
_____________________________
1 GALEXOS™ Product Monograph. Pg. 3 - November 18, 2013.
2 GALEXOS™ Product Monograph. Pg. 3 - November 18, 2013.
3 WebMD. Protease Inhibitors for Hepatitis C. http://www.webmd.com/hepatitis/protease-inhibitors-pis-for- hepatitis-c October 21, 2013.
4 GALEXOS™ Product Monograph. Pg. 9 - November 18, 2013.
5 Canadian Liver Foundation. What is Hepatitis C. http://www.liver.ca/liver-disease/types/viral_hepatitis/Hepatitis_C.aspx October 17, 2013.
6 Canadian Liver Foundation. Hepatitis C. http://www.liver.ca/liver-disease/types/viral_hepatitis/Hepatitis_C.aspx October 16, 2013.
7 A Canadian screening program for hepatitis C: Is now the time? Canadian Medical Association Journal. CMAJ 2013. DOI:10.1503/cmaj.121872.
8 GALEXOS™ Product Monograph. Pg. 27-37 - November 18, 2013.
9 GALEXOS™ Product Monograph. Pg. 3 - November 18, 2013.
10 GALEXOS™ Product Monograph. Pg. 9 November 18, 2013.
11 Health Canada Guidance For Industry - Priority Review of Drug Submissions http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/priorit/priordr-eng.php#a2 November 4, 2013.
12 Government of Canada. Healthy Canadians - Hepatitis C.http://healthycanadians.gc.ca/health-sante/disease-maladie/hepc-eng.php October 21, 2013.
13 Government of Canada. Healthy Canadians - Hepatitis C.http://healthycanadians.gc.ca/health-sante/disease-maladie/hepc-eng.php October 21, 2013.
14 Kwong JC, Ratnasingham S, Campitelli MA, et al. The impact of infection on population health: results of the Ontario burden of infectious diseases study. PLoS ONE 2012;7:e44103.
15 A Canadian screening program for hepatitis C: Is now the time? Canadian Medical Association Journal. CMAJ 2013. DOI:10.1503/cmaj.121872.
16 Public Health Agency of Canada. The Evaluation of Hepatitis C  http://www.phac-aspc.gc.ca/publicat/2008/er-re-hepc/er-re-hepc1-eng.php. October 17, 2013.

SOURCE: Janssen Inc.

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