Merck Receives Approval of ZEPATIER™ (elbasvir/grazoprevir) in Canada for the Treatment of Chronic Hepatitis C for Patients with Genotype 1, 3, or 4 Infection Following Priority Review

ZEPATIER Achieves High Cure Rates* (SVR12) of 95-98% in Broad Range of Patients with Chronic Hepatitis C Infection, Including Those with Compensated Cirrhosis, Renal Impairment of Any Degree and HIV-1/HCV Co-infection

KIRKLAND, QC, Feb. 3, 2016 /CNW Telbec/ - Merck (NYSE: MRK), known as MSD outside Canada and the United States, announced today that ZEPATIER (elbasvir/grazoprevir) is now available in Canada. It is indicated for the treatment of chronic hepatitis C (CHC) genotypes 1, 3 or 4 infections in adults; see the About ZEPATIER section below for full indication details.1

"We value this accelerated approval of ZEPATIER in Canada which allows us to offer an effective, simple and well tolerated treatment not only for Canadians with the hepatitis C virus with genotype 1 infection, but also for genotype 3 and 4 infected patients for whom options were limited until now," says Chirfi Guindo, President and Managing Director, Merck Canada Inc. "With this new product,  we now have the opportunity to help a broad range of patients overcome hepatitis C using a simple regimen of 1 pill daily, with most patients cured with an 8 to 12-week therapy."

"Chronic hepatitis C is a serious liver disease which, if left untreated, can lead to reduced liver function, liver failure or liver cancer, and is responsible for almost half of all liver transplants in Canada," added Billie Potkonjak, National Director of Health Promotion and Patient Services for the Canadian Liver Foundation (CLF). "ZEPATIER is indicated for patients with CHC genotype 1, 3 and 4 infection and genotype-1 infected patients with renal failure. The CLF welcomes this additional treatment option for hepatitis C, which broadens the patients that can be treated. We urge the provinces to take us another step closer to the elimination of hepatitis C in Canada by making this therapy financially accessible to patients across the country."

"Although I am Chairman of the Canadian Liver Foundation," explained Dr. Morris Sherman, Gastroenterologist, Toronto General Hospital Liver Clinic, "I am also a practicing hepatologist and it is as a liver doctor that I make this comment. Hepatitis C treatment has undergone a revolution in the last two years, and with the approval of this new product, we now have another agent to add to our armamentarium for a broad range of hepatitis C patients. In addition, this treatment is particularly indicated for patients with renal failure and with patients with genotype 4 infection, a group that continues to have difficulty in accessing treatment in Canada.  We hope that the funding agencies quickly approve reimbursement for ZEPATIER. There are patients who have been waiting a long time for this to be available." 

"It is important that Canadians address hepatitis C now," emphasized Lesley Gallagher, Hepatitis C Nurse Clinician, Vancouver Coastal Health.  "People are dying from this disease. The hepatitis C treatment community is setting a high bar for the elimination of hepatitis C in Canada, and advances like this one raise awareness with the public, health care professionals and patients. We are moving towards a time when Canadians can surpass the stigma of hepatitis C, and be empowered to deal with this disease sooner rather than later."

Strategy to Enable Broad Patient Access to ZEPATIER™
The latest innovations in chronic hepatitis C virus (HCV) treatment that have become available over the past three years, now including ZEPATIER, provide Canada with an unprecedented opportunity to significantly reduce the burden of HCV. The scientific community believes that control of HCV infection may be possible and is actively working to achieve that goal by 2030. A significant medical need remains: it is estimated that less than one in five patients with chronic HCV infection are currently treated, with thousands of new cases each year.  

"Merck's long commitment in chronic hepatitis has always been to scientific innovation, access, and to the Canadian hepatitis community," said Bruce McDonald, Vice-President, Hospital/Specialty Care, Merck Canada Inc. "We are embracing this opportunity to work with governments, payers, physicians and other stakeholders, to enable as many appropriate patients to be treated as quickly as possible."

About ZEPATIER™ (elbasvir/grazoprevir)
ZEPATIER is a new, once-daily, fixed-dose combination therapy containing elbasvir (HCV NS5A replication complex inhibitor) and grazoprevir (HCV NS3/4A protease inhibitor).



ZEPATIER is indicated for the treatment of chronic hepatitis C (CHC) genotypes 1, 3 or 4 in adults as follows:1

Treatment duration

Without ribavirin:



In genotype (GT) 1 or 4 treatment-naïve (TN) and peginterferon alfa + ribavirin (PR) treatment-experienced (TE) relapsers

12 weeks


In GT1 protease inhibitor (PI)/PR-TE relapsers

12 weeks


In GT1b TN, non-cirrhotic patients

8 weeks


In GT1b PR- or PI/PR-TE on-treatment virologic failures

12 weeks

With ribavirin:



In GT1a PR- or PI/PR-TE on-treatment virologic failures

16 weeks


In GT4 PR-TE on-treatment virologic failures

16 weeks

With sofosbuvir:



In GT3 TN patients

12 weeks

 

ZEPATIER was studied in one of the broadest hepatitis C clinical trial programs with nearly 1,800 patients enrolled in eight studies. These studies evaluated the rate of sustained virologic response 12 weeks after treatment completion (SVR12) in patients infected with chronic HCV GT 1, 3 or 4, with compensated liver disease (with or without cirrhosis).1

Across five studies of GT1-, GT3-, or GT4-infected treatment-naïve patients with or without cirrhosis, SVR12 was achieved in 95% (699/737) of patients on ZEPATIER. In GT1b-infected patients without cirrhosis, SVR12 after 8 weeks of treatment was achieved in 94% (29/31) of patients. In GT1- or GT4-infected treatment-experienced patients with or without cirrhosis, SVR12 was achieved in 92% (97/105) of patients on ZEPATIER alone and  94% (98/104) of patients on ZEPATIER + ribavirin (RBV) after 12 weeks of therapy and in 93% (94/101) of patients on ZEPATIER alone and 97% (101/104) on ZEPATIER + RBV after 16 weeks of therapy. In GT1-infected PI-experienced patients with or without cirrhosis, SVR12 was achieved in 96% (76/79) of patients on ZEPATIER + RBV after 12 weeks of therapy. In GT1-infected treatment-naïve patients with advanced chronic kidney disease, with or without cirrhosis, SVR12 was achieved in 94% (115/122) of patients on ZEPATIER alone. In GT3-infected treatment-naïve patients with or without cirrhosis, SVR12 was achieved in 93% (14/15) after 8 weeks of therapy and in 92% (24/26) of patients after 12 weeks of therapy with ZEPATIER + sofosbuvir, respectively.1

ZEPATIER is contraindicated in patients with moderate or severe hepatic impairment. It should not be used with organic anion transporting polypeptide 1B (OAT1B) inhibitors, strong inducers or cytochrome P450 3A (CYP3A), or efavirenz.1

The product's safety profile is based on data from two placebo-controlled trials and eight uncontrolled Phase 2 and 3 clinical trials in approximately 2,000 patients with compensated liver disease receiving ZEPATIER with or without RBV. In patients receiving ZEPATIER alone, the most commonly (≥10%) reported adverse reactions were fatigue and headache. No patient had serious adverse reactions. The proportion of subjects who permanently discontinued treatment due to adverse reactions was < 1%. In patients receiving ZEPATIER + RBV, the most commonly (≥10%) reported adverse reactions were fatigue, headache, anemia, and nausea. The majority of the adverse reactions were mild in severity. Less than 1% of these patients had serious adverse reactions. The portion of subjects who permanently discontinued treatment due to adverse reactions was 2%.1

For further information on ZEPATIER, please consult the product monograph available at http://www.merck.ca/assets/en/pdf/products/ZEPATIER-PM_E.pdf.

About Hepatitis C
Hepatitis C is a chronic liver disease caused by the hepatitis C virus (HCV). HCV affects approximately 130-170 million people worldwide, and in 2010, 500,000 people died from HCV-related liver diseases. Approximately 15 to 30 per cent of persons with chronic HCV will develop cirrhosis within 20 years. Approximately 40 per cent of people with HIV are co-infected with HCV and approximately 40 to 50 per cent of injection drug users with HCV.

In Canada, an estimated 242,500 individuals are infected with HCV. Approximately 21 per cent of those individuals don't know they are infected and remain undiagnosed. Many people infected with HCV remain unaware of their infection, but they are still infectious.3-5

Merck's Commitment to HCV
For nearly 30 years, Merck has been at the forefront of the response to the HCV epidemic. Merck employees are dedicated to applying their scientific expertise, resources and global reach to deliver innovative healthcare solutions that support people living with HCV worldwide.

About Merck Canada Inc.
Today's Merck is a global healthcare leader working to help the world be well.

Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information about our operations in Canada, visit www.merck.ca and YouTube.

Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA
This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the "company") includes "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company's management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company's 2014 Annual Report on Form 10-K and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (www.sec.gov).

###

ZEPATIER™ is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

_______________________________________________

References: *Title: The Canadian Association for Study of the Liver (CASL) considers sustained virologic response (SVR) a cure as per their 2015 Guidelines: "once achieved, an SVR is considered to be a long term cure of the virus because late relapses are rare."
1. ZEPATIER™ Product Monograph. Merck Canada Inc. January 19, 2016.
2. PHAC, 2014. Hepatitis C. Quick Facts. Online: http://www.phac-aspc.gc.ca/hepc/index-eng.php  (accessed June 2015). 
3. Mohd Hanafiah K, Groeger J, Flaxman AD, Wiersma ST. Global epidemiology of hepatitis C virus infection: New estimates of age specific antibody to HCV seroprevalence. Hepatology 2013;57:1333-42. 
4. Lozano R, Naghavi M, Foreman K, Lim S, Shibuya K, Aboyans V, Abraham J, et al. Global and regional mortality from 235 causes of death for 20 age groups in 1990 and 2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet 2012;380:2095-
5. CLF, 2015. Hepatitis C. What is Hepatitis C? Online: http://www.liver.ca/liver-disease/types/viral_hepatitis/Hepatitis_C.aspx  (accessed June 2015).
6. Public Health Agency of Canada. Hepatitis C in Canada: 2005-2010 Surveillance Report. Centre for Communicable Diseases and Infection Control, Infectious Disease Prevention and Control Branch, Public Health Agency of Canada; 2011.

 

SOURCE Merck Canada Inc.

Video with caption: "Video: Hepatitis C - The Big Picture". Video available at: http://stream1.newswire.ca/cgi-bin/playback.cgi?file=20160203_C3316_VIDEO_EN_611627.mp4&posterurl=http%3a%2f%2fphotos.newswire.ca%2fimages%2f20160203_C3316_PHOTO_EN_611627.jpg&order=1&jdd=20160203&cnum=C3316

Image with caption: "ZEPATIER(TM): Dose Pack (CNW Group/Merck Canada Inc.)". Image available at: http://photos.newswire.ca/images/download/20160203_C3316_PHOTO_EN_612363.jpg

PDF available at: http://stream1.newswire.ca/media/2016/02/03/20160203_C3316_PDF_EN_612379.pdf

For further information: Media Contact: Annick Robinson, (438) 837-2550; Montreal, Astrid Morin, NATIONAL Public Relations, 514-843-2374; Toronto, Candice Bruton, NATIONAL Public Relations, 416-848-1416; Calgary, Angela Cabucos, NATIONAL Public Relations, 403-531-0331 ext. 486; Vancouver, Jenna Livergant, NATIONAL Public Relations, 604-691-7396; Investor Contact: Amy Klug, (908) 740-1898

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