Pendopharm announces Priority Review of new therapy to support treatment of
patients with hepatitis C
MONTREAL, March 31, 2014 /CNW Telbec/ - New hepatitis C (HCV) treatment
regimens have advanced rapidly in recent years, including the recent Health
Canada approval of interferon-free therapy. To support patients to access
these newest options, Pendopharm, a division of Pharmascience Inc., today
announced that it has received a Priority Review designation from Health
Canada for the first stand-alone ribavirin tablet for the Canadian market.
In Canada, ribavirin, a component of the current standard of care for the
treatment of HCV, is only approved in a format that is co-packaged with
pegylated interferon. As such, Pendopharm has sought Health Canada approval
of the first stand-alone ribavirin to support the treatment of HCV. Health
Canada has granted Pendopharm a Priority Review given the need for
single-agent ribavirin in new and evolving HCV treatments.
Gilead Sciences Canada, Inc.'s Sovaldi(®) (sofosbuvir), the most recent HCV
treatment to receive a Notice of Compliance from Health Canada, is the first
treatment regimen that now allows some patients to eliminate interferon
entirely. Sovaldi is a once-daily direct-acting antiviral agent for the
treatment of genotypes 1 and 4 in combination with pegylated interferon and
ribavirin, and in genotypes 2 and 3 in combination with ribavirin alone.
Patients with genotypes 2 and 3 represent an estimated 30 per cent of HCV
cases in Canada.
Responding to Patient Treatment Needs
Pendopharm and Gilead Sciences share a mandate to address medical areas of
high unmet need and burden of illness, as well as to improve the quality of
life of patients. "Pendopharm and Gilead Sciences are pleased to be part of
the solution to bring the newest HCV interferon-free treatment regimens to
physicians and patients," commented Élise Vézina, Vice President and
Division Head, Pendopharm, and Edward Gudaitis, General Manager, Gilead
Sciences Canada, Inc. "Upon Health Canada approval of our ribavirin, we will
work diligently with provinces to support timely access for patients," added
Hepatitis C is an emerging and costly public health issue, but many Canadians
are not aware that HCV can be cured. It is estimated that more than 250,000
Canadians have chronic hepatitis C infection. Hepatitis C is the leading
cause of liver cancer and liver transplantation in Canada. Combined with the
indirect costs of HCV, the financial burden of the disease in Canada is
estimated at $500 million annually.(1)
"New HCV treatment regimens, specifically in genotypes 2 and 3 where we can
now eliminate interferon, have the potential to transform HCV treatment in
Canada," said Jordan Feld, MD, MPH, Staff Hepatologist, Toronto Western
Hospital, Department of Medicine, Division of Gastroenterology. "Interferon
has been the main stumbling block to treatment in the past. New regimens
without interferon are a huge advance, giving us higher cure rates and
shortened treatment duration with a lot fewer side effects. This gives us our
best opportunity to successfully treat and cure Canadians with hepatitis C,"
added Dr. Feld.
Pendopharm is a division of Pharmascience Inc., a Canadian privately-owned
company. Established in 1983, Pharmascience Inc. is the largest pharmaceutical
company in Quebec, with a highly-skilled workforce of 1,300 people. It
commercializes nearly 300 products, including branded prescription, OTC and
BTC products as well as generic products in Canada and with its affiliates and
distributors in Europe, Asia, Middle East, Africa and Oceania.
Strategically committed to growth, Pendopharm (www.pendopharm.com) is actively
engaged in licensing, partnering, developing and marketing late-stage
specialty prescription medicines as well as consumer brands.
Gilead Sciences, Inc. is a biopharmaceutical company that discovers, develops
and commercializes innovative therapeutics in areas of unmet medical need.
The company's mission is to advance the care of patients suffering from
life-threatening diseases worldwide. Headquartered in Foster City,
California, Gilead Sciences has operations in North and South America, Europe
and Asia Pacific. Gilead Sciences Canada, Inc. is the Canadian affiliate of
Gilead Sciences, Inc. and was established in Mississauga, Ontario in 2005.
1. Public Health Agency of Canada. The Evaluation of Hepatitis C
www.phac-aspc.gc.ca/publicat/2008/er-re-hepc/er-re-hepc1-eng.php. October 17,
Élise Vézina Pendopharm 514-340-9800 ext. 3482
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-0- Mar/31/2014 14:29 GMT
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