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
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
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 Ms.
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
"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, 2013.
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