PENDOPHARM Announces Priority Review of New Therapy to Support Treatment of Patients with Hepatitis CPrint
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 Ms. Vézina.
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 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.
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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.