Pendopharm announces Priority Review of new therapy to support treatment of patients with hepatitis C

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 
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. 
Company Information 
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. 
1. Public Health Agency of Canada. The Evaluation of Hepatitis C October 17, 

SOURCE  Pendopharm 
Élise Vézina Pendopharm 514-340-9800 ext. 3482 
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CO: Pendopharm
ST: Quebec
-0- Mar/31/2014 14:29 GMT
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