|[July 15, 2014]
Health Canada's Approval of IBAVYR™ Enables Specific Patients with Chronic Hepatitis C Infection to Be Treated with an All-Oral Regimen
MONTREAL --(Business Wire)--
Quebec-based Pendopharm, a division of Pharmascience Inc., today
announced Health Canada approval and market availability of IBAVYRTM
(ribavirin tablets), the first stand-alone oral ribavirin for the
treatment of chronic hepatitis C virus (HCV) infections in Canada.
Approved to be used in combination with other agents, IBAVYR will enable
some patients to receive an all-oral therapy (without interferon
injections), which represents a novel treatment approach in Canada.
"The approval of IBAVYR transforms the treatment of HCV as some patients
will now be able to receive treatment regimens without the use of
interferon, thus eliminating the potential side effects associated with
interferon that often lead patients not to start, or to complete,
treatment," said Dr. Alnoor Ramji, Clinical Associate Professor of
Medicine, Division of Gastroenterology, University Of British Columbia.
"IBAVYR will offer the opportunity for Canadian health care
professionals to provide patients ribavirin as part of an all-oral
treatment regimen that is well-tolerated, thus allowing more patients to
be treated and to achieve viral eradication."
Until the approval of IBAVYR, ribavirin, a component of the current
standard of care for the treatment of HCV, had only been approved by
Health Canada in a format that was co-packaged with pegylated
interferon. This approval will allow stand-alone ribavirin to be used
along with new and evolving treatments, such as Sovaldi®
(sofosbuvir), the first treatment to allow for interferon-free therapy
in genotypes 2 and 3. Patients with genotypes 2 and 3 represent 30 per
cent of HCV cases in Canada. Recently, new guidelines from the AASLD
recommended Sovaldi® and ribavirin as the preferred treatment
"New HCV treatments and regimens, especially interferon-free regimens,
have the potential to transform HCV treatment in Canada," said Jordan
Feld, MD, MPH, Staff Hepatologist, Toronto Western Hospital, Departmnt
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.
Responding to an Unmet Need in HCV Treatment
Health Canada approved IBAVYR after a Priority Review given the need for
stand-alone ribavirin to be used in combination with Sovaldi®
that achieves higher cure rates, shortens treatment duration, minimizes
side effects and is better tolerated. IBAVYR was developed and is
manufactured in Canada by Pharmascience.
"Pendopharm recognized this unmet need in patient treatment and is
pleased to be part of the solution to bring the newest HCV
interferon-free treatment regimen to physicians and patients," said
David Goodman, CEO, Pharmascience Inc. "A Sovaldi® and IBAVYR
treatment regimen will become a trusted partnership that will change the
treatment experience for some patients, and will allow physicians to
treat and cure more patients. Now, Pendopharm will work closely with the
provinces to ensure patients have access to IBAVYR and all-oral
treatments as quickly as possible, in order to achieve high cure rates
while improving quality of life," added Dr. Goodman.
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
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.
Note: Sovaldi® (sofosbuvir), manufactured by Gilead Sciences
Canada, Inc., received a Notice of Compliance from Health Canada in
December 2013. It is the first approved 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.
1. Public Health Agency of Canada. The Evaluation of
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