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Health Canada’s Approval of IBAVYR™ Enables Specific Patients with Chronic Hepatitis C Infection
to Be Treated with an All-Oral Regimen

- Elimination of Interferon Represents a Transformation in Treatment for Patients -

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.

“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”

“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 option.

“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, 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.

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

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 (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.

References:
1. Public Health Agency of Canada. The Evaluation of Hepatitis C http://www.phac-aspc.gc.ca/publicat/2008/er-re-hepc/er-re-hepc1-eng.php. October 17, 2013.

Contacts

Pendopharm
Isabelle Vézina, 514-340-9800 ext. 3055
or
Eakins Communications
Robert Eakins, 905-639-9587