Vertex receives Health Canada approval for INCIVEK to treat hepatitis C

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that Health Canada has approved INCIVEK™ (telaprevir) tablets for a broad group of people with genotype 1 chronic hepatitis C with compensated liver disease (some level of damage to the liver but the liver still functions), including cirrhosis (scarring of the liver). INCIVEK (in-SEE-veck) is approved for use in combination with pegylated-interferon and ribavirin, two other medicines approved to treat hepatitis C, and is indicated for people who are new to treatment, and for people who were treated previously but who did not achieve a sustained viral response (SVR, or viral cure). INCIVEK is approved for use in all three major groups of people who did not achieve a viral cure despite prior treatment including: relapsers, partial responders and null responders.

"Early diagnosis and the effective treatment of hepatitis C are critical to the prevention of long-term consequences of the disease, which may include end-stage cirrhosis, liver cancer and the need for a transplant," said Eric Yoshida, M.D., Professor of Medicine and Head, Division of Gastroenterology at the University of British Columbia and an INCIVEK investigator. "INCIVEK is an important new treatment option because it has been shown to help clear the virus for nearly four out of five patients new to treatment."

"Health Canada's rapid approval of INCIVEK underscores the urgent need for new medicines to treat hepatitis C, which affects about a quarter of a million Canadians," said Robert Kauffman, M.D., Ph.D., Senior Vice President and Chief Medical Officer for Vertex. "Until recently, approximately 40 percent of people who underwent a year of treatment for hepatitis C were cured. INCIVEK's ability to nearly double that rate of cure and cut treatment time in half for the majority of patients being treated for the first time marks a turning point in the fight against this disease."

INCIVEK is given as two 375-mg tablets, three times daily. It is given for 12 weeks in combination with pegylated-interferon and ribavirin. After the first 12 weeks, all patients stop receiving INCIVEK and continue treatment with pegylated-interferon and ribavirin alone for an additional 12 weeks or 36 weeks of treatment. With INCIVEK combination treatment, more than 60 percent of people treated for the first time, as well as those who relapsed after previous therapy, are expected to complete all treatment in 24 weeks — half the time needed if they were to take pegylated-interferon and ribavirin alone. All other patients will receive a total of 48 weeks of treatment. Rash and anemia are the most serious side effects associated with INCIVEK. The most common side effects reported with INCIVEK combination treatment include fatigue, itching, nausea, diarrhea, vomiting, anal or rectal problems, and taste changes.

The approval of INCIVEK was based on data from three Phase 3 studies of more than 2,500 people with hepatitis C, which showed that people who received INCIVEK combination treatment achieved significantly higher rates of viral cure (sustained viral response, or SVR) compared to those who received pegylated-interferon and ribavirin alone, regardless of their prior treatment experience:

Data from the Phase 3 REALIZE and ADVANCE studies were published on June 23, 2011 in the New England Journal of Medicine.

"As the world's first organization dedicated to providing support for research and education into the causes, diagnoses, prevention and treatment of all liver disease, we are all too familiar with the devastating consequences of hepatitis C," said Morris Sherman, Ph.D., FRCPC, M.B., Chairman of the Canadian Liver Foundation (CLF) and an INCIVEK investigator. "We applaud the approval of new medicines like INCIVEK that can significantly improve the treatment of hepatitis C and hope that all Canadians who need treatment will have access to these medical advances."