New Hepatitis Therapy Could Be Vertex's Windfall

August 13, 2010
By Michael Fitzhugh

Vertex Pharmaceutical (VRTX) says a new trial shows that its late-stage hepatitis C therapy, telaprevir, can help some people tackle the virus in half the time the current treatment takes. A quicker cure, one slashing typical treatment times to 24 weeks from 48 weeks, could help millions of infected people stick to their treatment regimens and represent a windfall for Vertex.

Knowing that it’s possible to treat infected patients in less time could “provide important information to motivate people to continue therapy,” says the trial’s principal investigator, Kenneth Sherman, a professor at the University of Cincinnati College of Medicine.

The trial, dubbed ILLUMINATE, was designed to evaluate whether there was any benefit to extending therapy from 24 weeks to 48 weeks in people whose hepatitis C virus was undetectable at weeks 4 and 12 of treatment. Vertex's analysis of the study's results found there was not.

Hepatitis C can lead to liver cancer and scarring and is thought to be carried by more than 4 million people in the United States and 180 million people worldwide, according to the National Institute of Allergy and Infectious Diseases. Between 55 percent and 85 percent of those people will develop chronic infection, and 75 percent of those with chronic infection will develop chronic liver disease, according to the Institute.

Analysts predict telaprevir sales could peak at more than $3 billion annually in the United States, garnering another $1 billion in peak annual sales overseas. Vertex's main competition in becoming the next standard of care for hepatitis C will be Merck's boceprevir. Telaprevir's efficacy has yet to be compared to boceprevir in a scientific study.

Vertex and its partners, Tibotec Pharmaceuticals and Mitsubishi Tanabe Pharma, plan to submit the positive trial results to support a new drug application for telaprevir to the U.S. Food and Drug Administration in the form of a rolling submission, a process that could accelerate the agency's review of the drug. A decision is expected in early 2011.

Source