Vertex delivered a blockbuster payload of new telaprevir data demonstrating that the experimental hepatitis C drug in combination with existing drugs is much better at erasing all signs of the virus than standard therapy. And it leaves Vertex precisely where it wanted to be: On track to an FDA approval that will deliver a mega-blockbuster marketing opportunity.
About three of every four patients taking the telaprevir combo therapy in a late-stage trial were cured of the virus, compared with 44 percent on interferon and ribavirin alone. And the therapy--which promises to shorten the time to a cure from 12 months to less than six months--appears poised to become a key ingredient in a new standard for the cocktail therapies being designed for hepatitis C. If the next two late-stage trials stay on this course, Vertex will be in position to file for an approval in the second half of this year.
"These first Phase III results are important for people with hepatitis C, as they represent a potential new era of therapy where doctors may be able to use direct acting antiviral medicines to improve treatment and help patients potentially avoid life-threatening liver-related consequences associated with chronic hepatitis C," says Ira Jacobson, M.D., Chief of the Division of Gastroenterology and Hepatology, Weill Cornell Medical College.
Some analysts expect to see the market for telaprevir top out at $3 billion a year. Investors were pleased and not terribly surprised by the solid trial numbers, driving up the company's shares by 12 percent.
Vertex now will have to see if it can hold on to the lead position it has taken among the growing development crowd pursuing a new hep C drug. Next up: Merck's boceprevir, which has also performed extremely well in clinical trials. Late-stage data will drop later in the year. Analysts are also tracking a new therapy from Anadys and Gilead.