Vertex Pharmaceuticals has finally got the definitive proof it needs to say it has made a breakthrough for hepatitis C patients. The Cambridge, MA-based biotech company said today that its experimental drug for the chronic liver damaging disease was able to cure three-fourths of patients in the last stage of clinical testing required for FDA approval.
Vertex’s telaprevir compound, when given in combination with two standard drugs, was able to eradicate any detectable sign of the hepatitis C virus in the blood for 75 percent of patients a full 24 weeks after they completed their course of therapy, Vertex said today in a statement. That is compared with 44 percent who did that well on a typical 48-week course of the usual drugs, pegylated interferon alpha and ribavirin. The results, which essentially represent the rate of clinical cures, were from a pivotal study of 1,095 patients known as “Advance.”
This is the first time a company has shown in the final phase of clinical testing that a protease inhibitor, a type of enzyme blocker on the virus, which can almost double the cure rate for hepatitis C patients, while cutting the course of treatment in half for the standard drugs, which cause flu-like symptoms. An estimated 170 million people worldwide, and about 3 million people in the U.S. are infected with chronic hepatitis C, which damages the liver and can shorten lifespans. If Vertex can confirm these results in two more pivotal trials that are expected to yield results in coming months, Vertex could seek FDA approval later this year and bring telaprevir to the U.S. market in 2011. U.S. sales alone could amount to more than $2 billion after a couple years, analysts say.
“These first Phase 3 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,” said Ira Jacobson, the chief of gastroenterology and hepatology, at Weill-Cornell Medical College, in a Vertex statement.
Shares of Vertex (NASDAQ: VRTX) climbed 11 percent to $38 in after-hours trading today following the announcement.
The data to support telaprevir shouldn’t come as a surprise given what the company has seen in its previous studies. This Advance trial enrolled patients who have chronic hepatitis C infections, but have never before been treated. That’s because many people consider the standard therapy—pegylated interferon alpha and ribavirin—as worse than the disease because of the flu-like symptoms they must endure for almost a year.
Doctors wanted to see in this study whether adding telaprevir, as a pill taken three times a day, would be able to provide enough benefit to outweigh the side effects. Patients were randomly … Next Page »
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