Merck announced a non-exclusive license agreement with Laboratory Corporation of America Holdings (LabCorp) for the commercialization of a genetic test that may help predict the response of patients with Hepatitis C virus (HCV) infection to peginterferon alpha-based therapy.
LabCorp has developed an in vitro genetic test designed to identify the presence of the IL-28B polymorphism in patients, which studies suggest may be associated with successful response to peginterferon alpha-based therapy, the current standard-of-care in HCV treatment.
"The discovery of a link between the IL-28B polymorphism and response to peginterferon alpha is a scientific finding that may potentially help identify a patient's genetic predisposition for successful response to HCV therapy," said Roger J Pomerantz, global franchise lead for Infectious Diseases and senior vice president, Merck Research Laboratories. "Viral hepatitis remains a key focus at Merck, and we are committed to seeking solutions that advance patient care, including treatment approaches that are tailored to patient response."
The association of IL-28B polymorphism with peginterferon alpha response was identified by Merck in collaboration with other researchers through a genome-wide association study of nearly 1,700 individuals with HCV genotype 1 who participated in the IDEAL study (Individualized Dosing Efficacy vs. Flat Dosing to Assess OptimaL pegylated interferon therapy), which was sponsored by Merck. The IL-28B association was first reported in a paper published in the journal Nature (September 2009), and the full study manuscript was published in Gastroenterology (May 2010). HCV genotype 1 is the most common form of the virus, accounting for approximately 70 percent of HCV cases in the United States, and is the most difficult to treat.
Under the terms of the agreement, LabCorp will pay a Merck affiliate, a one-time payment and royalties for tests covered under the agreement in exchange for a license to the Merck affiliate's patent rights covering the detection and use of the IL-28B polymorphism.
Merck intends to provide a limited number of non-exclusive licenses to established diagnostics companies.
Pegintron is indicated for use in combination with Rebetol (ribavirin, USP) for the treatment of chronic hepatitis C in patients three years of age and older with compensated liver disease.