According to the Centres for Disease Control an estimated 3.9 million Americans have been infected with HCV, of whom 2.7 million are chronically infected, and the prevalence of chronic HCV is increasing. Currently available therapies are insufficient, creating a need for the development of novel therapeutic approaches.
The program, which began in 2002, has produced novel small molecule inhibitors of the Hepatitis C Virus (HCV) NS3/4 protease. In addition to extending the current agreement, the program has been expanded to allow Array and InterMune to enhance their discovery efforts. Array will continue to conduct process research and cGMP scale-up of drug candidates to support clinical development.
"We have expanded the collaboration to accelerate the development of this important class of novel HCV inhibitors," said Dan Welch, chief executive officer and President of InterMune.
"In addition to our protease inhibitor program, we are advancing our late stage HCV pipeline in PEG-nonresponders and growing our marketed brand, Infergen (interferon alfacon-1) for the retreatment of chronic HCV," he added.
Additional terms of the agreement will see InterMune fund drug discovery, preclinical and process development at Array. InterMune maintains responsibility for clinical development and commercialisation of the resulting products.
Array will be entitled to receive milestone payments based on the selection and progress of clinical drug candidates, as well as royalties on net sales of products derived from the collaboration. Other terms were not disclosed.
Hepatitis C virus causes inflammation of the liver and degradation of liver function. Approximately 70 per cent of individuals infected with HCV progress to chronic hepatitis. The most common symptoms of chronic hepatitis, which may show no symptoms for many years, include an enlarged liver and spleen, jaundice, muscle wasting, excoriations (the result of scratching), ascites (swelling of the abdomen) and swelling of the ankles.
The current standard of care for chronic HCV is a combination of an interferon-alpha product and ribavirin. Sales of HCV drugs are expected to grow due to improved market penetration through increased awareness and improved diagnosis rates and therapies.