Novartis Hep C drug clears Phase II

Albuferon (albinterferon alfa-2b) was developed by Human Genome Sciences (HGS), who has teamed up with Novartis since June 2006 to bring the drug through the pipeline and this latest milestone, due in September, will bring the amount received by HGS to $132.5m. After clearing Phase II, the drug is now being prepped for two pivotal Phase III trials, one of which HGS has already managed to complete the enrollment of ahead of schedule, having recruited over 1,300 volunteers in 12 countries. The second, smaller trial is due to finish enrolling over 900 patients later in the year. The company said it expects to have Phase III data available by the second quarter of 2009, and plans to file global marketing applications by the third quarter. Under the arrangement between the two firms, HGS and Novartis are equally sharing all development costs and will also equally share the commercialisation costs and profits the drug generates in the US. Novartis will pay for the commercialisation in the rest of the world and HGS will receive a royalty on sales. From its inception, the relationship could be worth up to $507.5m for HGS. Albuferon is a novel long-acting form of interferon alpha - an approved treatment of HCV - and is created by genetically fusing it to human albumin, which has the effect of decreasing the clearance and prolonging the half-life of the therapeutic protein. HCV is a major cause of chronic liver disease and 170m people worldwide carry the disease. In 2006 worldwide sales of HCV drugs totalled €3.5bn. Novartis is active in the HCV arena, in addition to its partnership with HGS, it's also in co-development with Intercell for a vaccine against chronic HCV, which has recently shown promise in interim Phase II trial data.​