HGSI: NDA for Albuferon Expected to be Filed This FallWaiting for 2 Phase III Results for BenlystaNDA filing for Albuferon is expected in the fall for Hepatitis C      Albuferon is a novel long-acting form of interferon alpha. Recombinant interferon alpha is approved for the treatment of hepatitis C, hepatitis B and a broad range of cancers. Human Genome Sciences Inc. (HGSI) modified interferon alpha to improve its pharmacological properties by using its albumin fusion technology.HGSI has an exclusive worldwide agreement with Novartis (NVS) for the development and commercialization of Albuferon. The two companies are developing Albuferon as a potential treatment for chronic hepatitis C (HCV). Under this agreement, ...

Cash strain forces ANDS to restructure Early this morning, Anadys Pharmaceuticals, Inc. (ANDS) announced a strategic restructuring to focus its operations on the development of ANA598, its lead anti-hepatitis C drug candidate. In particular, the company will focus its resources on a proposed phase II study in hepatitis C patients of ANA598 in combination with pegylated interferon-alpha and ribavirin.As part of this restructuring, the company intends to suspend further development of its hepatitis C and oncology programs of ANA773 and is reducing its workforce by approximately 40%. ANA773 is under phase I trials for hepatitis C and solid tumors. The company intends to out-license the programs after the outcome and analysis of data from current cohorts in ongoing phase I studies in hepatitis C and oncology. As a reminder, these are the only two clinical programs ANDS has.The company recently reported positive ...

Highlights include Anadys Pharmaceuticals Inc. (ANDS), Roche Holding AG (RHHBY), Schering-Plough (SGP), Gilead Sciences (GILD), Vertex Pharmaceuticals (VTRX) and Valeant Pharmaceuticals International (VRX).Strong efficacy data observed in early phase Ib studies for ANA598, but a severe rash raises safety concernsANA598 is Anadys' (ANDS) lead anti-HCV (hepatitis C Virus) drug candidate currently under phase I studies. The company's share price got a boost recently on its strong efficacy data from a phase Ib study.Anadys presented the final antiviral and safety data from all three dose levels (200, 400 and 800 mg bid) at the 44th annual meeting of the European Association for the Study of the Liver (EASL) on April 23, 2009. The trial enrolled total 35 subjects. ANA598 treatment resulted in rapid and sustained reductions in HCV RNA with median reductions at end of treatment (day 4) ...