Human Genome Seeks Approval

Human Genome Sciences, Inc. (HGSI - Analyst Report) recently announced the submission of a Marketing Authorization Application, (MAA), to the European Medicines Agency (EMEA) seeking marketing approval of Joulferon (albinterferon alfa-2b) for treating chronic hepatitis C patients. The application was submitted by Novartis (NVS - Snapshot Report) with whom Human Genome entered into an exclusive global agreement for the development and commercialization of the drug in 2006.
 
The application  for European approval includes data from two pivotal late-stage trials which showed that 900-mcg albinterferon alfa-2b dosed every two weeks met its primary endpoint of non-inferiority to peginterferon alfa-2a (Pegasys of Roche [RHHBY]) dosed once each week.
 
The randomized, open-label, active-controlled, multi-center, non-inferiority studies, known as ACHIEVE 1 and ACHIEVE 2/3, evaluated albinterferon alfa-2b vs. peginterferon alfa-2a, in combination with ribavirin, for treating interferon-naïve patients with chronic hepatitis C.
 
Joulferon 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 modified interferon alpha to improve its pharmacological properties by using its albumin fusion technology.
 
Human Genome and Novartis have selected Zalbin as the brand name for albinterferonalfa- 2b (formerly Albuferon) in the United States while Joulferon is the brand name in the rest of the world. The drug is under review in the United States. Human Genome submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) last month.
 
Hepatitis C, an inflammation of the liver caused by the hepatitis C virus, affects approximately 170 million people globally. This is inclusive of nearly four million people in the U.S. Although the interferon alpha market is a multibillion dollar market, we believe Zalbin will face stiff competition from Merck’s (MRK - Analyst Report) PEG-Intron and Roche’s Pegasys. Additional competition could come in the form of Vertex Pharma’s (VRTX - Snapshot Report) Telaprevir, a protease inhibitor in late-stage development.
 
Currently, we are Neutral on Human Genome Sciences.

Read the full analyst report on HGSI

Read the full analyst report on NVS

Read the full analyst report on RHBBY

Read the full analyst report on MRK

Read the full analyst report on VRTX