Setback for Human Genome Pipeline - Analyst Blog

Recently, Human Genome Sciences Inc. (HGSI) received a setback when the Marketing Authorization Application (MAA) for its hepatitis C candidate Joulferon (albinterferon alfa-2b) was withdrawn by its partner Novartis AG (NVS).

 

Novartis, with whom Human Genome entered into an exclusive global agreement for the development and commercialization of the drug in 2006, submitted the MAA to the European Medicines Agency (EMEA) for its hepatitis C candidate in December 2009.

 

Human Genome and Novartis have selected “Zalbin" as the brand name for albinterferon alfa- 2b in the United States while “Joulferon" is the brand name for 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) in November 2009. The company expects the FDA to approve the drug in the fourth quarter of 2010 (target date: October 4, 2010)

 

The withdrawal of the MAA was based on indications that the European regulatory authorities would ask for additional data, which the companies may be not be able to furnish in the time frame permissible under the European Centralized Procedure.

 

The feedback from the European regulatory authorities queried whether the therapeutic benefit offered by Joulferon, dosed once every fortnight, outweighed the risks associated with the candidate.

 

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.

 

On approval, we believe that the drug will face tough competition from Merck’s (MRK) PEG-Intron and Roche’s (RHHBY) Pegasys in the interferon alpha market.

 

We believe that the most eagerly awaited candidate in Human Genome’s pipeline is the lupus candidate Benlysta, co-developed with GlaxoSmithKline plc (GSK), which has blockbuster potential. The company intends to seek approval for Benlysta during the second quarter of 2010 in the United States and Europe. Management expects the drug to be approved in the U.S. in the fourth quarter of 2010.

 

Currently, we are “Neutral" on Human Genome Sciences.