HGSI Seeks European Approval - Analyst Blog

Human Genome Sciences Inc. (HGSI) recently submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) seeking marketing approval for its potential blockbuster lupus drug candidate, Benlysta, in Europe. Human Genome and GlaxoSmithKline plc (GSK) are co-developing Benlysta for treating patients suffering from systemic lupus erythematosus (SLE).

 

The application includes data from the two late-stage trials, BLISS-52 and BLISS-76. Both double-blind, placebo-controlled, multi-center studies evaluated the efficacy and safety of Benlysta in combination with the standard of care against placebo plus standard of care, in seropositive SLE patients. The studies evaluated a total of 1,684 patients.

 

We remind investors that Benlysta, a human monoclonal antibody that specifically recognizes and prevents the biological activity of B-lymphocyte stimulator (BLyS), met the primary endpoint in the BLISS-52 trial in 2009. Furthermore, Benlysta met the primary end-point in BLISS-76 through 52 weeks in November 2009. However, Benlysta did not prove to be more effective than placebo in the long-term according to the complete 76-week data from the BLISS-76 trial announced earlier this year.

 

Benlysta, if approved, would be the first new lupus drug to be approved in 50 years. Lupus affects about 1.5 million people in the United States and 5 million people worldwide. If approved, we expect Benlysta to become a blockbuster drug. The company intends to file an application later in the month with the US Food and Drug Administration (FDA) to market the lupus drug in the US.

 

Apart from Benlysta, Human Genome has two other interesting late-stage candidates in its pipeline, namely Zalbin for hepatitis C and ABthrax for treating anthrax. Zalbin, which is co-developed with Novartis (NVS), is under review in the US (target date: October 4, 2010). However, the MAA for Zalbin was recently withdrawn by Novartis. The withdrawal of the MAA was based on indications that the European regulatory authorities would ask for additional data, which the companies may not be able to furnish within the stipulated time frame offered by the European Centralized Procedure.

 

Additionally, the FDA did not approve ABthrax for anthrax treatment late last year. The agency has asked for additional data pertaining to the drug before it grants approval.

 

 

Currently we have a Neutral outlook on Human Genome in the long-term, implying that it will perform in line with the overall U.S. equity market over the next six to twelve months. We advise investors to retain the stock over the time period.