Human Genome Seeks FDA Approval - Analyst Blog

(

) recently submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) seeking marketing approval for its potential blockbuster lupus drug candidate, Benlysta. Human Genome and

(

) are co-developing Benlysta for treating patients suffering from systemic lupus erythematosus (

).

We remind investors that Benlysta, a human monoclonal antibody that specifically recognizes and prevents the biological activity of the naturally occurring protein 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. The two studies evaluated a total of 1,684 patients.

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. Earlier in the month, the company submitted a Marketing Authorization Application (

) to the European Medicines Agency (EMA) seeking approval for Benlysta in Europe .

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

(

), is under review in the US (target date: October 4, 2010). However, the MAA for Zalbin was recently withdrawn by Novartis.

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. However, Human Genome, which has the contract of delivering doses of ABthrax to the US Strategic National Stockpile, for use in the event of an emergency to treat inhalation anthrax, has already delivered multiple doses.

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.