Human Genome Sciences Inc. (HGSI) recently received a huge boost when the US Food and Drug Administration (FDA) approved its lupus drug Benlysta. The drug, which has blockbuster potential, has been co-developed with GlaxoSmithKline (GSK). Benlysta is expected to hit the US markets before the end of March 2011.
The approval of Benlysta for treating patients suffering from systemic lupus erythematosus (SLE) makes it the first new lupus drug to be cleared in more than 50 years. Lupus is a potentially fatal autoimmune disease that is extremely difficult to treat. We believe that the approval of this potentially blockbuster candidate will drive Human Genome to profitability.
We note that the US regulatory body has approved Benlysta with certain restrictions. The drug has not been recommended to treat patients suffering from severe active lupus nephritis or severe active central nervous system lupus, as Benlysta has not been evaluated for these indications. Moreover, the drug is not recommended to be used in conjunction with other biologics or intravenous cyclophosphamide.
We remind investors that the Biologics License Application (BLA), seeking marketing approval for the lupus candidate in the US, was filed in June 2010. The application included data from two late-stage trials, BLISS-52 and BLISS-76. In December 2010, the FDA extended the original target date of December 9, 2010, to March 10, 2011.
The necessity to extend the review period arose as the agency, following the FDA advisory panel meeting on November 16, 2010, felt that it required additional data on the candidate. The approval came after the review of the additional information.
Benlysta is also under review in Europe. The Marketing Authorization Application (MAA) seeking approval for Benlysta in Europe was filed with the European Medicines Agency (EMA) in June last year. European approval is expected during the course of the current year.
The drug is also under review in Canada, Australia, Switzerland, Russia, Brazil and Philippines. We believe that the approval of Benlysta in additional territories would spur further top-line growth at Human Genome.
Our Recommendation
Human Genome currently has a Zacks #3 Rank, which translates into a short-term Hold rating. We are also Neutral on the stock over the long term. We believe that the approval of the lupus drug in the US has given a huge boost to Human Genome, which should help drive the company to profitability. However, we prefer to remain on the sidelines till visibility is obtained regarding Benlysta’s performance in the market.


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