HGSI to Seek Drug Approval in 2Q - Analyst Blog

Human Genome Sciences Inc. (HGSI) announced recently that it intends to seek approval for its potential blockbuster lupus drug candidate Benlysta during the second quarter of 2010 in the United States and Europe. Human Genome and GlaxoSmithKline plc (GSK) are co-developing Benlysta for treating patients suffering from systemic lupus erythematosus (SLE).

We remind investors that in Nov 2009, Benlysta met the primary end-point in BLISS-76, a pivotal phase III study, through 52 weeks. BLISS-76 is the second phase III trial in seropositive SLE patients. Complete 76-week data from the trial are expected to be available in the second quarter of 2010. Positive results from the first trial, BLISS-52, were announced in the third quarter of 2009. 

These results bring the company a step closer to becoming the first to have a new lupus drug approved in 50 years. Lupus affects about 1.5 million people in the United States and 5 million people worldwide. We expect the U.S. Food and Drug Administration (FDA) to approve the lupus drug candidate in early 2011. If approved, we expect Benlysta to become a blockbuster. 

Human Genome also announced that it expects cash and investments for fiscal 2009 to stand at approximately $1.19 billion, as opposed to approximately $373 million at the end of 2008. The huge increase is based on the two public offerings completed by the company in 2009. Human Genome Sciences further expects to register at least $150 million revenues in 2010, excluding potential milestone payments for the approval of Zalbin. Zalbin, co-developed with Novartis (NVS) for treating hepatitis C patients, is under review in the U.S. as well as Europe.
 
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. 

Currently, we are Neutral on Human Genome Sciences.
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