Human Genome Shares Volatile As Value Of Lupus Drug Debated .

 (Dow Jones)--Human Genome Sciences Inc. (HGSI) shares turned positive after trading sharply lower early Wednesday following a positive recommendation for Food and Drug Administration approval of its lupus drug Benlysta.

The drug, being developed with GlaxoSmithKline Plc. (GSK GSK.LN), is important to both companies, and Benlysta would be the first treatment for lupus in decades.


Lupus is an inflammatory connective tissue disease. It occurs mostly in women and is characterized by fever, skin rash, and arthritis.

An FDA panel late Tuesday voted 13-2 to recommend the FDA approve Benlysta. A separate vote on the effectiveness of drug was 10-5.

In a research note, B. of. A. analyst Rachel McMinn said FDA panel feedback at Tuesday afternoon’s meeting “underscored concerns that Benlysta will have a smaller than expected role in lupus treatment.”
McMinn had previously assumed treatment using the lupus drug would run $40,000 per patient. She lowered that calculation to $35,000.

She cut Human Genome to “underperform” from “buy” and shaved her long-range price target to $24 a share, from $33.

Citigroup analyst Yaron Werber downgraded Human Genome to “hold” from “buy” and cut his price target to $30 a share, from $35.

He now expects Benlysta to reach global sales of $1.6 billion by 2015, down from a previous assumption of $2.6 billion

BENLYSTA is an investigational human monoclonal antibody drug. It is the first in a new class of drugs called BLyS-specific inhibitors that recognize and inhibit the biological activity of B-lymphocyte stimulator, or BLyS, which was discovered by HGS in 1996. We and GlaxoSmithKline (GSK) are developing BENLYSTA under a co-development and commercialization agreement entered into in 2006. In lupus, rheumatoid arthritis and certain other autoimmune diseases, elevated levels of BLyS are believed to contribute to the production of autoantibodies – antibodies that attack and destroy the body’s own healthy tissues. BENLYSTA has successfully met its primary endpoint in two pivotal Phase 3 trials in seropositive patients with systemic lupus erythematosus (SLE). In June 2010, HGS and GSK submitted regulatory applications seeking approval to market BENLYSTA in the United States and Europe. The FDA has granted BENLYSTA a priority review designation with a Prescription Drug User Fee Act (PDUFA) target date of December 9, 2010 – so it is possible that BENLYSTA could receive regulatory approval in the United States before the end of 2010. Click here for more information on BENLYSTA.