UPDATE 3-Human Genome says lupus drug shows positive results

Thu Jun 11, 2009 1:21pm EDT

* Says results from mid-stage lupus drug trial encouraging

* Says no serious adverse events seen

* Shares soar as much as 28 percent (Recasts; Adds analyst comments, updates share movement)

By Anuradha Ramanathan

BANGALORE, June 11 (Reuters) - Human Genome Sciences Inc HGSI.O said its lupus drug, belimumab, continued to show positive results in a mid-stage trial conducted over a period of four years, sending its shares up as much as 28 percent.

The company said continued treatment with belimumab showed sustained improvement or stabilization of the disease, systemic lupus erythematosus (SLE), or lupus, and decreased frequency of SLE disease flares in patients.

Leerink Swann analyst Joseph Schwartz said the data, which showed a clean safety profile with no decrease in efficacy of the drug over time, makes him more positive on the expected results from the pivotal late-stage trial.

Although belimumab showed sustained improvement and no increase in serious adverse events in the mid-stage study, some analysts remain cautious on the anticipated results of the drug's late-stage trial.

Historically, SLE has been a "difficult indication" for drug development, Thomas Weisel Partners analyst Ian Somaiya said in his note to clients.

SLE occurs when the immune system attacks healthy cells and tissues, and is a disease that tends to flare up and wane, making it difficult to assess the effectiveness of any treatment. It has been more than 30 years since a new therapy has been approved for the disease.

"I think the (Phase 2 data) is still provocative. But we have to caution against how we think about this underscoring any confidence in the Phase 3, which is at different time points," JMP Securities analyst Liisa Bayko said.

In April, Sanford C. Bernstein analyst Geffrey Porges had slashed his price target and downgraded Human Genome stock, saying the odds of success for belimumab are low.

Earlier this year, Roche Holding AG's (ROG.VX) unit Genentech and Biogen Idec Inc (BIIB.O) said Rituxan, their non-hodgkin's lymphoma and rheumatoid arthritis drug, had failed to meet the main goal in a pivotal trial for the treatment of lupus nephritis, a type of kidney disease.

Human Genome, which is co-developing the drug with GlaxoSmithKline (GSK.L), said it has selected Benlysta as the brand name for belimumab (formerly known as LymphoStat-B).

Shares of the Rockville, Maryland-based company were trading up 49 cents at $3.19 Thursday afternoon on Nasdaq. They had touched a high of $3.48 earlier in the session. (Editing by Aradhana Aravindan and Deepak Kannan)