Seeking Alpha: Will Human Genome End Up Blazing A Trail For Others?

Human Genome Sciences' (HGSI) Benlysta isn't the first would-be blockbuster to disappoint investors with its initial launch, but it's one of the larger disappointments in recent memory. While there is still a good case to make for Benlysta eventually being a successful drug, it's starting to look as though Human Genome and GlaxoSmithKline (GSK) may do all of the heavy lifting and trailblazing in lupus only to ultimately get left behind.

Benlysta - Waiting For Trialing, Or Waiting For Godot?
At the time of its approval, Benlysta was hailed as a multi-billion dollar blockbuster drug in the making. What's more, reading sell-side research would lead one to think that the SEC passed a rule requiring all analysts to mention that Benlysta is the first new drug for lupus in 50 years.

Click here for the full piece:
Will Human Genome End Up Blazing A Trail For Others?

Investopedia: Glaxo And Human Genome Find Rare FDA Success

In a refreshing change of course, the FDA has approved a significant new drug. GlaxoSmithKline (NYSE:GSK) and Human Genome Sciences (Nasdaq:HGSI) announced after market close on Wednesday that the FDA had informed the companies of the approval of their application to market Benlysta for the treatment of lupus. It no doubt helped greatly that the safety/side-effect profile on Benlysta was quite clean, to say nothing of the clear clinical need for new lupus treatments. (For background reading on the FDA approval process, see A Primer On The Biotech Sector.)

Where Now? 

With approval in hand, the two companies will begin marketing the drug relatively soon, with a 50/50 split of costs. While there was a general expectation that HGSI and Glaxo would price Benlysta in line with drugs for multiple sclerosis or arthritis, the two companies went a bit more toward the high end of the range and Benlysta will cost about $35,000 a year (more in the first year of treatment). (For related reading, check out Pharmaceutical Phenoms: America's Best Selling Medicines.)

The FDA also gave the company a rather favorable label. While the drug is contraindicated in some of the most severe and lethal forms of lupus (those that involve the kidneys and central nervous system), the companies estimate that there are at least 200,000 eligible patients. In actual practice, though, it would be a bit surprising if more doctors did not give it a go in some less-severe cases. 

The FDA's approval is partly conditional; the two companies will have to conduct a study of the drug in African-Americans. So far to date, Benlysta's results in this patient group have not been favorable, but they have not been statistically convincing either. Given that the rate of lupus is almost three times higher in people of Afro-Caribbean descent (compared to the overall incidence rate in the U.S.), that is clearly a subject that merits study.

To read the full piece, please go to:
http://stocks.investopedia.com/stock-analysis/2011/Glaxo-And-Human-Genome-Find-Rare-FDA-Success-HGSI-GSK-IMMU-PFE-AZN-FRX0310.aspx

Human Genome Takes A Big Step Forward

One small step for an FDA advisory panel, one leap forward for biotech company Human Genome Sciences (Nasdaq:HGSI). 

Late Tuesday, an FDA advisory panel voted by the surprisingly wide margin of 13-2 to recommend approval of HGSI's Benlysta for the treatment of lupus. This drug, which top-tier pharmaceutical company GlaxoSmithKline (NYSE:GSK) has been developing under license from HGSI, would represent the first new lupus drug in more than 50 years - a potentially big step forward for the treatment of a disease that is life-altering (and life-threatening) but still not well-understood by doctors or scientists. (For more, see Measuring The Medicine Makers.)

A More Compassionate Panel? 
Benlysta's progress toward approval was not smooth or worry-free for HGSI investors. The FDA spooked the market a bit a few days ago when the agency released its pre-panel meeting assessment of the lupus drug candidate. Although these reviews are supposed to be tough, critical, and generally negative, it did focus on what it called "mild" efficacy and the fact that the drug does not seem to benefit African Americans much at all.

Nevertheless, the panel seemed to acknowledge that mild efficacy is still efficacy and that the impact of the drug varied with each patient. In other words, it may be significantly effective for some patients, and the side-effects did not outweigh that potential benefit.

 

Please follow the link for the full story:
http://stocks.investopedia.com/stock-analysis/2010/Human-Genome-Takes-A-Big-Step-Forward-HGSI-GSK-BIIB-IMMU-EBS-CEPH-RHHBY1117.aspx