Systemic lupus erythematosus (SLE)
is a chronic, inflammatory
autoimmune disorder. It may affect
the skin, joints, kidneys, and other
Almost all people with SLE have joint
pain and most develop arthritis.
Frequently affected joints are the
fingers, hands, wrists, and knees.
Inflammation of various parts of the
heart may occur as pericarditis,
endocarditis, or myocarditis.

Benlysta (belimumab), a systemic
lupus erythematosus (SLE) treatment
developed by Human Genome
Sciences (HGS) and GlaxoSmithKline
(GSK). It wa approved by the FDA in
March 2011.

Benlysta finished 2011 with $52
million in sales, accounting for about
40% of HGS' total sales of $131
million last year.

It has been more than 51 years since
the U.S. Food and Drug
Administration (FDA) approved a new
drug for lupus. But the field is
suddenly busy with activity.
GlaxoSmithKline and Human Genome
Sciences, ViforPharma, and UCB and
Immunomedics, Inc. all recently
reported promising results for
potential new treatments for lupus.
Benlysta by Human Genome and
GlaxoSmithKline  has been approved
by the FDA.  

Sales growth has been steady, from
$8 million in Q2 to $18 million in Q3,
to $26 million in Q4, helped in part by
EC's sanction of Benlysta in  May

Benlysta, which is administered
intravenously, showed that it can
reduce disease activity in two Phase
III clinical studies. Clinical research
also suggests that the drug may make
patients less prone to flare-ups, which
can cause serious organ damage.

A few venture-backed companies aim
to follow closely behind.
They include Anthera
Pharmaceuticals Inc., which went
public in March 2011 after raising
capital from VantagePoint Venture
Partners, Sofinnova Ventures and
others, and Neovacs S.A., which went
public in April after drawing support
from firms such as Novartis Venture

In lupus the immune system attacks a
patient's own tissue, causing
inflammation, pain and other
symptoms. The disease, which affects
1.5 million Americans, according to
the Lupus Foundation of America,
tends to flare up and then recede into
periods of remission. Its complexity
has frustrated drug companies, but
the success of Benlysta, which
analysts peg as a potential
blockbuster, is reviving hopes.

Research published online in May
2010 in Arthritis & Rheumatism, lead
author and Director of Rheumatology
and Immunology at Nanjing University
Medical School's  Drum Tower
Hospital Dr. Lingyun Sun and
colleagues report on 16 patients with
severe SLE that did not respond to
standard treatments. All 16 patients
received stem cell transplants. Ten
patients completed at least 6 months
of follow-up and 2 patients were
followed for more than 2 years. There
was no treatment-related mortality or
other adverse event during or after
UC-MSCT, according to the article.
In comments to Reuters on the report,
Dr. Sun said:  After nearly two years,
"most patients show clinical remission
with no adverse events detected to
date or treatment-related mortality."
The umbilical cord-derived
mesenchymal stem cells used in the
study were processed by Beike
Biotech's scientists  at the company's
new state-of-the-art Jiangsu Stem Cell
Regenerative Medicine Facility in
Taizhou, China. The facility was
recently awarded ISO9001
certification for its stem cell

A study of 50 lupus patients at
Chicago's Northwestern Memorial
Hospital found that transplanting
lupus patients with stem cells from
their own marrow can help bring on
remission. The researchers reported
that 50 percent of patients in the
study experienced promising results,
with a survival rate of 84 percent.