AC recommends Benlysta 13-2. Up almost 20% AH, last trade up 10%.
After Hours Last: $ 28.60
Net / % Change 2.72 (10.51%)
After Hours High: $ 30.02
After Hours Volume: 1,685,819
After Hours Low: $ 27.80
UPDATE 6-U.S. advisers recommend Human Genome lupus drug
Thomson Reuters
* FDA usually follows panel recommendations
* Agency decision expected by Dec. 9, but could slip
* Remarkable turnaround in fortune for Human Genome
* Annual global sales forecast at $2.2 billion by 2014
* Shares of Human Genome, partner Glaxo, rise after hours
(Rewrites lead, adds panel member, company comments; updates
shares)
By Lisa Richwine
ADELPHI, Md., Nov 16 (Reuters) - The first new lupus
treatment in half a century moved closer to U.S. approval on
Tuesday as an advisory panel endorsed a potential blockbuster
medicine from Human Genome Sciences Inc .
Benlysta could offer a new option for patients with lupus,
a debilitating and potentially fatal autoimmune disease that
has proved difficult to treat. Annual global sales are forecast
at $2.2 billion by 2014, according to Thomson Reuters.
That would transform unprofitable biotech Human Genome into
an industry star. [ID:nN05192427]
Benlysta profits will be split with British partner
GlaxoSmithKline Plc . Shares of both companies
rose in after-hours trading following the positive ruling from
the Food and Drug Administration advisers.
The FDA panel voted 13-2 to recommend approval of Benlysta.
Supporters said the medicine helped ease symptoms with
acceptable risks for a disease with limited options.
"The efficacy is mild, but I think there is a need for a
drug even with mild efficacy," said panel member Dr. Lenore
Buckley, a professor of internal medicine and pediatrics at
Virginia Commonwealth University.
The FDA usually follows panel recommendations when deciding
whether to approve new medicines. A final FDA ruling is due by
Dec. 9.
"It was a huge victory for the company (Human Genome),"
said ISI Group analyst Mark Schoenebaum. "I think the biotech
community has another blockbuster drug on its hands."
Trading in shares of Rockville, Md.-based Human Genome had
been halted while the advisory panel met on Tuesday. When
trading resumed after hours, its shares rose 9.7 percent to
$28.40 from Monday's $25.88 close. Glaxo's U.S. shares climbed
2.9 percent to $39.65 in extended trading from Tuesday's
regular close at $38.54.
INVESTORS ONCE DESPAIRED
Human Genome shares have soared with hopes for Benlysta.
Investors had largely written off the drug after mixed data
from an earlier trial. Shares fell below 50 cents a share in
March 2009 but jumped later that year after the first
encouraging Benlysta data was released.
(For a graphic on how prospects for Benlysta have affected
Human Genome shares, click on r.reuters.com )
Geoffrey Porges, an analyst with Sanford Bernstein, said
the drug's approval was highly likely, although it may not come
by Dec. 9 as the companies will need to negotiate label
instructions and post-approval studies with the FDA.
"You'll be left with a product with some restrictions on
who it will be used for. That will be a hook for the payors to
impose some restriction," Porges said. He sees the drug
reaching the market by the end of the first quarter of 2011 and
forecasts U.S. revenue of $2 billion by 2015.
Benlysta, known generically as belimumab, is given once a
month by intravenous infusion. Analysts expect the drug will
cost a patient between $15,000 and $30,000 annually, a price in
line with biotech medicines for other autoimmune diseases.
Current treatment typically includes immunosuppressant drugs such as Roche's CellCept and steroids such as
prednisone. Hopes for effective and safer alternatives were
dashed in recent years when several companies failed in
attempts to develop new treatments.
Lupus causes the immune system to attack the body's own
tissue and organs. It can lead to arthritis, kidney damage,
chest pain, fatigue, skin rash and other problems. Organ damage
can be fatal.
An estimated 5 million people worldwide have the disease,
and many cannot find relief with current drugs or suffer harsh
side effects such as severe bone loss from steroids.
Patients, family members and other advocates pleaded with
the panel to back Benlysta. Many spoke through tears as they
described how the disease caused crushing fatigue, joint pain,
and other symptoms.
TEARFUL PATIENTS
Forty-six-year-old Donna Flenory said lupus forced her to
give up her career as an occupational therapist. High doses of
steroids helped for a time but repeated flare-ups sent her to
the hospital every year, usually in the autumn.
After joining a study of Benlysta, "when fall rolled around
I was no longer sick. I had a life again," she told the panel,
adding "please realize we as patients need something."
FDA reviewers, however, suggested Benlysta might have only
a modest effect on lupus symptoms and might raise the risk of
death, infection, or psychiatric problems including suicide.
Two patients treated with Benlysta during clinical trials
killed themselves and there were no suicides with a placebo.
Panel members said there were too few suicides and other
deaths to conclude Benlysta was the cause but urged monitoring
of side effects if the drug reached the market.
The drug's safety "looks remarkably good compared to a lot
of other drugs we're using," said panel member R. John Looney,
a rheumatologist at the University of Rochester.
Benlysta is designed to inhibit BLyS, a protein in the body
that exists to keep B-cells functioning normally. B-cells make
antibodies that prevent infection. In lupus patients, B-cells
are overstimulated and make antibodies that attack the body.
Human Genome Chief Executive Thomas Watkins, speaking to
reporters after the panel meeting, said the company was pleased
with the ruling. "We will look forward to working with the FDA
as they complete their work," he said.
An application for approval also is pending in Europe, he
said.
[snip] |
