See bolded. It was down during the day, quite significantly, but up a tad after hours.
WASHINGTON, Oct 23 (Reuters) - A Human Genome Sciences Inc
(HGSI.O) drug worked better than a placebo but similar to
antibiotics for treating anthrax exposure in animal studies,
U.S. drug reviewers said in a summary released on Friday.
The rabbit and monkey studies of the experimental drug,
ABthrax or raxibacumab, had limitations and "it is still
unknown how well these models and results predict efficacy in
humans," the Food and Drug Administration staff said.
Human Genome shares fell 3.8 percent to close at $19.63 on
Nasdaq. Shares have gained nearly 500 percent since July after
unexpectedly positive results for an experimental lupus drug
that analysts see as a potential blockbuster.
The FDA will ask an advisory panel that meets Tuesday if
the drug's benefits outweigh risks for treating potentially
deadly infections caused from inhaling anthrax, a bacterium
feared as a possible biological weapon. FDA rules allow
companies to study two animals in lieu of people to show
effectiveness for some dangerous infections.
Adding a single intravenous dose of ABthrax to antibiotics
produced similar effectiveness to antibiotics alone, FDA staff
said. The advisory panel will be asked if the drug might
interfere with antibiotics, or if more data is needed to show
ABthrax provided any benefit. Antibiotics in the studies
successfully treated between 95 percent and 100 percent of the
animals, an unexpectedly high rate, the agency reviewers said.
"Given the high efficacy of the (antibiotic) arms" in the
rabbit and monkey studies, "the added benefit of raxibacumab
... could not be determined," FDA staff said.
The U.S. government already has ordered 65,000 doses of
ABthrax for a national stockpile of emergency medicines. In
July, the company said it would record more than $160 million
though the first two quarters of 2009 from government sales of
the drug. It is due to receive $10 million more if ABthrax wins
FDA approval.
Headaches were the most common reaction in people who took
the drug to test its safety, FDA staff said. Some animals that
died from anthrax had meningitis and other central nervous
system problems, but a review of that issue was "limited" in
people because they were not exposed to anthrax, reviewers
said.
In a separate summary prepared for the advisory panel,
Human Genome said antibiotics alone could cure all anthrax
infections in tests but "the 2001 attacks and other real-world
experiences have demonstrated that antibiotics alone are not
100 percent effective" and new options were needed.
If inhaled, anthrax can take hold quickly and by the time
symptoms start showing it is often too late for successful
treatment with antibiotics.
In 2001, letters carrying powdered anthrax killed five out
of 11 people who got sick from the bacteria and were treated
with antibiotics.
ABthrax was developed under the government's Project
BioShield effort to encourage new drugs and vaccines against
potential biological weapons.
The drug takes a new approach to fighting anthrax by
targeting the toxin made by the bacteria rather than the
microbe itself. It is designed to attack and neutralize the
toxin that makes anthrax so deadly.
The "demonstrated increase in survival rate and survival
time constitutes a meaningful clinical benefit in the treatment
of a serious, life-threatening infection," Human Genome said of
the drug.
(Reporting by Lisa Richwine, editing by Gerald E. McCormick
and Matthew Lewis) |
