The Food and Drug
Administration gave VaxGen Inc. permission to conduct human trials
of its experimental anthrax vaccine, news that sent shares of the
Brisbane biotech company soaring 93 percent in after-hours trading.
The FDA action keeps VaxGen in the running for lucrative
government contracts to produce a stockpile of as much as 25 million
vaccine doses in case of another anthrax outbreak. If VaxGen wins
the full stockpile contract, it could bring in revenue estimated at
between $100 million to $250 million.
The anthrax vaccine work has already provided a shot in the arm
for VaxGen, whose stock price plummeted in February on disappointing
results for its core product, an AIDS vaccine. VaxGen and a partner
are sharing a $16.2 million government grant to develop an anthrax
vaccine based on scientific discoveries at the U.S. Army Medical
Research Institute of Infectious Diseases.
The VaxGen product is vying for the stockpile contract with a
contender that is also receiving U.S. government support to develop
its anthrax vaccine candidate -- the Avecia Group PLC of Britain.
Both competitors must follow standard FDA procedures to win
commercial marketing approval for their vaccines. VaxGen scored the
FDA's go-ahead for the first step in that process. It can now test
the vaccine on 100 people to see whether it is safe.
The VaxGen and Avecia vaccines are both based on a recombinant
form of a protein called protective antigen, which induces
antibodies that neutralize anthrax toxins. The clinical trials
approved by the FDA will measure formation of those antibodies, but
no subjects will be exposed to the anthrax germ to test the
effectiveness of the vaccine.
The government began its drive for development of a new anthrax
vaccine after letters laced with the deadly microbe were sent to
media organizations and members of Congress in late 2001. Anthrax
spores released from the letters killed five people.
In regular trading, VaxGen shares closed up 20 cents at $3.34.
But on news of the FDA action, the shares gained 92.81 percent to
$6.44 in after-hours trading.
E-mail Bernadette Tansey at
btansey@sfchronicle.com.