VaxGen Selected by U.S. Government
to Develop New Anthrax Vaccine
October 3, 2002 - Brisbane, Calif. -VaxGen Inc. (Nasdaq: VXGN), the
current leader in AIDS vaccine development, has been awarded a contract from the
National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S.
National Institutes of Health (NIH), to develop a new anthrax vaccine and to
create a feasibility plan to manufacture an emergency stockpile of 25 million
doses. NIAID is expected to award a separate contract in 2003 to manufacture the
The only anthrax vaccine currently licensed, BioThrax(R), requires six
injections over 18 months. The goal of the new government contract is to develop
a vaccine that proves to be safe in humans, efficacious in animal challenge
studies and requires no more than three injections.
Under the initial phase of the NIAID contract, VaxGen will be awarded
$13.6 million to advance the development of a vaccine candidate initially
developed by the U.S. Army Medical Research Institute of Infectious Diseases
(USAMRIID). If results from the first phase are positive, VaxGen will be
eligible for an additional $13.6 million in 2003 as a continuation of the
current contract to support a Phase II clinical trial. A second, much larger
contract to manufacture the 25-million dose stockpile will be awarded by NIAID
through a competitive bid process next year.
"This award builds on VaxGen's expertise in the development, testing and
manufacturing of vaccines, and reflects our commitment to develop a broad array
of biopharmaceutical products for the prevention and treatment of human
infectious diseases," said VaxGen Chief Executive Officer Lance K. Gordon, Ph.D.
"Our objective is to meet or exceed the government's requirements and be
selected to supply vaccine for the stockpile. If successful we would also plan
to sell the vaccine to other approved governments and private customers."
As a major sub-contractor to VaxGen, Battelle of Columbus, Ohio, will have
primary responsibility for initial manufacturing of the vaccine candidate as
well as for conducting pre-clinical safety and efficacy studies in accordance
with FDA guidelines. VaxGen has budgeted approximately $4.5 million for
Battelle's contributions to this urgent initiative. Battelle has substantial
experience in biologics research and development, specifically including anthrax
VaxGen will have overall responsibility for the implementation and
management of the contract, including product design, regulatory compliance,
design and conduct of the Phase I human clinical trial and preparation of a plan
to manufacture the 25-million dose stockpile utilizing qualified manufacturing
operations. The plan may be based on use of VaxGen's South San Francisco
biologics manufacturing facility, currently under
development, which will also be used to manufacture up to 10 million doses per
year of VaxGen's AIDS vaccine candidates, if they are licensed.
Under an agreement with the USAMRIID, VaxGen and Battelle will continue
the development and testing of the recombinant Bacillus anthracis vaccine
candidate known as rPA102. This investigational vaccine, developed and tested at
USAMRIID, combines the safety benefits of a vaccine made through modern
recombinant technology with a record of efficacy documented in animal models. It
is an alum-adjuvanted, single component, recombinant protein vaccine candidate
similar in composition to VaxGen's investigational AIDS vaccines.
This contract has been funded in whole with Federal funds from the
National Institute of Allergy and Infectious Diseases, National Institutes of
Health, under Contract No. N01-A1-25494.
VaxGen is focused on the commercial development of biologic products for
the prevention and treatment of human infectious diseases. It is the only
company with AIDS vaccine candidates in Phase III clinical trials. VaxGen's two
trials, involving nearly 8,000 volunteers in North America, Europe and Thailand,
are designed to determine if VaxGen's AIDSVAX investigational vaccines can
prevent humans from becoming infected with HIV, the virus that causes AIDS.
VaxGen expects to announce primary results from the first trial in the first
quarter of 2003, with results from the second trial expected about nine months
VaxGen is also the major shareholder of Celltrion Inc., a joint venture
that plans to build a large-scale facility in South Korea for the manufacture of
biopharmaceutical products, including VaxGen's vaccine candidates, should they
be licensed. VaxGen is located in Brisbane, Calif. For more information, please
visit the company's web site at: www.vaxgen.com
AIDSVAX(R) is a registered trademark of VaxGen.
Contacts: Lance Ignon
Vice President, Corporate Communications
Associate Director, Corporate Communications
Note: This press release contains "forward-looking statements" within the
meaning of the federal securities laws. These forward-looking statements include
without limitation statements regarding the progress, costs, timing and results
of the anthrax contract with NIH; our and our subcontractors' ability to develop
a new anthrax vaccine in accordance with government specifications, or at all;
our ability to secure a government contract to manufacture and supply an anthrax
vaccine, if development of such a vaccine were successful; the progress, costs
and results of our Phase III clinical trials; domestic and foreign regulatory
approvals of AIDSVAX; the ability to manufacture and supply AIDSVAX or any other
vaccine or product; our ability to commercialize AIDSVAX or any other vaccine or
product; our ability to manage our foreign manufacturing joint venture; the
timing, and announcement of results, of either of our Phase III clinical trials,
including the timing and announcement of results from any interim analyses; our
beliefs regarding the future success of AIDSVAX and other products currently
under development or proposed to be developed; and the ability of our Celltrion
joint venture to raise necessary funding for execution of its business plan.
These statements are subject to risks and uncertainties that could cause actual
results and events to differ materially from those anticipated. Reference should
be made to VaxGen's Quarterly Report on Form 10-Q, filed with the Securities and
Exchange Commission on August 14, 2002, under the heading "Risk Factors" and to
VaxGen's Annual Report on Form 10-K, filed with the Securities and Exchange
Commission on April 1, 2002, under the heading "Business" for a more detailed
description of such factors. Readers are cautioned not to place undue reliance
on these forward-looking statements that speak only as of the date of this
release. VaxGen undertakes no obligation to update publicly any forward- looking
statements to reflect new information, events, or circumstances after the date
of this release or to reflect the occurrence of anticipated events.
Dates Referenced Herein and Documents Incorporated by Reference