Exhibit 99.1
Avanir and VaxGen Form Alliance to Develop
and Manufacture Anthrax Antibody
San Diego and Brisbane, California - January 29, 2004 - AVANIR
Pharmaceuticals (AMEX: AVN) and VaxGen, Inc. (Nasdaq: VXGN) have entered into a
cross-license and research collaboration agreement for the development and
manufacture of pre-clinical supplies of AVANIR's monoclonal antibody candidate
for prevention and treatment of anthrax infection. The collaboration will
combine AVANIR's proprietary expertise to discover, characterize and develop
highly potent anthrax antibodies with VaxGen's cGMP protein manufacturing
capability and experience gained through its anthrax vaccine development
program.
The companies have already initiated some of the preliminary steps of the
research collaboration, including early characterization of the selected
antibody, preliminary non-GMP production, and the submission of a grant
application under a request from the Department of Health and Human Services.
This grant application requests funding to complete the development process
required prior to submitting an investigation new drug application (IND) to the
U.S. Food and Drug Administration (FDA).
VaxGen will support development and manufacturing of AVANIR's anthrax
antibody utilizing its R&D and biologics manufacturing facilities in South San
Francisco, California. VaxGen will also have mammalian-cell-culture
manufacturing capacity for large-scale monoclonal antibody production, through
its joint venture, Celltrion, Inc.
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"As a result of our established programs in anthrax vaccines and
mammalian-cell-culture manufacturing, we have been studying anthrax monoclonal
antibodies closely for some time, and we think AVANIR's skills and technology
make them the ideal partner," said Piers Whitehead, VaxGen's Vice President of
Corporate and Business Development. "Together, we have the capabilities and
assets to take the product all the way through to commercial availability,
including large-scale production at Celltrion."
AVANIR's antibody is designed to provide immediate but temporary
protection prior to or after exposure to anthrax. VaxGen's vaccine candidate is
designed to provide long-term immunity before and after exposure to the
bacteria, although several days to a few weeks would be required for the
immunity to develop. If the products are approved for use, someone exposed to
anthrax could receive AVANIR's antibody to immediately neutralize the anthrax
toxins, followed by a course of VaxGen's anthrax vaccine to establish long-term
immunity to the pathogen.
"AVANIR and VaxGen believe that the government has clearly indicated that
complementary biodefense vaccines and therapeutics must be developed in order to
provide the maximum degree of protection against anthrax for both military and
civilian populations," said J. David Hansen, Senior Vice President of Corporate
Development at AVANIR. "We also believe that combining the strengths and
expertise of both companies will improve the likelihood of getting our antibody
product to market."
AVANIR Pharmaceuticals is developing antibodies for use as prophylactic
and therapeutic drugs to prevent and treat anthrax infections. Two of AVANIR's
lead antibodies, AVP 21D9 and AVP 22G12, completely inhibit toxin complex
assembly, and do so by attaching to distinct domains of the toxin. Both
antibodies bind to the anthrax toxin with a very high affinity, in the picomolar
range. Additionally, these are two of AVANIR's most potent anthrax toxin
neutralizing antibodies, exhibiting neutralizing potency in the stoichiometric
range. AVANIR's preclinical research to date has indicated that protection can
be afforded by a single dose of the anthrax antibodies. Mice protected by a
single dose of one of AVANIR's antibodies against a lethal challenge of anthrax
spores were still completely protected on subsequent exposure to anthrax spores
four weeks later.
VaxGen has received more than $100 million in government funding to
develop its anthrax vaccine candidate made from recombinant Protective Antigen
(rPA). The vaccine candidate is based on the work of the U.S. Army Medical
Research Institute of Infectious Diseases and combines the potential safety
benefits of a product made through modern recombinant technology with efficacy
demonstrated in animal models. The vaccine candidate, which VaxGen is developing
independently of AVANIR'S anthrax antibodies, is composed of an alum adjuvant
and a purified protein, rPA, which is designed to induce antibodies that
neutralize anthrax toxins.
Grants from the U.S. Department of Defense administered through CCAT -
Center for Commercialization of Advanced Technology - and from the National
Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes
of Health have already been awarded to assist AVANIR's early antibody
development efforts. AVANIR has submitted a proposal to NIAID for a $1 million
grant to discover and evaluate ancillary anthrax antibodies. This grant
application is currently under review at NIAID. AVANIR and VaxGen have
collaborated on seeking further funding for efforts that will develop the
anti-anthrax antibody through IND submission to the FDA.
The U.S. government has indicated that biodefense products against anthrax
are a top priority. The Department of Homeland Defense Appropriations Act has
already allocated $5.6 billion for the purchase of various biodefense products.
The total appropriation, which was passed on October 1, 2003, includes $890
million for the purchase of biodefense products in the government's current
fiscal year, which ends September30, 2004.
About VaxGen
VaxGen, Inc. is a biopharmaceutical company engaged in the development,
manufacture and commercialization of biologic products for the prevention and
treatment of human infectious disease. Based in Brisbane, California, the
company is developing preventive vaccines against anthrax, smallpox and plague.
It is also is the largest shareholder in Celltrion, Inc., a joint venture formed
to build operations for the manufacture of biopharmaceutical products. For more
information, please visit the company's web site at: www.vaxgen.com.
About Avanir
AVANIR Pharmaceuticals, based in San Diego, is a drug discovery and
development company focused on the development of treatments for central nervous
system disorders and inflammatory diseases. Using its proprietary Xenerex(TM)
technology, AVANIR also develops human monoclonal antibodies for infectious
diseases and other therapeutic applications. The Company's first commercialized
product, Abreva(R), is marketed in North America by GlaxoSmithKline and is the
leading over-the-counter product for the treatment of cold sores.
Note: Except for the historical information presented herein, matters
discussed in this press release contain forward-looking statements that are
subject to certain risks and uncertainties that could cause actual results to
differ materially from any future results, performance or achievements expressed
or implied by such statements. Statements that are not historical facts,
including statements that are preceded by, followed by, or that include such
words as "estimate," "anticipate," "believe," "plan" or "expect" or similar
statements are forward-looking statements.
Risks and uncertainties for AVANIR Pharmaceuticals include risks
associated with product discovery and development as well as risks shown in
AVANIR 's most recent Annual Report on Form 10-K and Quarterly Report on Form
10-Q and from time-to-time in other publicly available information regarding the
company. Copies of such information are available from AVANIR upon request. Such
publicly available information sets forth many risks and uncertainties related
to AVANIR 's business and technology. The Xenerex(TM) monoclonal antibody
technology competes with several technologies used by large pharmaceutical and
biotechnology companies and is subject to a number of uncertainties, including
risks associated with obtaining government grants, the success of preclinical
and clinical trials, the progress of research and product development programs,
the regulatory approval process, competitive products, future capital
requirements, and VaxGen's ability and level of support for the antibody
research. Any of the aforementioned risks could materially affect AVANIR 's
anthrax antibody development plan and the nature of the VaxGen alliance. There
can be no assurance that such development efforts will succeed, that such
products will receive required regulatory clearance, or that even if such
regulatory clearance were received, that such products would ultimately achieve
commercial success. The company disclaims any intent or obligations to update
these forward-looking statements.
With respect to VaxGen, forward-looking statements include without
limitation, statements regarding VaxGen's ability to support, and timing of,
development and manufacturing of Avanir's anthrax antibody in either
its South San Francisco facility or through its joint venture, Celltrion, Inc.
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 November 19, 2003, under the heading "Risk Factors", and
the company's Annual Report on Form 10-K/A, filed with the Securities and
Exchange Commission on November 19, 2003, 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 except as required by law.
Contacts:
At VaxGen: At AVANIR Pharmaceuticals:
Lance Ignon, Investor Relations Patrice Saxon, Investor Relations
Kesinee Yip, Media Relations 858-622-5202
(650) 624-1041