AVANIR Awarded SBIR Grant from NIAID to Expand Development of Anti-Anthrax Antibodies

SAN DIEGO--(BUSINESS WIRE)--Oct. 13, 2003--AVANIR Pharmaceuticals (AMEX: AVN) today announced the award of a $100,000 grant through the Small Business Innovative Research (SBIR) program of the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH). The grant will be used to further develop AVANIR's fully human monoclonal antibodies to anthrax toxins.

At the BIOPHEX meeting in San Jose on Sept. 24, 2003, AVANIR reported on multiple antibodies that demonstrate high potency against anthrax toxins in vitro and in vivo and against anthrax spores in vivo. Mice protected by a single dose of one of AVANIR's lead antibodies against a lethal challenge of anthrax spores were still completely protected on subsequent exposure to anthrax spores four weeks later.

"Antibodies work faster than a vaccination, and spore challenge data shows that our antibody seems to give mice adequate time to develop immunity to the anthrax," noted Dr. Angray Kang, AVANIR's associate director in Antibody Technology. "To our knowledge, no other companies working in this area have reported that their antibodies protect while allowing natural protective immunity to develop over such a short time."

All of AVANIR's six antibodies showed strong results in the latest evaluations. The research builds on data presented in February and April by demonstrating efficacy in situations that more closely resemble an actual infection state.

"This grant will expand the anthrax antibody research originally subsidized by the Center for Commercialization of Advanced Technology (CCAT) which is a Department of Defense funded program," stated Dr. Phillip Morrow, principal investigator on the SBIR grant and co-inventor of AVANIR's antibody technology. "We have additional grant applications in review that build upon the $100,000 grant we were awarded today and the $150,000 received last year from CCAT."

The grant from the National Institutes of Health will fund a portion of the pre-clinical testing of the additional anthrax antibodies AVANIR has in development. AVANIR has submitted a proposal to NIAID for a $1 million grant to perform many of the steps required to develop an antibody for clinical use. This grant application is currently under review at NIAID.

AVANIR is also submitting a significantly larger proposal requesting $8 - $12 million. This proposal will request funding to complete the process required to file an Investigational New Drug (IND) application with the Food and Drug Administration (FDA). These steps include primate and non-primate efficacy studies, toxicology testing and cGMP manufacture of clinical supplies.

Under the Bioterrorism Act of 2002, successful studies in relevant animal models will be considered sufficient to establish efficacy for licensure and marketing approval.

AVANIR Pharmaceuticals is a drug discovery and development company focused on the development of treatments for central nervous system disorders and inflammatory diseases. The company's first commercialized FDA-approved product, Abreva(R), is marketed in North America by GlaxoSmithKline and is the leading over-the-counter product for the treatment of cold sores. The company's lead product candidate, Neurodex(TM), is in Phase III clinical development for pseudobulbar affect and in Phase II clinical development for neuropathic pain. An internally developed small molecule, AVP 13358, is in a Phase I clinical trial for the treatment of allergy and asthma. Using its proprietary Xenerex(TM) technology, AVANIR also develops human monoclonal antibodies for infectious diseases and other therapeutic applications. Further information about AVANIR can be found at www.avanir.com.

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 the success of clinical trials, the progress of research and product development programs, the regulatory approval process, competitive products and future capital requirements. There can be no assurance that such development efforts will succeed, that additional grants will be received, 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.

CONTACT: Redington Inc.
Thomas Redington, 203-222-7399
tredington@redingtoninc.com
or
AVANIR Pharmaceuticals, San Diego
Patrice Saxon, 858-622-5202
psaxon@avanir.com

SOURCE: AVANIR Pharmaceuticals