Avanir Pharmaceuticals and VaxGen Inc. 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 programme.

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 US 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, Calif. VaxGen will also have mammalian-cell-culture manufacturing capacity for large-scale monoclonal antibody production, through its joint venture, Celltrion Inc.

"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 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."