VaxInnate grants license to Biological E. to develop and commercialize recombinant H1N1 vaccine in India

VaxInnate Corporation today announced that it has granted Indian biopharmaceutical company Biological E. Limited a license to its recombinant H1N1 pandemic swine flu vaccine and is collaborating to facilitate the manufacture, clinical development and commercialization of the vaccine in India.

“As a leading vaccine provider, we hope to play a key role in protecting Indians and other South Asians from pandemic H1N1 flu.”

Under the terms of the agreement, the vaccine will enter clinical development in India early this year and could become available for emergency use in India after completion of clinical trials. As with all new vaccines, the Indian Government must approve the vaccine based upon clinical evaluation before it can be used. Financial terms of the agreement include initial fees, milestone payments and royalties on sales. Additional details were not disclosed.

Biological E. is a leading provider of vaccines to the Indian government. The company has a long history of successful collaborations with many multinational companies.

The ability to produce VaxInnate’s recombinant vaccine in a bacterial expression system will enable Biological E. to manufacture vaccine at the company’s existing biotechnology facilities with microbial production capacity. Biological E. should be capable of manufacturing sufficient H1N1 vaccine in several months to address the needs of India’s 1.2 billion population in a public health emergency.

The agreement also permits Biological E. to sell excess vaccine to other South Asian countries, including Bangladesh, Bhutan, the Maldives, Nepal, Pakistan and Sri Lanka. South Asia is home to one-fifth of the world’s population.

“Biological E. looks forward to working closely with VaxInnate to rapidly develop and manufacture this innovative vaccine in India,” said Dr. Vijay Kumar Datla, Chairman & Managing Director of BE. “As a leading vaccine provider, we hope to play a key role in protecting Indians and other South Asians from pandemic H1N1 flu.”

Meanwhile, VaxInnate plans to pursue clinical development and licensure of pandemic and seasonal flu vaccines in the United States. In 2009, VaxInnate conducted successful clinical trials evaluating the potency, efficacy and safety of the vaccine using the Solomon Islands seasonal influenza strain of the H1N1 flu. VaxInnate’s pandemic H1N1 flu vaccine is expected to enter clinical development in the United States this year.

“VaxInnate is pleased to partner with Biological E. to meet the H1N1 vaccine needs of India and to demonstrate the speed and volume capabilities of our proprietary vaccine technology,” said Alan Shaw, PhD, President and CEO of VaxInnate. “We will continue to pursue domestic and other international partnerships for development of this and other vaccines to meet global needs.”

VaxInnate’s proprietary technology -- based upon a combination of toll-like receptor-mediated (TLR) immune enhancement and recombinant bacterial production of vaccine antigen -- conveys significant speed and volume advantages, making it capable of producing hundreds of millions of vaccine doses in weeks instead of months.