H1N1
CRANBURY, N.J. — VaxInnate Corp. has granted Indian biopharmaceutical company Biological E. Ltd. a license to its recombinant H1N1 flu vaccine and is collaborating to facilitate the manufacture, clinical development and commercialization of the vaccine in India, the company announced Jan. 12.
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 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 people 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.
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’s first vaccines focus on infectious diseases, including seasonal and pandemic flu, malaria, dengue, human papillomavirus and respiratory syncytial virus. In 2008 and 2009, VaxInnate generated positive phase I clinical data for its first two vaccines, a universal flu vaccine and a seasonal flu vaccine.