Novavax, Bharat Biotech form alliance for pandemic flu vaccine

By Elaine Rigoli

Tampa, Fla., March 6 - Novavax, Inc. and Bharat Biotech International Ltd. announced a strategic alliance to pursue the rapid development of a pandemic influenza vaccine for India and certain other south Asian markets.

Under the agreement, Bharat will fund 100% of the preclinical and clinical studies for these markets and assist in developing an efficient manufacturing process for the Virus-Like Particle (VLP) based influenza vaccine, according to a company news release.

Bharat will be responsible for the sale and distribution of the vaccine in India and other surrounding countries. Novavax will receive unrestricted access to all preclinical and clinical data generated by Bharat and will receive a double-digit royalty on all future sales located within Bharat's geographic territories.

Cases of avian influenza (bird flu) in poultry and humans have been occurring sporadically throughout the world, prompting the World Health Organization to call avian flu the greatest concern to human health, the release said.

There are at least 16 Hemagglutinin and nine Neuraminidase genes within various subtypes of influenza viruses known to circulate in wild waterfowl, each with the potential to infect and cause severe disease in poultry and humans.

Three avian influenza subtypes (H9N2, H7N7 and H5N1) have transmitted to humans in recent years and are considered major threats for a pandemic outbreak.

Novavax's VLP vaccines use recombinant DNA technology to produce antigenic structures that mimic a virus to produce a protective immune response without the risk of infection or disease.

Viral proteins can self-assemble into VLPs when over-expressed in certain cells. The use of VLP technology has already been proven with the success of the Hepatitis B vaccine.

In addition, the developmental human papilloma virus vaccines are also based on VLP technology. This is the first time that VLP technology has been applied to create an influenza virus vaccine, the release said.

Novavax has recently adopted a manufacturing process that reduces contamination risk and produces high, cost-effective yields of the influenza VLP vaccine.

In addition, this technology can be used to create vaccines against emerging threats or new strains of existing pathogens, the release said.

Novavax, based in Malvern, Pa., is focused on creating differentiated, value-added pharmaceutical and vaccine products and technologies.

Bharat Biotech, based in Hyderabad, India, is a privately held biotechnology company specializing in product-oriented research, development and manufacturing of vaccines and biotherapeutics.

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