Novavax, Bharat Enter Pandemic Flu Pact

Novavax, Inc. and Bharat Biotech International Ltd. (BBIL) have entered a strategic alliance to pursue the rapid development of pandemic influenza vaccine for India and certain other south Asian markets. Under the terms of the agreement, BBIL will fund all preclinical and clinical studies for these markets and assist in developing an efficient manufacturing process for the Virus-Like Particle (VLP) based influenza vaccine. BBIL 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 BBIL and will receive royalties on all future sales located within BBIL’s geographic territories. 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. This is the first time that VLP technology has been applied to create an influenza virus vaccine. The technology is a particularly good fit for addressing pandemic flu because it does not rely on the supply of embryonated eggs for the production of the vaccine, according to the company. Novavax has recently adopted a manufacturing process that reduces contamination risk and produces high, cost-effective yields of the influenza VLP vaccine. This technology can also be used to rapidly create vaccines against emerging threats or new strains of existing pathogens.

Commenting on the agreement, Dr. M.K. Bhan, secretary, Department of Biotechnology, Government of India said, “This is a very positive development. In the spirit of combining global expertise to collectively combat the threat posed by the rapidly spreading avian influenza virus, the department of biotechnology and the Government of India stand ready to provide all enabling support to ensure the success of this partnership between Novavax and BBIL”.

Dr. Rahul Singhvi, president and chief executive officer of Novavax said, “We are delighted that BBIL has chosen Novavax’s VLP and Novasome adjuvant technologies to develop, produce, and distribute a vaccine against H5N1 and other strains of avian influenza for the Indian population. BBIL has established itself as a leader in adopting innovative vaccine technologies as evidenced by their collaborations with Wyeth and Acambis. We believe that by leveraging the clinical, process and manufacturing capabilities of BBIL, we will be able to expedite the development and regulatory approval of our VLP-based pandemic influenza vaccines around the world”.