Hyderabad-based Biological E Limited, one of India’s leading vaccines and therapeutic healthcare companies has entered into an agreement with USA’s VaxInnate Corporation to license its recombinant H1N1 pandemic swine flu vaccine. VaxInnate is a privately-held biotechnology company based in USA and is focused on developing innovative, proprietary vaccines, including those for both pandemic and seasonal influenza.

The recombinant H1N1 vaccine is based on the novel Toll-Like Receptor (TLR) technology platform, which dramatically improves vaccine immunogenicity and efficacy. Using the TLR technology, vaccines can be produced by simple, low-cost, highly-scalable recombinant DNA techniques, avoiding many of the challenges and pitfalls of egg-based or cell-culture influenza vaccine production.

“This revolutionary technology can significantly improve the cost-effectiveness, manufacturing capacity, and potency of influenza vaccines and 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 and MD of Biological E Limited.

Biological E has a successful history of partnering with large multinational companies such as Intercell AG and Emergent Biosolutions and is a key provider of vaccines to the Ministry of Health (MOH), Government of India, in support of the National Immunization Programme (NIP).

“VaxInnate is pleased to partner with Biological E to meet the H1N1 vaccine needs of India and South Asia and are eager to demonstrate the speed and volume capabilities of our proprietary vaccine technology,” said Alan Shaw, president and CEO of VaxInnate.

Under the terms of the agreement, Biological E has gained rights to manufacture the vaccine for South Asian countries which are home to one-fifth of the world’s population, about 1.3 billion people. Biological E would produce vaccine for India and other South Asian countries, including Bangladesh, Bhutan, the Maldives, Nepal, Pakistan and Sri Lanka.

The vaccine is projected to enter clinical development in India in early 2010. Assuming positive clinical results, the vaccine could become available for emergency use in India by mid 2010.

This breakthrough technology, enables Biological E to produce more than 300 million vaccine doses every month and is a practical indigenous solution to meet the needs of India’s 1.2 billion population, making the country self sufficient in the event of an emergency.

Biological E is a globally focused biopharmaceutical company that develops, manufactures and markets innovative vaccines and biologics that respond to health care needs worldwide.