Hyderabad, Andhra Pradesh Hyderabad-based Biological E Limited, one of India leading vaccines and therapeutic healthcare companies announced today that it has entered into an agreement with USA 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 A.G. 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, PhD, 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 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 1.2 billion population, making the country self sufficient in the event of an emergency.

Notes to Editor

About Biological E Ltd.

Biological E., Ltd. (Bio E) is a globally focused biopharmaceutical company that develops, manufactures and markets innovative vaccines and biologics that respond to health care needs worldwide. The company product development efforts are driven by an internationally experienced management team through strategic partnerships with leading biotechnology and pharmaceutical companies and research institutes around the world. Based in Hyderabad, India, BioE is privately owned, and established in 1953, was India first private sector biopharmaceutical company.

VaxInnate is the sole technology currently capable of rapidly producing such high volumes of vaccine. VaxInnate proprietary technology based on a combination of toll-like receptor-mediated (TLR) immune enhancement and recombinant bacterial production of vaccine antigen conveys significant speed and volume advantages, which is also applicable in case of mutation of the strain. Hundreds of millions of vaccine doses can be produced in a time frame of weeks instead of months. Currently in preclinical development, the vaccine is expected to move into human testing in the United States in 2010.

Uptil now the Indian Govt has had to rely on Multinational companies for provisions of the swine flu vaccines and the first batch of vaccines from these companies is expected to arrive in 1st quarter 2010.

The 2009 flu pandemic, or swine flu, is a global outbreak of a new strain of influenza A virus subtype H1N1. It was first detected in March 2009 and the outbreak that had started in Mexico has pervaded to all parts of the world. The flu was first detected in India in May 2009 and has already claimed 560 lives. Reports of Swine Flu deaths continue to keep coming from all parts of India.