GSK and Biological E. announce joint venture to develop combination vaccine for India and other developing countries

Issued: Monday 28 January 2013, London UK and Mumbai/Hyderabad, India

GlaxoSmithKline (GSK) and Biological E Limited (Biological E.), a leading Indian vaccines company, today announced an agreement to form a 50/50 joint venture (JV) for the early stage research and development of a six-in-one combination paediatric vaccine to help protect children in India and other developing countries from polio and other infectious diseases.  The partnership reinforces the commitment of both companies to support the World Health Organisation’s (WHO) global polio eradication programme.

If approved, the vaccine, which would combine GSK’s injectable polio vaccine (IPV) and Biological E’s pentavalent vaccine for diphtheria, tetanus, whooping cough (whole cell pertussis), hepatitis B, and Haemophilus influenzae type b, could be the first of its kind. The vaccine would enable fewer injections for children thereby improving compliance in immunisation schedules.  The fully liquid formulation of the vaccine also means it would be ready to use with no additional ingredients or materials required, freeing up space at local storage facilities. 

The JV will bear the development costs for the candidate vaccine, which is expected to enter phase 1 development in the next two years. A small initial cash investment will be made by both companies to cover start-up costs for the JV and subsequent development costs will be split equally. 

Christophe Weber, President of GSK Vaccines said “We are delighted to be working with Biological E., an established company in the global vaccine market. This agreement is fully aligned to GSK’s vision of providing high quality vaccines to those in need and by leveraging Biological E’s strengths, this particular vaccine has the potential to be play a significant role in the fight against polio.”

Vijay Kumar Datla, Chairman Biological E. said “We are excited to be working with GSK, and this relationship is a validation of the investments we have made in vaccine technology and quality. We expect to leverage this partnership to accelerate the development of the hexavalent vaccine and make IPV accessible for developing countries in the post eradication phase for polio. We hope to continue playing our part in support of the public health community.”

Completion of the transaction is expected in 2013, subject to several conditions including regulatory approval of the JV.

GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.  For further information please visit www.gsk.com.

Biological E is a privately held company established in 1953. Biological E. Limited (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’s product development efforts are driven by an internationally experienced management team and the company has several strategic partnerships with leading biotechnology and pharmaceutical companies and research institutes around the world.

Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under 'Risk factors' in the 'Financial review & risk' section in the company's Annual Report 2011 included as exhibit 15.2 to the company's Annual Report on Form 20-F for 2011.