GlaxoSmithKline Biologicals and Aeras Global TB Vaccine Foundation Partner to Develop New TB Vaccine

PARIS -- GlaxoSmithKline Biologicals and the Aeras Global TB Vaccine Foundation today announced a new public-private partnership to develop GSK Biologicals' tuberculosis candidate vaccine Mtb72F/AS02A, which has shown promising results in preclinical studies. In addition, the vaccine has shown a good safety and immunogenicity profile in early-stage clinical trials conducted by GSK Biologicals. TB causes 2 million deaths a year, and is a leading cause of death amongst people with AIDS in the developing world.

The announcement was made during the World Conference on Lung Health in Paris.

Over the coming months, GSK Biologicals and Aeras plan to move forward with additional safety and immunogenicity trials in Europe involving adults previously infected with TB or vaccinated with Bacillus Calmette-Guerin (BCG). The plan is then to begin studies in Africa and other locations to test the safety and efficacy of the vaccine candidate in populations highly affected by TB. GSK Biologicals, who will provide its candidate vaccine, will be responsible for conducting these clinical trials.

    GSK Biologicals' candidate vaccine Mtb72F/AS02A consists of a recombinant fusion protein (Mtb72F) formulated in a proprietary GSK adjuvant system (AS02A) that appears to induce strong, long-lasting cellular and humoral immune responses.

"This vaccine candidate represents one of the most promising avenues for developing a safe and effective TB vaccine," said Dr. Jerald Sadoff, CEO of the Aeras Global TB Vaccine Foundation. "Cooperation between the public and private sector is essential to harness the most promising technologies so we can deliver an effective vaccine as quickly as possible to those who need it most. We salute GSK Biologicals for bringing the vaccine to this stage and look forward to moving it forward together."

"Aeras is a leader in the TB vaccine field, and we are proud to be working together to develop an effective vaccine as quickly as possible," said Jean Stephenne, president of GSK Biologicals, the vaccine division of GlaxoSmithKline PLC and one of the world's largest vaccine companies.

"Innovative public-private partnerships are the best hope for discovering and

delivering new tools to bring the resurgent TB epidemic under control. We are

delighted to be partnering with Aeras who brings its significant expertise in

TB vaccine research and development to this critically important effort."

This agreement is a milestone for GSK Biologicals, which is now working with public-private partnerships to develop vaccines against the three biggest global infectious disease killers, AIDS, TB and malaria.  GlaxoSmithKline is also the only pharmaceutical company with active R&D programs aimed at producing improved therapies for AIDS, TB and malaria.

This agreement also marks the fourth product development agreement for Aeras, the public-private partnership helping to coordinate the global effort to develop a more effective TB vaccine. The currently-available vaccine, Bacillus Calmette-Guerin (BCG), was developed in 1921 and fails to protect most people beyond childhood.

"For far too long, the world has relied on inadequate tools to fight the TB epidemic," said Dr. Helene Gayle, director of HIV, TB and reproductive health at the Bill & Melinda Gates Foundation. "By advancing this vaccine candidate into clinical trials, Aeras and GSK Biologicals are taking an important step toward developing an effective TB vaccine that could save millions of lives."

Today's announcement comes in the wake of the declaration in August by World Health Organization Director General Jong-Wook Lee that TB now constitutes a regional health emergency in Africa, where the number of TB cases has quadrupled since 1990. Of the 25 million Africans now living with HIV, about 8 million are also infected with the bacillus that causes TB. Most forms of TB can be treated with drugs, but the complex regimen takes at least six months to complete, and medicine is not always available in developing countries.

Source: GlaxoSmithKline Biologicals

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