GlaxoSmithKline Joins Combined White House, Industry, UN agencies Effort to Fight Pediatric AIDS in Developing Countries

Philadelphia, PA, March 13, 2006 – GlaxoSmithKline (NYSE: GSK) today joined a coordinated effort with the White House, US State Department, other pharmaceutical companies, UNICEF and UNAIDS to reduce barriers to treatment for children with AIDS in developing countries.
Launched at a White House event with First Lady Laura Bush, the collaboration will work to maximize the use of currently available pediatric medicines for AIDS, and to accelerate development of new treatment options for children.
The lack of “easy to use” pediatric formulations and the absence of fixed dose combinations for children create another hurdle for physicians who already face difficulties in treating pediatric AIDS, including diagnosis and monitoring the infection in children.
Liquid forms of HIV medicines are available for children and allow for dosing by a child’s weight, but liquids can be difficult to administer and to store in developing countries. Liquids also do not combine multiple medicines in one solution, so if a child is taking multiple drugs, each has to be administered separately.
Experts at WHO and UNICEF have identified that access to a tablet form of these medicines could improve treatment options for children able to swallow tablets. Pills are easier to store and distribute and are less complicated to administer – particularly when two or three medicines are combined in one pill.
GSK is currently assessing the development of scored tablets for use in children for the company’s key anti-retrovirals (ARVs): Epivir, Ziagen, and Combivir. Using a scored tablet could simplify treatment, if the right dose could be administered efficiently and safely to children in the appropriate weight range. GSK is in further discussions with both the US Food and Drug Administration and the European Medicines Evaluation Agency to move this project forward.
“In developing countries, 50% of children infected by HIV will die before the age of two if they do not have access to AIDS treatments. Even though the pediatric liquid formulations of our key AIDS medicines are available at a not-for-profit price in the world’s poorest countries, experience has taught us that many barriers remain in the way of increasing access to those medicines,” said Chris Viehbacher, President of US Pharmaceuticals for GlaxoSmithKline, who attended the White House event. “We hope that the development of the scored tablets will facilitate access to AIDS treatment.”
Viehbacher continued, “We commend the Administration for taking a leadership role in seeking ways to improve access to treatment for children in developing countries, and we are ready to share our experience as an active partner in this collaboration.”
GSK will continue to play its part to improve the treatment of children in developing countries. GSK has committed to support four pediatric clinical studies in resource-poor countries to determine the best ways to expand access to treatment in those situations.
Treatment and prevention must be addressed in parallel; therefore, GSK is also committed to reducing new infections of newborns through the company’s long-standing and continuous effort in research on reduction of mother-to-child transmission (MTCT) of HIV/AIDS.
GSK is currently involved in seven clinical MTCT studies involving over 6,000 patients in 13 resource-poor countries to determine the most effective way to break the cycle of infection from mother to child. In particular, the company has committed to support a study in Botswana for the prevention of MTCT, which is the first GSK-supported study investigating abacavir in pregnancy. The study should begin in the second half of 2006.
In 2004, an estimated 2.2 million children under age 15 years were living with HIV infection. Last year, 700,000 children under the age of 15 were newly infected, 88% of whom were in sub-Saharan Africa.
Very little data exists on the number of children treated with ARVs in developing countries, but some experts suggest that less than five percent of children infected by HIV have access to ARV treatment (and less than 10% of HIV pregnant women have access to prevention).
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 company information please visit www.gsk.com.

For more information, please read "Our contribution to the fight against HIV/AIDS in developing countries": www.gsk.com/media/aids_contribution_dev.pdf

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