Ugandan Children To Receive Abbott's Lower-Strength Aluvia Tablet

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Lower-Strength Aluvia Tablet

Abbott made its new lower-strength lopinavir/ritonavir (LPV/r) tablet, known as Aluvia in developing countries and Kaletra in developed countries, available to children living with HIV/AIDS in Uganda -- a step the company hopes willbegin to improve the lives of the 2.3 million children worldwide living with HIV/AIDS. The World Health Organization (WHO) recommends LPV/r for the treatment of children who no longer respond to "first line" HIV medicines.

As the first and only co-formulated protease inhibitor tablet that can be used in children, the new lower-strength tablet has the same benefits as the original tablet. The tablet does not require refrigeration and can be taken with or without food -- two important advances in delivering HIV medicine in developing countries.

Abbott shipped the medicine to Uganda under a waiver order approved by the country's government. Waiver orders allow medicines to be shipped, before they are approved in a specific country, provided that the national government gives specific permission. However, Abbott accepts waiver orders only after a medicine has been approved by at least one stringent regulator. The Ugandan Government approved the shipment when the U.S. Food and Drug Administration (FDA) approved the lower-strength tablet on Nov. 9. The Ugandan Government's early approval of the waiver order allowed Dr. Victor Musiime of the Joint Clinical Research Centre in Kampala to write the first prescription for the lower-strength tablet just days after it had received marketing authorization in the United States. Other African governments are now also talking to Abbott about the possibility of waiver shipments.

Abbott is also working with African governments to try to expedite registration of this medicine across the continent. Registration in most developing countries can only take place once the regulatory body in the country or region where the medicine is made has approved it, in this case the European Medicines Agency (EMEA).

"Nine out of every ten children with HIV live in sub-Saharan Africa. We developed Aluvia with the distinct needs of children in the developing world in mind," said Mark Masterson, vice president, Asia, Africa, Australia, Central Europe region, Abbott International.

Abbott has invested in sufficient manufacturing capacity to meet the anticipated global demand for the Aluvia tablets and plans to register the lower-strength Aluvia tablet in 150 countries -- broader registration than any other pediatric HIV medicine. The company will supply the lower-strength tablet at half the price of the original tablet in developing countries. Both the original strength and lower-strength versions of Abbott's Aluvia tablets are more affordable in these 69 countries than any generic copy.

"Introduction of second-line medicine for children living with HIV will help restore hope for millions of parents and children who would otherwise face a bleak future if first-line therapy failed," said Dr. Peter Mugyenyi, chair and director, Joint Clinical Research Centre (Uganda's pioneer AIDS research and treatment institution), and chairman of African Dialogue on AIDS. "Co-formulated lopinavir/ritonavir is a WHO-recommended second-line HIV treatment regimen for children, and Abbott is making its latest, most innovative version available to our most vulnerable sector of society: children who live in poor countries."

Abbott's effort to provide African children with HIV treatments is part of its five-point global strategy to expand access to HIV treatments around the world by:

-- Focusing on pediatric HIV care

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-- Continuing to innovate with an eye on the needs of the developing world

-- Investing in manufacturing capacity to ensure consistent, quality supply

-- Offering tiered and affordable pricing

-- Broadening registration of life-enhancing medicines

About Abbott's FDA-Approved Lower-Strength Aluvia Tablet

Abbott's new Aluvia tablet is a lower-strength LPV/r formulation intended to prevent HIV from spreading within the immune system. It is the first and only co-formulated protease inhibitor tablet that can be used in children and is suitable for pediatric patients who meet weight and age requirements for dosing and are reliably able to swallow the tablet intact.

Developed using breakthrough melt-extrusion technology (Meltrex(TM)), the new lower-strength tablet formulation offers the same benefits as the original full-strength tablet but contains 100 mg of lopinavir and 25 mg of ritonavir, as compared to the 200 mg lopinavir and 50 mg ritonavir in the original tablet.

About Abbott's Commitment to Fighting HIV/AIDS

HIV/AIDS is a global problem that demands shared commitment and shared responsibility. Abbott is committed to working with governments, multilateral organizations, nongovernmental organizations (NGOs) and civil society to expand access to HIV/AIDS treatments around the world.

Through its Access program, Abbott provides its HIV medicines at no-profit pricing in many developing countries. Since April 2007, Abbott has offered its HIV medicines in two pricing tiers across 115 low- and lower-middle-income countries. In addition, Abbott has consistently made its medicines available at a price below that of any generic competitor in each of the pricing tiers.

Abbott and Abbott Fund are investing more than $100 million in developing countries through the Abbott Global AIDS Care programs focusing on four areas: strengthening health care systems; helping children affected by HIV/AIDS; preventing mother-to-child transmission of HIV; and expanding access to testing and treatment.

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