Abbott cuts lopinavir price to $2200 for middle-income countries; new tablet marketed as Aluvia

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Abbott Laboratories announced today that it will sell the new tablet form of its protease inhibitor lopinavir/ritonavir under the name Aluvia at a price of $2200 a year in developing and middle-income countries outside sub-Saharan Africa. In Africa and other least-developed countries Aluvia will continue to be sold at what Abbott describes as a no-profit price of $500 a year.

Forty-five countries will qualify for the reduced price of $2200 a year. The countries include India, Ukraine, Vietnam, Thailand and China but exclude Russia and Brazil. The discounted price will also be available to central American countries, excluding Mexico.

Abbott has been criticised over the past year for the pricing of lopinavir/ritonavir in low income and middle income countries, and also for failure to register the product in all countries eligible for the `access` price of $500 a year. This criticism has grown following the licensing of a heat-stable tablet formulation of lopinavir/ritonavir by the US Food and Drug Administration earlier this year. Medecins sans Frontieres in particular has attacked Abbott for delays in obtaining licenses for the new product in Africa.

Glossary

middle income countries

The World Bank classifies countries according to their income: low, lower-middle, upper-middle and high. There are around 50 lower-middle income countries (mostly in Africa and Asia) and around 60 upper-middle income countries (in Africa, Eastern Europe, Asia, Latin America and the Caribbean).

European Medicines Agency (EMA)

Regulatory agency that evaluates medicines for safety and efficacy in Europe, performing a similar role to the Food and Drug Administration (FDA) in the United States. The EMA recommends to the European Commission that a medicine can be marketed in the European Union and European Economic Area.

Food and Drug Administration (FDA)

Regulatory agency that evaluates and approves medicines and medical devices for safety and efficacy in the United States. The FDA regulates over-the-counter and prescription drugs, including generic drugs. The European Medicines Agency performs a similar role in the European Union.

formulation

The physical form in which a drug is manufactured or administered. Examples of formulations include tablets, capsules, powders, and oral and injectable solutions. A drug may be available in multiple formulations.

Abbott says that the delay is caused by the need to obtain a license from the European Medicines Agency before it can submit its product dossier to licensing authorities in Africa and other least-developed countries. A European license is needed, the company says, because African authorities want approval from the licensing authority of the region in which the product is manufactured.

A further delay has been caused by the fact that the European Medicines Agency has refused to register two separate formulations of lopinavir/ritonavir with the same name but for different markets. Instead, the differentiated product must have a different brand name, requiring a separate approval process for packaging and labelling. This requirement is intended to prevent diversion of products intended for use in developing countries back into the European Union. This is the reason why heat-stable lopinavir/ritonavir tablets will be marketed as Aluvia through the company's access programme.