March 14, 2006
Abbott's New and Improved Kaletra: Only in the US... But What About the Rest of the World?
Médecins Sans Frontières (MSF) is deeply concerned that Abbott's new version of the second-line fixed dose combination lopinavir/ritonavir — LPV/r, marketed as Kaletra, is not available in developing countries. The US Food and Drug Administration (FDA) approved a new version of LPV/r in October 2005 that has critically important advantages for patients in developing countries: lower pill count [down from six to four per day], storage without refrigeration, and no dietary restrictions. Some MSF projects have an urgent need for this drug, as no other boosted protease inhibitors — the cornerstone of second-line therapy — are practical to use in the hot climates of many developing countries, where refrigeration is not readily available.
New LPV/r is available in the US, but not in any developing countries and there is no publicized differential price or system of distribution for developing countries. If made accessible and affordable, the new and improved version of LPV/r could offer major benefits to patients across the developing world.
In 2005, approximately six percent of MSF patients that had been on treatment for three years were on second-line drugs, and in one MSF program that has access to viral load monitoring, after four years of treatment, 16% of patients needed a new combination. These data underline the acute and growing need for access to newer, field-adapted second-line drugs. But new LPV/r remains out of reach to MSF medical professionals and others working in developing countries. Without access to this drug, there is no practical solution for patients who no longer can benefit from older first-line drugs.
Because Abbott Laboratories is the sole producer of the new LPV/r and no generic versions have been internationally validated, MSF and others are dependent on the willingness of the company to make this urgently needed drug widely available.
MSF therefore calls on Abbott to:
An Essential Medicine for Second-Line Treatment
Price for Developing Countries Should Be the Same As, or Less Than, the Old Version
The price of LPV/r in middle-income countries outside Africa is on average 7.4 times more expensive than in low-income countries (mean: $672 vs. $4,998). In some developing countries, the price for the old version of LPV/r is nearly as high as it was in the US ($6,944).
In Brazil, where the government has twice threatened to manufacture the drug at a lower cost under a compulsory license, Abbott Laboratories agreed to cut the price of old LPV/r formulation from $2,562 to $1,379 per patient/year, starting in March 20064. Although this is an improvement, Brazil will still have to pay nearly three times the price of the old formulation of LPV/r in Africa and least-developed countries.
In the Long Run, Alternate Suppliers Will Be Critical
Registration Should Be Immediately Sought For New Formulation
1 14th edition, WHO Model List of Essential Medicines (revised March 2005)
2 Summary is available for consultation at http://www.who.int/3by5/mediacentre/news51/en/
3 14th edition, WHO Model List of Essential Medicines (revised March 2005)
4 http://www.kaisernetwork.org/daily_reports/rep_index.cfm?hint=1&DR_ID=33054 Reported October 12, 2005
© 2006 Doctors Without Borders/ Médecins Sans Frontières (MSF)