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Page 1: · PDF fileco-signed a letter with MSF to Abbott's CEO ... +41 22 791 4509, email: desantisd@unaids.org WHO North American HIV/AIDS Media Line, tel: +1 212 584 5031 P

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requires refrigeration, comes with a high pillburden of six capsules per day and needs to betaken with food. The US Food and DrugAdministration (FDA) approved the improved newversion of LPV/r in October 2005: storagewithout refrigeration, lower pill count [down tofour per day], and no dietary restrictions.

New and improved Kaletra: Only in the US...But What About the Rest of the World?

No other boosted protease inhibitors are practicalto use in the hot climates of many developingcountries, where refrigeration is not readilyavailable. If made accessible and affordable, thenew and improved version of LPV/r could offermajor benefits to patients across the developingworld.

Yet, since its approval given by the US FDA, newLPV/r is available in the US, but not in anydeveloping countries.

In April 2006, HIV/AIDS researchers andclinicians, investor groups, treatment advocates,and policy-makers from around the worldco-signed a letter with MSF to Abbott's CEOcalling for the company to take immediate stepsto make heat-stable LPV/r available to patients indeveloping countries. Under pressure, Abbottagreed to fulfill an MSF's order for 400 patients in9 countries.

Several weeks later, Abbott announced that itwould charge $500 (down from $10,000 in theUnited States) per patient per year for the newLPV/r in African and least-developed countries;however, no one can buy the medicine yetbecause the company has not taken steps to makeit available in any of these countries except SouthAfrica. In addition, Abbott has not published aprice for middle-income countries such as China,Thailand or India.

China is among those middle-income countrieswhich are not eligible for the reduced price of thenew formulation of LPV/r. In fact, the problem iseven worse: there is no LPV/r available in China,neither the new nor the old formulation, becauseAbbott has chosen not to market the drug there.

Chinese patients: don't deserve Kaletra?

In China, 20,453 AIDS patients are currentlyreceiving ART. According to one study by theChinese Academy of Medical Sciences in 2004,27-31% of patients were already resistant to atleast one ARV drug.1 When the first-line ARVdrugs no longer work, these patients will need toswitch onto second-line drugs.

Since 2003, Medecins Sans Frontieres (MSF) hasrun two HIV/AIDS treatment and care projects inNanning, Guangxi Province and Xiangfan, HubeiProvince. At present, about 400 patients are onART, out of 800 total patients followed. MSFexpects 10 to 15 of them will require second-linedrugs by the end of this year, with the numbersincreasing over time. From a medical point ofview, one of the best options for treatment wouldbe LPV/r.

The old version of LPV/r has been registeredsince 2003, but Abbott has not marketed thedrug, despite the fact that it has a patentmonopoly on LPV in China until 2016. Thatmeans the drug is, practically speaking, notavailable to patients. By neglecting the patients ofChina, Abbott is failing to fulfill its commitment tobroadening "access by providing HIV careproducts at a loss" to the "programmes that needthem most".

Two years back in June 2004, in a meeting withAbbott China, MSF was informed that the oldformulation of LPV/r would be marketed inOctober in the same year. Despite repeatedrequests from MSF over the past two years, as ofMay 2006, the drug has still not been put on themarket.

In the Long Run, Alternative Suppliers WillBe Critical

The current inability to procure heat-stable LPV/r- and in China, any LPV/r at all -- underscoresthe ongoing challenge of access to medicines indeveloping countries. Generic competition has ledto the dramatic decrease in price and increase inavailability of first-generation ARV medicines.However prices of newer drugs remain muchhigher, as all new drugs may be subjected to atleast 20 years of patent protection practicallyeverywhere except in least developed countriessince the full implementation of the WTO TRIPS(Trade-related Aspects of Intelectual PropertyRights) Agreement in 2005 in India and otherdeveloping countries. The case of the newformulation of LPV/r which costs as much as$10,000 per patient per year in the United States- the only place it is currently available - illustratesthe danger of having only one source for alife-prolonging medicine. If access to neededdrugs depends on the marketing policies ofpharmaceutical companies, then the lives ofmillions of people with HIV/AIDS remain at risk.

1 Zhang Fujie, "Delivering antiretroviral therapy in China: progress and

challenges." Presentation made on 9 May 2005.

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tel: +41 79 509 0622, email: [email protected]

Tunga Namjilsuren, WHO, Geneva, tel: +41 22 791 1073,

email: [email protected]

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email: [email protected] WHO North American HIV/AIDS

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Tunga Namjilsuren, WHO, Geneva, tel: +41 22 791 1073,

email: [email protected]

Dominique De Santis, UNAIDS, tel: +41 22 791 4509,

email: [email protected] WHO North American HIV/AIDS

Media Line, tel: +1 212 584 5031

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17

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