Malaria drug passes major milestone

from Paul Chinnock, TropIKA.net:

Improving the control of malaria, and moving towards its eventual elimination, is a global health priority, and effective treatment of the disease with artemisinin combination therapy (ACT) is a cornerstone of control programmes. The manufacturers of one ACT, Coartem, have announced that July 2009 will see the delivery of the 250 millionth dose of the treatment.

Coartem (artemether-lumefantrine) is manufactured by Novartis, which has been supplying it without profit to malaria endemic developing countries since 2001. The company claims that since then it has saved 630,000 lives. Most of the treatments delivered have been to Africa.

"A full treatment course for children under five costs $0.37" Hans Rietveld, head of Marketing and Access for the Novartis Malaria Initiatives" told TropIKA.net. "Governments typically purchase Coartem using international donor funding. In many countries, Coartem is provided to patients free of charge, especially to infants and pregnant women."

Hans Rietveld says that several countries have reported significant reductions in morbidity and mortality from malaria since the introduction of Coartem, coupled with prevention efforts: Rwanda and Zambia, 66% reduction in mortality; Ethiopia, 50% reduction in infant mortality. "In South Africa, KwaZulu Natal district reported malaria case reduction of 78% in 2001 and 86% in 2002, and hospital admissions for malaria reduced by 82%."

Coartem for kids

In January this year, Novartis and the Medicines for Malaria Venture launched Coartem Dispersible, the first ACT specifically designed for children. The tablets are fruit-flavoured and disperse quickly in small amounts of water, easing administration and ensuring effective dosing. "Until now," says Ritveld, "many parents had to crush bitter-tasting antimalarial tablets for their children to swallow. Often children resisted and spat out some of the medicine, which placed them at greater health risk."

Like Coartem, Coartem Dispersible is provided without profit for public sector use in the developing world. Ritveld says: "In June, Mali became the first country to receive Coartem Dispersible and we expect other countries to receive it in the coming months. Feedback from healthcare professionals is that Coartem Dispersible is more convenient to administer. Saving time on the rather cumbersome practice of crushing tablets has been cited as relevant for healthcare professionals so that they have more time to spend in their dialogue with patients and caregivers".

Controversy

In some countries, for example Uganda, indigenous manufacturers of antimalarials (usually old, ineffective types) have claimed that the arrival of Coartem is harmful to local industry. Hans Ritveld says, "Our focus is on saving lives and reducing suffering. We do not think this should be viewed as harmful to local industry".

While there are currently no plans to license manufacture to local companies in endemic countries, Novartis works with some local operations to source artemisinin for use in Coartem production. (Artemisinin is extracted from the plant Artemisia annua.)

Another controversy has been the use of Coartem by Novartis to secure a "fast-track voucher" from the US Food & Drugs Administration, to allow early approval of a profitable drug for sale in the US. Ritveld says, however, "This has not held back any progress being made by the Coartem programme in malaria-endemic countries".

Ritveld continues: "Coartem is approved in over 80 countries worldwide, and by several regulatory authorities in Africa, the US FDA, Swissmedic, and EMEA. Coartem is the only artemisinin-based combination therapy which has been approved by the ICH regulatory authorities. The Coartem programme is the largest access to medicines programme for the developing world.

"The feedback we hear is that patients, caregivers, healthcare professionals, policy makers and funding agencies are grateful for Coartem which has proven to be one of the keys, in conjunction with prevention methods, to successfully roll back malaria in many countries."

Lessons

Asked what lessons have been learned from this project that can be applied to the development of other drugs for the infectious diseases of poverty, Riveld says, "Addressing the health problems of the developing world is complex and challenging and requires collaboration. One way that we're addressing these challenges of the developing world is by hosting a series of biannual workshops in Africa at which national malaria control programme managers (NMCPs) can share best practices in malaria control from their countries".

Despite the efforts to distribute Coartem in endemic countries, there are many reports of African countries running out of stock. The issue was discussed in June this year at a meeting an NMCP workshop, organized by Novartis, in Mali. Ritveld says, "We learned that while stock-outs remain one of the biggest challenges in fighting malaria in Africa, new solutions are being developed to help address these challenges. For example, we have seen great progress in countries that have switched to monthly supplies from the central medical stores to the district and health facility level, rather than quarterly, thereby better matching the actual demand with supply. Furthermore, the development of new technologies, such as use of mobile phones and text messaging, are being considered to help better manage supply and reduce stock-outs".

Looking to the future, he says, "To make a meaningful and sustainable impact for patients in the developing world, governments, international institutions, industry, and civil society must join forces. This month (July), we will officially become the first healthcare company to join the United Against Malaria (UAM) campaign".

UAM is a partnership of footballers, non-governmental organizations, foundations, governments, corporations and individuals, which is focusing on increasing the number of insecticide-treated bednets used in Africa, during the run up to next year's World Cup in South Africa.