Novartis announced that the production capacity for its artemisinin-based combination therapy Coartem (artemether-lumefantrine) has been expanded to reach the level of five million treatments per month. The World Health Organization (WHO) expects in 2005 patient needs will reach 60 million treatments, an exponential increase over three years ago when only 100,000 treatments were produced.
"The introduction of artemisinin-based combination therapy (ACT) is of highest priority for malaria control in Africa and Coartem is the only therapy currently available as a fixed-dose combination providing both active ingredients in a single tablet," said Professor Marcel Tanner, Director of the Swiss Tropical Institute. "Due to the fact that many African countries now recommend Coartem as first line treatment, demand for Coartem has risen dramatically and Novartis has moved admirably to ramp up production capacity. This move will certainly help to reduce the malaria burden for millions of people, especially children, and prevent malaria deaths and severe and complicated malaria episodes."
Novartis has also concluded agreements for supply of 11.6 tons of artemether by its Chinese partner Kunming Pharmaceuticals Corporation (KPC) and 15 tons of artemisinin by several other suppliers, most prominently Chongqing Holley. This is an amount sufficient to produce 60 million Coartem treatments. Final Coartem production in 2005 is highly dependent on the timely delivery of sufficient quantities of the key raw materials artemisinin and artemether by Chinese suppliers who currently dominate the world market. Most deliveries to Novartis will occur in the second half of the year, resulting in a production forecast of 30 million Coartem treatments in 2005.
"In partnership with WHO since 2001, we have provided at cost six million treatments of Coartem for malaria patients, many of whom are children. Based on the escalation of WHO estimates of the number of treatments needed, we have invested in new production capacity and supply agreements with our Chinese partners," said Dr. Daniel Vasella, chairman and CEO of Novartis. "In addition, we are committing additional resources to work together with governments in the developing world and NGOs to research how to help those most vulnerable to malaria, especially pregnant women and children. To help ensure that the medicine is broadly accessible to needy patients, we make Coartem available at cost to the WHO for supply to the public sector of malaria endemic developing countries. Up to now we have been subsidizing Coartem and do not anticipate ever making a profit from future sales."
Artemether-lumefantrine is on the WHO's Essential Medicines list and is the only ACT pre-qualified by the WHO for use in countries experiencing high levels of resistance to conventional anti-malaria drugs.
The immense scale up of ACTs requires strong collaboration between the WHO, other stakeholders in the Roll Back Malaria partnership, the manufacturers of ACTs and raw material suppliers.
"The effort of Novartis to expand its manufacturing capacity will make it possible for tens of millions of malaria patients to benefit from this highly effective treatment in 2005," said Dr. Jack C. Chow, WHO Assistant Director-General - HIV/AIDS, TB and Malaria.
Artemisinin, the active ingredient in Coartem and all other ACTS, is a plant derived raw material and crops of Artemisia annua must be planted one growing season ahead of harvesting and extraction for use in production. The cultivation of Artemisia annua requires a minimum of six months. The supply chain for manufacturing ACTs is particularly complex and time-consuming, adding an additional two to five months to production timelines depending on product formulation.
"Artemisinin-based combination therapies like artemether-lumefantrine are central to our fight against malaria. We have seen remarkable results with this new class of drugs. In some regions the number of malaria cases dropped by more than 90 per cent when ACTs were used in combination with other malaria control measures," said Professor Nick White, Wellcome Trust Research Laboratories, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand. "The demand for artemether-lumefantrine has risen dramatically. Production capacity has been ramped up as usage has risen exponentially, but we need to ensure sufficient agricultural production of artemisinin to sustain this progress."
Coartem is a highly effective and well tolerated antimalarial that achieves cure rates of up to 95 per cent, even in areas of multi-drug resistance. It is indicated for the treatment of falciparum malaria, the most dangerous form of malaria. Coartem is the only pre-qualified, fixed-dose ACT combining artemether, an artemisinin derivative, and lumefantrine.
Artemisinin is a compound derived from the sweet wormwood plant and has been used for centuries in traditional Chinese medicine to treat fever. An artemisinin-based combination therapy is a combination of two or more drugs (one of which is an artemisinin derivative) that have different modes of action and different targets. Studies have shown that using two or more drugs in combination has the potential to delay the development of resistance in areas of low transmission. Artemisinin-based combination therapies in particular have been found to be highly effective in treating malaria and their potential to delay resistance in areas of intense transmission is under investigation.
Coartem was co-developed by Novartis in collaboration with Chinese partners who also supply the active ingredients (artemether and lumefantrine) and is produced in China by Novartis. Coartem is currently registered in 77 countries worldwide and more than four million patients have benefited from this innovative treatment since its first registration in October 1998. Coartem has been extensively studied in multi-center clinical trials involving more than 3,000 patients.