Norvatis offers Africa Coartem to combat malaria

By Henry Neondo

The Swiss based pharmaceutical company, Novartis announced yesterday that it is on track to produce 100 million treatment courses of its anti-malarial Coartem in 2006.
The target is an increase from last year’s 30 million.

But the press release said that these would depend on orders as placed by malaria-endemic developing countries in a timely manner.

Coartem is the only WHO pre-qualified, fixed- dose artemisinin-based combination therapy (ACT) and achieves cure rates of up to 95 per cent.

Reflecting its commitment to helping patients who are suffering from malaria in developing countries where the disease is endemic, Novartis continues to provide Coartem at cost for public sector use. Last year, the firm received orders for 14 million Coartem treatments for delivery in 2005.

To achieve the unprecedented scale-up in production, the company invested heavily in expanding production capacity at state-of-the-art manufacturing facilities in Beijing, China and Suffern, New York, and Beijing, China as well as extending the supply agreements to procure raw materials and active ingredients in Africa and China.

The two Chinese firms that manufacture the active ingredients - Kunming Pharmaceutical Corporation (KPC) which provides artemether, and Zhejiang Medicine Company (ZMC) which provides lumefantrine - recently completed major capacity-expansion programs to help insure continued supply of Coartem.

“Having adequate supply of ACTs like Coartem and getting this life-saving medicine to those in need is central to our fight against malaria,” said Dr. Fred Binka, Associate Professor of Epidemiology at the School of Public Health, University of Ghana, and Executive Director of the INDEPTH Network, based in Accra, Ghana. “We applaud efforts by Novartis to dramatically increase the supply so that more patients can benefit from this important therapy.”

With a cure rate of above 95 per cent and very few side effects, Coartem clears parasites from the blood faster than other non-artemisinin anti-malaria drugs, also helping to reduce the transmission of the disease. In some regions of Africa, the number of malaria cases has dropped by more than 90 per cent when ACTs were used in combination with other malaria control measures.

“We have seen much success from our malaria control efforts in Zambia, including the nationwide usage of Coartem in the public sector,” said Dr. Naawa Sipilanyambe, Coordinator of the country’s National Malaria Control Program in Zambia.

“ We have witnessed a 10.5 per cent drop in malaria incidences in 2004 as compared to 2003, and a decline in malaria deaths from 50,000 to 33,000 over the same time period,” added Dr. Sipilanyambe.

The WHO estimates that there are between 300 and 500 million new cases of malaria each year, resulting in over one million deaths annually, 90 per cent of which occur in children in Africa.

Malaria morbidity and mortality rates are rising in developing countries, largely due to the emergence of drug resistant parasites rendering traditional antimalarial drugs, such as chloroquine and sulfadoxine-pyrimethamine (SP) ineffective.

In addition to the devastating toll malaria takes on human life in terms of morbidity and mortality, the disease also has substantial negative impacts on the economic development of nations in which the disease is endemic.

The drain on African economies alone is estimated to be USD 12 billion each year (WHO, 2000) and the threat of malaria can be a serious deterrent to tourism, further hampering economic development and growth.

But as the pharmaceutical company announced its offer, the WHO released a request to pharmaceutical companies to end the marketing and sale of “single-drug” artemisinin malaria medicines, in order to prevent malaria parasites from developing resistance to this drug.

“It is critical that artemisinins be used correctly,” said Dr LEE Jong-wook, WHO’s Director-General. “We request pharmaceutical companies to immediately stop marketing single-drug artemisinin tablets and instead market artemisinin combination therapies only. The new treatment guidelines we are releasing provide countries with clear and evidence-based direction on the best treatment options for malaria.”

According to the new WHO malaria treatment guidelines, uncomplicated falciparum malaria must be treated with ACTs and not by artemisinin alone or any other monotherapy.

“So far, no treatment failures due to artemisinin drug resistance have been documented, but we are watching the situation very attentively,” said Dr Arata Kochi, the newly appointed director of WHO’s malaria department. “We are concerned about decreased sensitivity to the drug in South-East Asia which is the region that has traditionally been the birthplace of anti-malarial drug resistance.”

WHO also announced other measures it will take to maximize the benefits and correct use of ACTs. In order to contain the circulation and use of counterfeit antimalarial medicines, WHO plans to strengthen its collaboration with international and national health and regulatory authorities. It is estimated that up to 25% of medicines consumed in developing countries are counterfeit or sub-standard. In parts of Africa and Asia this figure exceeds 50%, according to a WHO report on counterfeit drugs.

Additionally, to anticipate and prevent the onset and spread of drug resistance in the long term, WHO urges the global malaria research community and the pharmaceutical industry to rapidly invest in the design of the next generation of antimalarial drugs.

By creating ACTs with multiple-drug combinations and transmission blocking components, resistance can be prevented.

“Our biggest concern right now is to treat patients with safe and effective medication and to avoid the emergence of drug resistance. If we lose ACTs, we’ll no longer have a cure for malaria,” said Dr Arata Kochi,“ and it will probably be at least ten years before a new one can be discovered.”

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