New malaria drug welcomed in developing world
By KEVIN SPURGAITIS
TORONTO — Bed-nets steeped in insecticide can’t always ward off lethal malaria-carriers. In endemic zones where old and pricey drugs are widely circulated, where resistance rates now fall below 25 per cent, more than 3,000 people still die from the neglected disease every day. However, dozens of millions of people — with access to only typical malaria treatments — may soon benefit from a new, non-patented formulation.
The Drugs for Neglected Diseases Initiative (DNDI) Foundation and Sanofi-Aventis recently developed a new malaria drug, which is easier to ingest and less costly than other medications currently available. Expected to become available to patients in 2006, the drug — a fixed-dose combination (FDC) of artesunate and amodiaquine (AS/AQ) — is an artemisinin-based therapy or ACT. Artemisinin is a drug derived from a weed that grows wild in Africa and the Far East, and makes up the most effective treatments for malaria, according to the DNDI Foundation and Sanofi-Aventis.
Recommended by the World Health Organization (WHO), this combo is one of the first-line treatments adopted by various African countries and Indonesia. The new formulation is designed to be taken twice daily for three days, instead of 8 tablets per day. The paediatric formulation for infants will also be simplified: one tablet a day for three days. As well, it can be dispersed in water, which better helps with drug administration. Compared with the presently available “co-blisters,” the fixed dose combination is considered to be a vast improvement, because of the reducation of tablets.
Médecins Sans Frontières (MSF) welcomed the new product, calling it a “step forward for treating malaria patients.” The formulation, they say, is attractive because patients only have to take one pill (combining artesunate and amodiaquine) twice a day for three days, whereas existing ACTs for adults consist of as many as 24 pills. With the two drugs combined in a single tablet, the risk of developing resistance is reduced, MSF maintained.
DNDI was launched in 2003 as a collaboration between MSF, the Pasteur Institute, Brazil’s Oswaldo Cruz Foundation and the Indian Council for Medical Research, as well the Kenyan Medical Research Institute and WHO’s programme for Research and Training in Tropical Diseases (TDR). DNDI’s mission is to address the lack of research and development in neglected diseases. Sanofi-Aventis is one of the world’s largest pharmaceutical companies. It is developing leading positions in seven major therapeutic areas: cardiovascular, thrombosis, oncology, metabolic diseases, central nervous system, internal medicine and vaccines. Through its Impact Malaria programme, Sanofi-Aventis continues its historic involvement in the fight against malaria.
Jean-François Dehecq, chairman and CEO of Sanofi-Aventis, said:”This highly innovative partnership between DNDI and Sanofi-Aventis will ensure that this new product is rapidly made available to the poorest among the poor and that it is tailored to their needs.”
Five years after the Abuja declaration of 2000, in which 53 African heads of state pledged to halve malaria deaths by 2010, it is the right moment to take stock, health practitioners say. Globally, more than 500 million people still suffer from the disease, with more than one million dying from it each year, according to WHO. The scale on which the mosquito-transmitting parasite kills is “breathtaking.” Like HIV/AIDS and TB, malaria is considered one of the major public health challenges in the developing world. An estimated 40 per cent of the world’s population — mainly those living in the poorest countries — is at risk of contracting it.
Today, more people have access to prevention and treatment of the malaria, due to the 1998 Roll Back Malaria programme, which helped raise the profile of the sickness and double international spending. For 40 years, chloroquine was the standard treatment for malaria. Fever-stricken patients simply swallowed a couple of pills and would get better within 48 hours. However, a drug-resistant strain of malaria, plasmodium falciparum, has grown in Africa in recent decades, accounting for more than 90 per cent of cases. In east Africa, surveys show that almost two-thirds of patients given chloroquine and nearly half of those on its successor, sulfadoxine-pyrimethamine, still died. Nonetheless, large sums are still being spent on chloroquine and similar “ineffective” treatments.
Mixing two well-known ingredients widely used in single-drug-therapy, the new co-formulation will be less expensive than all other combinations with artemisinin. More importantly, it is promised to be non-patented. This means that any generic producer is allowed to make a similar product, which will generate more competition between manufacturers — and even lower prices.
In the coming years, WHO proposes costs to be set at one dollar for adults and 50 cents for children. This pricing is expected to dramatically lower the budgetary impact of malaria treatment. However, this target price will only be achievable if international groups provide adequate financial assistance to affected countries, according to the organization. This will help them undertake that vital therapeutic switch.
“One of the key goals of the DNDI’s development strategy was to create a drug that is simple to use, at a cost below a dollar,” Dr Bernard Pecoul, DNDI Foundation Executive Director, said. “This objective can now be met thanks to the determination of Sanofi-Aventis to bring this drug into the public sector at cost price.”
For the most part, the announcement of the new ACT co-formulation is good news for health practitioners. However, they say it will not solve all problems related to malaria. Globally, the parasite responsible for malaria is ever-evolving in response to new treatments. And for the moment, new and improved drugs remain’out-of-reach’ in resource-poor settings like many African countries, where malaria takes its greatest toll. Experts say the political will and financial commitment of governments is now needed.
