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Bio-Tech Breakthrough Could End Malaria Drug Shortages

In Malaria on November 12, 2011 at 8:41 am


Wormwood plants growing in China. Photo by Flickr user Novartis AG.

A synthetic biology breakthrough, achieved at laboratories in northern California, could expand access to malaria treatment around the globe beginning in 2012.

Scientists at the University of California, Berkeley, and the biotech start-up Amyris developed a process to manufacture artemisinin, a crucial ingredient in first-line malaria drugs that until now had to be extracted from a natural crop called sweet wormwood.

Nearly one million people die each year around the world from malaria, despite the existence of effective drugs against the disease. One reason is the lack of access to affordable treatment with artemisinin combination therapy.

Fluctuations in the annual crop output of sweet wormwood, a fern-like plant grown mostly in China and Vietnam, have caused instability in the market price for these malaria drugs. Shortages of the crop can also lead to shortages of the medicine.

Fermentation tank photo courtesy Sanofi-aventis.

The new semi-synthetic artemisinin, produced in large-scale fermintation tanks (pictured to the right) from engineered synthetic microbes, successfully entered the production phase through a public-private partnership with the drug company Sanofi-aventis earlier this year. It is considered “semi-synthetic” because it is uses natural substances in the process.

It will hit the market beginning in 2012, and those involved with the research hope it will stabilize prices and take the boom and bust nature of artemisinin production out of the malaria treatment equation.

Richard Chin, CEO of the non-profit drug development organization OneWorld Health, said production will ramp up from 20 tons in the first year to 40 tons annually in 2013. His organization coordinated the public-private partnership and development of the technology with funding from the Bill and Melinda Gates Foundation*.

“It will be about half, a little less than half, of the world’s supply and it will alleviate the shortage predicted for next year,” said Chin.

The influx of artemisinin will help make the best quality malaria treatment more affordable for governments and consumers in poor countries, said Dr. Olusoji Adeyi, who runs the affordable malaria medication program at the Global Fund to Fight AIDS, Tuberculosis and Malaria, and is not involved in the research.

“This is a benefit to the consumer, at the country level, and the resources that governments and donors provide can cover more treatments,” said Adeyi.

The project is aiming for an artemisinin market price of about $350 a kilo so that farmers can also stay in business growing sweet wormwood. Currently, Chin said, artemisinin is priced higher than $500 a kilo and climbing because of an anticipated shortage in the crop for next year.

“The price is rising as we speak,” he said.

The high price of artemisinin has played a big role in the lack of access to the combination therapies, Adeyi said, leaving many in malaria endemic areas to turn to the cheap — but now mostly ineffective — chloro­quine malaria treatments.

In many countries, artemisinin combination therapy can still cost anywhere between $4 and $10 for the consumer, while chloroquine costs around 50 cents. The difference in price makes the higher quality drug prohibitively expensive to most people in malaria endemic areas, Adeyi said.

The Global Fund has designed a financing mechanism to reduce those prices, which is showing good success so far in its pilot stage, but Adeyi said any expansion of access to medication will require a steady dependable supply of artemisinin like what the semi-synthetic roll out could provide.

The project intends to be a complimentary source of artemisinin for malaria drugs, not to edge natural artemisinin out of the market.

“We are not trying to make it a monopoly,” Chin said. “We don’t want to lower [the price] below a point where it is fair to the farmers.”

Through the partnership, Sanofi-aventis is producing the artemisinin on a large scale, and has agreed to sell it at production price in a fair manner to any qualified drug producer who promises to use it in combination therapy.

The company will also be able to use the ingredient for its own manufacturing purposes. Amyris has also benefited from the project, and is now using the technology developed for the malaria project for work on synthetic fuels. But, says Chin, the real payoff for all the groups involved will come when effective treatment starts to drive down transmission of new malaria cases, and he hopes it will encourage other drug companies and institutions to get involved in global health research down the road.

“The ultimate goal is eradication,” Chin said. “To make malaria a forgotten disease would be incredible.”

*For the record, the PBS NewsHour‘s global health unit is funded by the Bill and Melinda Gates Foundation.


Pyrethroid Insecticides are Losing Their Edge Against Malaria

In Malaria, Uncategorized on July 20, 2011 at 5:15 pm

Published online 5 July 2011 | Nature 475, 19 (2011) | doi:10.1038/475019a


Mosquitoes score in chemical war

Growing resistance is threatening global malaria-control efforts.

Declan Butler

Key weapons in the fight against malaria, pyrethroid insecticides, are losing their edge. Over the past decade, billions of dollars have been spent on distributing long-lasting pyrethroid-treated bed nets and on indoor spraying. Focused in Africa, where most malaria deaths occur, these efforts have greatly reduced the disease’s toll. But they have also created intense selection pressure for mosquitoes to develop resistance.

Data are coming in thick and fast indicating increasing levels of resistance, and also of resistance in new places,” says Jo Lines, an entomological epidemiologist and head of vector control at the Global Malaria Programme of the World Health Organization (WHO) in Geneva, Switzerland. The WHO now intends to launch a global strategy to tackle the problem by the end of the year.

Pyrethroids are the mainstay of malaria control because they are safe, cheap, effective and long-lasting. Alternatives such as organophosphates and carbamates are available for indoor spraying, although they cost more and are less effective. But pyrethroids are the only insecticides approved by the WHO for use in bed nets. “We have lots of our eggs in the pyrethroid basket,” says Robert Newman, director of the Global Malaria Programme.

The international community has been slow to respond to the threat despite warnings, says Janet Hemingway, director of the Liverpool School of Tropical Medicine, UK, and chief executive of the non-profit Innovative Vector Control Consortium, a public–private venture set up in 2005 to develop new insecticides and monitoring tools. “A number of us had been banging the drums, saying: ‘As soon as you scale up you are going to get resistance.'” But Lines says that the malaria-control community felt too many lives were at stake to let the threat of resistance stand in the way of massively scaling up the bed-net and spraying campaigns.

Teasing out the impact of resistance on the success of malaria-control interventions is difficult because so many other factors influence their outcome. More systematic and more sophisticated monitoring of resistance is also vital, says Lines. The best surveillance data (see ‘Resistance on the rise’), although useful, do not give a complete picture of where resistance is emerging and how prevalent it is, he says. Malaria-control programmes often lack insect-resistance monitoring, and detection of all forms of resistance is not easy. Quick, cheap tests can pick out gene mutations that help the mosquitoes’ nerve cells withstand pyrethroid attack. But other forms of resistance, which depend on increased levels of mosquito enzymes that can destroy pyrethroids before they reach their target, require more complex tests to detect (H. Ranson et al. Trends Parasitol. 27, 91–98; 2011).

But uncertainties about the extent of resistance or its impact are “no excuse for inaction”, says Newman, arguing that the proposed WHO strategy needs to be urgently implemented, and also rolled out preemptively in places where resistance has yet to be detected. The WHO’s plan will recommend, for example, that control programmes rotate insecticides sprayed indoors, using pyrethroids one year and a different class the next. This would be more costly and less effective than relying only on pyrethroids, however, so control programmes may be reluctant to adopt this measure.

Lines says that new combinations of insecticides also need to be developed, so that mosquitoes resistant to one would be killed by the other. In areas where pyrethroid bed nets are used, a different class of insecticides should be used for wall spraying, he adds.

Ultimately, entirely new classes of insecticides — particularly those that can be applied to bed nets — are needed to alleviate the dependence of malaria-control efforts on pyrethroids. For indoor spraying, some longer-lasting and more cost-effective non-pyrethroid insecticides should be available by next year, Hemingway says, although developing wholly new classes will take five to seven years. Repurposed agricultural insecticides might also act as a stopgap were resistance to pyrethroids to develop rapidly. Research targeting mosquito control is “grossly underfunded” compared with that on malaria drugs and vaccines, she adds, which is why control efforts have had so few options to call on.

Malaria: Eliminate or Control?

In Malaria on November 2, 2010 at 11:20 am

The british medical journal Lancet examines the technical, operational and financial challenges that confront malaria-eliminating countries…More

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