News Clippings of the Synthetic Peroxide (OZ) Story 18-23 August

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News Clippings of the Synthetic Peroxide (OZ) Story 18-23 August




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Financial Times (UK)

'BETTER, CHEAPER' MALARIA MEDICINE BEGINS HUMAN CLINICAL TRIALS

Geoff Dyer

Scientists will announce today the discovery of a new malaria medicine that could be more effective and considerably cheaper than the best drugs currently available.

In what could be one of the biggest recent breakthroughs in the treatment of malaria, which has been on the rise in much of sub-Saharan Africa for two decades, the drug has entered the first phase of clinical trials in humans.

Researchers in the US, Australia and Switzerland believe they have developed a synthetic version of the powerful artemisinin malaria therapies, which do not suffer from the resistance problems that other drugs face, but which are too expensive for most patients in developing countries.

Details of the discovery - a goal scientists have been working on for 15 years - will be published in today's edition of the science journal Nature.

"This new class [of drugs] could offer the best solution to date for destroying drug-resistant malaria," said Paul O'Neill at the University of Liverpool.

The drug is the flagship project of Medicines for Malaria Venture (MMV), one of a number of public-private partnerships that have been set up in recent years to foster research into medicines for the developing world, which will then be made available at low prices. The Geneva-based non-profit group backed the research and has a patent on the molecule.

It will also be a big test of the drug development expertise of Ranbaxy, the Indian company that is conducting the development work in partnership with MMV.

Artemisinin-based drugs, which are derived from a plant used for centuries in Chinese herbal medicine, have been available for a number of years to treat malaria. Unlike traditional malaria drugs such as the chloroquines, they have encountered no resistance among patients in sub-Saharan Africa.

However, because the raw material has to be derived from a plant, they are 10-20 times more expensive to make than the older drugs. Moreover, as the drugs are short-acting, patients need regular doses, which can lead to poor compliance.

The scientists behind the synthetic version of the artemisinin drugs come from the University of Nebraska in the US, Monash University in Australia, the Swiss Tropical Institute, and the Swiss drugs group Roche.

If the drug - currently known as OZ277 - makes it through clinical trials, it should be much cheaper to produce than the artemisinin derivatives. The scientists believe the compound is also more powerful than the existing medicines, which could mean patients would need fewer drugs.

Malaria causes 1m deaths a year and is the biggest killer of young children in sub-Saharan Africa. International health organisations estimate that 300m-500m treatments are needed each year for the disease. However, the artemisinin-based drugs are not widely used at the moment in Africa because of the cost.

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The Times (UK)

A sweet pill: A new anti-malarial drug promises more than a cure

In the sad task of getting to grips with a global Aids epidemic, the world’s second most deadly disease has been overshadowed. The World Health Organisation (WHO) estimates that 38 million people worldwide were living with HIV in 2003; almost three million were killed by Aids the same year. Malaria, in contrast, is reckoned to have caused the deaths of a million people last year. It is the number one killer of young children in sub-Saharan Africa, where a child dies of malaria every 30 seconds. As a result of the malaria parasite’s daunting ability to evolve to resist new drugs as they become widely used, the number of deaths from the disease in Africa is on the increase. And those who do not die may well be debilitated.


Yesterday’s announcement from the Medicines for Malaria Venture (MMV), an international public-private partnership aimed at developing and delivering new anti-malarial drugs, is at least some welcome news for that sorry region of the world. Scientists sponsored by MMV have developed a new drug, known as OZ, a synthetic compound which copies the molecular structure of the most effective existing anti-malarial medicine but which, because it is synthetic, will be much cheaper to produce. It is expected to cost less than a single dollar to cure an adult of malaria using OZ, putting the treatment within reach of poor countries in Africa, South America and Asia where malaria is endemic. Tests of the new drug’s efficacy will begin next year and scientists are optimistic about its potential.

OZ also represents a breakthrough of a broader kind: it proves the potential for public-private partnership, in pursuit of a common good, on a global scale. The drug was developed by MMV, a non-profit-making body, in partnership with an Indian pharmaceutical company Ranbaxy. Scientists from the University of Nebraska, Monash University in Australia, the Swiss Tropical Institute and F. Hoffman Roche worked together on the original research. Some two thirds of MMV’s funding comes from the US entrepreneur Bill Gates, via the Bill and Melinda Gates Foundation which has donated $65 million (£35million) over eight years. The UK’s Department for International Development gives £1 million a year. The Rockefeller Foundation, WHO, the World Bank and the Swiss, Dutch and US governments all contribute, as well as the Wellcome Trust, ExxonMobil and BHP-Billiton. The international pharmaceutical industry also participates. Profits from OZ, which are expected to be small, will be split between Ranbaxy and MMV, which will plough the money back into further research.

The dispute over treatments for Aids in the Third World has pitted non-governmental organisations, some worthy, some not, against Western goverments and pharmaceutical companies. The latter, particularly in the US, have been accused of conspiring to keep up the price of Aids drugs in the developing world. American politicians and pharmaceutical industry representatives protest that this conveniently overlooks the fact that research into the Aids-tackling drugs was carried out in the US, at the ultimate expense of American consumers who subsidised a multibillion-dollar project.
The excellent work of MMV has the potential, thankfully, to transform the territory. It proves that where the will, the funding and the right organisational skills exist, public and private, voluntary and philanthropic organisations can successfully be linked to tackle some of the world’s great challenges. It is not only the ravaged peoples of sub-Saharan Africa who should today be celebrating an apparent cure which could prove efficacious in unexpected ways.

Daily Telegraph (UK)

Chairman Mao's secret cure for malaria
By Roger Highfield

(Filed: 19/08/2004)

A synthetic version of a drug used for more than 1,500 years in Chinese medicine is hailed today as a breakthrough in efforts to reduce the million deaths caused each year by malaria.

Treatment based on the Chinese herbal remedy qinghaosu was developed during Chairman Mao's Cultural Revolution but tensions with the West delayed its spread.

Today, derivatives of artemisinin, a compound extracted from sweet wormwood, offer the most effective antimalarial therapy available. Malaria parasites have never evolved resistance to it.

Like all drugs, artemisinin-based drugs have drawbacks: relatively expensive extraction - the plant takes about 18 months to grow; treatment regimens can be too long for the Third World and, although it can quickly kill 96 per cent of the parasites, it has to be combined with longer acting variants to be completely effective.

Dr Jonathan Vennerstrom and colleagues say in the journal Nature they have made a fast-acting synthetic counterpart to artemisinin in which many of those problems have been overcome.

Dubbed OZ, the drug has entered clinical trials on 48 people in Britain. Initial studies suggest it is well-tolerated in healthy volunteers. This new class of drug is "a huge breakthrough," said Dr Paul O'Neill, of Liverpool University.

It is being developed by Ranbaxy Laboratories in India after various studies around the world. Because OZ is a synthetic drug, its costs can be significantly reduced as industrial production is easier.

The drug will be tried on malaria patients in January. The non-profit public private partnership driving drug development, Medicines for Malaria Venture, said yesterday it could become the most potent weapon against drug-resistant malaria, which affects 40 per cent of the global population.

Standard cheap malaria drugs are failing as much as 80 per cent of the time as malaria parasites become more resistant to older drugs, such as chloroquine. Standard cheap medicines are rendered useless in sub-Saharan Africa where every 30 seconds, a child dies of malaria.

Prof Andrew Read, of Edinburgh University, welcomed the advance but added: "There is always great optimism when a new 'wonder drug' comes along yet malaria parasites are extremely adept at evolving drug resistance."


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The Guardian (UK)
New drug boosts world fight against malaria

Treatment mimicking herbal remedy could be biggest breakthrough for a generation in combating disease that ravages Africa



Tim Radford, science editor
Thursday August 19, 2004

A new drug developed in India and based on a herb discovered in China could prove to be the biggest breakthrough in malaria treatment for a generation, scientists say today.

Malaria kills a child every 30 seconds in Africa. Worldwide, it kills more than a million people every year and 40% of the planet is always at risk. Malarial parasites have steadily become resistant to older treatments.

But researchers from the US, Switzerland, Australia and Britain report in Nature today on a synthetic drug that mimics a Chinese treatment called artemisinin, itself based on the herb sweet wormwood or Artemisia annua. Because the new drug is entirely factory made it could be cheaper, more consistent and produced more swiftly than any herbal extracts.

Safety tests on the drug, nicknamed OZ277, have begun in Britain. Tests for efficacy in malaria patients will begin in January.

The drug is produced by a partnership called Medicines for Malaria Venture. Although the research began in Europe and the US, the drug was developed by Ranbaxy Laboratories, a partner company in India.

The announcement was hailed by UK scientists as a major advance. Artemisia has been known as a herbal remedy for 1,500 years, but its value in malarial treatments was first observed about 30 years ago. Artemisinin, extracted from artemisia, is now in frequent use.

It works by killing the parasite - spread by a malarial mosquito - as it circulates through the human bloodstream. But its manufacture is both difficult and expensive.

"This is because the plant takes about 18 months to grow and then the drug needs to be extracted," said Brian Greenwood of the London School of Hygiene and Tropical Medicine.

"This new research has produced a drug very similar to that from plants, but without the time and expense of waiting for the plant to grow and extracting the compound. This should make the drug easier to produce and less expensive."

Sick people cannot work, and often cannot feed themselves. Malaria costs Africa an estimated£6-7bn in lost production, and accounts for two fifths of all public health spending in sub-Saharan Africa. Up to 500 million doses of medicine are needed every year.

ACT, based on artemisinin, is not widely used in Africa because it costs 20 to 30 times as much as the previous drugs. The discovery of a way to directly synthesise this family of compounds could cut production costs and therefore increase the availability of these drugs, and was a major step forward, said Robert Sinden, a parasite expert from Imperial College.

But all scientists sounded a note of caution. Malaria is a clever enemy, and difficult to outwit for long.

"There is always great optimism when a new 'wonder drug' comes along, yet malaria parasites are extremely adept at evolving drug resistance," said Andrew Read, a biologist at Edinburgh University.

"Let's hope the optimism is well placed this time, though history is not on our side.

"But a new drug that works even only in the medium term will save many, many lives and is to be greatly welcomed."

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The Independent (UK)

Ancient Chinese remedy may provide new treatment for malaria

By Steve Connor

19 August 2004

Scientists have created a new treatment for malaria which they believe will result in a cheap, mass-produced drug to fight the disease that kills a million people a year.

The researchers said that the drug was a synthetic version of the active ingredient found in a Chinese herbal remedy for malaria that has already proved an astounding success against the disease. The new synthetic drug will begin clinical trials within six months. Its synthesis in the laboratory will mean that it should be cheaper and more effective than its herbal equivalent, the scientists said.

An international research team made the drug, called trioxolane or "OZ", after studying the chemical constituents of artemisinin, a herbal remedy that has been used for 1,500 years.

Artemisinin is extracted from the sweet wormwood plant and, since the 1980s, has been used as the basis for making modern anti-malarial drugs such as artesunate and artemether. However, these are expensive to make and their effects are short term.

Paul O'Neill, a pharmacologist at Liverpool University, said: "These artemisinin derivatives are increasingly important in the treatment of drug-resistant malaria as they are the most potent anti-malarials available."

So far there have been no signs of malaria developing a resistance to artemisinin.

The Herald (Scotland)
Malaria: why make a killing?

BETH PEARSON

August 20 2004

IN the UK, it is often said there is a postcode lottery for receiving certain health services. In the 41 countries in which malaria is endemic, there isn't even a lottery: nearly everyone's a loser.


Malaria kills an estimated 2.5 million people a year, the majority of these African children aged below five years old. While western pharmaceutical companies have invested approximately £11bn over the past decade in "lifestyle drugs" for impotence, weight loss, baldness, smoking and ageing, the product development budget for the Tropical Disease Research (TDR) programme, a joint effort from the World Health Organisation (WHO), World Bank, and United Nations Development Programme (UNDP), averages £6m per year.

The victims of malaria and other neglected tropical diseases aren't living in the wrong area; they're just poor. It would be impossible for the drugs companies to make a profit in African and Asian countries where the average wage can be as little as £1 per day and, in Africa, economic growth is slowing by 1.3% per year as a direct result of malaria alone. As a result, research into tropical diseases by the pharmaceutical companies themselves is estimated to account for no more than 1% of their budget.

The new generation of malaria treatments, however, may circumvent the large pharmaceutical companies altogether and a new centre opening at Dundee University next year will be in the vanguard of such research.

The publication yesterday of a report detailing the development of a new malaria drug modelled on artemisinin, an extract from the Chinese sweet wormwood herb, demonstrates how scientists working in the field of tropical disease have been forced to innovate if they are to see their research become reality. The drug, known as OZ277 and developed by the Medicines for Malaria Venture (MMV), is a synthetic version of an existing treatment which can be made more cheaply and quickly than its mother drug. It has now entered human trials in the UK and will be tested for efficacy in malaria patients early next year.

From the very beginning, the pharmaceutical industry had little, if any, input in the drug's development. Dr Christopher Hentschel, chief executive of MMV, says that a number of pharmaceuticals were interested in the early stages of the project, which was funded by the TDR. "In terms of pharmaceutical industry interest, essentially there wasn't any because malaria isn't commercial," he says. "The idea has a history which involved a number of pharmaceuticals including Roche. They were interested and supported some of the work at an early stage but, basically, they just did it on the side with interested scientists."

When the project reached the stage of clinical development, it was decided that a pharmaceutical manufacturer should become involved. Rather than approach one of the major companies that were initially interested in the drug, however, the MMV team looked for a generic drugs manufacturer which could produce large quantities of the drug at a low cost. They began a partnership with Ranbaxy, the largest pharmaceutical company in India and one of the top 10 generic drugs companies worldwide, three years ago.

MMV's operation exemplifies how drugs for neglected diseases can be developed in the absence of major investment. It is a public-private partnership, which aims to make diseases like malaria more commercially-viable for private investors. This may involve emphasising the market for anti-malarials among western travellers, who are increasingly visiting destinations where malaria is a risk, offering tax credits, reducing research costs through grants or showing that there is considerable public support for a cause.

"The organisation was founded through discussion between the WHO and the representative body of the research-based pharmaceutical industry, the IFPMA (International Federation of Pharmaceutical Manufacturers' Associations), which is like a trade association," says Dr Hentschel. "They said they were willing to work on these kind of problems provided there was a public-private partnership involved in the management and helping fund the projects, because they obviously didn't want to be involved in funding all the projects themselves as they would never get any return on that funding.

"It's much better than what was before, which is almost nothing. Now the funding is shared between the public sector and the private sector. It's certainly a model which works and that's a significant advance on what we had before."

Well-funded research and development of anti-malarials is vital because malaria parasites constantly mutate and become resistant to treatments (Celtic player Bobo Balde, for one, missed Saturday's match thanks to malaria). The growing prevalence of the drug-resistant malarial strain P falciparum, is a particular concern to the WHO and the pressure to find new drugs combined with the lack of interest from pharmaceutical companies has increasingly frustrated scientists.

It's this frustration that has led one Scottish university to go it alone. When the £17.5m Centre for Inter-disciplinary Studies opens at Dundee University in July next year, it will circumvent the major pharmaceutical companies entirely, and therefore revolutionise the way drugs are developed. It is thought to be the only British university to adopt such an approach. Usually, profitable drug "leads" are picked up by pharmaceutical companies from the academic research stage, but this isn't the case with tropical diseases. It's something Mike Ferguson, professor of molecular parasitology, knows only too well. "Other areas of research are very often picked up by the pharmaceutical industry because they see a nice profitable market at the end of developing it through to a medicine you can sell to patients," he says.

"What goes wrong in tropical disease is the industry looks at the marketplace and sees there'd be no profitable market for it, therefore they don't do it. Rather than sitting and wringing our hands about the situation, we've decided to do something about it."

Once the Dundee team has taken the drug to this stage, they will present their work to the TDR, which will put it through the clinical trial phase. "In the normal drug development world, clinical trials are a very expensive and time-consuming component of drug development," says Professor Ferguson, whose department researches African sleeping sickness and Chagas's disease as well as malaria. "Clinical trials in a tropical disease context are somewhat less expensive, not because they're done to lower standards, but because they're being conducted in endemic tropical countries where salaries of doctors and nurses are lower, the logistical costs of carrying out these kind of tests are lower and you don't have to handle any marketing costs."

Without the huge burden of trial and marketing costs, public-sector academics can develop the research to the point that it can be picked up by the WHO. "That's what we're hoping to achieve. It's pretty revolutionary. I wouldn't say we're the only show in town worldwide, but the number of places taking this kind of approach is pretty small."

Like MMV, the drugs developed by Ferguson and his team would be manufactured at low-cost generic drug factories in Africa and Asia, not by big pharmaceutical companies.

It is expected the process will take 10 years from the point of developing drug to clinical trial standard and then from clinical trial phase to manufacturing.

Hentschel welcomes Dundee's approach: "The Dundee model is about getting early stage opportunities, and that's very important and very valuable. All I can do is wish it the best of luck. We need as many of these things as possible."

Ferguson envisages a cottage industry of small-scale pharmaceutical companies producing low-cost treatments for tropical diseases. Others, such as Philippe Kourilsky of the Pasteur Institute, imagine a "global, not-for-profit pharmaceutical industry". In the long term, Medicines Sans Frontieres have said the public need to take more responsibility for healthcare, with pharmaceutical industry moving out of private and into public sector.

For Hentschel, the motivation will be an ethical one but the solution a practical one. "There's a strong feeling among scientists that this ought to happen," he says. "The problem is to find an organisational methodology that will allow it to happen. The pharmaceutical industry itself will


not do it. The public sector, which is interested in it, cannot do it, because it doesn't have the resources and skills. Somehow you've got to get the two together."
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The Scotsman (Scotland)

Drug Breakthrough in Malaria Fight

By Louise Barnett, PA News

A new drug based on an ancient Chinese remedy could revolutionise treatment of malaria.

Clinical trials are under way in the UK to test how effectively it combats the increasingly drug-resistant malaria parasite.

The drug is a synthetic, simpler version of a traditional Chinese cure which could be around five times cheaper to produce than other treatments.

Malaria kills around one million people every year and causes a further 300 million to fall sick.

Drugs based on the Chinese remedy artemisinin have already been developed as a means of tackling chloroquine-resistant strains of the parasite.

Called RBx-11160, the new drug is a simpler, synthetic and slightly altered version of artemisinin, according to a report in Nature magazine published today.

Developed by the non-profit organisation Medicines for Malaria, the drug is soluble and can be given orally or injected intravenously.

In tests already carried out on infected mice, between 95% and 100% of parasites disappeared within four days following treatment with the new drug.

This compares with conventional artemisinin drugs which take a week to clear 95% of parasites.

The new drug entered clinical trials in Britain last month.

Malaria researcher Paul O’Neill, from Liverpool University, said: “This is potentially extremely important.”

Mr O’Neill said that, if the drug was found to be effective, it would probably be given to patients in combination with a second drug.

“The parasites find it more difficult to develop resistance when bombarded by two drugs targeting multiple pathways,” he said.

Malaria can be contracted by those who live in or visit around 100 countries across the tropics and subtropics, with about 40% of the world’s population at risk.

Some 90% of deaths from malaria happen in sub-Saharan Africa – mostly among young children. Malaria kills an African child every 30 seconds.

There are four main types of malaria, which are all spread by mosquitoes.

The main symptoms are high fever, chills, headache and sickness and the illness is often mistaken for flu.

RBx-11160 was produced in collaboration by three academic groups and three biotechnology firms, according to Nature magazine.




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