Generic Malaria Drug Approval Granted to Glenmark Pharmaceuticals

The United States Food and Drug Administration (FDA) has granted Glenmark Pharmaceuticals final approval to sell a generic version of GlaxoSmithKline (GSK) malaria drug Malarone.

In April 2010, Glenmark settled a patent litigation with GlaxoSmithKline over atovaquone and proguanil hydrochloride 250 milligram/100mg tablets–the generic version of Malarone.

The Indian company can sell the generic tablets under a royalty-bearing license from GlaxoSmithKline in the third quarter of 2011, or earlier under certain circumstances.

KAM

January 17, 2011January 17, 2011

Global Action on Malaria Resistance Urgent, WHO

The WHO has launched a worldwide ‘call to action’ to governments, agencies, researchers and non-governmental organisations over the malaria parasite’s growing resistance to the most potent weapon against it — the drug, artemisinin.

If recently discovered resistance spreads, said the WHO, the formidable successes of anti-malaria campaigns in recent years will be threatened. Artemisinin lies at the heart of malaria treatment worldwide and has no obvious successor.

“The consequences of widespread resistance to artemisinins would be catastrophic,” WHO director-general Margaret Chan told a press conference held after the launch of the ‘Global plan for artemisinin resistance containment’ yesterday (12 January).

“We need to maintain this medicine. What is at stake it is not just the goals on malaria but, frankly, the whole related Millennium Development Goals”, said Robert Newman, director of the WHO Global Malaria Programme.

Resistance to artemisinin was identified in the Plasmodium falciparum parasite on the Cambodia–Thailand border in studies conducted between 2001 and 2009. It is now reported in other areas of the Greater Mekong Subregion and some fear that the resistance will spread to Africa, where most malaria deaths occur.

GPARC calls for increased surveillance of resistance and improved access to diagnostics and treatment with artemisinin combination therapies (ACTs), and for more research on topics ranging from new methods for containing resistance to mathematical modelling of its spread.

“We don’t have all the knowledge and tools we need,” said Newman, adding that finding a quick way of testing for resistance should be a priority.

“We need a molecular marker for drug resistance that will allow us to know much earlier where this problem may be emerging.”

“The research community must be engaged in the development of new classes of antimalarial medicines that would not fall into the same trap of resistance that we have with ACTs,” he added.

But it will not be easy to pin down the parasite’s genes responsible for resistance, according to Pascal Ringwald, coordinator of the drug resistance and containment unit of the WHO Global Malaria Programme.

“It took 30 years to find the gene related to chloroquine resistance,” he told SciDev.Net. “There are thousands of mutant genes in the parasite and the problem is to find which mutation could be related to artemisinin resistance.”

“Now we have better molecular tools,” he said. “I don’t think it’s going to take another 30 years, but it is very difficult and also very expensive.”

Call for action also aims to bring in new funds to bridge the estimated US$175 million funding gap for the project. So far, the UK’s Department for International Development (DFID) has agreed to fund a project to improve surveillance and map the extent of resistance.

January 13, 2011January 16, 2011

Glaxo Malaria Vaccine Cuts Risk by Half

for at Least 15 Months, Study Says

By Simeon Bennett – Jan 13, 2011

GlaxoSmithKline Plc’s experimental malaria vaccine, already shown to cut the risk of children contracting the disease by half after 8 months, was equally effective after 15, a study showed.

Youngsters in Africa who got the shot, called Mosquirix, were 46 percent less likely to contract malaria than those who received a rabies vaccine, according to the study published in the journal Lancet Infectious Diseases.

The findings suggest the London-based drugmaker may have succeeded where others have failed in developing the world’s first effective shot against the deadliest mosquito-borne disease. Glaxo expects to have the results of final-stage trials by late this year or early next, Chief Executive Officer Andrew Witty said in October.

“We’ve never had a malaria vaccine get this far in its development and continue to show such promise,” Robert Newman, director of the World Health Organization’s Global Malaria Programme, said in a telephone interview today. “It’s promising and encouraging.”

Malaria infected about 225 million people and killed about 781,000 in 2009, mostly children in sub-Saharan Africa, the Geneva-based WHO said in December. That makes it the world’s third-deadliest infectious disease behind AIDS and tuberculosis.

Researchers including Philip Bejon, from the Kenya Medical Research Institute in Kilifi, Kenya, tested the vaccine on more than 800 children between ages 5 and 17 months in Tanzania and Kenya. The children either received a rabies vaccine or Mosquirix with a so-called adjuvant designed to boost the effect.

New Analysis

An initial analysis, published in December 2008, showed the vaccine cut the number of children infected with malaria by 53 percent after 8 months. The new analysis found “no evidence of waning efficacy,” Bejon and colleagues wrote.

The most common adverse events were pneumonia, fits with fevers and stomach inflammation, with fewer events reported among children who received the malaria vaccine compared with those who got the rabies shot. The researchers are now studying the vaccine in 15,000 infants in seven countries.

Glaxo expects the cost of the vaccine, if successful, to be “the lowest practical cost sustainable over time,” Witty told reporters on a conference call in October. The drugmaker will “price it at the cost of manufacturing, with only a very small return, around 5 percent,” which Witty has pledged to deploy in research for more treatments of neglected tropical diseases.

The study was funded by Glaxo and the Bethesda, Maryland- based PATH Malaria Vaccine Initiative, which is in turn sponsored by the Bill and Melinda Gates Foundation, the world’s richest charity.

Assuming results of the next trial are positive, Glaxo plans to seek regulatory approval for the shot in Europe, Stephen Rea, a spokesman, said in a telephone interview today. The WHO wants to wait for data on the effectiveness of the vaccine after 30 months, due in 2014, before it makes a policy recommendation on the vaccine, Newman said.

To contact the reporter on this story: Simeon Bennett in Singapore at sbennett9@bloomberg.net

January 10, 2011January 14, 2011

President Jonathan, I Can Hear You

Last week President Goodluck Jonathan of Nigeria presented what he referred to as “the plans” that his administration will be implementing in 2011.

The President posted on his Facebook page what he anticipates the budget to help Nigeria to accomplish. Among the many things he said, the one that interests me most is what appears to be Mr. Jonathan’s commitment to fight malaria.

This is what he wrote:

“As part of the budgetary allocation to the health sector are funds to establish scientific research institutes that will focus on areas that directly impact health care in Nigeria such as HIV, Malaria, Cholera, sickle cell anemia and Cancer.”

He said he will work with his administration to tap the creativity of Nigerian scientists in solving the country’s greatest health challenges because

“some of these diseases are peculiar to Africa; they may not be a priority to the research institutes of governmental and private pharmaceutical research industries of the West.”

I could not agree with the President any more. One of our goals at talkafrique is to promote the idea that African problems must be solved by Africans and also that politics must be about problems and solutions and not just signboards and slogans. As Gen. Collin Powell said,

“You can’t just have slogans; you can’t just have catchy phrases. You have to have an agenda”

I believe on this, President Jonathan is on the correct path.

Malaria was eradicated in the US and Canada about 5 to 6 decades ago. It is laughable for us to expect American corporations to focus on malaria research and development in such challenging economic times while such efforts could be expended in the development of drugs that target erectile dysfunction. Malaria, like some other diseases, is referred to as a ‘Neglected Disease’ for a reason. No financial consultant or market analyst will encourage a client to borrow money to develop anti-malaria drug, except on humanitarian grounds. We salute the few companies that continue to screen for anti-malaria drugs and vaccines.

To us as Africans, malaria is a pressing issue. A child dies of malaria every 30 seconds in Sub-Saharan Africa. This is not just statistics

I hope that President Jonathan will stay true to his word. I will be checking his Facebook wall for updates. I will also be watching very carefully for what the Presidents of Ghana, Togo, Kenya, Botswana and the rest of our leaders have to offer.

Thanks for reading

December 30, 2010January 3, 2013

The fight against HIV/AIDS needs a pragmatic approach (update)

K. Amponsah-Manager

On December 14 2010, the World Health Organization (WHO), the UN agency which over ten years ago started a campaign to cut the number of malaria cases and deaths in half by 2010, reported that Malaria is fast declining in countries where it had been endemic. The report was surprisingly optimistic that we could have a malaria-free world by 2015!

The progress on the malaria front did not come by wishful thinking; it was the result of pragmatic efforts on the part of governments and various organizations. In the past three years alone, 578 million people at risk of malaria have been provided with insecticide-treated mosquito nets. Another 75 million have benefited from indoor residual spraying, the report said.

While such a report gladdens our hearts, it should also remind us of the twin brother HIV/AIDS.

Significant efforts have been expended in combating the spread of HIV with some results to show already. However, it is believed that what has been achieved is minimal compared to what is possible if the energy already spent was used to do the right thing most of the time.

There is the popular notion that HIV is caused by people doing stupid things, and some even think it is a curse for our disobedience of natural laws. Surely, there are some who are living with the virus as a result of doing stupid things, but that is just part of the story. In any case, such perception does nothing to save the millions who continue to contract the virus each year. Some of them are our brothers, sisters, uncles, and our teachers.

Rather than perpetuating the stigma associated with AIDS, I will suggest it is time we spend that energy to discuss how to curtail the rate of spread of the killer and save lives of mothers, fathers, and infants, some of whom have to live with the parasite for no fault of theirs.

There are practical ways that work and those are what we need to focus on. I’ll mention only two here for the sake of space.

Case 1: Sharing needles by drug users: The consequences of the use of illicit drugs on the health of our citizens and the effect it has on our economies and health care system are well known. The practice can therefore never be condoned or encouraged

But the reality is that people will continue to abuse drugs. Several studies have established that the sharing of needles by drug users is a significant avenue for contracting the HIV.

The approach here has to be two fold. The first is a continued education on the consequences of sharing needles which I believe is already well known. The second I think should be an effort on the parts of governments and foundations to consider providing accessible avenues by which the addicts can obtain clean needled when the lust for the substance is uncontrollable. They will continue to use the drugs anyway, but why should we look on while such acts continue to overburden the already stressed health and economic structures and continue to add to the AIDS statistics.

Case 2: Laboratory and epidemiologic studies have shown that even though condoms are not 100% HIV/AIDS-proof, the use of condoms in sexual intercourse reduces the risks of HIV infection significantly. We would wish that people will abstain from sex until they’re in a committed relationship, but the reality is that this approach will not work for all. The truth is that HIV is acquired by having unprotected sex with someone carrying the virus, and not just by having sex.

The massive campaign to encourage the provision and use of mosquito nets is yielding results with the possibility that we could have a world without malaria in less than a decade. It’s time to do same for AIDS.

The campaign to encourage people to stay away from sex until marriage or until they’re in a committed relationship should continue. However, this weapon will work for only a fraction of the population. It is time to be practical and tell people in a plain language that if you cannot abstain, then they should simply cover it.

Even though, it may be appear rather radical, I may suggest that Governments, Non-governmental Organizations (NGOs) and foundations working on HIV/AIDS in Africa should consider making condoms (both male and female condoms) available for free to prostitutes (at least, until a solution is found to the problem of prostitution).

Given the choice, I’ll rather opt to use our scarce national resources to do that which will produce tangible and measurable results.

To the toddler taking care of a sick single HIV/AIDS parent, the issue here is not just statistics, it is life.

Let us learn from the anti-malaria campaign.

(To learn more on Condoms and HIV, click here)

December 27, 2010January 19, 2011

What Americans percieve as Africa’s serious problems, Gallup poll

Six in 10 say malaria a very serious problem in Africa

A recent Gallup survey finds that roughly 6 in 10 Americans say malaria is a very serious problem in Africa right now, but they are much more likely to view HIV or AIDS and poor nutrition as very serious problems for that continent. When asked more broadly about the seriousness of malaria worldwide, significantly fewer Americans, only about 3 in 10, consider it a very serious problem, ranking it at the bottom of a list of global health conditions that includes HIV or AIDS, cancer, poor nutrition, and tuberculosis. Democrats are more likely than Republicans to say malaria is a serious health problem in both Africa and around the world more generally.

Overall Results

HIV or AIDS and poor nutrition are, by far, perceived as the most serious health conditions in Africa right now, of the five tested in the poll. Nearly all Americans, 96%, say that HIV or AIDS is a very serious problem in Africa, and 88% say poor nutrition is a very serious problem. A smaller percentage of Americans, but still a majority, say malaria (62%) and tuberculosis (53%) are serious problems facing that continent. Only 30% say cancer is a serious problem in Africa.

On a worldwide basis, at least 8 in 10 Americans say HIV or AIDS, cancer, and poor nutrition are very serious problems around the world right now. Americans perceive tuberculosis and malaria to be less serious problems, with only 31% saying tuberculosis and 28% saying malaria are very serious problems in the world.

The public is almost three times more likely to say cancer is a more serious problem around the world (87%) than it is in Africa (30%). Conversely, Americans perceive malaria (62% vs. 28%) and tuberculosis (53% vs. 31%) to be much more of a problem in Africa than in other parts of the world. Americans are equally likely to say AIDS and poor nutrition are serious problems in the world and in Africa.

December 17, 2010December 18, 2010

“Sleeping beauty’ and societal implications

The key to looking attractive and healthy is simpler than you will imagine: it’s all in a ‘good sleep’, a new scientific research suggests.

The idea of ‘beauty sleep’ was an ancient myth but now experts say they have uncovered the first scientific backing for the concept.

The team of researchers from the Karolinska Institute in Sweden, recruited 23 healthy adults aged 18 to 31. The volunteers were photographed after eight hours sleep and again after being kept awake for 31 hours.
The photographs were standardised, meaning the people were the same distance from the camera, wore no make-up and wore the same expression.

The pictures were then presented in a random order to 65 untrained observers. The observers were asked to rank the participants on a scale according to how healthy, attractive or sleep-deprived they looked.

The results: The observers scored the sleep-deprived participants as less healthy and less attractive while the volunteers who had adequate sleep were ranked the opposite: healthier and more attractive.

The result is published in the British Medical Journal.

Conclusion: Humans are sensitive to sleep-related facial cues, with potential implications for social and clinical judgments and behavior.

My personal commentary:

Whether it is the University student’s apprehension about a pending examination, or the petty trader’s anxiety about the economy, sleep debt is a major problem in most hard-pressed economies such as those in Africa.

If not dealt with, an escalating sleep debt can result in fibromyalgia syndrome, also called chronic fatigue syndrome. This syndrome leads to prevalent pain and fatigue of just about any muscle in the body. Usually, it brings about other forms of psychological conflicts like depression disorders.

In fact, losing sleep can even have negative consequences for your heart health. Heightened risk of cardiovascular diseases and mortality has been associated with sleep debt.

What you can do:

Spread the word. Help your people.[ad#Adsense-200by200sq]

December 16, 2010January 8, 2011

Text messaging to combact malaria

Mobile phones could soon be helping re-assure Nigerians and Ghanaians they are getting genuine medicine.

A pilot scheme in the two nations has begun putting unique scratch codes on more than 500,000 medicine bottles and packets of pills.

When the code is texted to a free phone number, a return message will reveal that a drug is genuine.

The scheme hopes to boost efforts to tackle diseases such as malaria and combat the rise in fake medicines.

Security alert

About 700,000 people suffering from malaria and tuberculosis die every year around the world because of fake drugs, suggest statistics from think tank International Policy Network

Globally, about 10-15% of all drugs are believed to be fake but in some parts of Africa this rises to 50%. The problem is made more acute in Africa because some fake medicines being offered to the sick are watered down versions of the real thing and dent the efficacy of the full strength drug.

“Some genuine medicines have lost their potency because of the counterfeiting,” said Gabriele Zedlmayer, a spokeswoman for HP which is a partner in the labelling scheme.

Fake pills are a big problem in Africa where diseases such as malaria are endemic

This can be a particular problem with malaria as the disease is so widespread in sub-saharan Africa where it is the leading cause of death.

The scheme is being backed by governments and drug companies who have pledged to publicise how it works in pharmacies, surgeries, hospitals and community centres.

Painkillers, anti-malaria drugs and amoebicides from pharmaceutical firms May & Baker in Nigeria and Kama in Ghana will be the first to get the scratch-off labels.

Such a scheme was very important in Africa where about 80% of medicines are generic, said Bright Simons, founder of mPedigree which developed some of the technology to underpin the pilot.

By using the codes, people would get to know pharmacies, hospitals and other outlets they can trust, he said.

Mobiles were the best way for people in Nigeria and Ghana to find out about their medicines because they were so ubiquitous said Mr Simon, adding that even those who do not own a handset themselves can get access via friends and family.

Each packet or bottle has a scratch-off code that can be used only once, said Mr Simons. The security system behind the scenes flags any attempt to re-use codes. As well as letting people know they are getting genuine medicine, it will also alert people when fake medicines are being peddled.

If the pilot proves successful, the scheme will be extended to cover more than six million bottles and packets in the next 12 months.

“This is just the first step,” said Ms Zedlmayer. “It can be applied to any kind of medication.”

(Story by BBC)

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