Results tagged “malaria”

World Malaria Day: Why It Matters in the US

WorldMalariaDayMumBabyNet315.jpgOver the last five years, we've seen that scaling up existing malaria control interventions--bed-nets and anti-malarial treatments--leads to dramatic reduction in the burden of the disease in some countries and eradicating it completely in others, and with our malaria vaccine candidate in late stage development there is much to be optimistic about. So it is timely that World Malaria Day happens smack in the middle of World Immunization Week!

 

For most of us who were born in the US, there is no first-hand knowledge of malaria, but that doesn't mean we shouldn't care about it.  It used to be a problem, especially in warmer parts of the Lower 48. Thankfully, a well-coordinated effort eliminated it in the US in 1951.

 

Because despite recent successes, half the world's population remains at risk of malaria and it still kills almost 655,000 people every year--mostly young children in sub-Saharan Africa. One of our researchers recounted a trip where he saw "children's lives hanging by a thread, mothers waiting anxiously for news of their child's survival, communities suffering from the loss of another life, over-burdened hospitals and over-worked doctors making tough decisions, not about how to treat but who to save." 

 

We won't tackle malaria by adopting a business-as-usual approach. This is why our program is not only about ensuring access to existing interventions, it's about continuing to invest in innovation and science to ensure we are playing our part in supporting the theme of this year's World Malaria Day: Sustain Gains, Save Lives, Invest in Malaria.

 

GSK and the PATH Malaria Vaccine Initiative (MVI), together with prominent African research centers, have partnered to develop a malaria vaccine candidate, known as RTS,S.  RTS,S which is currently in a Phase III trial, is the world's most clinically advanced malaria vaccine candidate.  If licensed and approved by the World Health Organization (WHO) it will be used exclusively for children in sub-Saharan Africa who suffer the greatest burden of disease.  A vaccine, if approved, would be an important component of a comprehensive malaria control program which already includes bed nets and anti-malaria medicines.

 

We're committed to making this vaccine candidate available to those who need it most.  The eventual price of RTS,S will cover the cost of manufacturing the vaccine together with a small return of around 5% that will be reinvested in R&D for second-generation malaria vaccines or vaccines against other neglected tropical diseases.

 

We're also working in partnership with other organizations to increase the availability and uptake of preventative measures and improve management of malaria, particularly for young children and pregnant women. This includes providing our anti-malarial medicines at deeply discounted prices in LDCs and sub-Saharan Africa to ensure access for as many people as possible.

 

In communities in Tanzania, Ghana, Nigeria, and Kenya, we're working with partners and with national malaria control programs to help build capacity of community health workers and mobilize families to become the frontline in the fight against malaria.

 

Up next...polio, a great example of a successful combination of public health policy and sound science.

New Promise in the Malaria Pipeline

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GlaxoSmithKline has not shied away from discussing the progress we've made towards finding preventative measures and treatments for neglected tropical diseases such as malaria.  We've also been quite vocal about our intention to stimulate new research in this area through open innovation.  As the latest step in our commitment, today we have published new research in Nature.   It is a seminal piece of work identifying promising potential leads to develop new medicines to treat malaria. The research comes from a year-long screening of more than 2 million compounds in GSK's chemical library to seek out those that could inhibit the parasite, P. falciparum, the most deadly strain the malaria. 

 

I believe the Nature editorial comment describing GSK's decision to place this information in the public domain as "momentous" is very close to the mark. It is certainly a big step for GSK to have reached this milestone as part of our commitment to open innovation in this area.  I think it is also momentous as it could mark a change in how we approach research for neglected diseases.  We hope other pharmaceutical companies and institutions will follow our lead. 

 

Malaria is a devastating disease. Every 30 seconds a child dies from malaria, and in 2009, there were 243 million cases reported causing nearly one million deaths, mostly among African children. The best available treatment - particularly against P. falciparum - is a combination of drugs known as artemisinin-based combination therapies (ACTs). There are no effective alternatives to artemisinins for the treatment of malaria either on the market or nearing the end of the drug development process. Medicines that are used are inadequate for treatment and are dogged by problems of resistance.

 

There is a long road ahead in drug discovery, but GSK hopes that by putting 13,500 'hits' from our screens that may have potential activity against malaria into the public domain, both  online and available free of charge, we can stimulate new ideas and approaches that could lead to better treatments.  Specifically, the data will be available on three Web sites commonly used by researchers.  Realistically, only a small percentage of these compounds may prove fruitful, which is characteristic of the whole nature of drug discovery. The compounds might suggest a new way to target the malaria parasite, or they could just help in identifying a metabolic pathway that could be altered to negatively impact the malaria parasite. 

 

What is certain is that GSK does not have all the ideas and that is why this is such an exciting step. I hope that sharing this data will create a wave of interest and activity that will set us on the path to finding new treatments. It would give us all immense satisfaction for the next treatment to come from these 13,500 hits but if it doesn't, it may well come from their legacy of a new way of working which will have enormous benefits to society.  

 

Photo courtesy of Alfonso Esteban.

World Malaria Day

mosquito.jpgThis weekend the world observed World Malaria Day, an opportunity to focus international attention on the epidemic and review progress in the fight against the disease.

 

As someone who grew up in Nigeria in West Africa, I experienced malaria as a normal part of childhood.  Malaria was everywhere in my community, as common as the flu is in the United States.   But unlike the regular seasonal flu shots we are accustomed to here, we essentially waited for malaria to strike and then were left to treat it. 

 

My siblings and I are all incredibly allergic to quinine--formerly the main ingredient in malaria medicine--so our family spent a lot of time and energy on malaria prevention.  Most nights we could be found sealing all the windows and doors of our bedrooms and spraying our rooms with heavy-duty mosquito repellant. We would then wait for about half an hour or so for the fumes to dissipate before heading off to sleep. 

 

Despite our nightly efforts--combined with the mosquito nets and screen doors we had all over our home--we all managed to contract malaria.  One of my younger sisters, Mimi, says "I spent my entire childhood with malaria!" This is a slight exaggeration but she did have malaria quite frequently!  The effects of malaria were a high fever, achy joints, chills, lethargy, and loss of appetite which lead to weight loss.  However, we were the fortunate ones.  Our mother worked in healthcare, and our aunt is a doctor.  That meant that we had an easier time accessing medical care, and we often received special attention.

 

The average person living in Sub-Saharan Africa is not as lucky.  Each year there are more than 800,000 malaria deaths in Sub-Saharan Africa alone, and more than 900,000 globally. 

 

This is why I am so proud to work for a company with such a strong commitment to malaria research. 

 

GSK has invested more than $300 million and two decades developing a malaria vaccine, now in advanced testing across 11 sites throughout Africa.  We join a consortium of world-class African research institutions leading this trial on the ground and together we are more than halfway to our projected enrollment of 16,000 children and infants.  Our partnerships--with the PATH Malaria Vaccine Initiative, incredible African researchers, and local communities across Africa--are the key factors in our progress.

Additionally, my colleagues across the company are working on exciting initiatives to spur research into new drugs across the globe; develop unique partnerships to speed our R&D efforts; and partner with communities to promote education about malaria prevention.

 

To address the growing resistance to current malaria treatments, GSK works in partnership with Medicines for Malaria Venture to research new therapies. In addition to our own drug R&D program, GSK helps to advance the work of other researchers in the field. After scanning more than two million drug compounds in our library, we found 13,500 that could potentially inhibit the malaria parasite. In January 2010, GSK made these compounds freely available in the public domain to researchers around the globe.

 

We also work with local communities through our Africa Malaria Partnership program to prevent and treat malaria in sub-Saharan Africa. The organizations we partner with on-the-ground promote the use of existing interventions such as bed nets, insecticide spraying and existing treatments.

 

When I was a child, there was no such thing as World Malaria Day.  Now, as the world pauses and calls out for continued commitment in the fight against malaria, we can say that we are well on our way to developing new tools to answer that call.

  

Listen to GSK CEO Andrew Witty on BBC this weekend to mark World Malaria Day.

The Decade of Vaccines

Thumbnail image for Jean Stéphenne.jpgRecently, Bill Gates injected new energy and resources into the immunization field with an unprecedented pledge of $10 billion through 2020 for vaccine development and delivery.

 

This month, the blog for ONE, a grassroots campaign and advocacy organization cofounded by Bono and other campaigners, is featuring a series, "Vaccines: The Next 10 Years."

 

Check out what Jean Stephenne, President, GSK Biologicals, had to say about the three conditions needed to truly succeed over the next 10 years.

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GSK is one of the world's largest suppliers of vaccines. Eighty percent of all the vaccine we produce goes to developing countries. Forty percent of all the vaccine we produce is supplied to GAVI.  And over the past year, we became the first company to have WHO prequalified vaccines for pneumococcal disease, rotavirus and H1N1 pandemic flu.

 

Pneumococcal disease is a great example of partnership. GSK is likely to be the first company to supply the $1.5 billion Advanced Market Commitment. The AMC is the largest financing mechanism ever designed for a single vaccine and will dramatically increase sustainable access to pneumococcal vaccines with prices at a fraction of the cost paid by industrialized nations.

 

And the public health benefit will be incalculable: it's a little known fact, but pneumonia kills more children than AIDS, malaria and TB combined.   

 

We are also--importantly--on the cusp of completing the world's first malaria vaccine, which is now in late-stage trials in seven African countries. Of course we don't actually have a registered vaccine yet, and we are in no way taking anything for granted. But that doesn't mean we shouldn't be thinking now about how we ensure this vaccine--should it make it--gets to all those that could benefit from it.

 

Each time we have a new vaccine we try to ensure the widest possible access by using tiered pricing--where the poorest countries pay the least. As a result, vaccines in the world's poorest countries are typically a fifth--or less--of the price in industrialized countries.  So far GSK has invested $300 million in R&D for this vaccine. Our partner, PATH Malaria Vaccine Initiative, has invested a further $200 million.

 

The dilemma we face is this: unlike virtually every other vaccine there is no rich market for our potential malaria vaccine--tiered pricing simply doesn't apply.  So we cannot apply our normal model. It's a unique problem and requires a unique solution. One that is sustainable and incorporates responsible pricing.  Let me describe the principles of how we will price this vaccine.

 

First, it must be sustainable to allow for continued investment in high quality manufacture and follow on R&D.

 

Second, we must also ensure that we do not do anything which would discourage other companies from entering into this field. If we set a precedent of not-for-profit we could discourage others from doing research into malaria or other neglected tropical diseases.

 

We want to avoid that. But we want to be responsible too. That's why what we will do is set a price which covers our costs and generates a small return.  A small return, all of which will be ploughed back into R&D for next-generation malaria vaccines and vaccines against other neglected diseases.  In addition to this price commitment we are also committed to donating at least 12.5 million doses of vaccine to PATH.

 

Whatever the price, what we need is a partnership with donors and recipient countries to ensure access to all those that could benefit.  We should be looking now to build on the fine example of the AMC for pneumococcal vaccination.

Reinvesting in the Least-Developed Countries

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At GSK, we have a proud history of working with communities in the world's poorest countries and helping them address their healthcare challenges.  As I mentioned yesterday, we are committed to reinvesting 20% of profits made in the LDCs back into the LDCs.

 

Yesterday I gave a speech at the Council on Foreign Relations, where I discussed four new community malaria projects in Africa worth approximately $2 million.  All these projects involve working with NGOs, in partnership, to address healthcare needs at the community level.

 

NGOs like AMREF, Family Health International, Planned Parenthood Federation, and Save the Children who will work with communities in Tanzania, Ghana, Nigeria and Kenya. At the heart of all these programs is the training of healthcare workers and educational programs to teach parents and children how to minimize the risk from Malaria. 

 

But we're not only focused on malaria. We are looking to support projects with partners like WHO and the Ministry of Health in Zambia, where we are working to reduce maternal, neonatal and under-five mortality.

 

To truly understand patients and disease we need to be engaged at the patient level--both physically and emotionally. That is why we are involved in these projects. By working with NGOs like AMREF we learn valuable lessons about disease and patients and diseases, and how we can play an ever more valuable role in addressing healthcare needs on the ground. 

 

We also work with NGOs in LDCs--and around the world--by sending employees to share their expertise through our PULSE program.  Employees in the program are given 3-6 months away from their jobs to help organizations on the ground to make a positive impact in the community. 

 

These individuals will come back with new ideas, energized and motivated, which will help us be better and more effective in the future.  This is not just philanthropy. Healthcare is our business and our mission.

The Open Innovation Strategy

Witty.gifFor GSK to really embrace open innovation, we must first be more open with our intellectual property. Last year, we announced that we would put 800 patents and patent applications into the public domain--commonly known as a 'patent pool'--to help the search for new medicines for neglected tropical diseases. Since we made that announcement, one small company, Alnlyam, has joined us. We hope others will join--and not just companies, but NGOs, not-for-profits, academics.

 

But our approach will go much further than just patents.  We will allow access to our general "know how" and other knowledge and expertise. In fact we shouldn't call the pool a patent pool--we should call it a knowledge pool, because so much more than just patents are included.

 

That is why the second element of our open innovation strategy was to create a new concept called the Open Lab which will be part of our Tres Cantos Medicines Development Campus in Spain, dedicated to discovering new medicines for diseases of the developing world.

 

We are creating capacity for up to 60 outside researchers at our Tres Cantos Campus.  At the Open Lab, researchers will be able to pursue their projects as part of a drug discovery team, allowing these visiting experts to tap into our expertise, facilities, knowledge and industrial-scale infrastructure.  In addition to the resources and benefits-in-kind we are putting into this project, we will also set up a not-for-profit foundation to help fund these research projects, with initial seed funding from us of US$8 million.

 

This concept has already gained some traction. We are in discussions with two organizations--on projects for malaria and on TB--and we hope to conclude agreements soon and welcome these scientists into the Open Lab.

 

The third element of our open innovation strategy is to share our malaria drug-development expertise with the world's scientific community. How? Well, we have recently screened our entire compound library for molecules that inhibit the malaria parasite P. falciparum, the deadliest form of malaria found primarily in sub-Saharan Africa. This exercise has identified more than 13,500 'hits' that inhibited the parasite.

 

Today I am pleased to announce that we commit to put these 13,500 compounds, their chemical structures and associated assay data, into the public domain, making them freely available on leading scientific websites. Over 85% of these are proprietary to GSK. Our hope and expectation is that this will encourage further research by the scientific community on these findings and the opportunities they offer.

 

We believe that we are the first company to put in the public domain this level of data--and critically these specific chemical structures--from the screening of the entire compound library.  By putting together our compounds, access to our patents and know-how and access to our R&D center and infrastructure we are demonstrating our commitment to R&D for the NTDs.

Looking Back as RTS,S Moves Forward

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Seated from left: Salim Abdulla, Tanzanian PI; Joe Cohen (at microphone); Christian Loucq, PATH MVI; Regina Rabinovitch, Bill & Melinda Gates Foundation

Looking out at the packed room full of reporters this afternoon, ready to announce the progress we have made with the RTS,S Phase III trial, I could not help but think about the past.  One moment in particular comes to mind.

 

It was five years ago, in 2004, in a cramped room in Mozambique. The walls were sweating and so were we as we waited for the results of the very first RTS,S safety and efficacy trial in children. What would be revealed during that unblinding could make or break the vaccine. We were literally at the edge of our seats.

Those early results, later published in The Lancet, were proof that this vaccine could work in children.

Fast forward five years to today; this time we were the ones giving the good news. From Nairobi, we told the world that more than 5,000 children had been enrolled in the pivotal efficacy trial in just six months. No one person could have done this alone, and I am so grateful to every member of the RTS,S team, which has evolved and grown over the years. It has been my honor to work with them.

Today represented a turning point of sorts. It felt like I, along with all the scientists who have worked on this vaccine over the past two decades, was passing the baton to Africa. The future of this vaccine is now in the capable hands of Salim and Patricia, the two African Principal Investigators who joined me at the briefing today, and all of the other talented researchers leading the trial across Africa. As we head into the last part of this journey, they will usher RTS,S into the future on the ground.

For years, people have questioned whether this vaccine would ever see the light of day. And doubts still linger. But today we showed the world that our dream can become a reality in just a few short years. Looking into the future of RTS,S, I cannot help but echo the words of Kenya's most famous son: "Yes We Can." Indeed we must.

More from MIM

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Hello from the Kenyatta International Conference Center in Nairobi, Kenya!

 

It is a privilege to be here among the world's leading malaria researchers. I've had a busy first day already--connecting with colleagues old and new and attending plenaries, symposiums and scientific sessions.

 

I am really looking forward to tomorrow since we'll have a chance to update the media and many African journalists about RTS,S.

 

It's great to see the awareness grow about the vaccine--including an important commentary piece in The Lancet by the conference organizers. How few people would have imagined this historic milestone a few years ago?

 

Tomorrow, joining me at the media briefing, will be two African Principal Investigators who can explain what goes on to make this possible. Salim Abdulla and Patricia Njuguna are just two of the world-class African scientists in Burkina Faso, Gabon, Ghana, Kenya, Malawi, Mozambique and Tanzania who are spearheading this effort. In the months leading up to Phase III, they have coordinated an incredible amount of training and capacity building just to get the trial off the ground. Their leadership has been extraordinary and just another reason why there is so much excitement here.

 

Will report back again after tomorrow's briefing...

Malaria Vaccine in Final Stretch

The excitement at GSK's Belgium-based vaccine research center is palpable as we make our last preparations to leave for Nairobi, Kenya, for next week's MIM Pan-African Malaria Conference.  MIM stands for Multilateral Initiative on Malaria and it is the world's largest malaria meeting.

 

The conference brings together malaria researchers and control experts from malaria-endemic countries as well as malaria researchers, science administrators, and representatives from other countries, private foundations, governments and international organizations throughout the world.

 

We'll be giving a progress report on RTS,S, the world's most clinically advanced malaria vaccine candidate.  A pivotal Phase III efficacy trial that will involve up to 16,000 children is underway in Africa.

 

This moment has special relevance to me because I helped invent RTS,S in the late 1980's and I have been working on it ever since.   This is truly a shared endeavor, and we've enlisted such great partners as the Walter Reed Army Institute of Research, PATH's Malaria Vaccine Initiative, the Bill & Melinda Gates Foundation, and research centers in the U.S., Europe and Africa.

 

Malaria kills about 800,000 African children every year and this vaccine has the potential to save hundreds of thousands of lives.  I'm proud that the company I work for has not shied away from this technological and commercial challenge, and has invested over $300 million of its own resources in this project.

 

(To learn more, watch this story on CNBC.)

Dude, Where's My Bednet?

malaria-sudan-mother-baby.jpgYou may have heard that an online war was raging this week. A war between kings: Larry King and Ashton "Twitter King" Kutcher. 

 

Kutcher told King that he could amass 1,000,000 followers on Twitter before CNN could.  He tweeted that if he did, he would donate 10,000 treated bednets to Malaria No More.  Bednets prevent mosquitos--which spread malaria--from infecting people.  It is such a simple way to prevent the disease.

 

Well, he didDuring the run up to the big win (which happened today), Kutcher had been tweeting a great deal about malaria. As a consequence, other celebrities on Twitter have lent their support and are donating bednets:

 

CNNBrk - 10,000

Ryan Seacrest 10,000

Oprah - 20,000

 

At GSK we are committed to playing a significant role in improving the health of communities affected by malaria in three ways:

  • Through on-going research--we have a new vaccine in development to prevent malaria
  • With preferential pricing of our anti-malarials in the least developed countries and sub-Saharan Africa
  • Through our community investment activities funded by the GSK African Malaria Partnership, founded in 2001 to improve the prevention and treatment of malaria in sub-Saharan Africa.

Defeating this disease, which kills one million people each year, is no simple feat. It will require both collaboration and creativity, not to mention multiple interventions, like bednets and medical advances.  This week we got to witness an interesting real-time case study of what celebrity and social media can do for the greater good.

 

Well done, Mr. Kutcher.

A Catalyst for Change

hands.jpgLast week, I traveled with Andrew Witty as he spoke with media, government leaders, and faculty and students at Harvard Medical School about GSK's new policies to address the needs of the developing world. 

 

With refreshing candor, Andrew outlined our goal to be more innovative, open-minded and flexible to help people afflicted with neglected tropical diseases--diseases like malaria and lymphatic filiriasis (LF) which often don't take precedence--and the barriers to access facing the world's poorest countries.

 

Our plan includes four specific changes, including:

·         a more flexible approach to intellectual property in the 50 least-developed countries in the world through the development of a patent pool for neglected tropical diseases

·         a reduction in prices for patented medicines in these countries so that they will be no higher than 25 percent of the price in the developed world, assuming we can cover our cost of goods

·         a "bricks and mortar" approach to the patent pool by opening the doors of our R&D facility in Tres Cantos, Spain to external partners with the goal of creating a truly world-class, global center of excellence for diseases of the developing world

·         the re-investment of 20% of the-albeit very small-profit we make selling medicines in the least developed countries in infrastructure projects, such as the building of clinics, nurse education and training, and perhaps even new supply chain mechanisms to get medicines to rural areas.

 

The message was simple: we do not claim to have all of the answers, nor that we can change the world.  However, we have chosen to take a risk by evolving our business practices and model for the developing world.  We will not to shirk from difficult issues or hard decisions.  In doing so, we aim to be a catalyst for change.

 

While we cannot predict the response of our allies or our critics, we hope that others will join us in these endeavors because it's the right thing to do.  So far, the response has been supportive.  (Read more from The Wall Street Journal, Bloomberg and The Guardian (UK)).

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