PDP FUNDERS GROUP UPDATE 15: APRIL 1 TO APRIL 30, 2010 ** items in blue or purple should be hyperlinked to the full text version; if I have made mistakes many apologies If you have any issues that you would like to include in the Update please send them to Jane Rowley (jtfrowley@btinternet.com) Funder Announcements (since April 1, 2010) DFID 1 April 2010 • UK drive to end child diarrhoea deaths A new UK drive to rid developing countries of the scourge of child deaths by providing £10 million for new and more effective diarrhoea vaccines and treatment was announced today by International Development Minister, Mike Foster. Diarrhoea is the second biggest child killer in the world, claiming the lives of 4,000 children every day. The world’s poorest countries are hit the hardest because of a lack of clean water, basic sanitation and effective treatment. Five million pounds UKaid will go to PATH to support the discovery of a vaccine that, for the first time, will protect against the two leading bacterial causes of diarrhoea – Shigella and Escherichia coli. The UK funding to PATH will also help create additional vaccines for Rotavirus, the most common cause of extreme child diarrhoea, which will help make treatment more affordable. In addition, £5 million will be given to the Institute for OneWorld Health to support the development of an innovative new drug that aims to shorten the duration of episodes of diarrhoea. … Gates Foundation 22 April 2010 Statement by Joe Cerrell, Director, Europe Office, on the EU’s Twelve Point Action Plan in Support of the Millennium Development Goals The Bill and Melinda Gates Foundation welcomes today’s proposals by the European Commission (EC) of its twelve point action plan to meet Europe’s commitment to the Millennium Development Goals (MDGs) and address the needs of the world’s poorest people. We applaud the call for other international donors to match Europe’s level of ambition and the Commission’s plans to work with member states to strengthen the accountability of their Overseas Development Assistance (ODA) commitments. 23 April 2010 Ernest Loevinsohn Joins the Foundation as Director of Global Health Policy and Advocacy The Bill & Melinda Gates Foundation announced today that Ernest Loevinsohn will join the Global Health Program as Director of Policy and Advocacy on June 21. Loevinsohn has more than twenty years of experience applying strategic vision to complex international issues, most recently with the Canadian International Development Agency (CIDA). Loevinsohn will lead the foundation’s efforts to encourage political commitment and effective investment in global health in both donor and developing countries. He will also manage a grant program, oversee work to build evidence to support effective policy making, and help lead the foundation’s work on the Global Fund to Fight AIDS, Tuberculosis, and Malaria. Wellcome Trust 6 April 2010 Vaccine to stop pig parasite could reduce human disease A vaccine against the tapeworm Taenia solium has eliminated transmission of the parasite in pigs in a field trial in Africa. It is hoped that the vaccine could indirectly reduce the incidence of a debilitating neurological disease in humans. Taenia solium is transmitted among humans and also between humans and pigs. Pigs are infected by ingesting food contaminated with human faeces containing the parasite's eggs. In countries without proper sanitation, and where pigs and humans live in close quarters, there is a constant cycle of re-infection from the parasite. In humans the infection causes neurocysticercosis - the most frequent preventable cause of epilepsy in the developing world. Seizures are the most common symptom, but infection can also cause blindness, meningitis, dementia and in some cases death. .... 23 April 2010 People with HIV hold clues to Salmonella vaccine development A study published today in the journal ‘Science’ offers a long-awaited explanation for the link between HIV infection and susceptibility to lifethreatening nontyphoidal strains of Salmonella. The research, funded by the Wellcome Trust and GlaxoSmithKline, goes on to identify targets that could be pursued for vaccine development. Nontyphoidal strains of Salmonella (NTS) usually cause vomiting and diarrhoea in high-income countries and are mainly contracted by consuming infected foods, such as uncooked meat and eggs. NTS can also cause fatal bloodstream infections in people with compromised immunity, such as HIV-infected individuals, and children under two years of age or with malaria, anaemia or malnutrition. This is a particular problem in Africa where Salmonellae are the most common bacteria to infect the blood. Such bloodstream infections can be treated with antibiotics, but drug resistance is on the increase and there is currently no vaccine available. "The association between HIV infection and fatal cases of nontyphoidal Salmonella disease has been known since the onset of the AIDS pandemic 26 years ago, but this is the first time we've been able to offer a scientific explanation why," said Dr Cal MacLennan from the University of Birmingham, who led the research. ... 25 April 2010 Control, not elimination, key to Africa malaria battle, argue experts Global efforts focusing on eliminating malaria are counterproductive to the fight against the disease in Africa, experts have warned. They emphasise the importance of maintaining, and building on, control strategies rather than aiming for a target that may not be met. Buoyed by a reduction in malaria mortality in Africa, health leaders at a 2007 meeting on global malaria control switched their primary goal from control to elimination. But researchers from the Kenya Medical Research Institute-Wellcome Trust Research Programme in Nairobi say that the emphasis on elimination or eradication in strategic plans for the next 10-20 years in Africa is "at best irrelevant and at worst counterproductive", raising expectations that cannot be met. Writing in the 'Lancet', they argue that using currently available methods can reduce malaria from a major health priority to a fairly minor burden. "Reaching low endemic control is achievable, its financing requirements are predictable and its effects measureable," says Professor Bob Snow, one of the authors. "The result would be a huge public health success, a legacy we'd all be proud of, but this isn't elimination, which seems to a more attractive term to donors." ... PDP Press Releases (since April 1, 2010) Aeras 14 April 2010 Aeras and Crucell Announce Start of Phase II TB study in South Africa Dutch biopharmaceuticalcompany Crucell N.V. (NYSE Euronext, NASDAQ: CRXL; Swiss Exchange: CRX)and the Aeras Global TB Vaccine Foundation today announced the start of aPhase II clinical trial of the jointly developed tuberculosis (TB) vaccine candidateAERAS402/Crucell Ad35 in HIV infected adults. The Phase II study is designed to test the safety and efficacy of AERAS402/Crucell Ad35 in adults infected with HIV and will be conducted by the AurumInstitute in Klerksdorp, South Africa. … IVCC 23 April 2010 IVCC and Syngenta reach key milestone in development of new product for malaria mosquito control The Innovative Vector Control Consortium (IVCC) and Syngenta announced today that the latest field trials of the new Actellic® 300CS micro-encapsulated formulation demonstrate effective control of pyrethroid resistant mosquitoes on treated construction materials for more than eight months. Developed by Syngenta, and tested in laboratory and field evaluations by Syngenta and IVCC partner laboratories in Switzerland and Africa, Actellic® 300CS has subsequently been submitted to the World Health Organization Pesticide Evaluation Scheme (WHOPES) for independent performance and safety assessment. A recommendation from the WHO at the end of the evaluation process is a key requirement for many aid funded malaria control programs. “The field data for Actellic 300CS has surpassed our original expectations and shows real promise as a valuable tool to complement our existing products,” said Mark Birchmore, Syngenta’s Global Brand Manager for Vector Control. “Working together with the IVCC enables us to leverage our expertise and capabilities to develop new products that meet the needs of current and future malaria control programs.” Actellic® 300CS is the result of applying advanced micro-encapsulation technology to the WHO recommended insecticide, pirimiphos-methyl, to develop a new long lasting product which targets malaria mosquitoes resistant to the pyrethroid class of insecticides. Current alternatives to pyrethroids typically only last for 3 months after application resulting in additional cost and complexity for malaria programs. The submission to WHOPES is a major step forward in making the product available to national malaria control programs. …. IOWH 7 April 2010 San Francisco Non-Profit Receives Funds from UK Government to Target Neglected Diseases The Institute for OneWorld Health (iOWH), a nonprofit organization based in San Francisco, working to fulfill the promise of medicine for the developing world, has received a grant from the Department for International Development (DfID) in the United Kingdom (UK) to help develop safe, effective and affordable new medicines for people with infectious diseases. This funding was announced last week by the UK International Development Minister, Mike Foster. … The grant funds, ₤5,000,000 (approximately $7,616,033 US) from DfID given to the Institute for OneWorld Health will, in part, support the development of an innovative new drug that aims to shorten the duration of episodes of diarrhea. The drug being developed is intended to speed up the recovery time by reducing the amount of fluid loss, thereby decreasing the likelihood of death as a result of diarrhea. This new drug will be used in conjunction with Oral Rehydration Therapy (ORT) and will also enhance the adoption of ORT. IAVI 22 April 2010 IAVI and Lentigen to Collaborate on Design of Novel AIDS Vaccine Candidate The International AIDS Vaccine Initiative (IAVI) and Lentigen today announced a collaboration to design a preventive AIDS vaccine based on Lentigen’s technology. The candidate AIDS vaccine will be devised to safely mimic biological aspects of HIV infection and tested first in preclinical studies as part of an initial 18-month agreement. Lentigen’s technology relies on a synthetic version of a virus related to HIV that has been engineered, along with other safety modifications, to be incapable of inserting itself into the human genome. … MMV 8 April 2010 Pyramax® submitted to EMA for regulatory approval On March 30, Shin Poong Pharmaceutical Co Ltd, Seoul, submitted the registration dossier for a new artemisinin combination therapy (ACT), Pyramax® (pyronaridine-artesunate) to the European Medicines Agency (EMA) for regulatory approval under Article 58. This promising new antimalarial has been developed by Shin Poong in collaboration with the not-for-profit, Geneva-based research foundation Medicines for Malaria Venture (MMV). Pyramax is a fixed-dose combination artesunate with the mannich base pyronaridine. These two drugs have never been developed and clinically validated in combination before. Shin Poong and MMV have demonstrated via four pivotal Phase III clinical trials in 23 study sites in 18 countries across Africa and Southeast Asia that together, they are as efficacious and safe as the widely accepted ACT, artemetherlumefantrine, and other treatments of reference. … 23 April 2010 MMV supports trials of a new preventive treatment option for pregnant women Pfizer Inc. and Medicines for Malaria Venture (MMV) entered into an agreement for the development, access and delivery of a fixed-dose combination treatment consisting of azithromycin dihydrate (AZ) and chloroquine phosphate (CQ) for the Intermittent Preventive Treatment of P. falciparum malaria in pregnancy (IPTp). There is currently an unmet need for new treatment options and the World Health Organization (WHO) estimates that some 30 million pregnant women are at risk for malaria in endemic areas in Africa each year. A Product Development Team (PDT) comprised of representatives from Pfizer, MMV and the London School of Hygiene and Tropical Medicine (LSHTM) will coordinate the trials and an external independent Data Monitoring Committee of malaria experts will oversee them.Under the agreement, Pfizer plans to seek marketing authorization in selected malaria-endemic African countries where, with MMV, it will seek to introduce the use of this important potential therapy to improve pregnancy outcomes and neonatal survival. “Pfizer believes that an affordable price for public sector sales of the medicine, in endemic countries, if approved, is an important step towards increasing access and safe intermittent preventive treatment for pregnant women,” stated Jean-Michel Halfon, president & general manager of Pfizer’s Emerging Markets Business Unit. …. 26 April 2010 MMV and Anacor join hands in hunt for new antimalarial compounds Anacor Pharmaceuticals today announced that it has entered into a research agreement with not-for-profit Medicines for Malaria Venture (MMV) to explore Anacor’s novel boron chemistry platform for developing new therapeutics for the treatment of malaria. Under the agreement, Anacor will be responsible for leading the research effort and MMV will contribute its extensive malaria drug research expertise as well as financial support. … TB Alliance 1 April 2010 ATS Convenes World TB Day Congressional Briefing In honor of World TB Day on March 24, the AmericanThoracic Society (ATS) held a briefing in the House of Representatives …. 16 April 2010 Congressional briefing to highlight role of innovation in creating health products for the developing world On April 21, 2010, the Global Health Technologies Coalition (GHTC) will host its first annual Congressional expo to highlight the need for and role of new health products for diseases affecting people around the world. GHTC advocates for research and development for new products— including vaccines, diagnostics, drugs, microbicides and other tools—so the most effective health solutions are available when we need them. In order to meet the needs of tomorrow and ensure a long-term, sustained approach to global health, it is critical to invest in research today. The event—titled “Innovation in action: advancing new tools to combat global health diseases"—will include a high-level panel to examine key policy issues most critical in meeting the future needs of the developing world. 29 April 2010 TB Alliance Appoints Robert C. Lorette Senior Vice President, Business Development Global Alliance for TB Drug Development (TB Alliance), a not-for-profit product development partnership (PDP) accelerating the discovery and development of new drugs to fight tuberculosis (TB), has appointed Robert C. Lorette, Esq., Senior Vice President of Business Development. PDP Related News/ Articles General 2 April 2010: New blog series “Vaccines: The Next 10 Years” highlights role of vaccines in saving lives worldwide 5 April 2010: New UCSF Global Health Initiative Will Help Bridge Gap Between Knowledge, Action UCSF and SEEK Development, a global health and development consulting group based in Berlin, Germany, have launched an international partnership that aims to improve global health by helping to turn scientific evidence into policy and action. The Evidence-to-Policy Initiative, or E2Pi, officially launches this week in San Francisco and Berlin, Germany. "For many of the world's major health challenges – including HIV, tuberculosis, malaria, and maternal and child deaths – a failure to translate evidence on what works into practical health policies is costing lives," said Sir Richard Feachem, director of the UCSF Global Health Group, which is leading the collaboration. E2Pi aims to help address some of these challenges by closing the gap between what is known and what gets done in practice. "The gap between available scientific knowledge and its application in solving global health problems is one of the reasons why poor countries suffer such a high burden of disease and premature death," said Feachem, who was formerly the founding executive director of the Global Fund to Fight AIDS, Tuberculosis and Malaria. "E2Pi will help to address this issue by conducting rigorous and independent analyses of the available research evidence leading to specific, action-oriented recommendations to policy- and decisionmakers." Funding for the initiative's first three years is provided by a $3.2 million grant from the Bill & Melinda Gates Foundation. Innovation in Action: Policies to accelerate the development and delivery of global health tools. Global Health Technologies Coalition (GHTC). April 2010. The first annual report of the Global Health Technologies Coalition (GHTC) on global health research and development. The report focuses on the GHTC's three priority areas—US policies related to public financing, regulatory pathways, and incentives and innovating financing. It highlights the role US agencies and policymakers play in advancing innovation for global health products, as well as makes policy recommendations to help accelerate the development of new global health technologies. Diagnostics The Diagnostics Innovation Map: Medical Diagnostics for the Unmet Needs of the Developing World. BVGH. April 2010. Report produced by BVGH outlining the groundbreaking technologies that are paving the way for rapid, accurate diagnoses in the developing world. Malaria 6 April 2010: Crucell Announces Collaboration with GlaxoSmithKline Biologicals on Second Generation Malaria Vaccine Candidate 21 April 2010: Next Generation Malaria Control BASF has signed an agreement with the London School of Hygiene & Tropical Medicine (LSHTM) and the Innovative Vector Control Consortium (IVCC) to develop a new generation of malaria prevention products based on the BASF insecticide chlorfenapyr. TB Efficacy and safety of a fixed-dose oral combination of pyronaridine-artesunate compared with artemetherlumefantrine in children and adults with uncomplicated Plasmodium falciparum malaria: a randomised noninferiority trial. AK Tshefu et al. Lancet . 375(9724). April 24 2010. Financial Times special report “Combating Malaria”. April 23 2010. 8 April 2010: MicuRx Pharmaceuticals,Cumencor Pharmaceuticals Partner with Pfizer to Discover and Develop Antibiotics for Drug-Resistant TB HIV Progress towards development of an HIV vaccine: report of the AIDS Vaccine 2009 Conference. AL Ross et al. The Lancet Infectious Diseases, Volume 10, Issue 5, Pages 305 316, May 2010 Clinical Trials 19 April 2010: Evaluation report of the end-of-term review on EDCTP programme released 20 April 2010: EC public consultation on the impact and future of the EDCTP Programme The European Commission is conducting a public consultation regarding the impact and future of the European and Developing Countries Clinical Trials partnership (EDCTP) programme. This public consultation aims at collecting views and opinions of all interested EDCTP stakeholders. The consultation is open from from 08/04/2010 to 15/06/2010.