World AIDS Day 2014: DNDi welcomes new Medicines Patent Pool licensing agreement and joins PEPFAR, Global Fund, PHTI commitment to reduce HIV treatment gap for HIV-positive children

[Geneva, Switzerland, and New York, USA, 1 December 2014]
The Drugs for Neglected Diseases initiative (DNDi) welcomes the Medicines Patent Pool announcement this World AIDS Day that it has negotiated an agreement with AbbVie, which is placing two key paediatric HIV medicines, lopinavir and ritonavir, into the Pool. The agreement means that where 99% of children with HIV live, there will be no intellectual property barriers to the development or delivery of much-needed improved paediatric antiretroviral (ARV) formulations, including a key lopinavir/ritonavir-based treatment that DNDi and its partner Cipla are developing for infants and young children. Importantly, the MPP-AbbVie agreement includes South Africa, which has the highest burden of paediatric HIV in the world.

Patient access to miltefosine in developing countries not secure despite award of US FDA PRV sold for USD 125 million

[Geneva, Switzerland & New York, USA 25 November 2014]
DNDi and MSF urge Knight Therapeutics, Paladin, and Endo to commit to key drug access requirements for treatment of leishmaniasis worldwide
Knight Therapeutics has landed a USD 125 million windfall after selling its Priority Review Voucher (PRV) granted for the registration of miltefosine (Impavido®), even while access to the life-saving drug remains unsecured. The Drugs for Neglected Diseases initiative (DNDi) and Médécins Sans Frontières Access Campaign (MSF) are urging the drug’s license-holders and manufacturers – Knight Therapeutics, Paladin, and Endo – to ensure broad, sustainable access to the drug for the millions of people who need it.

Strategic collaboration for developing urgent innovative therapies for neglected diseases in Latin America

[Rio de Janeiro, Brazil, and Medellin, Colombia – November 25, 2014]
Ruta-N and DNDi signed an agreement establishing a strategic alliance, with an initial contribution of US$ 647,500 by Ruta-N, against leishmaniasis, a disease with an average 64,000 new cases per year in Latin America – more than 60% of which in Brazil and Colombia
Ruta-N and the Drugs for Neglected Disease initiative (DNDi) signed an unprecedented agreement for the development of health innovation with a shared investment of 647,500 US dollars for a period of two years in Latin America. The collaboration begins with a programme dedicated to the battle against leishmaniasis, a disease that is highly endemic and greatly burdens socio-economic development in the region. Ruta-N is an organization based in Medellin, Department of Antioquia, Colombia, which focuses on knowledge as a primary source for research and development. DNDi is a non-profit research and development organization made up of public and private partners.
[Español] [Português]

DNDi Latin America Receives FINEP Innovation Award in Social Technology

[Rio de Janeiro  – 6 November, 2014]
Institution was awarded for innovative cooperation model for developing antimalarial in Brazil
The Drugs for Neglected Diseases initiative (DNDi) received the FINEP Award for Innovation in Social Technology on 5 November 2014. The award was in recognition of an innovative Research & Development (R&D) model that has delivered a new antimalarial drug developed in Brazil. The drug is now also being produced in India thanks to a technology transfer from Brazil. The findings of a recent study released this month also revealed the treatment potential for children of five years of age and younger in Africa.
[Español] [Português]

Artesunate-Mefloquine Fixed-Dose Combination (ASMQ FDC) Proves Safe and Efficacious to Treat Children in Africa with Malaria

[New Orleans, LA, USA  4 November, 2014]
Clinical Trial Results Provide Evidence for Introducing This Artemisinin Derivative-based Combination Therapy (ACT) into Africa’s Current Malaria Treatment Arsenal to Help Tackle the Number One Parasitic Killer
Presented today at the 63rd annual meeting of the American Society of Tropical Medicine and Hygiene (ASMTH), results of a multi-centre clinical trial in Africa, launched in 2008, to test the efficacy and tolerability of ASMQ fixed-dose combination (FDC) in children under 5 years of age with uncomplicated falciparum malaria showed that ASMQ FDC is as safe and efficacious as Artemether-Lumefantrine (AL) FDC – Africa’s most widely adopted treatment.

DNDi Receives USD 60 Million to Fill Research and Development Gaps for Neglected Patients

[New Orleans, LA, USA  2 November, 2014]
The Drugs for Neglected Diseases initiative (DNDi) has been awarded USD 60 million by the Bill and Melinda Gates Foundation towards the development of new and effective treatments for patients suffering from neglected tropical diseases in the world’s poorest communities. Announced today by Mr Bill Gates at the annual meeting of the American Society of Tropical Medicine and Hygiene (ASTMH) in New Orleans, this grant will help fill critical gaps in research and development (R&D) for human African trypanosomiasis (sleeping sickness), filarial diseases (notably onchocerciasis, or river blindness), and visceral leishmaniasis (kala-azar).

Study Results Support WHO Recommendations for Safe and Effective Kala-azar Treatments in Bangladesh

[Dhaka, Bangladesh and Geneva, Switzerland, 15 October 2014]
Today in Dhaka, Bangladesh, results of a four year-long clinical study to test the safety and efficacy of new combination treatments for kala-azar (visceral leishmaniasis) were presented to the Ministry of Health (MoH) of Bangladesh in the presence of Health Minister, Mr Mohammed Nasim. The treatments tested had been recommended by the World Health Organization in 2010 and form part of the treatment arsenal to support the targets for controlling this parasitic disease that infects up to 300,000 people and kills up to 40,000 people worldwide each year. The disease burden in the Indian sub-continent is particularly high, but is currently declining with efforts exerted within the regional elimination programme.

Phase III Clinical Study in Ethiopia Launched to Test Two Treatments for HIV-Visceral Leishmaniasis Co-infected Patients

[Gondar, Ethiopia and Geneva, Switzerland – 6 October, 2014]
The international research & development (R&D) consortium, AfriCoLeish, formed by six research organizations from East Africa and Europe, has launched a Phase III clinical study to address the extreme difficulty in treating visceral leishmaniasis (VL) in patients who also are HIV-positive. The study will assess the efficacy and the safety of two treatments: a combination treatment of AmBisome® and miltefosine, and AmBisome® alone. This is the first randomized clinical trial in Africa to confirm the World Health Organization’s recommendation for HIV-VL treatment. Two sites, Gondar and Abdurafi, in northwest Ethiopia, one of the highest burden areas in the world, have begun recruiting patients.
[Deutsch] [Español] [Français] [Português]

Results of Large-Scale Roll Out of Combination Treatment for Kala-Azar in Eastern Africa Points to Urgency to Treat Disease Victims as Outbreak Surges in South Sudan

[Bahir Dar, Ethiopia and Geneva, Switzerland – 1 October 2014]
Today in Bahir Dar, Ethiopia, at the occasion of the Leishmaniasis East Africa Platform meeting, which has gathered some 150 African and international leishmaniasis experts, results of a pharmacovigilance – or large-scale treatment safety and efficacy monitoring – plan, carried out by MSF, DNDi, and national partners in Kenya, Sudan, Uganda, and Ethiopia, were presented to key decision makers in order to boost patient access to treatment of kala-azar with the combination of Sodium Stibogluconate and Paromomycin (SSG&PM) in the region. In this large cohort of patients, treated under normal field conditions, the results confirmed the safety and high rate of efficacy of the combination treatment in the fight against this fatal neglected tropical disease.

Celgene Global Health and DNDi Expand Collaboration to Identify Innovative Therapies to Benefit Patients with Neglected Tropical Diseases

[Geneva, Switzerland, and Summit, NJ, USA – 24 September 2014]
Celgene Global Health (CGH), a division of Celgene Corporation (NASDAQ: CELG), and the Drugs for Neglected Diseases initiative (DNDi) strengthen their collaboration with a four-year Research Collaboration Agreement to identify and optimize new drug candidates for the treatment of neglected tropical diseases (NTDs). Celgene will provide DNDi with new data and resources to accelerate clinical development of new treatments for patients with NTDs.

New Drug Candidate for Chagas Disease Tested in Patients in Bolivia

[Mexico City, Mexico – 12 August 2014]
Phase II Trial Launched to Test Safety and Efficacy of ‘Rediscovered’ Fexinidazole in 140 Adults with Chronic Indeterminate Chagas Disease
The Drugs for Neglected Diseases initiative (DNDi) announced today at the International Congress of Parasitology (ICOPA), the launch of a Phase II drug trial to test fexinidazole, a drug shelved in the 1980s and ‘rediscovered’ by DNDi nearly a decade ago, for Chagas disease patients. The drug is also being tested in patients in Africa for two other parasitic diseases, sleeping sickness and visceral leishmaniasis.
[Español] [Português]

The Global Chagas Disease Coalition stages high-level event to encourage increased access to diagnosis and treatment of patients fighting Chagas disease

[Mexico City, Mexico – 11 August 2014]
Of the 8 million people infected in the world, 1 million are Mexican
At the 2014 International Congress of Parasitology (ICOPA), the Global Chagas Disease Coalition launched the event “Let’s Raise Our Voice” to alert the world that of the 8 million patients infected with Chagas disease, 99% have not been treated. The aim of this event is to promote an alliance among governments, civil society, doctors, researchers, and patients to discuss simple actions that can be taken to boost patient access to diagnosis and treatment.
[Español] [Português]

DNDi Welcomes Progress Made at WHA in R&D Financing and Coordination for Developing Country Health Needs

[Geneva, Switzerland – 3 June 2014]
Overall political consensus and initial financial commitments secured during recent World Health Assembly, laying foundations for publicly-led research and development to bridge innovation of and access to essential health tools in developing countries
At the recent 67th World Health Assembly (WHA) in Geneva, a global political consensus by the Member States gave a solid ‘go-ahead’ to advance a process that began over a decade ago to ensure that research and development (R&D) for the priority health needs of developing countries benefits from global public leadership. The process, referred to as the Consultative Expert Working Group (CEWG) process, notably aims at securing sustainable financing and coordination to fundamentally link innovation and access to essential health tools. Initial financial commitments were announced by France, Switzerland, Brazil, and Kenya.

DNDi Receives Support from NORAD for its R&D on Sleeping Sickness

[Geneva, Switzerland – 22 May 2014]
The Drugs for Neglected Diseases initiative (DNDi) welcomes new public funding from the Norwegian Agency for Development Cooperation (NORAD). This grant of NOK 15 million (EUR 1.85 million), to be disbursed over three years (until 2015), will be dedicated to the development of an oral treatment for sleeping sickness, as well as to strengthen local capacities in the endemic African countries through the Human African Trypanosomiasis (HAT) Platform, a network of key regional actors in clinical research for the disease.

Paediatric HIV Treatment Initiative (PHTI) to spur innovation and access to improve the lives of children living with HIV

[Geneva, Switzerland – 19 May 2014]
UNITAID, DNDi, and the Medicines Patent Pool gather global experts, health ministries, and industry leaders in support of the initiative to expedite development and delivery of new antiretroviral formulations
On the eve of the 67th World Health Assembly, Ministers of Health from over fifteen countries including Brazil, Chile, Mauritius, and South Africa; industry and global public health leaders; as well as senior representatives from the HIV/AIDS community joined UNITAID Chair Philippe Douste-Blazy at a special event last evening to urge a more coordinated response to caring for the 3.3 million children currently living with HIV. While significant progress has been made over the past 15 years in improving access to antiretroviral treatment for adults, only a quarter of children in need receive ARV therapy today. Each day, 500 children die of HIV/AIDS-related causes.

Research & Development for Diseases of the Poor: A 10-Year Analysis of Impact of the DNDi Model

[Paris, France & Geneva, Switzerland – 5 December 2013]
Report provides real and estimated costs of repurposing drugs and new chemical entities, evoking the lessons learned based on alternative pathways and partnerships
Today, at a scientific meeting at Institut Pasteur, France, entitled ‘Best Science for the Most Neglected: Where Do We Stand Ten Years On?’, co-organized with Institut Pasteur and MSF and in collaboration with PLOS, the Drugs for Neglected Diseases initiative (DNDi) marks its 10-year anniversary by issuing a report that explores the lessons learned from a decade of research and development (R&D) of new treatments for neglected diseases via a cost-effective, innovative, not-for-profit drug development model. The report also comes at the time of discussions at the WHO aiming at gaining Member State agreement on ‘demonstration projects’ meant to provide evidence for the feasibility and sustainability of collaborative and open approaches to R&D for the health needs of developing countries.
[Deutsch] [Español] [Français] [Português]

New Collection from PLoS and DNDi highlights a decade of R&D into neglected tropical diseases

[Cambridge, UK – 27 November, 2013]
As part of a collaborative initiative, PLoS and the Drugs for Neglected Diseases initiative (DNDi) are delighted to be launching a special Collection—PLoS & DNDi: a decade of Open Access and Neglected Tropical Diseases R&D (Research and Development)—to coincide with a joint event at the Institut Pasteur in Paris celebrating the 10-year anniversary of DNDi.

Drug Trial for Leading Parasitic Killer of the Americas Shows Mixed Results but Provides New Evidence for Improved Therapy

[Washington, DC – 14 November, 2013]
First placebo-controlled study in adults with Chagas disease highlights urgent need to scale up treatment for millions of patients at risk
According to results of the first-ever Phase 2 clinical trial in Bolivia, conducted by the Drugs for Neglected Diseases initiative (DNDi), the experimental drug candidate E1224 showed good safety and was effective at clearing the parasite that causes Chagas disease, but had little to no sustained efficacy one year after treatment as a single medication. On the other hand, standard therapy for Chagas, benznidazole, was shown to be effective in the long term but continued to be associated with side effects. The results, presented today at the Annual Meeting of the American Society of Tropical Medicine and Hygiene (ASTMH), highlight the need to investigate alternative dosing regimens and possible combination therapies to improve patient care.
[Español] [Português]

Mundo Sano and DNDi Join Forces to Provide Access to Treatments for Chagas Disease Patients

[Geneva, Switzerland – 11 November 2013]
Strategic agreement signed today to ensure crucial second source of pediatric formulation of benznidazole for millions of children in need of treatment
Today the Mundo Sano Foundation and the Drugs for Neglected Diseases initiative (DNDi) signed a wide-ranging accord to collaborate closely on a vital second source of the drug benznidazole for children affected by Chagas disease. From production to patient access, securing affordability and accessibility, the agreement unites the two not-for-profit organizations, highly involved in advocacy and drug research and development, in their common effort to fill treatment gaps for Chagas disease patients worldwide.
[Español] [Português]

Deadly Gaps Persist in New Drug Development for Neglected Diseases

[Geneva, Switzerland – 24 October 2013]
New study shows that, despite some progress, only 4% of new drugs and vaccines approved 2000-2011 were for neglected diseases, and a ‘fatal imbalance’ remains in R&D for many neglected patients
In a study published today in the open-access journal The Lancet Global Health, the Drugs for Neglected Diseases initiative (DNDi) and other researchers report a persistent deficiency in truly new therapeutics for neglected diseases, despite nominal progress and an acceleration in research and development (R&D) efforts. This continued ‘fatal imbalance’ in medical R&D points to the urgent need to develop and deliver groundbreaking new treatments for the world’s poorest and most neglected patients.
[Deutsch] [Español] [Français] [Português]