Drugs for Neglected Diseases initiative and Eisai Co., Ltd. to Test Drug Candidate for Eumycetoma

[Basel, Switzerland , Tokyo, Japan-10 September 2015]
Patients suffering from virtually no R&D for this neglected disease
The Drugs for Neglected Diseases initiative (DNDi) and the Japanese pharmaceutical company Eisai Co., Ltd. have signed an agreement to proceed with the clinical development of Eisai’s anti-fungal drug fosravuconazole for the potential new treatment of eumycetoma, a fungal form of mycetoma, one of the world’s most neglected diseases.
[日本語] [العَرَبِية‎]

Pivotal Clinical Trial to Begin for First Oral Drug Candidate Specifically Developed for Sleeping Sickness

[Basel, Switzerland – 8 September 2015]
Phase I study shows favourable safety profile and can be tested in patients
The Drugs for Neglected Diseases initiative (DNDi) has announced today at the 9th European Congress on Tropical Medicine and International Health (ECTMIH) in Basel, Switzerland, the successful completion of Phase I human clinical trials for SCYX-7158 (AN5568), the first oral drug candidate specifically developed from the earliest drug discovery stage to combat human African trypanosomiasis, or sleeping sickness, a deadly parasitic disease transmitted by the tsetse fly.

Drugs for Neglected Diseases initiative Unveils New Plan for Neglected Patients

[Basel, Switzerland – 7 September 2015]
Aims to Deliver 16-18 Treatments for Up to 10 Diseases with EUR 650 Million
After having built the world’s largest drug development pipeline for the most neglected diseases, the Drugs for Neglected Diseases initiative (DNDi) has unveiled plans for a more flexible, dynamic portfolio approach, integrating various operating models to better respond to the needs of patients, notably in low- and middle-income countries. The plan also paves the way for new diseases to be taken up in DNDi’s portfolio.
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Child-Friendly Formulation of WHO-Recommended Treatment Now Approved by the US FDA for Children Living with HIV

[Geneva, Switzerland – 3 June 2015]
The Paediatric HIV Treatment Initiative* welcomes this important step towards closing the treatment gap for children with HIV

Infants and young children living with HIV will finally have access to an improved formulation of an antiretroviral (ARV) treatment, following the U.S. Food and Drug Administration’s (FDA) tentative approval last week of lopinavir/ritonavir (LPV/r) oral pellets developed by the Indian generic company Cipla.

DNDi and Four Pharmaceutical Companies Announce ‘Drug Discovery Booster’ Experiment to Accelerate and Expand Discovery of New Drugs for Two Highly Neglected Diseases – Leishmaniasis and Chagas disease

[Geneva, Switzerland; Osaka and Tokyo, Japan; London, United Kingdom – 28 May 2015]
First multi-company engagement in project with DNDi to tackle neglected tropical diseases, supported by the Japanese Global Health Innovative Technology Fund
The Drugs for Neglected Diseases initiative (DNDi) and four pharmaceutical firms, Eisai Co Ltd, Shionogi & Co Ltd, Takeda Pharmaceutical Ltd, and AstraZeneca plc have announced the start of a ground-breaking initiative to accelerate and cut the cost of early stage drug discovery for two of the world’s most neglected diseases, leishmaniasis and Chagas disease. The ‘Neglected Tropical Diseases Drug Discovery Booster’ consortium, through a carefully engineered modus operandi, will circumvent early stage commercial barriers between the four pharmaceutical participants, allowing DNDi, for the first time, to search millions of unique compounds simultaneously, in the hunt for new treatment leads for leishmaniasis and Chagas disease.

MSF and DNDi Join Call for a Biomedical Research and Development Fund and Mechanism to Meet Pressing Global Health Needs

[Geneva, Switzerland, 11 May 2015]
A group of renowned global health experts*, including from Médecins Sans Frontières (MSF) and the Drugs for Neglected Diseases initiative (DNDi), are calling for the creation of a global health research and development (R&D) fund and mechanism to address deadly gaps in innovation for emerging infectious diseases such as Ebola, anti-microbial resistance, and a host of other diseases that have been neglected by the pharmaceutical market. The call comes at a time when these and other public health challenges are high on political agendas in the lead up to World Health Assembly next week and the G7 Summit in June.

Ministry of Health and partners disclose recommendations to overcome barriers to access to diagnosis and treatment for Chagas Disease in Colombia

[Bogotá, Colombia – April 23, 2015]
At an international seminar that gathered international and Colombian experts in Bogotá, capital, representatives of the General System of Social Security in Health, knowledge management, civil society and international cooperation agreed upon necessary measures to rebuild and reinforce proposals to guarantee the right to health on affected areas, including a model project for the treatment of Chagas disease, both at regional and national levels.
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DNDi Receives US$ 10 Million from USAID to Develop New Drugs for Neglected Filaria Patients

[New York, NY, USA and Geneva, Switzerland – December 16, 2014]
The Drugs for Neglected Diseases initiative (DNDi) has been awarded US$ 10 million by the United States Agency for International Development (USAID) to develop new treatments for onchocerciasis (river blindness) and lymphatic filariasis (elephantiasis) – the first-ever USAID grant for neglected tropical disease research and development (R&D).

Bayer and DNDi Sign First Agreement to Develop an Innovative Oral Treatment for Human River Blindness

[Berlin, Germany and Geneva, Switzerland – 9 December 2014]
Bayer HealthCare and the Drugs for Neglected Diseases initiative (DNDi) have signed an agreement under which Bayer will provide the active ingredient emodepside to support DNDi in its effort to develop a new oral drug to treat river blindness (or onchocerciasis). The world’s second leading infectious cause of blindness, river blindness is a neglected tropical disease caused by a filarial worm.
[Deutsch]

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.
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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.
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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.
[Français]

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.
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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.
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