“Towards Ending the Neglect?” DNDi Releases Update on its Paediatric HIV Programme

[July 2016]

As the International AIDS Conference kicks off in Durban, the Drugs for Neglected Diseases initiative (DNDi) has released an update on its efforts to develop optimal child-adapted antiretroviral formulations. This document details some recent progress towards its final goal of developing “4-in-1” fixed-dose combinations using the World Health Organization (WHO) recommended treat­ment regimen for infants and young chil­dren. DNDi’s update also discusses some promising developments for treatment for children living with both HIV and tuberculosis (TB).

Celgene joins DNDi’s “Drug Discovery Booster” to accelerate discovery of new treatments for neglected diseases

[Summit, New Jersey and Geneva, Switzerland, June 15, 2016]
First US-based biopharmaceutical partner to join global consortium
The biopharmaceutical company Celgene has become the fifth company to join the “Neglected Tropical Diseases Drug Discovery Booster” consortium, a new 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.

DNDi, Mundo Sano and Chemo team up to register benznidazole in US and Latin America

[8 June 2016 – Rio de Janeiro, Brazil]
Plans will boost access to Chagas treatment throughout Americas
In a bid to overturn a situation where less than 1% of people with Chagas disease have access to treatment, non-profit drug development organisation Drugs for Neglected Diseases initiative (DNDi), pharmaceutical company Chemo Group and non-profit foundation Mundo Sano are entering into a formal collaboration to boost affordable access to benznidazole, by registering this essential medicine in countries affected by this deadly disease, including the US.
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Mycetoma is added to WHO List of ‘Neglected Tropical Diseases’

[28 May 2016 – Geneva, Switzerland]
Move helps bring the disease to the attention of governments and funders
During the 69th World Health Assembly, the decision-making body of the World Health Organization (WHO), the devastating infection mycetoma has been added to WHO’s official list of ‘neglected tropical diseases,’ an important step in addressing the suffering of patients afflicted by this disease around the globe. Mycetoma becomes the 18th disease to be included on this list.

Drugs for Neglected Diseases initiative and Pharco Pharmaceuticals to test affordable hepatitis C regimen with support of Malaysian and Thai governments

[The International Liver Congress 2016, Barcelona, Spain, 13 April 2016]
Potentially pan-genotypic combination of ravidasvir and sofosbuvir to be tested in Malaysia and Thailand with target price of under $300
The Drugs for Neglected Diseases initiative (DNDi) and the Egyptian drug manufacturer Pharco Pharmaceuticals have signed agreements covering the clinical testing and scale-up of a hepatitis C treatment regimen at a price of just under $300.
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Clinical Research Malaysia and the Drugs for Neglected Diseases initiative sign agreement to launch clinical studies for a public health approach to hepatitis C in Malaysia

[Putrajaya, 13 January 2016]
Joint Media Release: Ministry of Health Malaysia and the Drugs for Neglected Diseases initiative (DNDi)
The Drugs for Neglected Diseases initiative (DNDi) and the Ministry of Health of the Government of Malaysia have agreed to work together to develop a public health approach to Hepatitis C within the framework of the future National Strategic Plan on viral hepatitis. The immediate goal is to conduct clinical studies of promising new treatment regimens for Hepatitis C, to be followed by scale-up of treatment for patients, with the overall objective of ensuring equitable access to affordable and effective treatments for patients suffering from this disease in Malaysia.

DNDi statement on KaloBios’ intention to raise price of Chagas drug and file for FDA priority review

[New York, December 14, 2015]
As reported this weekend in the New York Times, the pharmaceutical company KaloBios has announced its intention to register the drug benznidazole with the United States Food and Drug Administration (FDA) and to charge exorbitant prices for this treatment, which is an essential medicine for Chagas disease, the leading parasitic killer in Latin America. By registering this drug in the U.S., KaloBios also hopes to obtain a neglected disease “priority review voucher,” which it would likely be able to sell for a large sum – the latest “priority review voucher” was sold for $350 million.

Although details about this move are still emerging, documents filed with the US Securities and Exchange Commission (SEC) show that KaloBios intends to price benznidazole at levels “similar to Hepatitis C antivirals,” which are some of the most highly-priced drugs on the planet. Currently, benznidazole is available in many Latin American countries for $60-100, while the new generation of Hepatitis C antivirals cost up to $94,000.

World AIDS Day 2015: Study Begins in Kenya for Recently-Approved Paediatric HIV Treatment

[Nairobi, Kenya – 1 December 2015]
One small but important step towards better treatment for children
The Drugs for Neglected Diseases initiative (DNDi) has begun an implementation study of a recently-approved paediatric antiretroviral (ARV) treatment in order to address the urgent need for better medicines for children living with HIV. This study, which has begun in Kenya, is an important step towards DNDi’s ultimate goal of developing, together with the Indian generic pharmaceutical company Cipla Ltd and in partnership with UNITAID, improved and easy-to-take combinations of the key HIV medicines children need to survive into adulthood.

Drugs for Neglected Diseases initiative unveils new plan for neglected patients at a key gathering of experts in India

[New Delhi, 16 October 2015]
Drugs for Neglected Diseases initiative Unveils New Plan for Neglected Patients at a key gathering of experts in India
At a gathering of over 100 global public health experts, notably Dr Soumya Swaminathan, Secretary, Department of Health Research & Director General, Indian Council of Medical Research (ICMR) and Dr A C Dhariwal, Director, National Vector Borne Disease Control Programme of India, as well as scientists, researchers, civil society representatives, and partner organizations, the Drugs for Neglected Diseases initiative (DNDi) unveiled its global Business Plan as well its plans for India and the region to better respond to the needs of patients suffering from neglected diseases. At the occasion, held on 15 October 2015, ICMR and DNDi signed a Memorandum of Understanding to reinforce their research and development (R&D) technical collaboration in the field of neglected diseases and the patronage of the ICMR as a key institutional partner of DNDi.

French Development Agency AFD and DNDi sign partnership agreement for control of leishmaniasis in East Africa

[Paris, France and Geneva, Switzerland – 8 October 2015]
The French Development Agency AFD and the Drugs for Neglected Diseases initiative (DNDi) signed today a partnership agreement EUR for €2 million, spanning to the end of 2018 for the development of a new, safe, and effective oral treatment, to support efforts to control leishmaniasis in East Africa (Sudan, Ethiopia, Kenya and Uganda).
[Français]

DNDi Awarded USD 2.34 Million from New Pooled Fund Mechanism at WHO-TDR in Support of Global Leishmaniasis R&D Demonstration Project

[Geneva, Switzerland – 6 October 2015]
The Drugs for Neglected Diseases initiative (DNDi) has been awarded USD 2.34 million from a new pooled fund for health research and development (R&D) set up by Member States of the World Health Organization (WHO) and hosted by the Special Programme for Research and Training in Tropical Diseases (WHO-TDR), for a large-scale R&D project for the parasitic disease leishmaniasis.
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DNDi Applauds 2015 Nobel Prize Winners for Key Advancements in Fighting Malaria, River Blindness, and Lymphatic Filariasis

[Geneva, Switzerland – 5 October 2015]
Calls to fill remaining gaps in R&D pipeline of treatments for neglected patients
The Drugs for Neglected Diseases initiative (DNDi) applauds the three winners of the ‘2015 Nobel Prize in Physiology or Medicine’ announced today by the Nobel Assembly at Karolinska Institutet. The important research conducted by eminent scientists, William C. Cambell, Satoshi Omura, and Youyou Tu, ultimately led to therapies for the highly debilitating parasitic worm diseases, lymphatic filariasis and river blindness (onchocerciasis), and the world’s largest parasitic killer, malaria.
[Deutsch]

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.