Welcome to Tigrai Online,      Daily News that matters


Deadly Gaps Persist in New Drug Development for Neglected Diseases

Press Releases

dndi.org, Nairobi, Kenya
Tigrai Online, October 24, 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

Mosquitoe bite in a perosn
Very few drugs are approved for neglected diseases that are prevalent primarily in poor countries: like malaria, tuberculosis and HIV every year.

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 ground-breaking new treatments for the world's poorest and most neglected patients.

Researchers from DNDi, Médecins Sans Frontières/Doctors Without Borders (MSF), the Special Programme for Research and Training in Tropical Diseases (WHO-TDR),  and three universities (University Hospital of Grenoble, France; Joseph Fourier University, France; University of Oxford, UK) found that of the 850 new drugs and vaccines approved for all diseases, 4% (37) were for neglected diseases, defined broadly as those prevalent primarily in poor countries: malaria, tuberculosis, 17 neglected tropical diseases (NTDs) as defined by the World Health Organization (WHO), 11 diarrheal diseases, and 19 other diseases of poverty, excluding HIV/AIDS. Globally these neglected diseases represent an 11% health burden, based on a recent assessment of 2010 disability-adjusted life-years (DALYs).

Most newly developed therapeutic products were repurposed versions of existing drugs. Of the 336 brand-new drugs (new chemical entities, or NCEs) approved for all diseases in 2000-2011, only four, or 1%, were for neglected diseases; three were for malaria, and one for diarrheal disease. None were for any of the 17 WHO-listed NTDs.

‘While drug and vaccine development shows signs of acceleration for neglected diseases, we must keep pushing to keep these diseases on the international policy agenda and move quickly to deliver truly transformative, life-saving treatments’, said Dr Bernard Pécoul, Executive Director of DNDi.

Study highlights:

  • New drugs for neglected diseases have a measurable medical benefit: Using inclusion on the WHO Essential Medicines List (EML)as a proxy measure for medical benefit, 48% of all new therapeutic products (excluding vaccines/biological products) approved 2000-2011 for neglected diseases were on the EML, compared with 4% for all other diseases.
  • Clinical trials are lacking for neglected diseases: Of the nearly 150,000 registered clinical trials for new therapeutic products in development as of December 2011, only 1% were for neglected diseases.
  • Most new candidates in development are vaccines: 123 new products are currently in development for neglected diseases, with over half (55%; 68) being vaccines or biological products, including 21 for malaria. A little over a quarter (28%; 34) are for the 17 NTDs, with only 3 NCEs (for onchocerciasis, Chagas disease, sleeping sickness).
  • Drug repurposing and NCEs are further along in development than vaccines: 56% (38/68) of vaccine/biological product candidates are in Phase I clinical trials, whereas 85% (29/34) of repurposed-drug products and 63% (10/16) of NCEs are in Phases II-III.
  • Nearly 80% of neglected diseases have R&D gaps: Of the 49 neglected diseases included in the study, 11 (22%) had no R&D gaps; 25 (51%) had R&D gaps and some on-going R&D; and 13 (27%) had R&D gaps and no on-going R&D.
  • Public sponsorship leads R&D: Clinical trial sponsors were 54% public (governments, academia, public research institutes), 23% private industry (pharma/biotech), and 15% private non-for-profit (product development partnerships, charities, foundations). Remaining 8% were mixed.
  • Forecasting sees numerous vaccines but few brand-new drugs: Applying attrition rates, the authors forecast 28 new registered products for neglected diseases over the next six years, but only five being NCEs. Fifteen new vaccines or biological products are forecasted to be registered in the next 10 years.
  • Neglected-disease R&D has accelerated somewhat over the past 35 years: Previous studies reported 0.6-1.3 new products/year for neglected diseases for 1975-1999. This study reports a slight increase of 2.4 new products/year for 2000-2011 and predicts 4.7 new products/year through 2018.

Although strides have been made in the last decade, we still see deadly gaps in new medicines for some of the world's least visible patients’, said Dr Nathalie Strub-Wourgaft, Medical Director of DNDi. ‘We need to get more treatment candidates, NCEs or existing ones for repurposing, into and through the R&D pipeline to fundamentally change the way we manage these diseases.’

‘Our patients are still waiting for true medical breakthroughs’, said Dr Jean-Hervé Bradol of MSF, a co-author of the study. ‘People are still suffering and dying from these diseases, and healthcare providers must be able to offer all patients - irrespective of their ability to pay - the best treatment possible. Only then will we say that we have made progress.’ Read Study http://www.thelancet.com/journals/langlo/article/PIIS2214-109X(13)70078-0/fulltext

Study Background

This study comes a decade after MSF hosted a major conference in New York to examine the crisis in R&D for neglected diseases and lay the groundwork for the creation of DNDi in 2003. In a 2001 study carried out by MSF and the Drugs for Neglected Diseases Working Group, the precursor to DNDi, only 1.1% of new drugs approved between 1975 and 1999 were found to be for neglected diseases, including NTDs, malaria, and TB, though they accounted for 12% of the global disease burden.

Media Contacts:

(North America) Oliver Yun: e-mail: oyun@dndi.org/ Tel:+1-646-616-8681 Mobile:+1-646-266-5216
(Europe) Samantha Bolton: e-mail: samanthabolton@gmail.com/ Mobile:+44 797 242 8633
(Africa) Renee Olende: e-mail: rolende@dndi.org / Mobile:+254 705 639 909
Website: www.dndi.org
Regional Communications Manager  DNDi Africa Regional Office
P. O. Box 20778-00202, KEMRI Headquarters, Ngumo, Nairobi
Tel: +254 20 2077767| Fax: +254 20 2733031

About Drugs for Neglected Diseases initiative (DNDi)

DNDi is a not-for-profit research and development (R&D) organization working to deliver new treatments for the most neglected diseases, in particular sleeping sickness (human African trypanosomiasis), Chagas disease, leishmaniasis, specific helminth (filarial) infections, and pediatric HIV. Since its inception in 2003, DNDi has delivered six treatments: two fixed-dose antimalarials (ASAQ and ASMQ), nifurtimox-eflornithine combination therapy (NECT) for late-stage sleeping sickness, sodium stibogluconate and paromomycin (SSG&PM) combination therapy for visceral leishmaniasis in Africa, a set of combination therapies for visceral leishmaniasis in Asia, and a pediatric dosage form of benznidazole for Chagas disease. DNDi was established in 2003 by MSF, the Indian Council of Medical Research, Brazil’s Oswaldo Cruz Foundation, the Kenya Medical Research Institute, the Ministry of Health of Malaysia, and the Institut Pasteur in France, with the UNICEF/UNDP/World Bank/World Health Organization’s Special Programme for Research and Training in Tropical Diseases as a permanent observer.

Sponsored Links

More Articles

The Latest Success Story Out of Ethiopia

Reasons Why Ethiopia Won’t Sell Its Large Institutions

75th anniversary of the Fascist Invasion of Ethiopia

IMF's new report highlights Ethiopia's inclusive growth

Human Rights Watch still in love with sub-par methodology

The Body Shop launched Honeymania Collection with Ethiopian honey

IMF Executive Board Concludes 2013 Article IV Consultation with Ethiopia

Dr. Tedros Adhanom met with senior executives of General Electric

PM Hailemariam re-affirms the socio-economic stride will continue unabated

Ethiopia the fastest-growing economy and African Tiger

Two Somali terrorists kill themselves while assembling a bomb in Addis Ababa

A Comparative Review of Ethiopian and Western Anti-Terrorism Legislations

Kenyan intelligence discovered Eritrean hand on the Westgate Al-Shabab attack

Kefelgn Alemu Worku was convicted in Denver, Colorado

Another ship carrying about 250 people capsized Friday off the coast of Sicily

Why is the world ignoring the biggest Al-Qaeda Sponsor

U.S. to cut military aid to Egypt after coup and continuous turmoil in the country

Political Socialization in the era of Globalization in Ethiopian Schools

UDJ: Striving to Punch above its Weight

Dr. Mulatu Teshome elected as the new president of Ethiopia

American elite Special Force commandos twin operation in Somalia and Libya

Eritrea: the African North Korea which thousands will risk anything to escape

First Power Africa Transaction Moves Forward with Landmark Agreement between Ethiopian Government and Reykjavik Geothermal

70 Eritreans among them 20 children rescued 13 drowned off of Sicily

Some facts about Ethiopia’s Nile Dam and unsound downstream concerns [reply to National Geographic megazine]

Birhanu and Andargatchew: the enemy of my enemy is not my friend

ADA-UK urges members to support development endeavours

Reykjavik Geothermal to Build 1,000 Megawatt power plants in Ethiopia

Isaias Afeworki feels nauseous about the Grand Ethiopian Renaissance Dam

Ethiopia-Eritrea peace: The ball is in President Isaias Afeworki's court

Ethiopian Wins another Award, African Business of the Year

Medrek says Ethiopia should pull out of Somalia for fear of Al-Shabab

Al-Shabab terrorists attacked a mall in Nairobi

Underground newspaper was circulated on the streets of Asmara yesterday

Iceland to help Ethiopia develop its geothermal capacity

Ethiopians in Vancouver, Canada raised over 106 thaousand dollars for GERD

Conquering Famine in Ethiopia

Wondemu Mekonen: getting a taste of his own medicine.

Ginbot 7's and ESAT's unabashed adoration of President Isaias Afeworki

Abba Yohani Monastery in Tembein, Tigrai northern Ethiopia

Ethiopia achieved the millennium development goal to cut the mortality rate for children

Ethiopian Chosen by Passengers as Best Airline in Africa

Reflections on the Ethiopian Anti-Terrorism Law Debate between the EPRDF and the Ethiopian Opposition Parties

Convicted terrorist Eskinder Nega calls for sanctions against Ethiopia

A year after Meles Zenawi, Ethiopia remains on track

REST-Health Grabs the Eye of Milinda Gates and the US Senior Officials

Girma Seifu Maru: are you kidding, or is MEDREK limping?

Impacts of Grand Renaissance Dam on Economic Development in Ethiopia

Impacts of Grand Renaissance Dam on Economic Development in Ethiopia

Millions of Ethiopians staged a rally to say no to religious extremism

Ethiopian Airlines has made a record profit