A New Model of Drug Development
Our approach is simple: assemble an experienced team; identify the most promising drug candidates; develop them into safe, effective, and affordable medicines; then collaborate with companies to manufacture and distribute newly approved therapies that will impact the health of millions.
Challenging Models - Changing Minds
OneWorld Health was founded by Drs. Victoria Hale and Ahvie Herskowitz in 2000, and received 501(c)(3) tax-exempt status in 2001, becoming the first nonprofit pharmaceutical company in the United States. In 2011, OneWorld Health became an affiliate of PATH, an international nonprofit organization that transforms global health through innovation.
PATH received £16 million from the British Department for International Development to fund new drugs, vaccines, and diagnostics to prevent, diagnose, and treat malaria and diarrheal disease over the next five years. £6 million was allocated to the drug development program.
iOWH032—antidiarrheal drug candidate—entered phase 2(a) trials in healthy Bangladeshi volunteers and in patients with acute cholera.
The World Health Organization prequalified semisynthetic artemisinin for use in the manufacture of active pharmaceutical ingredients and finished pharmaceutical products.
Phase 2 clinical trial launched in Bangladesh to test a new formulation of oral rehydration solution.
Launched industrial-scale production of semisynthetic artemisinin.
Dr. Hing Sham was appointed as director of research and preclinical development.
Completed phase 3(b) clinical trials of PMIM, studying the safety and efficacy of the treatment for kala-azar.
Concluded phase 1 clinical trials for the antidiarrheal drug candidate iOWH032, with no serious adverse events reported.
Dr. Ponni Subbiah was named the global program leader for PATH's Drug Development (formerly, OneWorld Health).
PMIM to treat kala-azar is registered by the government of Nepal.
OneWorld Health became a drug development affiliate of PATH.
Received $1.9 million as part of a larger grant for the project led by the Drugs for Neglected Diseases Initiative, and in collaboration with the World Health Organization's Special Programme for Research and Training in Tropical Diseases. The four-year long consortium project aims to boost strategies for control and eventual elimination of kala-azar in India and Bangladesh.
Partnered with the Jharkhand State Department of Health to support a soil transmitted helminth control initiative aimed at reducing chronic worm infection and high incidence among children in India.
PMIM is approved for the Essential Drug List of Nepal.
Partnered with the Center for World Health and Medicine at Saint Louis University, and announced a joint research agreement to develop new drugs to combat diarrhea.
Partnered with Anacor Pharmaceuticals to discover antibacterial compounds for treating bloody diarrhea (shigellosis).
The United States Food and Drug Administration granted phase 1 trials for iOWH032, a drug to treat secretory diarrheas as a result of diseases like cholera.
Received an additional grant of ₤2.2M from the British Department for International Development to fund existing projects and to expand the diarrheal diseases portfolio.
Received a ₤5M (approximately $7.6M US) grant from the British Department for International Development to target neglected infectious diseases affecting the world's poorest people.
Received a grant of $10.7M from the Bill & Melinda Gates Foundation for large-scale production and commercialization of semisynthetic artemisinin.
Completed a major phase 4 pharmacovigilance study of PMIM for the treatment of kala-azar in India.
In collaboration with Rajendra Memorial Research Institute of Medical Sciences, completed field research on kala-azar in India in the district of Bihar.
Extended kala-azar campaign to Bangladesh and Nepal.
Began collaboration with Novartis to discover and develop a novel therapy for secretory diarrhea, designed to prevent excessive loss of water from the body via the gastrointestinal tract.
Completed first screening campaign of the Roche proprietary compound library and identified 40 new drug leads to treat diarrhea.
Collaborated with BioFocus DPI and Roche on a project to screen 700,000 compounds from the Roche library to identify a potential new drug to combat diarrheal diseases.
Partnered with synthetic biology innovator Amyris Inc. and leading pharmaceutical company Sanofi to develop semisynthetic artemisinin, a key ingredient in first-line malaria treatments.
PMIM approved for the Essential Drug List of Bangladesh.
Named one of the Social Enterprises of the Year by Fast Company.
Launched phase 4 program for PMIM in India.
PMIM was designated by the World Health Organization for inclusion on its Model List of Essential Medicines.
In collaboration with Amyris, completed due diligence and selected French pharmaceutical company Sanofi as a contract manufacturing partner to scale-up the development process of semisynthetic artemisinin.
Received approval for PMIM from the Drug Controller General of India for the treatment of kala-azar. Gland Pharma produces the medicine at no-profit, no-loss.
The antimalarial drug precursor, artemesinic acid, is produced in engineered yeast. This great technical achievement resulted from the unique three-way partnership between OneWorld Health, UC Berkeley, and Amyris, Inc.
Received a grant of $46M from the Bill & Melinda Gates Foundation to expand unique research on new treatments to complement traditional approaches to fighting diarrhea.
Implemented collaboration with BioFocus DPI to identify new drug candidates for the diarrheal disease program.
Received a grant of $10M from the Bill & Melinda Gates Foundation to fund the program for PMIM through the approval and post-approval process.
Received Orphan Drug Designation from the two leading regulatory agencies in the world, the United States Food and Drug Administration and the European Medicines Agency, for PMIM to treat kala-azar.
A Lehman Brothers Foundation grant accelerated identification of drug compounds for pediatric diarrheal disease.
In collaboration with the Special Programme for Research and Training in Tropical Diseases of the World Health Organization, completed a large phase 3 clinical trial using PMIM.
Received a $42.6 million grant from the Bill & Melinda Gates Foundation for development of artemisinin using synthetic biology.
Partnered with the University of California, Berkeley and Amyris Inc., with the goal of using synthetic biology to provide a stable supply of the first-line antimalarial drug ingredient artemisinin.
The University of California, Santa Barbara donated a patent for a discovery involving the novel use of calcium channel blockers to control the schistosomiasis parasite.
The Bill & Melinda Gates Foundation funded the development of a vaccine for the prevention and treatment of malaria. Sanaria, Inc. is selected as partner.
Collective licensing agreement was signed with the Special Programme for Research and Training in Tropical Disease of the World Health Organization to develop a new treatment for kala-azar.
Largest phase 3 clinical trial for kala-azar began in India for paromomycin (PMIM), an off-patent aminoglycoside antibiotic that has been marketed internationally for over 40 years.
Promising new compounds to treat Chagas infections were in-licensed from Yale University and the University of Washington.
The Bill & Melinda Gates Foundation funded the first two drug development projects for kala-azar and Chagas disease. The National Institute of Allergy and Infectious Diseases collaborated with OneWorld Health to develop Chagas disease drug leads.
Received first in-licensing of promising new drug lead for Chagas disease from Celera Genomics.