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2006
OneWorld Health receives approval for Paromomycin IM Injection from the
Drug Controller General of India (DCGI) for the treatment of Visceral
Leishmaniasis. Gland Pharma will make the medicine available at-cost,
or approximately $10 per treatment course, a significantly lower price
than currently approved VL therapies.
The antimalarial drug precursor, artemesinic acid, was produced in engineered
yeast. This great technical achievement resulted from the unique three-way
partnership between the Institute for OneWorld Health, UC Berkeley and
Amyris Biotechnologies. This achievement is an early proof of concept
that the biosynthetic manufacturing strategy can be achieved at the laboratory
scale.
A grant of US$46 million from the Bill & Melinda Gates Foundation
funds OneWorld Health's Diarrheal Disease program to expand its unique
research on new treatments to complement traditional approaches for fighting
diarrhea (in developing countries).
OneWorld Health implements collaboration with BioFocus DPI; who will apply
their medicinal chemistry expertise to identify new drug candidates for
the Diarrheal Disease program.
Victoria Hale was named a 2006 MacArthur Fellow, honored as a Pharmaceutical
Entrepreneur for creating a nonprofit model of drug development that is
driven by the neglected health needs of people in the developing world.
2005
A grant of US$10 million from the Bill & Melinda Gates Foundation funds
OneWorld Health's program for paromomycin, its promising drug for visceral
leishmaniasis, through the approval and post-approval process.
OneWorld Health receives Orphan Drug Designation from the two leading
regulatory agencies in the world, the US Food and Drug Administration
(FDA) and the European Agency for the Evaluation of Medicinal Products
(EMEA), for paromomycin to treat visceral leishmaniasis.
The Sapling Foundation awards a second grant in support of OneWorld Health's
outreach programs to collaborate with executives and scientists in the
pharmaceutical and biotechnology industries.
A Skoll Award for Social Entrepreneurship is bestowed on OneWorld Health
from the Skoll Foundation, whose mission is to advance systemic change
benefiting communities around the world by investing in, connecting and
celebrating social entrepreneurs.
A Lehman Brothers Foundation grant helps accelerate identification of
drug compounds for pediatric diarrheal disease.
2004
OneWorld Health and WHO/TDR complete the largest Phase III clinical trial
to cure visceral leishmaniasis, a deadly parasitic disease, in India using
paromomycin. Expect to file for approval with Indian government in 2006.
The Bill & Melinda Gates Foundation awards $42.6 million to OneWorld Health
for development of artemisinin through synthetic biology. OneWorld Health
partners with UC Berkeley and Amyris Biotechnologies with the goal of
providing unlimited, affordable supplies of first-line antimalarial ingredient
using synthetic biology.
The University of California Santa Barbara donates a patent for a discovery
involving the novel use of calcium channel blockers to control the schistosomiasis
parasite.
The Bill & Melinda Gates Foundation funds the development of a vaccine
for the prevention and treatment of malaria. OneWorld Health selects Sanaria,
Inc. as a partner.
The Chiron Foundation award grants to further studies in visceral leishmaniasis
treatment, and the Sapling Foundation awards a grant to study the feasibility
of engaging pharmaceutical scientists in OneWorld HealthÕs drug development
programs.
2003
Collective licensing agreement is signed with the Special Programme for
Research and Training in Tropical Disease (TDR) of the World Health Organization
(WHO) to develop a new cure for visceral leishmaniasis.
Largest Phase III clinical trial for visceral leishmaniasis begins in
India for paromomycin, an off-patent antibiotic.
Promising new compounds to treat Chagas infections are in-licensed from
Yale University and the University of Washington.
2002
The Bill & Melinda Gates Foundation funds the first two drug development
projects (visceral leishmaniasis and Chagas disease). The National Institute
of Allergy and Infectious Diseases (NIAID) collaborates with OneWorld
Health to develop Chagas disease drug lead.
OneWorld Health receives first in-licensing of promising new drug lead
for Chagas disease from Celera Genomics.
2001
The Institute for OneWorld Health is granted 501(c)(3) tax-exempt status,
becoming the first nonprofit pharmaceutical company in the U.S.
2000
The Institute for OneWorld Health is founded in the U.S., and the first
business plan is completed.
1998
Dr. Hale writes the strategic plan for nonprofit pharmaceutical
company and invests seed money.
A coalition of pharmaceutical scientists is assembled and international
parasitic disease experts are consulted.
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