Developing and moving a potential drug from research lab to pharmaceutical
company is an undertaking fraught with potential failure at every turn.
Enormous costs and time, with little or no prospect of return upon investment,
can stop a project in its tracks.
A University of Nebraska Medical Center College of Pharmacy-led team
of scientists has taken another step towards success with their new class
of anti-malarial compounds. Recently at the World Economic Forum Headquarters
at Cologny, Switzerland, Roche, a leading pharmaceutical and healthcare
company, symbolically handed over the UNMC-led Synthetic Peroxide Project
to Ranbaxy Laboratories Ltd., Indias largest pharmaceutical company.
Ranbaxy will carry out the development and file an investigational new
drug application once it has established safety and effectiveness in pre-clinical
phase. If the drug works as is hoped, it may treat malaria in three days
at a cost much less than the commonly used Artemisinin derivatives.
The UNMC-led team, which has been funded by Medicines for Malaria Venture
(MMV) of Geneva, Switzerland, since 2001, is made up of scientists from
the UNMC College of Pharmacy, Monash University in Australia, the Swiss
Tropical Institute and the F. Hoffmann-LaRoche pharmaceutical company in
Switzerland. It has received a patent on the compound and shares a four-year,
$4.4 million grant funded by MMV.
The anti-malarial drug compounds have been called spectacular by the
World Health Organization. Drug company involvement moves the project from
laboratory to technical and clinical development, said Jonathan Vennerstrom,
Ph.D., associate professor of pharmaceutical sciences, UNMC College of
Pharmacy and principal investigator of the MMV grant. Its a positive
thing to see a pharmaceutical partner identified. One always hopes to get
this far, Dr. Vennerstrom said. Its exciting for the group to get to
this point.
He said Ranbaxy will take the anti-malarial compound, now called a clinical
candidate, and put it through a series of experiments a battery of toxicity
tests in animals in preparation for clinical trials.
I think everyone is eagerly anticipating if MMV can pull this off,
said Dr. Vennerstrom, who has been studying malaria for 18 years and said
he became aware of the disease while growing up in Ethiopia when his parents
taught at mission schools. If all goes well, phase I clinical trials could
begin as early as 2004. It depends on the results of the safety and tolerance
of the drug.
The research team continues to perfect the compounds in the lab and
learn how the compound work.
We still are working on a backup drug candidate if the first one fails,
Dr. Vennerstrom said. We may have found something much better. It could
have higher oral activity and could provide a cure at a lower dose that
would reduce potential side effects. We are learning more as we get more
feedback from animal studies.
The Synthetic Peroxide Project in 2001, the first new drug candidate
to be entirely funded by MMV, was voted Project of the Year in 2001 by
the MMVs Expert Scientific Advisory Committee.
Though now the malaria epidemic seems like a world away, in places like
Africa, Asia, Central and South America, the disease kills more than 1
million people each year, most of them children and pregnant women, according
to the World Health Organization (WHO). In addition, an estimated 300 to
500 million new cases of malaria are diagnosed each year. More than 90
percent of all malaria cases occur in Africa.
The U.S. Centers for Disease Control and Prevention says malaria could
re-emerge in the U.S. due to the malaria parasite building up resistance
to current drugs, environmental changes and increased air travel. American
travelers and military personnel who travel to countries where malaria
is prevalent are at risk.
In the 1840s, malaria was a major cause of 600 deaths among Mormons
living in Omahas Florence area. In 1914, an estimated 600,000 cases of
malaria occurred in the United States. Today, malaria is rare in the U.S.
due to urbanization, improved sanitation, housing, nutrition and living
standards, as well as eradication of mosquitoes with insecticides beginning
in the 1940s.
Ranbaxy is the ideal partner to drive this project forward. The company
has demonstrated skills and expertise to discover new molecules, and take
them through the process of development and also conduct clinical trials
to international standards, said Christopher Hentschel, chief executive
officer, MMV. Their presence in several African countries makes them the
right partner for MMV in achieving its mission to discover, develop and
deliver medicines to the disease endemic countries, at affordable cost.
Developing a new medicine for Malaria affords Ranbaxy an opportunity
to provide better health care options in this segment, said D.S. Brar,
chief executive officer and managing director, Ranbaxy Laboratories Limited,
Indias largest pharmaceutical company. We are delighted to join hands
with MMV in this venture to enhance our social responsibilities cause.
MMV was officially launched in 1999 as a non-profit foundation dedicated
to reducing the burden of malaria in disease endemic countries by discovering
new affordable anti-malarials through effective public-private partnership.
MMV in its three years of operation is managing a portfolio of over 14
Projects in different stages of Drug Research and Development.
It receives funding and support from the following organizations: Bill
and Melinda Gates Foundation, ExxonMobil Corporation, Global Forum for
Health Research, International Federation of Pharmaceutical Manufacturers
Associations, Netherlands Minister for Development Cooperation, Rockefeller
Foundation, Swiss Agency for Development and Cooperation, United Kingdom
Department for International Development, World Bank, World Health Organization,
Roll Back Malaria, UNDP/World Bank/WHO Special Programme for Research and
Training in Tropical Diseases (TDR), The Wellcome Trust.
For more information about MMV, go to www.mmv.org