Developing and moving a potential drug from research lab to pharmaceutical company is a mammoth 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.
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Jonathan Vennerstrom, Ph.D., far left, associate professor of pharmaceutical sciences at the UNMC College of Pharmacy and principal investigator of the MMV grant, with collaborators, from left to right, Reto Brun, Swiss Tropical Institute in Switzerland, William Charman, Monash University in Australia, and Hugues Matile of F. Hoffmann-La Roche of Switzerland. |
The international research group took another step toward success recently at the World Economic Forum Headquarters at Cologny, Switzerland, where Roche, a leading pharmaceutical and healthcare company, symbolically handed over the UNMC-led Synthetic Peroxide Project to Ranbaxy Laboratories Ltd., India’s largest pharmaceutical company.
The UNMC-led team has developed several anti-malarial compounds in a new class of chemical structures that’s been called “spectacular” by the World Health Organization. The international drug discovery project has advanced from laboratory to technical and clinical development, said Jonathan Vennerstrom, Ph.D., associate professor of pharmaceutical sciences at the UNMC College of Pharmacy and principal investigator of the grant.
The team, which has worked on the project since 2001, consists 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 Medicines for Malaria Venture (MMV).
“It’s a positive thing to see a pharmaceutical partner identified. One always hopes to get this far,” Dr. Vennerstrom said. “It’s exciting for the group to get to this point.
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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.”
While the pharmaceutical company proceeds, the UNMC research team will continue to perfect the compound in the lab and do more experiments to learn how the compound works.
“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 MMV’s Expert Scientific Advisory Committee.
Although 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 million 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 United States 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 Omaha’s Florence area. In 1914, an estimated 600,000 cases of malaria occurred in the United States. Today, malaria is rare in the United States due to urbanization, improved sanitation, housing, nutrition and living standards, as well as eradication of mosquitoes with insecticides beginning in the 1940s.
Ranbaxy was chosen as an MMV partner for its research and development strengths in process chemistry, formulation development and other pre-clinical expertise, strong regulatory submission capabilities and cost effectiveness. It will carry out the development and file a 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.
“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, India’s 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 November 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.