A cheap anti-malarial drug based on an ancient Chinese medicine is going into human trials in the United Kingdom. OZ, a synthetic peroxide, is believed to have similar mode-of-action as the most effective antimalarial drug currently available — artemisinin, a herbal remedy based on the Artemisia annua plant. However, because of the costly and lengthy extraction process from the plant, artemisinins are at least ten times more expensive than the cheap standard antimalarials. Although artemisinin-based combination therapies (ACTs) are currently the best cure for drug resistant malaria, access to ACTs in disease endemic countries has been limited due to their cost. An effective synthetic drug would be superior to the current ACTs as it will not be dependent on the artemisia plant and will likely be much cheaper to manufacture.. From Ranbaxy Laboratories:
RANBAXY AND MMV ACHIEVE POTENTIAL BREAKTHROUGH
IN MALARIA DRUG ENTERS HUMAN TRIALS PHASE
Ranbaxy Laboratories Limited (Ranbaxy) and Medicines for Malaria Venture (MMV) announced today, that a potential breakthrough antimalarial drug, has entered into human clinical trials. Findings in the discovery of this new antimalarial drug will be published on 19 August in Nature, a premier international scientific journal.
Ranbaxy Laboratories Ltd, MMV’s pharmaceutical partner for the development of this drug, has obtained authorisation from Medicines and Healthcare Products Regulatory Agency (MHPRA) to conduct clinical trials in the United Kingdom. This is the first regulatory step in new drug development after safety and drug activity is established in the pre-clinical phase.
The drug, OZ277/RBx11160, is currently being evaluated in a Phase I study for its safety, tolerability and pharmacokinetics (PK) in humans in the United Kingdom.
OZ, a synthetic peroxide, is believed to have similar mode-of-action as the most effective antimalarial drug currently available — artemisinin, a herbal remedy based on the Artemisia annua plant. However, because of the costly and lengthy extraction process from the plant, artemisinins are at least ten times more expensive than the cheap standard antimalarials. Although artemisinin-based combination therapies (ACTs) are currently the best cure for drug resistant malaria, access to ACTs in disease endemic countries has been limited due to their cost. An effective synthetic drug would be superior to the current ACTs as it will not be dependent on the artemisia plant and will likely be much cheaper to manufacture.
”The need to develop a low-cost, potent synthetic antimalarial drug is more urgent than ever,” said MMV CEO Dr. Christopher Hentschel. ”This project has surpassed our expectations as it moved so successfully and rapidly through candidate selection and scale-up. Its publication in Nature is another validation that the team has done a fantastic job in moving the project forward with professionalism, dedication and speed. This could be the biggest breakthrough in malaria treatment of our generation.”
This synthetic peroxide project originated from work done in the late 1990’s by teams of researchers at University of Nebraska Medical Center (UNMC), Monash University in Australia, the Swiss Tropical Institute and F. Hoffmann-La Roche of Switzerland. Dr. Jonathan Vennerstrom of UNMC, the chief investigator on the project said that he was humbled by Nature selecting the article for publishing.
”We were overjoyed that we’re getting published in Nature,” Dr. Vennerstrom said. ”The researchers on this project all feel enormous pride in the progress of this drug and feel privileged to be able to contribute to its development. The momentum and synergy created from this project can be greatly attributed to MMV’s steadfast commitment and leadership.”
”Ranbaxy is privileged to carry on the baton from this team of talented researchers. Our scientists are excited to be able to work on a drug that could save millions of lives,” said Dr. Brian Tempest, CEO & Managing Director of Ranbaxy. ”We are pleased with the progress of the project. Developing drugs is indeed not easy.” He further added, ”We have many hurdles to overcome, but we will rise to the challenge. Ranbaxy is committed to developing a drug that is not only safe and effective, but also affordable to people in India and hundreds of millions others who have to live with this terrible disease everyday.”
In May 2003, Ranbaxy, India’s largest pharmaceutical company and rapidly growing globally, entered into an agreement with MMV, Geneva, for the development of Synthetic Peroxide anti-malarial drug.
The resurgence of malaria, starting in the late 1970’s, is largely attributable to drug resistance. The standard cheap medicines such as chloroquine have been rendered useless in almost every corner of sub-Saharan Africa where every 30 seconds, a child dies of malaria. More than a million people die every year from this curable disease. Beyond the human toll, malaria costs Africa an estimated US$12 billion a year in lost GDP and accounts for 40% of its public health spending.
Although ACTs are currently the most effective malaria treatment, because of cost, donors have been reluctant to provide the necessary subsidies to make ACTs accessible to the poor in the disease endemic countries. It is estimated that 300-500 million malaria treatments are needed every year.
According to a recent report released by the Institute of Medicine (IOM), the malaria crisis can be halted and reversed with the dramatic scale-up of ACT use and commitments from donor governments to provide the necessary subsidies for the drug. The report also stressed that additional resources are urgently needed for malaria drug R&D in order to develop cheaper and effective alternatives to supplement and replace older drugs and prevent drug resistance from winning the malaria battle. This new synthetic antimalarial could become a major new weapon in this fight against multi-drug resistant malaria.
Medicines for Malaria Venture (MMV) is a non-profit organisation dedicated to reducing the burden of malaria in disease-endemic countries by discovering, developing and delivering new affordable antimalarials through effective public-private partnership. After four years of operation, MMV is managing the largest-ever portfolio of malaria research with 21 projects in different stages of drug research and development. MMV’s goal is to register at least one new antimalarial before 2010 and maintain a sustainable pipeline of antimalarials to meet the needs of the 2.4 billion people living with malaria. http://www.mmv.org
About Ranbaxy Laboratories Limited
Ranbaxy Laboratories Limited, India’s largest pharmaceutical Company, manufactures and markets branded generic pharmaceuticals and Active Pharmaceutical Ingredients. Ranbaxy’s continued focus on R&D has resulted in several approvals in developed markets and significant progress in New Drug Discovery Research. Ranbaxy’s foray into Novel Drug Delivery Systems has led to proprietary ”platform technologies” resulting in a number of products under development. http://www.ranbaxy.com