Ranbaxy Drug Synriam Receives Indian Government Approval to Treat Plasmodium Vivax

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Single treatment for both Plasmodium vivax and Plasmodium falciparum malaria Permission received to conduct Phase III clinical trials for pediatric formulation

Gurgaon, India,: Ranbaxy Laboratories Limited (Ranbaxy) today announced that the company has received approval from the Central Drugs Standard Control Organisation (CDSCO), Government of India to manufacture and market Synriam (arterolane maleate and piperaquine phosphate tablet 150+750 mg) in India for the treatment of uncomplicated malaria in adults caused by Plasmodium vivax parasite.

Phase III clinical trials for the drug conducted in India, successfully demonstrated the efficacy and tolerability of Synriam as comparable to chloroquine.

Last year on World Malaria Day, April 25, Ranbaxy had launched India’s first new drug, Synriam for the treatment of uncomplicated Plasmodium falciparum malaria in India. Since its launch, Synriam has successfully treated around one million patients.

The company has also received permission to conduct Phase III clinical trials for the pediatric formulation in pediatric patients of uncomplicated Plasmodium falciparum malaria.

Commenting on the approval, Arun Sawhney, CEO & Managing Director, Ranbaxy, said, “Synriam is a new age cure for malaria and is fast emerging as the preferred option in the hands of doctors. This approval makes Synriam one of the few therapies in the world that successfully treats both, Plasmodium vivax and Plasmodium falciparum malaria. Ranbaxy remains committed in its fight against malaria and we are making all efforts to make this new therapy accessible to patients around the world.”

Ranbaxy is working to make this new treatment available in African, Asian and South American markets where malaria is rampant. The company has filed New Drug Applications (NDAs) for marketing Synriam in some African countries and will be filing more applications during the year. Once approved, the product will be launched in these markets.

Synriam provides quick relief from most malaria-related symptoms, including fever, and has a high cure rate of over 95%. It conforms to the recommendations of the World Health Organization (WHO) for using combination therapy in malaria.

As the dosage regimen for Synriam is simple, it leads to better compliance. A patient is required to take just one tablet per day, for three days, compared to other medicines where two to four tablets are required to be taken, twice daily, for three or more days. The drug is also independent of dietary restrictions for fatty foods or milk, as is the case with older anti-malarial therapies. Since Synriam has a synthetic source, unlike artemisinin-based drugs, production can be scaled up whenever required and a consistent supply can be maintained at a low cost.

According to the World Malaria Report 2012 published by WHO, India sees about 1.3 million confirmed cases of malaria each year, about 50% of which are caused by Plasmodium vivax, the second most important species after Plasmodium falciparum. Worldwide, 40% of total malaria burden globally is due to Plasmodium vivax , which shows the vast potential of Synriam in India and globally.

Traditional drugs are proving ineffective against the deadly malarial parasite because it has progressively acquired marked resistance to available drugs. Availability of plant based Artemesinin, a primary ingredient in established anti-malarial therapies is finite and unreliable. This leads to price fluctuations and supply constraints, which is not the case with a synthetic drug like Synriam.

Source: Ranbaxy

New Drug Synriam Approved to Treat Malaria in India

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A new drug to treat malaria, Synriam, was launched in India by Ranbaxy Laboratories Limited. The drug will provide additional options for malaria treatment as  traditional drugs become increasingly ineffective against the deadly malarial parasite because of acquired resistance to available medications.

Taken as a tablet once a day for three days, Synriam may be more effective, cheaper, and have fewer side effects and does not have to be taken with food, according to the University of Nebraska Medical Center (UNMC). From 2000 to 2010, Jonathan Vennerstrom, Ph.D., a professor at the UNMC College of Pharmacy, led an international team that created the drug compound that led to the development of Synriam. Developed by Ranbaxy Pharmaceuticals Limited, the medication now is approved for treatment in adults in India. The company also is working to create a children’s formula and make the drug available in Africa, Asia and South America.

“With more than 200 million cases of malaria each year, the potential impact this drug could have on saving and improving lives worldwide is significant,” Dr. Vennerstrom said. “That’s been our goal and now we are at the finish line.

Tim Wells, MMV’s chief scientific officer, said the completion of a phase III study in Indian adults and the approval of the combination by the Indian regulators was a major milestone. “We look forward to more data from patients in Africa and from studies with children, since this is where the vast majority of the disease is,” he said.

Courtney Fletcher, Pharm.D., dean of the UNMC College of Pharmacy, said another benefit of arterolane, the key component in the new drug invented by Dr. Vennerstrom, is it’s a synthetic. “This is an importance advance in antimalaria drugs. Since it’s a synthetic drug, it doesn’t depend on the availability of a natural plant source like some other antimalarials, which also makes it less expensive.”

Dr. Vennerstrom and his team also have developed a second drug candidate that might be even more superior than the first. It currently is being tested in phase II clinical trials by MMV in Bangkok, Thailand.

“This drug candidate seems to stay in the body longer, and therefore it may be possible to use a single dose instead of three doses,” Dr. Vennerstrom said. “We all forget to take our medications from time to time, so compliance becomes much easier when you have a single-dose drug.”

As a child of missionary parents working in Ethiopia, Dr. Vennerstrom took medications to prevent malaria.

Dr. Vennerstrom and his team received more than $12 million in grants from Medicines for Malaria Venture (MMV), a non-profit organization in Geneva, Switzerland. He has been studying malaria for more than 25 years. The research team included scientists at the Swiss Tropical and Public Health Institute in Switzerland and Monash University in Australia. MMV receives about 60 percent of its funding from the Bill and Melinda Gates Foundation.

“We were very fortunate to receive the support for our project from MMV,” he said. “It is always unpredictable whether or not a drug candidate will be successful.”

Source: University of Nebraska Medical Center (UNMC)