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It is first indigenously developed drug of the country – an anti-malaria drug, Synriam (arterolane maleate and piperaquine phosphatethe). Ranbaxy said that it would be the cheapest therapy for malaria in the market. It would be priced at Rs130 for the required dosage of three tablets (1 tablet a day for three days). Interestingly, a bigger rival, Cipla also announced the launch of a fixed-dose combination of Artesunate (AS) and Mefloquine (MQ) medicines for the treatment of falciparum malaria.
GURGAON: Opening a new chapter in the history of Research & Development in India, Ranbaxy Laboratories Limited (Ranbaxy) today launched India’s first new drug, Synriam, for the treatment of uncomplicated Plasmodium falciparum malaria, in adults.
At a function held in New Delhi, Mr. Ghulam Nabi Azad, Minister of Health and Family Welfare, Govt. of India and Mr. Vilasrao Deshmukh, Minister of Science & Technology and Earth Sciences, Govt. of India, unveiled India’s first new drug Synriam with Ranbaxy dedicating the New Age Cure for Malaria to the Nation, on World Malaria Day.
The new drug, has been approved by the Drug Controller General of India (DCGI) for marketing in India and conforms to the recommendations of the World Health Organization (WHO) for using combination therapy in malaria. Synriam provides quick relief from most malaria-related symptoms, including fever, and has a high cure rate of over 95 per cent.
Phase III clinical trials for the drug conducted in India, Bangladesh and Thailand successfully demonstrated the efficacy and tolerability of Synriam as comparable to the combination of artemether and lumefantrine.
The dosage regimen is simple as the 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. This makes Synriam a convenient option, leading to better compliance. 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.
Felicitating the scientific team from Ranbaxy, Dr. Tsutomu Une, Chairman, Ranbaxy, said, “I applaud all our scientists who have worked incessantly over 8 years and with great diligence to successfully develop a new drug. This is a tribute to the indomitable spirit of the Indian scientific community. The drug fills a vital therapy gap not only in India but also worldwide. We will make all possible efforts to make Synriam accessible to the world.”
Arun Sawhney, CEO and Managing Director, Ranbaxy said, “It is indeed gratifying to see that Ranbaxy’s scientists have been able to gift our great nation its first new drug, to treat malaria, a disease endemic to our part of the world. Synriam will certainly become the preferred option in the hands of doctors to fight malaria, which every year claims more than half a million lives globally.”
“This is a historic day for science and technology in India as well as for the pharmaceutical industry in the country. Today, India joins the elite and exclusive club of nations of the world that have demonstrated the capability of developing a new drug.” added Mr. Sawhney.
Heralding the arrival of the new drug, Dr. Sudershan Arora, President-R&D, Ranbaxy, said. “The new drug, which will be marketed first in India, is developed as a fixed dose combination consisting of arterolane maleate 150 mg and piperaquine phosphate 750 mg drug, in line with WHO recommendations. It is among the best options available today. I applaud the success of R&D at Ranbaxy in the creation of this New Age Cure for Malaria and am sure that innovative drug products will continue to be developed at Ranbaxy-R&D labs, even in the future.”
Ranbaxy is also working to make this new treatment available in African, Asian and South American markets where Malaria is rampant. Synriam trials are ongoing for Plasmodium vivax malaria and a paediatric formulation.
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. Most of the existing therapies have a high pill burden that increases the possibility of missing a dose. There was a critical need for a new anti-malaria drug that would address these challenges. Ranbaxy embarked upon this development project with the aim of coming up with a new anti-malarial drug that would be highly effective as well as address the issues associated with the most commonly used therapies.
Malaria Disease Burden: Malaria remains one of the deadliest diseases affecting humanity and a major global public health challenge. India accounts for over 75 per cent of the 2.5 million reported cases of malaria in South East Asia. More than two-thirds of the Indian population lives in the malaria-affected parts of the country. According to WHO*, 15,000 people die annually due to malaria in India whereas Lancet#, one of the world’s leading medical Journals, points out that 205,000 people die of malaria annually in India. In India around 117 districts are Chloroquine resistant. SynriamTM has been shown to be effective in these geographical regions also.
What causes Malaria: Malaria spreads through the bite of the infected female anopheles mosquito. There are four types of malarial parasites, of which Plasmodium falciparum and Plasmodium vivax are the most common. Plasmodium falciparum accounts for about 90 per cent of the deaths caused due to malaria.
Ranbaxy Laboratories Limited: Ranbaxy Laboratories Limited, India’s largest pharmaceutical company, is an integrated, research based, international pharmaceutical company producing a wide range of quality, affordable generic medicines, trusted by healthcare professionals and patients across geographies. Ranbaxy’s continued focus on R&D has resulted in several approvals, in developed and emerging markets many of which incorporate proprietary Novel Drug Delivery Systems (NDDS) and technologies, developed at its own labs.
The company has further strengthened its focus on generics research and is increasingly working on more complex and specialty areas. Ranbaxy serves its customers in over 125 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 43 countries and manufacturing operations in 8 countries. Ranbaxy is a member of the Daiichi Sankyo Group. Through strategic in-licensing opportunities and its hybrid business model with Daiichi Sankyo, a leading global pharma innovator headquartered in Tokyo, Japan, Ranbaxy is introducing many innovator products in markets around the world, where it has a strong presence. This is in line with the company’s commitment to increase penetration and improve access to medicines, across the globe.
*Source: WHO (2008) World Malaria Report, Geneva
#Source: The Lancet, 20 November 2010