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Ranbaxy launches India’s first homegrown drug

Branded drug Synriam offers advantages over older anti-malarial treatments

Ranbaxy launches India's first homegrown drug

India's Ranbaxy Laboratories has launched what it says is the country's first original pharmaceutical product, Synriam, a new treatment for uncomplicated Plasmodium falciparum malaria, in adults.

The Gurgaon-based company, which is part of Daiichi Sankyo, says the anti-malarial opens a "new chapter in the history of research and development in India".

Ranbaxy's CEO and managing director Arun Sawhney said: “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.”

Ranbaxy was responsible for the drug's late-stage development and launch, making Synriam the first new chemical entity to come to market from an Indian pharmaceutical company.

Synriam, a fixed dose combination of arterolane maleate 150mg and piperaquine phosphate 750mg, claims a number of advantages over existing treatments for malaria.

One tablet has to be taken just once a day for three days, rather than a twice daily regimen of two to four pills, as is usually the case. It is also independent of the dietary restrictions for fatty foods or milk that affect some 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, Ranbaxy said.

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.

Malaria remains a major global public health challenge and India accounts for over 75 per cent of the 2.5m reported cases of malaria in South East Asia.

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.

Dr Tsutomu Une, chairman, Ranbaxy, said: “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.”

Synriam has marketing approval from the Drug Controller General of India (DCGI) and conforms to of the World Health Organization (WHO) recommendations for using combination therapy in malaria.

It will be launched first in India, with Ranbaxy preparing to take it to African, Asian and South American markets next. The company is also working on a paediatric formulation of the drug.

Ranbaxy is India's largest pharmaceutical company and was acquired by Daiichi Sankyo in 2008. The company has traditionally focused on developing low cost generics but has turned its attentions of late to producing its own branded medicines.

In addition to Synriam the firm is collaborating with GlaxoSmithKline on the clinical development of a new chemical entity.

1st May 2012

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