Ranbaxy Laboratories Ltd. announced that it has received the regulatory approval to launch India's first New Chemical Entity (NCE) , Synriam (arterolane maleate 150 mg + piperaquine phosphate 750 mg drug) in seven African countries, namely, Nigeria, Uganda, Senegal, Cameroon, Guinea, Kenya and Ivory Coast.
The company said the product had been launched in Uganda and would be made available in other countries towards end of January 2015.
The new drug conform 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 percent.
Ranbaxy CEO & MD Arun Sawhney said, "Most malaria cases and deaths occur in sub-Saharan Africa. It is the need of the hour to make available new therapy options to patients in the region. Synriam is among the best options available today as it is highly effective, affordable and a convenient therapy option, leading to better compliance. We are confident that the drug will help the government and healthcare system in Africa to fight the menace of malaria."
The company conducted double-blind, randomized, multi-center, Phase III clinical trial for the drug at multiple sites in Asia and Africa including India, Thailand, Bangladesh, Ivory Coast, Mozambique, Malawi, Senegal, Mali and Democratic Republic of Congo. This clinical trial has demonstrated that Synriam ( fixed dose combination of arterolane maleate and piperaquine phosphate 150 mg + 750 mg) has comparable safety and efficacy profile to existing gold standard (fixed dose combination of artemether and lumefantrine 20 mg + 120 mg) for treatment of acute uncomplicated Plasmodium falciparum malaria in patients aged 12 years and above.
Ranbaxy is also conducting Phase III clinical trials for the pediatric formulation of Synriam in pediatric patients of uncomplicated Plasmodium falciparum malaria.
Every year around 169 million people in Nigeria and around 32 million people in Uganda are at the risk of malaria. In Nigeria, malaria contributes to an estimated 11 percent of maternal mortality. It is the number one public health problem in Guinea and according to national health statistics, the morbidity rate for malaria is 148/1000 population. The disease is endemic throughout Senegal, and the entire population (around 13.4 million) is at risk. Vulnerable groups comprise around 2.2 million children under five and 0.5 million pregnant women. Around 70 percent of the Kenyan population is at risk for malaria. Plasmodium falciparum is the most predominant parasite species accounting for maximum malaria cases in these countries, the company said.
At the BSE, Ranbaxy Laboratories shares are currently trading at Rs.643.80, up 0.11 percent from the previous close.
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