Drug manufacturer Ranbaxy Laboratories said that it has received regulatory approval to launch its new chemical entity (NCE) Synriam in seven African countries namely Nigeria, Uganda, Senegal, Cameroon, Guinea, Kenya and Ivory Coast. The product has already been launched in Uganda and will be made available in other countries towards the end of January 2015, the company said.
Synriam is a new age therapy recommended for the treatment of uncomplicated Plasmodium falciparum malaria in adults.
While the drug research started in 2003, the company received an approval from the Drug Controller General of India (DCGI) to manufacture and market it in India in 2011. Ranbaxy launched the drug in 2012 in India, and since then the drug has successfully treated around one million patients in India.
Arun Sawhney, CEO and managing director, Ranbaxy 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 new drug 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%, the company further said in the statement.
Since the drug 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.
"Double-blind, randomized, multi-center, phase 3 clinical trial for the drug was conducted at multiple sites in Asia and Africa including India, Thailand, Bangladesh, Ivory Coast, Mozambique, Malawi, Senegal, Mali and Democratic Republic of Congo," Ranbaxy said in the release, adding that it is also conducting Phase III clinical trials for the pediatric formulation of Synriam in pediatric patients of uncomplicated plasmodium falciparum malaria.
Plasmodium falciparum is the most predominant parasite species accounting for maximum malaria cases in these countries. 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% 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 (approximately 13.4 million) is at risk. Vulnerable groups comprise about 2.2 million children under five and 0.5 million pregnant women. About 70% of the Kenyan population is at risk for malaria.
Sarabjit Kour Nangra, VP research - pharma, Angel Broking, said, "A rough estimate puts the market for the drug in these markets at around $300-350mn, on a conservative basis. Thus the development is positive and can add around easily around $80-100mn, within first year of sales and would be fully reflected in FY2016."
Post announcement, however, the share price of the company closed at Rs 639.35 on BSE, down 0.58% from previous close.
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