Daiichi Sankyo-controlled Ranbaxy Laboratories 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—Nigeria, Uganda, Senegal, Cameroon Guinea, Kenya and Ivory Coast, as per a company release.
The product has been launched in Uganda and will be made available in other countries towards the end of January 2015.
The new drug conforms to the recommendations of the World Health Organization (WHO) for using combination therapy in malaria. Synriam provides relief from most malaria-related symptoms, including fever and has a cure rate of over 95 per cent.
Arun Sawhney, CEO and managing director of 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 and affordable. The drug will help the government and healthcare system in Africa fight the menace of malaria.”
The Phase III clinical trial for the drug has demonstrated that Synriam has comparable safety and efficacy profile for treatment of 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 for treating Plasmodium falciparum malaria.
Synriam was launched by Ranbaxy in India in 2012.
Earlier this year Ranbaxy received approval from the US drug regulator to manufacture and market Valsartan 40 mg, 80 mg, 160 mg and 320 mg tablets. Valsartan is indicated for the treatment of high blood pressure and heart failure. It is a generic version of Novartis’ innovator branded drug Diovan. The total annual market sale of Diovan is pegged at $2.19 billion.
Ranbaxy has been under the scanner of US FDA over various issues which had led the US drug regulator to ban import of products made at all its Indian plants.
Earlier this year US FDA had prohibited Ranbaxy from producing and selling active pharmaceutical ingredients for American markets from its Toansa facility in Punjab, citing manufacturing violations. With this, all Indian plants of the company had been banned from shipping products for sale in the US.
Previously, US FDA had banned Ranbaxy from selling products made at its factories in Paonta Sahib, (Himachal Pradesh), Dewas (Madhya Pradesh) and Mohali (Punjab) over irregularities.
(Edited by Joby Puthuparampil Johnson)