Strides Shasun gets regulator’s nod to manufacture hepatitis C drug1 min read . Updated: 21 Dec 2015, 05:25 PM IST
Strides became the third drug maker to get the DCGI's approval to manufacture Gilead Sciences Inc.'s sofosbuvir
Strides Shasun Ltd has got approval from the Drug Controller General of India (DCGI) to make generic hepatitis-C drug sofosbuvir 400 mg, the company said on Monday.
Strides became the third drug maker to get the DCGI’s approval to manufacture sofosbuvir, after Natco Pharma Ltd and Hetero Drugs Ltd. Sofosbuvir is a hepatitis C drug of Gilead Sciences Inc. sold under the brand name Sovaldi.
In September 2014, Strides entered into a licensing agreement with Gilead Sciences to bring the hepatitis C cure to 91 developing countries.
Strides launched sofosbuvir for sale in India and overseas under the brand name Virso in March.
With the manufacturing approval in place, Strides said it’s considering tie-ups with other drug makers for contract manufacturing.
Gilead also signed similar non-licensing agreements with 10 other large generic drug makers, including Natco Pharma, Hetero Drugs, Cadila Healthcare Ltd, Cipla Ltd, Mylan Laboratories Ltd, Ranbaxy Laboratories Ltd (now owned by Sun Pharmaceutical Industries Ltd) and Sequent Scientific, to sell cheaper versions of Solvadi in developing countries having an average per capita income of less than $1,900. Such nations account for about 54% of those with hepatitis C.
In January, the Indian patent office rejected an application filed by Gilead for Sovaldi and its follow-on hepatitis C treatments after Natco and US-based non-profit organization, the Initiative for Medicines, Access & Knowledge, challenged Gilead’s patents, questioning the drug’s novelty.
Sovaldi costs $1,000 a day in the US for a 12-week regimen.
Following strong criticism from healthcare groups and various governments on the exorbitant cost of the new drug, Gilead had decided to licence the manufacturing right of the medicine to generic companies to make it accessible in low-income countries soon after its launch in the US.
Hepatitis C is a growing public health concern, particularly in developing countries. In India alone, it is estimated that 12-18 million patients are infected with hepatitis C. If left untreated, chronic hepatitis C increases the risk of liver failure, cirrhosis of liver and hepatocellular carcinoma.
Shares of Strides gained 0.14% to ₹ 1,308 on BSE, while the benchmark Sensex rose 0.85% to 25,735.90 points.