Hepatitis-C drug Launched in India by Biocon

Hyderabad: Biocon Ltd, India’s largest biotechnology company, on Thursday, December 24, said it has launched the generic version of US-based Gilead Sciences Inc.’s hepatitis-C drug Harvoni in the Indian market.

Harvoni, the fixed-dose combination of ledipasvir-sofosbuvir of 90mg and 400mg, respectively, is an improved version of Gilead’s hepatitis-C drug Sovaldi or sofosbuvir.

Biocon will sell generic Harvoni under brand name CIMIVIR-L.

The Drugs Controller General of India (DCGI) recently approved the sale of the sofosbuvir-ledipasvir combination, which is being manufactured in India under a license from Gilead.

Harvoni, approved by the US Food and Drug Administration (USFDA) for the treatment of chronic hepatitis-C genotype-1 infection, was shown to have high cure rates of around 90%.

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The cost of a 12-week course of this Harvoni therapy in the US is $94,500 or Rs.63 lakh.

Biocon didn’t disclose the price, but said it will make CIMIVIR-L at the fraction of Harvoni’s cost in the US.

Biocon entered into a non-exclusive licensing agreement with Gilead Sciences early this year to manufacture and market chronic hepatitis-C medicines, including Sovaldi and Harvoni, for India and 91 other developing countries by paying 7% royalty on sales.

Gilead also signed similar non-licensing agreements with 10 other large generic drug makers—including Natco Pharma Ltd, Hetero Drugs Ltd, Cadila Healthcare Ltd, Cipla Ltd, Mylan Laboratories Ltd, Ranbaxy Laboratories Ltd (now owned by Sun Pharmaceutical Industries Ltd), Sequent Scientific Ltd and Strides Arcolab Ltd––to sell cheaper versions of Solvadi and Harvoni in 91 developing countries having an average per capita income of less than $1,900 that account for about 54% of those with hepatitis-C.

CIMIVIR-L, a once-a-day oral therapy, will offer a convenient, effective and safe alternative to people infected with the Hepatitis-C virus (HCV), the company said.

It is estimated that nearly 100,000 people die annually in India from HCV infection and co-morbidities. Around 25% of 18 million HCV patients in India are indicated for hepatitis-C genotype 1.

“The introduction of CIMIVIR-L will strengthen Biocon’s current portfolio of virology products. It furthers our commitment to offer affordable therapy for unmet patient needs in debilitating and life-threatening conditions,” said Ravi Limaye, president, marketing, Biocon.

Hepatitis-C is a viral disease that causes liver inflammation leading to diminished liver function or liver failure. It is referred to as a “silent epidemic” as most people infected with HCV have no symptoms of the disease until liver damage becomes apparent, which may take decades.

Chronic HCV infection could lead to scarring and poor liver function (cirrhosis) over many years, resulting in complications such as bleeding, jaundice, fluid accumulation in the abdomen, infections and liver cancer.

Shares of Biocon rose 5.04% and were trading at Rs.506.05 at 10.30am on BSE, while the benchmark Sensex advanced 0.07% at 25,868.02 points.


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