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Natco wins India regulator nod for Sovaldi generic

Shares of Natco Pharma on Tuesday jumped almost 15% after the company announced that it has received approvals to market first generic copy of hepatitis C drug sofosbuvir from the Drug Controller General (India).

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Shares of Natco Pharma on Tuesday jumped almost 15% after the company announced that it has received approvals to market first generic copy of hepatitis C drug sofosbuvir from the Drug Controller General (India).

In a statement on BSE, the company said, "Natco Pharma is pleased to announce that it is the first company in India to get approval for generic sofosbuvir tablets, 400mg, from Drugs Controller General (India). Natco will market generic sofosbuvir under its brand Hepcinat and through strategic partners in India."

Sofosbuvir is a medicine used for chronic hepatitis C infection and sold globally by Gilead Sciences, Inc, under its brand Sovaldi.

The price of Sovaldi, developed and patented by Gilead, has been the topic of debate globally. Priced at $1,000 a pill, the cost of 12-week course of treatment in the US was $84,000.

Natco had recently signed a non-exclusive licensing agreement with Gilead Sciences, to manufacture and sell generic versions of its chronic hepatitis C medicines in 91 developing countries.

The company said it plans to price its generic medicine at a maximum retail price of Rs 19,900 for a bottle of 28 tablets and expects to launch the generic drug in India very soon.

The company launched the generic Sovaldi early this week in Nepal under the same brand name and at the same price.

The stock has touched a 52-week high on BSE at Rs 2132.60 in intra-day, an increase of 19% before recovering to Rs 2056.85-level, up 14.78% the previous close. However, the shares of the company has rallied 50% so far from Rs 1368.7 on February 28, after it informed BSE regarding non-exclusive licensing agreement it has signed with Gilead Sciences on March 2.

Pharma analyst Hitesh Mahida of Antique Stock Broking in a research report said, "The non-oncology business of Natco Pharma has not really taken off for the company, with only 12 brands in the market generating revenues of Rs 15.3 crore in 2013-14. The business is set to witness a revival with the launch of Sovaldi in the domestic market. Natco is the first company to get an approval for the drug in India."

The report pointed out that Sovaldi generated sales in excess of $10 billion for Gilead in 2014 and is believed to be a breakthrough treatment in chronic Hepatitis. The drug reduces Hepatitis treatment to 12 weeks from 48 weeks and has a much higher curing rate than rival therapies like Boceprevir, Telaprevir, Thymalfasin, etc.

"Two major markets for the company would be India and Egypt, with a cumulative patient population of 30m. We believe the drug can easily generate domestic sales of Rs 150 crore for Natco. Natco has launched the drug at almost $960 for three months treatment. Even if the drug price falls to $300 for a 3 -month treatment, its market potential is high," Mahida said.

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