Natco Pharma jumps as partner gets USFDA tentative approval for Sorafenib Tablets

Natco Pharma surged 8.58% to Rs 518.50 at 15:16 IST on BSE after the company announced that its marketing partner, Mylan Inc. has received a tentative approval for its ANDA for Sorafenib Tablets, 200mg, with the USFDA.

The announcement was made during market hours today, 3 June 2016.

Meanwhile, the S&P BSE Sensex was down 2.50 points or 0.01% at 26,840.64

On BSE, so far 4.69 lakh shares were traded in the counter as against average daily volume of 59,833 shares in the past one quarter. The stock hit a high of Rs 522.65 and a low of Rs 480 so far during the day. The stock had hit a 52-week low of Rs 382.20 on 24 August 2015. The stock had hit a record high of Rs 623.60 on 5 January 2016. The stock had underperformed the market over the past one month till 2 June 2016, rising 0.07% compared with Sensex's 5.53% gains. The scrip also underperformed the market in past one quarter, rising 8.96% as against Sensex's 10.73% gains.

The mid-cap company has equity capital of Rs 34.83 crore. Face value per share is Rs 2.

Natco Pharma announced today, 3 June 2016 that its marketing partner, Mylan Inc. has received a tentative approval for its Abbreviated New Drug Application (ANDA) for Sorafenib Tablets, 200mg, with the US Food and Drug Administration (USFDA). This product is the generic version of NEXAVAR, which is indicated for the treatment of certain types of cancers including unresectable hepatocellular carcinoma and advanced renal cell carcinoma. Natco Pharma and Mylan have filed an ANDA containing a Paragraph IV certification for this product. Natco Pharma manufactures this product at its facility in Kothur, Telangana.

Bayer Healthcare LLC, Bayer Healthcare Pharmaceuticals Inc., and Onyx Pharmaceuticals Inc., sells Sorafenib Tablets, 200mg, under Brand name NEXAVAR, in the US market. For the 12 months ended 31 December 2015, NEXAVAR had US sales of approximately $300 million (as per Bayer's annual report).

Natco Pharma's consolidated net profit rose 10.7% to Rs 60.24 crore on 103% growth in net sales to Rs 386.77 crore in Q4 March 2016 over Q4 March 2015.

Natco Pharma manufactures generic dosage forms, bulk actives and intermediates for the Indian and international markets.

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