Natco Pharma jumps on filing 2 ANDAs with USFDA

Natco Pharma rose 4.49% to Rs 1,420.50 at 15:30 IST on BSE after the company said it filed abbreviated new drug applications for two separate products with the US drug regulator.

The announcement was made during trading hours today, 10 February 2015.

Meanwhile, the BSE Sensex was up 121.94 points, or 0.43%, to 28,349.33.

On BSE, so far 15,000 shares were traded in the counter, compared with an average volume of 8,299 shares in the past one quarter.

The stock hit a high of Rs 1,473.40 and a low of Rs 1,353.40 so far during the day. The stock hit a record high of Rs 1,586.25 on 19 January 2015. The stock hit a 52-week low of Rs 655.55 on 1 April 2014.

The stock had underperformed the market over the past one month till 9 February 2015, falling 3.48% compared with 2.80% rise in the Sensex. The scrip had also underperformed the market in past one quarter, falling 1.98% as against Sensex's 1.29% rise.

The mid-cap company has an equity capital of Rs 33.23 crore. Face value per share is Rs 10.

Natco Pharma announced that it has filed abbreviated new drug applications (ANDAs) for Fingolimod, 0.5 milligram (mg) capsules and Cabazitaxel, 60mg/1.5ml injection, with the US Federal Drug Administration (USFDA), through the company's respective marketing partners in the USA.

Natco and its associated marketing partners for the above products in the USA, believe that they are the first company to have filed a substantially complete ANDA which includes a paragraph IV certification for Fingolimod, 0.5mg Capsules & Cabazitaxel, 60mg/1.5ml Injection, providing 180 days of marketing exclusivity upon its final USFDA approval, Natco said in a statement.

Novartis sells Fingolimod 0.5mg capsules under brand name Gilenya, in the US market and used for the treatment of certain patients with multiple sclerosis. The market size of Gilenya in the US is approximately $1.2 billion for twelve months ending September 2014, according to IMS Health.

Sanofi sells Cabazitaxel 60mg/1.5ml Injection under brand name Jevtana, in the US market and used for the treatment of certain patients with hormone-refractory prostate cancer. The market size of Jevtana in the US is approximately $116.8 million for twelve months ending September 2014, according to IMS Health.

Natco will announced Q3 results tomorrow, 11 February 2015. On a consolidated basis, Natco Pharma's net profit rose 20.25% to Rs 32.37 crore on 28.40% rise in net sales to Rs 212.65 crore in Q2 September 2014 over Q2 September 2013.

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

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