Natco jumps after USFDA final nod for generic drug

Natco Pharma jumped 4.73% to Rs 625.55 at 13:55 IST on BSE after the company said it has received final nod from US drug regulator for generic version of Bendamustine Hydrochloride powder.

The announcement was made during market hours today, 6 January 2017.

Meanwhile, the S&P BSE Sensex was down 27.79 points or 0.1% at 26,850.45.

On the BSE, 95,000 shares were traded on the counter so far as against the average daily volumes of 30,653 shares in the past one quarter. The stock had hit a high of Rs 632 and a low of Rs 596.95 so far during the day.

The stock had hit a record high of Rs 703.95 on 25 August 2016 and a 52-week low of Rs 390 on 29 March 2016. It had underperformed the market over the past one month till 5 January 2017, advancing 0.96% compared with the Sensex's 2.01% rise. The scrip had also outperformed the market in past one quarter, declining 1.12% as against the Sensex's 4.76% fall.

The large-cap company has equity capital of Rs 34.86 crore. Face value per share is Rs 2.

Natco Pharma said it has received the final approval of abbreviated new drug application (ANDA) containing a paragraph IV certification filed with the US Food and Drug Administration (FDA) for generic version of Bendamustine Hydrochloride powder for Injection, 25 mg/vial and 100 mg/vial (singe-dose vial).

Pursuant to the settlement of the Paragraph IV litigation, Natco plans to launch this drug on 1 November 2019, or earlier under certain circumstances, through its marketing partner Breckenridge Pharmaceutical, Inc., in the US market. Natco and Breckenridge filed their ANDA with a Paragraph IV certification on the first-to-file date and expect to share 180-day exclusivity with other ANDA first filers.

Cephalon (acquired by Teva in 2011) sells Bendamustine Hydrochloride powder for Injection, 25 mg/vial and 100 mg/vial (singe-dose vial) under Brand name TREANDA in the US market. TREANDA is indicated for the treatment of patients with chronic lymphocytic leukemia (CLL) and non-Hodgkin's lymphoma. TREANDA had US sales of approximately $133 million for twelve months ended November 2016, according to IMS Health.

On a consolidated basis, net profit of Natco Pharma rose 127.2% to Rs 66.55 crore on 75.6% rise in net sales to Rs 415.21 crore in Q2 September 2016 over Q2 September 2015.

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

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