Aurobindo Pharma gains after receiving tentative approval from USFDA for drug

Aurobindo Pharma jumped 5.12% to Rs 847.45 at 14:10 IST on BSE after the company said it received tentative approval of Dolutegravir 50mg from US Food & Drug Administration for the treatment of HIV.

The announcement was made during trading hours today, 22 September 2016.

Meanwhile, the S&P BSE Sensex was up 232.98 points or 0.82% at 28,740.40.

High volumes were witnessed on the counter. On BSE, so far 4.4 lakh shares were traded in the counter as against average daily volume of 1.64 lakh shares in the past one quarter. The stock hit a high of Rs 846.90 and a low of Rs 811.50 so far during the day. The stock had hit a record high of Rs 891.50 on 30 December 2015. The stock had hit a 52-week low of Rs 582 on 25 February 2016. The stock had outperformed the market over the past one month till 21 September 2016, gaining 5.57% compared with 1.53% rise in the Sensex. The scrip had also outperformed the market in past one quarter, gaining 11.65% as against Sensex's 6.32% rise.

The large-cap company has equity capital of Rs 58.52 crore. Face value per share is Re 1.

Aurobindo Pharma said that this important milestone marks the first US Food & Drug Administration (USFDA) approval of a generic version of Dolutegravir (DTG), an integrase strand transfer inhibitor recommended for use in treatment-nae patients by the US Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO). Through an innovative collaboration with ViiV and the Clinton Health Access Initiative, Inc. (CHAI), the product is expected to be launched in sub-Saharan Africa in late 2016. The approved Abbreviated New Drug Application (ANDA) is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Tivicay, of ViiV Healthcare. ViiV Healthcare and Aurobindo Pharma signed a licensing agreement in 2014 that allows Aurobindo Pharma to supply Dolutegravir 50mg in 92 licensed countries, following completion of required local regulatory approval processes.

Dolutegravir 50mg is indicated for the treatment of HIV-1 infection in combination with other antiretroviral agents.

Aurobindo Pharma's consolidated net profit rose 23.8% to Rs 584.96 crore on 13% growth in net sales to Rs 3663.91 crore in Q1 June 2016 over Q1 June 2015.

Aurobindo Pharma manufactures generic pharmaceuticals and active pharmaceutical ingredients. The company's robust product portfolio is spread over 7 major therapeutic/product areas encompassing antibiotics, anti-retrovirals, CVS, CNS, gastroenterologicals, anti-allergies and anti-diabetics, supported by an outstanding R&D set-up. The company is marketing these products globally, in over 150 countries.

Powered by Capital Market - Live News