Aurobindo Pharma surges over 6 per cent on getting tentative USFDA nod for HIV drug

Aurobindo Pharma surged over 6 per cent on Thursday after it received tentative approval for Dolutegravir 50mg from US Food & Drug Administration (USFDA) used in the treatment of HIV-1 infection in combination with other antiretroviral agents. At 3.15 pm, Share price of the company was trading 6.56 per cent up at Rs 859. The scrip opened at Rs 814.90 and touched a high and low of Rs 860 and Rs 811.50, respectively. Later, the scrip ended 6.33 per cent up at Rs 857.15.

The BSE group ‘A’ stock of face value Rs 1 has touched a 52-week-high of Rs 891.50 on Dec 30, 2015 and a 52-week-low of Rs 582.00 on Feb 25, 2016. The promoters holding in the company stood at 53.79%, while Institutions and Non-Institutions held 34.08% and 12.13% respectively.

The USFDA tentative approval to Dolutegravir (DTG) marks the first FDA approval of a generic version of Dolutegravir (DTG), an integrase strand transfer inhibitor recommended for use in treatment-naive 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.

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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.

N. Govindarajan, managing director, Aurobindo Pharma said, “The approval of the generic version of DTG shows the commitment towards the larger cause of bringing affordable HIV drugs to millions of people. This is a one-of-its-kind agreement between innovator and generic company where the generic version of the drug will be launched in around three years from the originator product. Further, we are also developing a fixed dose combination of DTG.”