Lupin gains after US FDA OKs Trizivir generic

Lupin rose 1.25% to Rs 863.45 at 10:57 IST on BSE after the company said it received final approval for its generic version of Trizivir tablets from the US drug regulator.

The announcement was made during trading hours today, 10 December 2013.

Meanwhile, the BSE Sensex was down 107.33 points, or 0.50%, to 21,219.09.

On BSE, so far 27,000 shares were traded in the counter compared with average volume of 90,944 shares in the past one quarter.

The stock hit a high of Rs 864.50 and a low of Rs 856 so far during the day. The stock hit a record high of Rs 946.35 on 11 October 2013. The stock hit a 52-week low of Rs 569 on 1 March 2013.

The stock had underperformed the market over the past one month till 9 December 2013, sliding 3.49% compared with the Sensex's 3.19% rise. The scrip had also underperformed the market in past one quarter, rising 1.64% as against Sensex's 10.67% rise.

The large-cap company has an equity capital of Rs 89.64 crore. Face value per share is Rs 2.

Lupin said that it received final approval from the United States Food and Drugs Administration (US FDA) to sell Abacavir Sulfate, Lamivudine, and Zidovudine tablets, a generic version of ViiV Healthcare's (ViiV) Trizivir tablets, in the US market in strengths of 300 milligram (mg) (base)/150 mg/300 mg.

Lupin said the drug is indicated in combination with other antiretrovirals or alone for the treatment of HIV-1 infection.

Lupin said that since it was the first applicant to file an Abbreviated New Drug Application (ANDA) for Trizivir tablets, it will be entitled to 180 days of marketing exclusivity.

Trizivir tablets had annual US sales of approximately $111.6 million (IMS MAT September 2013).

Lupin's consolidated net profit surged 39.8% to Rs 406.18 crore on 17.5% growth in net sales to Rs 2631.46 crore in Q2 September 2013 over Q2 September 2012.

Lupin is a transnational pharmaceutical company producing and developing a wide range of branded and generic formulations and APIs globally. The company is a significant player in the cardiovascular, diabetology, asthma, pediatric, CNS, GI, anti-infective and NSAID space and holds global leadership positions in the anti-TB and cephalosporin segment.

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