Aurobindo Pharma gains after getting USFDA approval for Levetiracetam

Aurobindo Pharma rose 2.06% to Rs 707.05 at 09:55 IST on BSE after the company received final approval from the US Food & Drug Administration to manufacture and market Levetiracetam.

The announcement was made on Saturday, 7 January 2017.

Meanwhile, the S&P BSE Sensex was up 6.28 points, or 0.02%, to 26,765.51

On the BSE, so far 1.35 lakh shares were traded in the counter, compared with average daily volumes of 1.81 lakh shares in the past one quarter. The stock had hit a high of Rs 725 and a low of Rs 706.10 so far during the day. The stock hit a record high of Rs 895 on 6 October 2016. The stock hit a 52-week low of Rs 582 on 25 February 2016.

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

Aurobindo Pharma announced that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Levetiracetam in Sodium Chloride Injection, 500 mg/100 mL (5 mg/mL), 1000 mg/100 mL (10 mg/mL), and 1500 mg/100 mL (15 mg/mL) (single-use bags). Aurobindo's Levetiracetam in Sodium Chloride Injection is a generic equivalent of HQ Specialty Pharma Corp's Levetiracetam in Sodium Chloride Injection. The product will be launched in January 2017.

Levetiracetam in Sodium Chloride Injection is a CNS drug and indicated for partial onset seizures in adults (16 years and older) with epilepsy; myoclonic seizures in adults with juvenile myoclonic epilepsy; primary generalized tonic-clonic seizures in adults with idiopathic generalized epilepsy. The approved product has an estimated market size of $32 million for the twelve months ended November 2016, according to IMS.

This is the 41st Abbreviated New Drug Application (ANDA) (including 2 tentative approvals) to be approved out of unit IV formulation facility in Hyderabad used for manufacturing general injectable products. Aurobindo now has a total of 304 ANDA approvals (263 final approvals including 16 from Aurolife Pharma LLC and 41 tentative approvals) from USFDA.

Separately, Aurobindo Pharma's wholly owned step-down subsidiary Agile Pharma B.V., Netherlands has announcing signing of a binding agreement to acquire Generis Farmaceutica S.A for 135 million euro from Magnum Capital Partners. Generis is engaged in manufacture and sale of pharmaceutical products in Portugal. The acquisition includes the manufacturing facility in Amadora, Portugal, which has the capacity to produce 1.2 billion tablets/capsules/sachets annually.

This deal consolidates Aurobindo's footprint in Portugal, which currently consists of Aurovitas, Unipessoal LDA and Aurobindo Pharma (Portugal), Unipessoal Limitada, the company said. The management estimates that the net sales for the acquired business will be approximately 72 million euros in 2017, compared to 64.8 million euros in 2016. Adjusted Earnings before interest, tax, depreciation and amortization (EBITDA) estimate for 2016 is 12.7 million euros, which is projected to improve to 15.8 million euros in 2017, Aurobindo Pharma said.

On consolidated basis, Aurobindo Pharma's net profit rose 33.53% to Rs 605.64 crore on 12.03% growth in total income to Rs 3783.73 crore in Q2 September 2016 over Q2 September 2015.

Aurobindo Pharma manufactures generic pharmaceuticals and active pharmaceutical ingredients. The company's 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.

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