Biocon scales record high after securing USFDA nod

Biocon rose 0.92% to Rs 660.15 at 10:15 IST on BSE after the company and Mylan's Biosimilar Pegfilgrastim received USFDA approval.

The announcement was made before market hours today, 5 June 2018.

Meanwhile, the S&P BSE Sensex was down 83.32 points, or 0.24% to 34,928.57.

On the BSE, 2.40 lakh shares were traded in the counter so far compared with average daily volumes of 2.10 lakh shares in the past two weeks. The stock had hit a high of Rs 695 so far during the day, also its record high. The stock had hit a low of Rs 658.95 so far during the day. The stock hit a 52-week low of Rs 305 on 10 July 2017.

Biocon and Mylan N.V announced that the US Food and Drug Administration (FDA) has approved Mylan's Fulphila (pegfilgrastim-jmbd), a biosimilar to Neulasta (pegfilgrastim), co-developed with Biocon. Fulphila has been approved to reduce the duration of febrile neutropenia (fever or other signs of infection with a low count of neutrophils, a type of white blood cells) in patients treated with chemotherapy in certain types of cancer.

Fulphila is the first FDA-approved biosimilar to Neulasta and the second biosimilar from Mylan and Biocon'sjoint portfolio approved in the US. Mylan anticipates launching Fulphila in the coming weeks, representing the first alternative, more affordable treatment option to Neulasta for oncology patients. A suite of patient services also will be available at launch to further support patients and caregivers with treatment. Neulasta had US sales of $4.2 billion for the 12 months ended 31 March 2018, according to IQVIA.

Mylan and Biocon are exclusive partners on a broad portfolio of biosimilar and insulin products. Biosimilar to Neulasta is one of 11 biologic and insulin products co-developed by Mylan and Biocon for the global marketplace. Mylan has exclusive commercialization rights for the product in the US, Canada, Japan, Australia, New Zealand and in the European Union and European Free Trade Association countries. Biocon has co-exclusive commercialization rights with Mylan for the product in the rest of the world.

On a consolidated basis, net profit of Biocon rose 2.27% to Rs 130.40 crore on 26.39% rise in net sales to Rs 1169.50 crore in Q4 March 2018 over Q4 March 2017.

Biocon is India's largest and fully-integrated, innovation-led biopharmaceutical company.

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