Claris Lifesciences spurts after securing USFDA nod for Tobramycin injection

Claris Lifesciences surged 7.04% to Rs 232.50 at 13:19 IST on BSE after the company received approval from the US Food and Drug Administration to market Tobramycin injection in the US.

The announcement was made yesterday, 6 July 2016, when the stock market was closed for a public holiday.

Meanwhile, the BSE Sensex was up 27.41 points, or 0.1%, to 27,194.88

On BSE, so far 2.46 lakh shares were traded in the counter, compared with average daily volume of 93,741 shares in the past one quarter. The stock hit a high of Rs 246.05 and a low of Rs 230 so far during the day. The stock hit a 52-week high of Rs 266 on 30 July 2015. The stock hit a 52-week low of Rs 126.10 on 12 February 2016. The stock had underperformed the market over the past 30 days till 5 July 2016, falling 2.64% compared with Sensex's 1.45% rise. The scrip, however, outperformed the market in past one quarter, gaining 47.96% as against Sensex's 9.1% rise.

The small-cap company has an equity capital of Rs 54.57 crore. Face value per share is Rs 10.

Claris Lifesciences said that the approval is for Tobramycin injection USP, 80mg/2mL and 1,200mg/30mL multiple dose vials. Tobramycin injection is an anti-infective used to treat certain serious infections that are caused by bacteria such as meningitis and other infections of the blood, abdomen (stomach area), lungs, skin, bones, joints and urinary tract. The estimated market size of the drug in the US is $6 million and the product is currently in shortage list of US Food and Drug Administration (USFDA).

With the approval for Tobramycin injection, Claris Lifesciences now has a total of 14 approvals and 24 under approval ANDAs (Abbreviated New Drug Applications) in the US. The total addressable market size of the approved ANDAs is estimated to be a little above $300 million, the company said. Claris Lifesciences expects more product approvals during the year, which will allow the company to continue its growth in the US market, the company said in a statement.

Claris Lifesciences' consolidated net profit fell 65.8% to Rs 3.57 crore on 7.77% rise in net sales to Rs 166.76 crore in the quarter ended 31 March 2016 over the quarter ended 31 March 2015.

Claris Lifesciences is holding company of Claris Injectables, a wholly-owned subsidiary dealing in specialty injectables business. It is also the holding company of Claris Otsuka Private Limited, a joint venture with Japan's Otsuka Pharmaceutical Factory, Inc. and Mitsui & Co. for Infusion business in India and emerging markets.

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