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Ranbaxy jumps after winning USFDA approval for generic

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Ranbaxy Laboratories rose 5.74% to Rs 498.85 at 10:39 IST on BSE after the company won US drug regulator's approval to make a generic version of Diovan, a blood pressure drug from Novartis AG.

The company made the announcement during trading hours today, 27 June 2014.

Meanwhile, the BSE Sensex was up 86.55 points, or 0.35%, to 25,149.22.

On BSE, so far 4.84 lakh shares were traded in the counter, compared with an average volume of 3.30 lakh shares in the past one quarter.

The stock rose 8.20% at the day's high of Rs 510.45 so far during the day, which is also a 52-week high for the counter. The stock fell 4.27% at he day's low of Rs 491.90 so far during the day. The stock hit a 52-week low of Rs 253.95 on 2 August 2013.

 

The stock had outperformed the market over the past one month till 26 June 2014, rising 6.85% compared with 1.40% rise in the Sensex. The scrip had also outperformed the market in past one quarter, rising 32.96% as against Sensex's 13.43% rise.

The large-cap company has an equity capital of Rs 211.90 crore. Face value per share is Rs 5.

Ohm Laboratories, Inc. (Ohm), a wholly-owned subsidiary of Ranbaxy Laboratories (Ranbaxy), announced that Ohm has received approval from the US Food and Drug Administration (USFDA) to manufacture and market Valsartan 40 mg, 80 mg, 160 mg, and 320 mg tablets, with 180-day marketing exclusivity.

Valsartan is indicated for the treatment of high blood pressure and heart failure. The Office of Generic Drugs, USFDA, has determined the Ohm formulations to be bioequivalent and have the same therapeutic effect as that of the branded drug Diovan. Total annual market sales for Diovan, a patented product of Novartis AG, were $2.19 billion (IMS - MAT: April 2014), the company said in a statement.

Ohm, based in North Brunswick, New Jersey, is a wholly-owned subsidiary of Ranbaxy, India's largest pharmaceutical company. Ohm is engaged in the manufacturing, sale and distribution of generic and branded private label, (OTC) products in the US healthcare system.

According to reports, Ranbaxy's application with USFDA to launch Valsartan was pending since September 2012. With the sole marketing rights for 180 days, Ranbaxy may capture around 50% market share, and earn a revenue of around $150 million, reports said.

Ranbaxy Laboratories reported a consolidated net loss of Rs 73.65 crore in the quarter ended March 2014, compared with net profit of Rs 125.75 crore in the quarter ended March 2013. Total income fell 1.73% to Rs 2490.51 in the quarter ended March 2014 over the quarter ended March 2013.

Ranbaxy Laboratories is an integrated, research based, international pharmaceutical company producing a wide range of quality, affordable generic medicines, trusted by healthcare professionals and patients across geographies.

On 7 April 2014, Sun Pharmaceuticals Industries and Ranbaxy announced entering into definitive agreements pursuant to which Sun Pharma will acquire 100% of Ranbaxy in an all-stock transaction. Under these agreements, Ranbaxy shareholders will receive 0.8 share of Sun Pharma for each share of Ranbaxy.

The combination of Sun Pharma and Ranbaxy creates the fifth-largest specialty generics company in the world and the largest pharmaceutical company in India. The combined entity will have operations in 65 countries, 47 manufacturing facilities across 5 continents, and a significant platform of specialty and generic products marketed globally, including 629 ANDAs. On a pro forma basis, the combined entity's revenues are estimated at $4.2 billion with EBITDA of $1.2 billion for the twelve month period ended December 31, 2013. The transaction value implies a revenue multiple of 2.2 based on 12 months ended 31 December 2013.

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First Published: Jun 27 2014 | 10:43 AM IST

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