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Feb
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Dr Reddy’s goes beyond generic products, gets nod for two branded drugs – The Economic Times
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MUMBAI: Dr Reddy’s Laboratories has received the US Food and Drug Administration’s approval for two new drugs in three days, in a sign that top Indian drug makers might be looking to move beyond generics to come out with some original drugs of their own.

Just a couple of days after the Hyderabad-based drug maker received FDA approval for anti-migraine injection Zembrace, it has got the US regulator’s tentative approval for skin treatment drug Zenavod.

The approvals have come at a time when Indian drug companies are facing the FDA’s ire for non-compliance of good manufacturing process.

Analysts are not betting big on Zenavod yet as they expect its launch only in 2020. All attention seems to be on the anti migraine injection, which is assumed to have a market size of nearly $1.4 billion, or about Rs 9,450 crore. Analysts expect sales worth $40-50 million from this product in the next two years.

Raghav Chari, executive vice president, proprietary proprietary products group, at Dr Reddy’s Laboratories, said Zembrace injection is the first branded product in the firm’s neurology portfolio. “Migraine affects millions of patients. Many of these patients have busy lives and quick pain relief is critical to help them manage through their daily routines,” he said.

He said that in many cases migraine episodes are accompanied by severe nausea, making it difficult to swallow and retain pills. Zembrace SymTouch, a drug-device combination product, is specifically designed for patients who may experience certain migraine episodes and for whom a pill may not be the right option, the company said. The product will be marketed in the United States by Promius Pharma, a wholly owned specialty company of Dr Reddy’s Laboratories.

Analysts have given a thumbs up for the product. “In our view, Zembrace could be material for Dr Reddy’s if it manages to prove its clinical superiority over existing treatments for migraine. Another area of differentiation could be less side-effects,” said Girish Bakhru, analyst, healthcare, at HSBC Securities. A research report from brokerage firm Kotak Securities noted that since 2009, Dr Reddy’s has spent 27% of its revenues on R&D.

However, challenges to the proprietary drug remain. Morgan Stanley noted that this new injection, unlike a generic product, will need to be marketed to doctors to generate prescriptions in order to monetise it. Other challenges include high competition in this segment, because of the modest innovation in the segment (Reddy’s have tweaked around the dosage form).

Dr Reddy’s, according to the brokerage firm, will target nearly 7,000 neurologists in the US with roughly 40 sales representatives. Shares of Dr Reddy’s shares closed at Rs 3,050 on the Bombay Stock Exchange on Monday, down 1.73% from the previous close



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