DRL GETS FDA NOD FOR DEADDICTION DRUG, SHARES SOAR OVER 3.5%

Shares of Dr Reddy’s Laboratories Ltd, India’s second largest drug maker, soared over 3.5% on the BSE on Friday after the firm said the US Food and Drug Administration (FDA) had given it the go-ahead to launch generic versions of a drug used to treat adults with opioid addiction.

The original drug, Suboxone Sublingual Film, is manufactured by London-listed Indivior. Dr Reddy’s generics are called Buprenorphine and Naloxone Sublingual Film.

The approval means Dr Reddy’s will be able to launch a cheaper version of Suboxone Film in the US, which accounted for 80% of Indivior’s revenue last year.

“Buprenorphine helps suppress withdrawal symptoms caused by discontinuation of opioid drugs, and Naloxone reverses and blocks the effect of opioids. This combination of medications is used as part of a complete treatment programme including prescription monitoring, counselling, and psychosocial support,” the company said in a filing to the exchanges.

“With opioid addiction becoming increasingly prevalent in America, the full approval and launch of our generic equivalent of Suboxone could not have come at a more critical time to help patients,” explains Alok Sonig, chief executive officer, developed markets, Dr Reddy’s.

According to a report from the US council of economic advisers, more than 33,000 Americans died of drug overdose involving opioids in 2015.

According to IMS Health, Suboxone registered US sales of approximately $1.86 billion moving annual turnover for the 12 months to April 2018.