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Drug maker Dr Reddy's on Wednesday said that it has received an approval from US FDA to launch anti-cancer drug doxorubicin hydrochloride liposome injection.
Doxorubicin hydrochloride liposome injection used intravenously is the generic version of Janssen's Doxil .
Dr Reddy's partnered with Natco Pharma to develop the drug, considered to be an extremely complex product and getting US FDA approval remained a challenge.
Doxorubicin is a chemotherapy drug used against several types of cancers. The drug prevents the growth of cancer cells by interfering with the genetic material DNA, which is necessary for reproduction of cells.
The Doxil brand and generic had US sales of USD 196 million for the 12 months ending in March 2017, according to IMS Health.
"This approval represents the first of its kind for Dr Reddy's in the complex depot injectables arena," said Alok Sonig, Executive Vice President and Head of the North America generics business at Dr Reddy's.
"The approval further validates our capabilities to successfully develop and manufacture complex liposomal formulations. We are preparing for a commercial launch soon," Sonig added.
Analyts said generic Doxil approval provides relief to Dr Reddy's that's struggling with very low visibility of launches.
"If there is no incremental competition the drug is an USD 40-50 million opportunity," said Amey Chalke, Research Analyst tracking pharma at HDFC Securities.
Another analyst painted an even rosier picture saying it could mean USD 80 million in peak sales contribution from generic Doxil.
To be sure both Dr Reddy's and Natco will share profits. The ratio of the profit-sharing is not disclosed.
Blow to Sun Pharma
Sun Pharma is the only generic company that markets Doxil for which it got the approval in February 2013.
Generic Doxil has been the heavy-lifter for the company in the US for several years with annual sales clocking over USD 100 million.
Sun Pharma was also helped by the fact that the Janssen part of US-based Johnson & Johnson withdrew from the market due to capacity constraints.
Analysts say approval to Dr Reddy's is negative for Sun Pharma as the company in recent quarters is seen losing grip on the drug due to supply constraints given the regulatory issues at Halol plant and reentry of Janssen's Doxil.
Shares of Dr Reddy's and Natco gained 0.40 percent and 1.01 percent, respectively, and were trading at Rs 2734.05 and Rs 958, respectively on BSE at 1.40 pm. Shares of Sun Pharma dropped 0.68 percent to Rs 647.60, while the BSE Sensex gained 0.27 percent to 30,665.98 points.
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