Dr Reddy's Laboratories will aggressively pursue its focus on the US generic market and file 15-18 Abbreviated New Drug Applications (ANDAs) during the current fiscal. The company had filed 14 ANDAs with the US Food and Drugs Administration last year, of which 10 were Para-IV filings and seven were believed to be first to file that provide 180-day marketing exclusivity in the US generic market, if approved by the FDA. The company had enjoyed such marketing opportunity for Fluoxetine between August 2001 and January 2002.
In a conference call from New Jersey on Monday, G V Prasad, CEO of Dr Reddy's, said, “We now have one of the most exciting generic pipelines in the US industry, with the potential of introducing drugs whose innovator sales last year topped $ 19 billion.”
He said it had been only three years since the company entered the global generics business and already it touched the $ 100 million sales mark. “It has been a tremendous three years and we believe it is only the beginning. With the US now contributing fully a third of our sales, we're well on the way towards making it our number one market and transforming Dr Reddy's from a regional marketer into an integrated global player,” Prasad said.
On the discovery front, he said the company had active development programmes on a number of truly differentiated compounds in major therapeutic categories. “ In March we began phase-II clinical trials on our lead cancer compound DRF 1042, a topoisomerase1 inhibitor, against osteosarcoma, renal cell carcinoma, CNS tumours and breast cancer,” he said.