Sun Pharma's research arm Sun Pharma Advanced Research Company (SPARC) Monday announced top-line results of the pivotal BE study for its Paclitaxel injection concentrate for suspension (PICS) which has been found to be a bioequivalent to Abraxane, used to treat metastatic breast cancer.
Paclitaxel injection concentrate for suspension (PICS) is a novel formulation of Paclitaxel developed using SPARC's proprietary Nanotecton technology.
The company said it is targeting a new drug application with the US health regulator in the next few months.
"Pivotal bioequivalence (BE) ," SPARC said in a regulatory fling.
SPARC CEO Anil Raghavan said overall US Paclitaxel market is estimated to be about USD 700 million (IQVIA MAT Sep 2018). The current market is dominated by Cremophor-based Paclitaxel formulations, which accounts for 70 per cent of unit sales.
"With launch of novel formulations, market for nano-formulations of Paclitaxel is expected to grow," he added.
Shares of SPARC were trading 2.15 per cent at Rs 278.05 apiece on BSE.
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