SPARC announces top-line results of Pivotal Bioequivalence Study

Sun Pharma Advanced Research Company (SPARC) recently announced top-line results of the pivotal BE study for Paclitaxel Injection Concentrate for Suspension (PICS).

The pivotal BE study was a randomized, open label, two period, single dose, crossover study of PICS and Abraxane in subjects with locally recurrent or metastatic breast cancer. A total of 142 patients were randomized to characterise the pharmacokinetic (PK) profile of PICS for both unbound and total paclitaxel compared with Abraxane. The study also provided information on the safety profile of PICS.

The study met all the required pharmacokinetic endpoints for both unbound and total paclitaxel. There were no new adverse events observed in this study.

Pivotal Bioequivalence (BE) study showed Paclitaxel Injection Concentrate for Suspension to be bioequivalent to Abraxane in patients with locally recurrent or metastatic breast cancer.

New Drug Application filing through 505(b)(2) pathway with USFDA will be targeted in the next few months.

According to Anil Raghavan, CEO, SPARC, "We are pleased with the results of the PICS BE study, and it provides a validation of our NanotectonTM technology. The study results pave the way forward for us, with US FDA and NDA filing using 505(b)(2) approval pathway planned in the coming months. Overall US Paclitaxel market is estimated to be about $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 the launch of novel formulations, market for nano-formulations of Paclitaxel is expected to grow."