Sun Pharma Advanced Research Company Ltd, the research focused unit of Sun Pharma, said a trial of its cancer formulation, Paclitaxel Injection, “met all the endpoints” of a bioequivalence study and the company was looking forward to filing a new drug application.
SPARC’s study involved Paclitaxel and Abraxane. If two products are said to be bioequivalent it means that they are considered, for all intents and purposes, the same drug.
The overall US Paclitaxel market is estimated to be about $700 million.
“The study met all the required pharmacokinetic endpoints for both unbound and total paclitaxel. There were no new adverse events observed in this study,” SPARC said.
CEO Anil Raghavan said the results of the study provided a validation of the company’s Nanotecton technology.
“The study results pave the way forward for us, with a USFDA NDA filing using 505(b)(2) approval pathway planned in the coming months,” he said.
The pathway is for companies that want to file for approval for a new drug using data from clinical trials already conducted by another company or for another drug.
The Paclitaxel Injection Concentrate for Suspension (PICS) 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 characterize 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 current market is dominated by Cremophor based Paclitaxel formulations, which accounts for ~70% of unit sales. “With launch of novel formulations, market for nano-formulations of Paclitaxel is expected to grow,” Raghavan said.
PICS is a Cremophor and Albumin-free formulation of Paclitaxel and allows quick and easy “one step” dilution and infusion preparation.
The formulation, unlike solvent based formulations, does not require premedication with steroids or antihistamines.