Sun Pharma Advanced Research Company (SPARC) has received an approval from the Drug Controller General of India (DCGI) for paclitaxel injection concentrate for nanodispersion (PICN), indicated for the treatment of metastatic breast cancer. In a clinical study in metastatic breast cancer patients, PICN was found to be equally effective and safe when compared to Abraxane. PICN is approved in India for both the 260mg/m2 and 295mg/m2 doses to be administered every three weeks.
PICN is a novel formulation of paclitaxel using SPARC’s proprietary Nanotecton platform technology and is a cremophor and albumin-free formulation. It offers the convenience of a quick and easy one-step dilution and infusion preparation for healthcare professionals. PICN can be administered in a short 30 minute infusion and unlike conventional Paclitaxel formulations it does not require premedication with steroids and anti-histamines and does not lead to any significant hypersensitivity reaction in patients.
SPARC has licensed Sun Pharmaceutical Industries Ltd (SPIL) or its assignee to manufacture, promote and distribute PICN in the Indian market. As a part of the arrangement, SPARC is eligible for milestone and royalty income.
EP News Bureau – Mumbai