SPARC slips after USFDA rejects application for cancer drug Taclantis

Sun Pharma Advanced Research Company (SPARC) slumped 7.79% to Rs 176.25 after the US drug regulator rejected the company's cancer drug application for Taclantis in its current form.

SPARC, in an exchange filing made after market hours on Tuesday, said it has received a complete response letter (CRL) from the United States Food & Drug Administration (USFDA) for the new drug application (NDA) for Taclantis (Paclitaxel Injection Concentrate for Suspension). SPARC said it is reviewing the CRL and intends to work with the USFDA as soon as possible to address the concerns raised.

USFDA sends a complete response letter to communicate it has completed its review of a new or generic drug application, and it decided that it will not approve it for marketing in its present form.

SPARC had informed the bourses on 1 July 2019 that USFDA has accepted the company's NDA for Taclantis, a novel formulation of Paclitaxel developed with SPARC's proprietary Nanotecton technology. Paclitaxel is one of the most widely used cytotoxic agents and is approved for the treatment of breast cancer, ovarian cancer, non-small cell lung cancer and pancreatic cancer.

Sun Pharma Advanced Research Company is a global pharmaceutical company.

The company reported a standalone net loss of Rs 55.51 crore in Q3 December 2019 as compared a net loss of Rs 69.02 crore in Q3 December 2018. Net sales declined 1.4% to Rs 19.60 crore in Q3 December 2019 over Q3 December 2018.

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