SPARC seeks approval for drugs from alternate sites

Elepsia, Xelpros failed to receive approval from US drug regulator

Failing to receive product approval from US drug regulator (US FDA), Sun Pharma's research arm will initiate site transfer for its anti epilepsy drug Elepsia and eye drop Xelpros.

Both products were filed from Sun Pharma's Halol plant which received US Food and Drug Administration's warning letter in 2015. The two products did not receive approval. Sun Pharmaceutical Advanced Research Company (SPARC) now plans to resubmit its application for product approval to the regulator from an alternate site, chief executive officer Anil Raghavan said on Thursday.

SPARC licensed these products under development drugs to Sun Pharma in lieu of an upfront payment and royalties on sales. However, delays in commercialisation of the drugs led to widening of loss to Rs 120 crore in FY17. The company's cash flow was also impacted as it continued to invest in clinical development.

The company's stock slipped 7 per cent today to close at Rs 392.95 today. On a year to date basis however, the stock gained 29 per cent.

Raghavan said the company has made progress in development of dry powder inhaler and spasticity drug Baclofen which it plans to out-license after completion of trials. It plans to file application for Baclofen in first quarter of next fiscal and has a peak sales potential of $100 million.

The company has over ten products in various stages of development and is pursuing clinical development opportunities in oncology, ophthalmic and central nervous system.