DRL may file new drug applications with FDA within year

Drug maker Dr Reddy's Laboratories has said it may file two new drug applications (NDA) with the US Food and Drug Authority (FDA) by the end of next year.
Chief Operating Officer and Member of the Management Council, DRL, Abhijit Mukherjee said one drug is currently in the late phase-III of clinical trials.
"Parallelly, for the proprietary products business, several assets are in the late stage registration trial. The portfolio of assets, both in dermatology and neurology, is quite robust.
"In dermatology, our assets are targeting the indications of steroid-response kits, dermatoses, acne, rosacea and actinic keratosis.
"While in neurology, it is primarily migraine. We are targeting our first NDA filing by the end of this fiscal year," Mukherjee said in a recently-held earning call with analysts.

G V Prasad, co-chairman and CEO, DRL, had said in an interview to a news channel that the company is all set to file at least one NDA before the end of this year and another in the next few months after that, thus making two NDAs in the next year or so.

When contacted, a senior official of the drug major declined to disclose the area of therapy in which the first NDA would be filed.
"Currently, trials are conducted in dermatology and neurology. We cannot say now which NDA will be filed first as it may vary," the official told PTI.

The drug maker, in a filing with SEC, had earlier said it is working on six new drugs in different areas, including metabolic and cardiovascular disorders, psoriasis and migraine and had 21 active products in the proprietary products pipeline, of which 6 were in clinical development stage.
DRL may invest between USD 300-400 million on research and development in Biologics and Proprietary products (of this, part amount spent in FY14) till these respective businesses become self-sufficient and cash accretive.
The company expects to file 1-2 NDAs per year from 2016-17 onwards, it said in the latest investor presentation.