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Natco Pharma's novel anti-cancer drug has received ‘Orphan drug designation', from the US Food and Drug Administration (USFDA). It is the first Indian company's drug to get such a designation for three indication.
Claiming this, the Hyderabad-based pharma company said in a press release that the categorisation is for three indications — Glioma (brain tumour), pancreatic cancer and chronic myelogenous leukaemia.
Orphan drug designation is given by the USFDA for rare diseases that affect less than 20,000 patients in the US.
Since the market for the drugs intended to treat rare diseases is small, the USFDA extends special incentives to companies involved in the discovery and development of such drugs.
These incentives include a seven-year marketing exclusivity, specific tax credits and waiver of prescription drug user fee (which is about $1.5 million/indication), special grants and benefits to defray the costs of clinical research, Natco Pharma said in the release.
These drugs may also be eligible for fast track approval process facilitating early market launch. Natco is close to completing Phase-I clinical trials of the novel drug in India. It plans to take the drug forward for further clinical trials in the US and other countries.
The drug has been granted patents in nine countries including the US. Patents are expected in Canada, Europe and Japan shortly, according to the release.
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