Natco Pharma, a Hyderabad based pharma major, has received 'Orphan Drug Designation' for its novel anti-cancer drug (NRC-AN-019) from US FDA. This is for three indications – Glioma (brain tumour), pancreatic cancer and chronic myelogenous leukaemia. It is for the first time that an Indian company's drug is designated an 'Orphan' drug by the US FDA.
Orphan drug designation is given by US FDA for rare diseases that affect less than 2 lakh patients in the USA. Since the market for drugs intended to treat rare diseases is small, US FDA 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 fees (which is about $1.5 million per indication) Special grants and benefits to defray the costs of clinical research on these drugs may also be extended by US FDA. These drugs maybe eligible for a fast track approval process facilitating early market launch.
Natco is close to completing the phase I clinical trial of NRC-AN-019 in India and planning to take the drug forward for further clinical trials in USA and other countries in addition to India.
The drug has been granted patents in nine countries including USA and the patents in Canada, Europe and Japan re expected shortly. He drug which is expected to be effective in multiple indications, would address, if commercialized, a significant market.