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Natco's anti-cancer drug gets USFDA Orphan status

Press Trust of India   |  New Delhi 

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today said it has received 'Orphan Drug' designation for its new chemical entity (NCE) aimed at treating different types of cancers, from the the US health regulator.

In a filing to the Bombay Stock Exchange, Natco Pharma said its NCE 'NRC-AN-0119' has been designated 'Orphan drug', which is accorded to drugs that are used for treating rare diseases that affect less than 200,000 patients in the US.

"Natco is close to completing the phase I clinical trial of NRC-AN-019 in India. Natco has plans to take the drug forward for further clinical trails in USA and other countries, in addition to India," the company said.

Companies which get the 'Orphan Drug' designation for their drug molecules get special incentives to market the product.
    
"The 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," the company said.
    
These drugs may be eligible for a fast track approval process facilitating early market launch, it added.
    
Shares of Natco Pharma today closed at Rs 275.90 on the BSE, up 4.31 per cent from its previous close.

Natco's anti-cancer drug gets USFDA Orphan status

Natco Pharma today said it has received 'Orphan Drug' designation for its new chemical entity (NCE) aimed at treating different types of cancers, from the the US health regulator.

today said it has received 'Orphan Drug' designation for its new chemical entity (NCE) aimed at treating different types of cancers, from the the US health regulator.

In a filing to the Bombay Stock Exchange, Natco Pharma said its NCE 'NRC-AN-0119' has been designated 'Orphan drug', which is accorded to drugs that are used for treating rare diseases that affect less than 200,000 patients in the US.

"Natco is close to completing the phase I clinical trial of NRC-AN-019 in India. Natco has plans to take the drug forward for further clinical trails in USA and other countries, in addition to India," the company said.

Companies which get the 'Orphan Drug' designation for their drug molecules get special incentives to market the product.
    
"The 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," the company said.
    
These drugs may be eligible for a fast track approval process facilitating early market launch, it added.
    
Shares of Natco Pharma today closed at Rs 275.90 on the BSE, up 4.31 per cent from its previous close.

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