‘Orphan’ status for Natco drug in US

Marking a new beginning for Indian pharma companies in the US market, the Hyderabad-based Natco Pharma has gained the “orphan” drug status for its new anti-cancer candidate NRC-AN-019.

The US Food and Drug Administration (FDA) accords orphan drug status to a drug for rare diseases that affect less than two lakh people in the US.

Considering the smaller market size for these drugs, the FDA extends special incentives to the manufacturers to cover the discovery and development of these drugs.

The incentives include a seven-year exclusivity, specific tax credits waiver of prescription drug user fee, which is about $1.5 million per indication.

According to a Natco statement, the new anti-cancer drug has been given the orphan drug status by the US FDA. The drug has been found to be fit for three indications—brain tumour, pancreatic cancer and chronic myelogenous leukemia.

“This is for the first time an Indian company’s drug has been designated an orphan drug by the US FDA for three indications,” the company said.

“We should be able to launch the drug in the next 36 months pending required approvals,” a company official told DNA.

Natco is currently said to be at an advanced stage of completing Phase I trials in India and further clinical trials on the drug would also be conducted in the US shortly.

The drug has already been patented in the US and eight other countries. Patents in Canada, Japan and Europe are expected shortly.

Though Natco is not willing to quantify the market size at this point, sources said that the value would not be significant. “The launch would be more for having a niche positioning in the US market. These drugs would bring in more brand value than the revenues,” a source said.