Aurobindo Pharma looks to sell cancer drugs in the US by year end

Hyderabad-based pharma major says US FDA approval likely to come after upcoming audit

Hyderabad-based Aurobindo Pharma Limited is hoping to receive three-four product approvals in the oncology space from the US Food and Drug Administration (US FDA) before March 2018.

The company's optimistic prediction about a possible good start in this high-margin product business comes just ahead of a maiden audit slated to be conducted for its oncology formulations manufacturing facility by the US drug regulator.

A research and development facility and a manufacturing plant, both dedicated to the development and production of oncology and hormonal drugs, was set up in Hyderabad by Aurobindo-controlled Eugia Pharma Specialties Ltd, a joint-venture with Sequoia-backed Celon Laboratories.

Aurobindo holds around 68 per cent stake in Eugia Pharma.

The product approvals are expected to follow once the facility clears the US FDA inspection, which is scheduled to be conducted in the July-August period.

"This year, we will be filing 15-17 products (in the oncology segment, including hormonal drugs) and we can get some four-five products in hormonal and oncology injections. We have an audit in July-end or August-beginning and we hope that we will definitely start selling from the unit by the end of this year," P V Ramprasad Reddy, executive chairman of Aurobindo Pharma USA and founder of Aurobindo, said in a recent investor call.

If everything goes as planned, oncology will become the latest addition to the company's generics business this year. In the fields of vaccines and biosimilars, the other two new product verticals, the company may come out with its first set of product applications between 2019 and 2020.

The share of the company's US business in its total revenues rose to 45.3 per cent in 2016-17, from 44 per cent last year, despite the price erosion challenges. The possible launch of oncology products, along with other generic products, is likely to help Aurobindo maintain the momentum of its US business, according to analysts.

The company's US revenues touched $1 billion for the first time last year.

By hinting at multiple approvals in the oncology space in the first year itself, the company's management seems to be confident about a faster turnaround time when it comes to securing approvals from the US FDA. So far, it has filed only two abbreviated new drug applications in the oncology space, which has a total market size of $600 million in the US. The global generics oncology products business was pegged at over $20 billion last year.

Aurobindo is a relatively late entrant into the oncology products space compared to other domestic companies such as Sun Pharma, Dr Reddy's and Lupin. Dr Reddy's Laboratories and its partner Natco Pharma have received the US FDA's approval for an ovarian cancer drug last month.

Aurobindo, which had launched 24 new products in the US market last year, currently has 26 final product approvals on hand.