IDT Australia (ASX:IDT) has announced FDA approval of its oral brain cancer drug Temozolomide.
The approval, which triggered a significant jump in the company's share price, will pave the way for the commercial launch of what is to be the first product in a portfolio of IDT’s own generic drug products into the US market.
The approval is the first for IDT under the Abbreviated New Drug Application (ANDA) system and has been granted over six months earlier than initially expected.
The company said the addressable market for Temozolomide in the US alone is currently over US$200 million. A US distribution partner is already in place and commercial launch preparations are now underway.
In September 2015, IDT announced the appointment of Mayne Pharma as the distributor for IDT’s Temozolomide product in the US. Following FDA approval, IDT and Mayne will immediately begin planning for a commercial US launch for the product, which is expected to deliver revenues in 2016.
“Securing FDA approval for the first of IDT’s proprietary products is a major milestone for the Company, and to have this ahead of schedule is a fantastic result,” said IDT’s chief executive, Dr Paul MacLeman.
“We expect this launch to pave the way for the introduction of other IDT productsinto the US market as we build our manufacturing capabilities and expand our marketed generic drug portfolio.”