IDT breaks into generic drugs with US filing

IDT Australia (ASX:IDT) has filed for approval to market generic temozolomide in the US once the drug goes off-patent in the market next year.

The pharmaceutical contract manufacturing company has submitted an Abbreviated New Drug Application (ANDA) with the US FDA covering six different strengths of  temozolomide capsules.

Temozolomide is an oral chemotherapy used to treat melanoma and gioblastoma multiforme. Trade names include Temodar and Temodal.

By filing an ANDA, IDT need only show an ability to manufacture dose stability batches and demonstrate its bioequivalence - a far less onerous path to market than the regulatory process required for new chemical entities.

IDT Managing Director Dr Paul MacLeman said the filing fits in with the company’s strategy of using the infrastructure and knowledge acquired as a pharmaceutical manufacturer to develop its own generic drug portfolio.

“IDT is now in the process of moving up to a greater share of the industry value chain as the owner of a range of registered and marketed drugs rather than solely as a contract manufacturer of pharmaceutical ingredients,” he said.

“This change could potentially take our share of the value chain for such products from single digit percentages to tens of percentages of the wholesale price.”

The company plans to file approval for additional generic drugs over the next 12-18 months focusing on targets where IDT has a competitive manufacturing advantage, he said. Due to the difficulty manufacturing chemotherapeutics, IDT expects many of its other generic filings to cover cancer drugs.

IDT Australia (ASX:IDT) shares were trading 4.6% higher at $0.455 as of around 12.30 pm on Monday.