IDT Australia release on FDA nod for 23 generics begs the question: Where's the beef?

Australia Stock Exchange-listed IDT Australia has issued another in a series of announcements about acquiring 23 generic drugs marketed in the United States, with the latest release stating the U.S. FDA has noted the transfer of ownership to IDT.

It would appear that the Australia drugmaker had licensed the generics from Pfizer ($PFE) and several other drugmakers, according to listings at the Library of Medicine and the FDA's Orange Book of approved drugs, but nowhere does IDT say where or how it got them.

Without naming a company or describing the actual arrangement, IDT first announced the deal last November, complete with financial arrangements, such as upfront payments and milestones.

In that initial announcement, IDT called the deal "a conditional purchase agreement," which could mean a licensing agreement, or not revealing the name of the seller or sellers or the type of purchase. It said the arrangement called for a $13.5 million upfront payment, plus $4.5 million in regulatory and sales milestones.

IDT Managing Director Paul MacLeman

IDT even estimated the global market for the 23 drugs at $460 million and added that it would be producing the drugs at its Australia plant to be ready for launch by mid-2016, presumably in the United States. The drugs already have FDA approval, IDT went on to say.

The latest action was an FDA acknowledgement of IDT ownership, to be reflected in its Orange Book of approved drugs, which lists their owners, such as Pfizer of doxazosin, a prostate drug Pfizer markets as Cardura XL, Minipress (prazosin) for hypertension and Diflucan (fluconazole) for infectious diseases.

Most of the 23 are listed under many other drugmaker names, many of them generics companies.

Paul MacLeman, managing director, said in response to emailed questions from FiercePharmaAsia that the company managed to accumulate those drugs and package them into a single deal via an unnamed global company.

"We bought 23 approved generic drugs from a global generics company," MacLeman said. "They have now been transferred formally into our ownership."

- here are the IDT Generics update and deal releases and presentation