IDT Australia (ASX:IDT) has signed a U.S. distribution deal for...

IDT Australia (ASX:IDT) has signed a U.S. distribution deal for its melanoma and glioblastoma multiforme treatment, which has already generated US$220 million (A$310.5 million) in the country over FY2015.

The agreement with a U.S. subsidiary of Mayne Pharma Group (ASX:MYX) will expose IDT’s generic Temozolomide product to the marketing potential of Mayne’s full-service speciality pharmaceutical business that develops, manufactures, markets and distributes more 25 products in the U.S. with an impressive pipeline of products under development.

The Abbreviated New Drug Application (ANDA) for Temozolomide has been “Accepted for Review” by the U.S. FDA and is currently progressing through the FDA’s review process. IDT and Mayne are targeting a commercial launch of Temozolomide in the U.S. in late calendar 2016 to early 2017.

Mayne will pay certain upfront payments totalling just over $1.06 million to IDT upon the filing of IDT’s Temozolomide ANDA, execution of this distribution agreement, acceptance of the ANDA by the FDA and IDT’s first commercial supply of Temozolomide to Mayne.

The agreement also contains a product pricing and profit share arrangement based on IDT’s manufacture and Mayne’s U.S. sales of Temozolomide, respectively.

This milestone follows an August agreement with U.S.-based ANI Pharmaceuticals, Inc. (NASDAQ:ANIP) to market and distribute in the U.S. up to eighteen of I
DT’s recently acquired generic pharmaceutical products. Under this agreement ANI makes an upfront payment of $1 million to IDT for exclusive rights to commercialise the products in the U.S. market.

Launch milestones of up to a further $1.25 million will also be payable as the products come back on market. ANI and IDT will share in the net profits from commercialisation. IDT and ANI are aiming at launching the first of IDT’s portfolio of generic products in the course of calendar 2016.

The total current U.S. market for these products is $538 million per annum.

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