FDA backs IDT thalidomide facility

The Institute of Drug Technology (ASX:IDT) has been granted US Food and Drug Administration (FDA) approval to supply commercial quantities of Thalomid (thalidomide) to its US-based global biopharmaceutical client Celgene.

"Any FDA approval for any pharmaceutical company is a positive affirmation of that company's quality systems and approach to pharmaceuticals," said IDT CEO Graeme Blackman.

IDT established a manufacturing and supply agreement with Celgene in September 2003. IDT then constructed a purpose-built facility to manufacture the thalidomide capsules, a process which requires high levels of containment, said Blackman. "IDT has a lot of expertise in handling potent drugs," he said.

According to Celgene's web site, the agreement with IDT "requires minimum payments for Thalomid capsules of US$4.7 million for the three-year term commencing with the FDA's approval of IDT as an alternate supplier". Celgene also states that its agreement with IDT "provides us with additional capacity and reduces our dependency on one manufacturer for the production of Thalomid."

IDT will begin supplying the thalidomide capsules in bulk to Celgene in the next financial year.

While the current agreement with Celgene is only for supply of thalidomide, Blackman said the lines of communication were open and that "once you've established a productive relationship with a client often they do lead to other business opportunities".

Thalidomide is approved for treatment of cancer in Australia and is heading towards FDA approval for this indication in the US, said Blackman.