New deal suggests FDA approval closer for Gradipore

FDA approval for Sydney-based separation technology company Gradipore has come a step closer, after the signing of a new agreement with Canadian hyperimmune product specialist Cangene.

The exclusive agreement will allow Cangene to evaluate the performance of Gradipore's Gradiflow technology in its hyperimmune manufacturing process.

In the first phase, Gradipore will be aiming to prove that Gradiflow can achieve industrial-scale purity and recovery levels on one of Cangene's products. If that goes well, the companies may sign further agreements leading to commercialisation and FDA licensing for Gradiflow.

Gradipore will receive up-front and milestone payments, worth a total of about $900,000, throughout the life of the project. Gradipore expects to receive the first payment in six months.

Gradipore's chief operating officer, Tim Wawn, said the deal's commercial focus was a first for Gradiflow, which has been previously involved in proof-of-principle arrangements with Bayer and Aventis. "This is important for the next stage - commercial acceptance of the technology," Wawn told Australian Biotechnology News.

Cangene was founded in 1984, and uses patented manufacturing processes to produce plasma-derived and recombinant therapeutic proteins. The company has two approved products, another two in clinical trials, and another awaiting FDA approval.

In a statement, Gradipore's US-based CEO Robert Lieb said the company's future growth was directly tied to licensing agreements for Gradiflow with international companies like Cangene. "Not only will it permit us to further our development program by applying the Gradiflow process to large-scale commercial use, but more importantly it establishes a path by which the whole process can achieve widespread regulatory approval."

Gradipore first approached Cangene in May 2001, but expects the agreement to progress quickly from here. Providing the first stage is successful, Cangene will buy a production-scale Gradiflow unit and begin manufacturing products with Gradiflow once FDA approval is achieved. After that, Gradipore will supply consumables to order, and eventually start to receive royalty payments.

Gradipore said it expected that FDA approval for the Gradiflow process would be faster than for a biological product.

Cangene's key hyperimmune globulins are purified from donated human plasma containing high levels of the antibody of interest, which must be isolated and purified. One of Gradipore's claims for Gradiflow is its ability to purify proteins and remove viral and bacterial pathogens simultaneously. Cangene CEO Dr John Langstaff said in a statement that Gradiflow promised Cangene the chance to improve product yield at reduced cost.

Meanwhile, Wawn said, Gradipore's proof-of-principle deal with Aventis was now in its final stages. "We're talking with them about where we will move to from there," he said.

Gradipore is also expected to name its new chair before the end of this month.