AFTER four years of research and development nanotechnology company pSivida has taken the step of entering into a commercial agreement to manufacture a product.
Under the terms of the agreement Auriga Medical will manufacture pSivida’s anti-cancer treatment BrachySil in a purpose-built facility in Braunschweig, Germany.
One of the big benefits for pSivida from the deal is that Auriga will design and build the facility for it.
Work on building that facility is already underway.
Auriga is a subsidiary of AEA Technology, which was the UK Atomic Energy Agency.
BrachySil has been developed as a "device" for the direct intratumoural treatment of cancers.
It uses BioSilicon that contains a cancer-treating isotope of phosphorous.
Clinicians will receive it as a sterile powder that can be dissolved in an injectible aqueous formulation.
pSivida managing director Gavin Revos said the agreement marked a significant step forward in the commercialisation of the company’s flagship product BioSilicon.
"This relationship will service the pre-registration trials as well as the market requirements for this unique product," he said.
Initial BrachySil production will supply Phase IIa clinical trials at Singapore General Hospital with primary liver cancer as the first clinical indication.
Those trials are scheduled to start in May.
Phase IIb clinical trials have been scheduled to start in the first quarter of 2005 in Singapore and may also involve patients in the US.
The product is expected to be launched in 2006.
pSivida is not expecting to meet the costs of the commercialisation of the product.
The company’s investor relations officer Josh Mann said the company was looking for partners who would bear the marketing and distribution costs needed to commercialise the BrachySil product.
"We don’t have the marketing or distribution networks in place to do that, nor do we want to take that sort of risk," he said.
Besides the BrachySil product, pSivida is also looking to partner other drug companies that are looking for new delivery systems.
The company’s main product BioSilicon is being developed as a drug delivery system.
Mr Mann said there would be about $US80 billion worth of drugs coming out of patent in 2005.
To get their patents renewed the drug companies need to find ways to improve them. A better delivery system is one of the ways they can do that.
"A lot of these companies are looking for better ways to deliver their drugs," Mr Mann said.
"So far we have committed to drugs into our BioSilicon."
pSivida has been a bit of a market darling recently, peaking around $1.40. Its share price is now about $1.
However, back in September its price was around $0.47.
One of the criticisms levelled at pSivida is that it has been spending more of its resources on promoting itself than on R&D, a view hotly denied by Mr Mann.
"We expend 78 per cent of our funds on R&D," he said.
Mr Mann said the company’s collaborations with Epitan and C3 were more in the nature of giving them some BioSilicon to work with than anything else.
"There is a core focus that we have which is drug delivery and diagnosis," he said.
"We’re collaborating out the non-core ideas to others."
