Psivida subsidiary signs manufacturing deal
Tuesday, 23 March, 2004
PsiMedica, the UK subsidiary of Perth-based nanotechnology company Psivida (ASX:PSD), has signed a three-year manufacturing agreement with nuclear pharmaceuticals company Auriga Medical as it gears up to start Phase II clinical trials of its BioSilicon-based brachytherapy product in Singapore later this year.
Auriga Medical, a subsidiary of AEA Technology QSA, will manufacture BrachySil at its German facility using a process of neutron bombardment to create particles of BioSilicon containing the 32P radionuclide, and is planning a purpose-built dedicated cGMP facility for both clinical trials supply and commercial production of BrachySil.
"AEA Technology QSA's Auriga Medical is a world leader in the manufacture of radiation source products and we are extremely pleased to have been able to secure their services for what is an integral role in the overall production and supply process," said pSivida managing director Gavin Rezos in a statement.
Rezos noted that the agreement marked a significant step forward for the commercialisation of BioSilicon.
A Phase IIa clinical trial examining the use of BrachySil in patients with primary liver cancer is scheduled to start at Singapore General Hospital in May, with results from the eight-patient trial due in the last quarter of this year. Phase IIb trials are expected to follow early in 2005 and the company hopes to launch the product in 2006.
PsiMedica is in discussions with potential development and marketing partners for BrachySil.
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