Pharmaceutical Business review

pSivida gets new manufacturing plant

QSA was until late a subsidiary of AEA Technology. On September 13, 2005 AEA announced plans to sell QSA, along with other assets, to private equity company Coller Capital. QSA’s medical facility, the new home of BrachySil manufacturing, is located in Braunschweig, Germany. QSA’s manufacturing agreement with pSivida began in March 2004 and will run for a minimum of three years.

The facility will fulfill the final process in the manufacture of BrachySil for future clinical and commercial use, and represents what pSivida calls a crucial final stage in establishing the supply infrastructure to support BrachySil as it advances through clinical trials towards the market.

BrachySil (32-P BioSilicon) has shown positive results in clinical trials as a radiotherapy for the treatment of inoperable primary liver cancer, where it is delivered directly into the tumors without surgery, a procedure known as brachytherapy.

pSivida is currently preparing to begin phase IIb dose-profiling studies with BrachySil in this indication and expects to treat its first patient before the end of 2005. The company is also planning phase IIa trials with BrachySil to evaluate its safety and efficacy in patients suffering from pancreatic cancer. This trial is also on schedule to begin in late 2005.