Diosynth to manufacture Agenix' Thromboview

Agenix (ASX:AGX, NASDAQ:OTC:AGXLY) has signed a multi-million dollar contract with US company Diosynth Biotechnology to begin the process of manufacturing its ThromboView blood clot imaging product for phase III clinical trials and commercial sale.

Agenix said it had increased its productivity of the cell line ten-fold over the last 12 months, working with Swiss-based ExcellGene. The new agreement will see Agenix transfer the manufacturing process to Diosynth Biotechnology's facilities in North Carolina for further process refinement and cGMP manufacturing, commencing immediately.

"This is a crucial milestone for Agenix in the lead-up to phase III clinical trials and the commercialisation of the product," said Agenix MD Don Home.

He said Diosynth -- a division of Organon, the human healthcare business unit of Akzo Nobel -- had a proven track record, "We spent the last 12-18 months reviewing all of the major manufacturers and found Diosynth had the best manufacturing and skills to meet our needs," he said.

The goal of the collaboration is to enable Agenix to supply cGMP material for phase III clinical trials by the third quarter of 2006. Recruitment for the phase Ib PE (pulmonary embolism) safety trial in Australia has commenced with four patients now successfully enrolled out of the planned 14.

The phase II DVT (deep vein thrombosis) trial in the US and Canada commenced in March and has recruited 32 patients. After 50 patients have been recruited, the company will conduct an interim analysis.

Home said Agenix planned to conclude a sales, marketing and distribution agreement by the end of 2005 and the manufacturing transfer -- the results of the ongoing studies are key components of this agreement.