This notification follows Progen's end-of-phase II meeting with the FDA. According to Progen, manufacturing the first step of PI-88 in-house saves Progen approximately AUD$7.8 million in outsourcing fees to a contract manufacturing organization.
Progen's facility in Darra will manufacture the first step in the process, while a large US-based contract manufacturing company has been contracted to produce the final active ingredient, PI-88. Up to 150,000 doses of PI-88 will be manufactured in advance of the phase III trial starting in mid-2007.
The end-of-phase II meeting has allowed Progen to avoid manufacturing related delays for the phase III trial.
Progen now has PI-88's manufacturing and quality control schedule defined, and will fill excess capacity by renewing contract manufacturing services for the pharmaceutical and biotechnology industries.