Asia PR News

BRISBANE, 29 Nov. /Medianet International-Asianet/ –

Key points:

Receives green light from the Food and Drug Administration (FDA)
to manufacture PI-88 for upcoming Phase III trial Manufacturing
in-house saves Progen approximately AUD$7.8 m in outsourcing fees
Successful FDA meeting forms basis for New Drug Application (NDA)
Chemistry Manufacturing and Control (CMC) section submission

Progen Industries (ASX: PGL; NASDAQ: PGLA) today announced it has received
notification from the U.S. FDA that the appropriate CMC procedures have been
put in place to progress its anti-cancer drug PI-88 to Phase III clinical
trials.

This notification follows Progen’s End-of-Phase II CMC meeting with the
FDA, held on 24 October, and gives Progen the “green-light” to manufacture
PI-88 for its upcoming Phase III clinical trial. Manufacturing the first step
of PI-88 in-house saves Progen approximately AUD$7.8 million in outsourcing
fees to a contract manufacturing organisation.

Progen’s facility in Darra will manufacture the first step in the process,
while a large U.S.-based contract manufacturing company has been contracted to
produce the final active ingredient (API), 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 CMC meeting plays a critical part in the rapid
development of drugs with the FDA. At the meeting, the details on the
specifications, stability and release procedures for the active ingredient and
the final product were reviewed and discussed. No issues were identified that
would delay the manufacture of the Phase III product. Holding this meeting now
avoids manufacturing related delays for the Phase III trial and forms the basis
for proceeding efficiently to submitting PI-88’s CMC section of the NDA with
the FDA.

The first step of manufacturing PI-88 will continue to be carried out at
the Progen TGA cGMP (Therapeutic Goods of Australia, current Good Manufacturing
Practice) certified facility. Following the positive meeting with the FDA,
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.

Justus Homburg, Progen’s Chief Executive Officer, commented: “The
manufacturing division at Progen has worked very hard to ensure that our
Company meets world class standards. The successful outcome of this meeting is
a direct result of their skills and dedication. We intend to use these skills
to win further contract manufacturing revenue for the division with the excess
capacity now created.”

SOURCE: Progen Industries Limited

CONTACT: Justus Homburg
CEO
Progen Industries Limited
justus.homburg@progen.com.au
Ph: 61 7 3842 3333