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THE PATH TO COMMERCIALISATION
FDA APPROVAL PROCESS
PRR is well advanced through the US Food & Drug Administration (FDA)
approvals process and is making solid progress towards the
commercialisation of CVac. Following the successful completion of
Phase I and Phase IIa trials and a pre-Investigational New Drug
Application (IND) meeting completed in October 2008, the company is
awaiting an imminent grant by the FDA of an IND application for CVac,
which will then allow PRR to commence Phase IIb and Phase III pivotal
trials.
PRR has a well-credentialed scientific and advisory team to guide the
company through the FDA approval process. Key members of the
scientific team include Professor Ian Frazer from the University of
Queensland, who is best known for his work on the development of the
world’s first cervical cancer vaccine Gardasil™ and Dr Bruce Loveland,
who was involved with the Phase I and Phase IIa trials for CVac.
The company’s key advisers in the US include Dr Joyce Frey-
Vasconcells, who is the former US FDA Director of Cell and Gene
Therapy and is managing PRR’s regulatory submission process for CVac
IND.
An advantage for PRR in terms of the FDA approval process is that
ovarian cancer is an orphan drug designation. This means that in the
US, it provides a 7-year extension to patent life after approval and
allows for a fast track approval through the FDA. In Europe, it is a 10-
year extension.
PHASE IIb/III PIVOTAL TRIALS
Phase IIb trials are likely to commence in the 4th quarter of
2009 and expected to take approximately two years to
complete, during which time, PRR is likely to explore partnering
opportunities. Obtaining FDA approval for CVac would widen CVac’s
market potential, which in turn could enhance the opportunity for
licensing or sale to a major pharmaceutical company. PRR have already
held discussions with a number of North American hedge funds and
other biotech-focused funds on new funding and partnering
opportunities for the commercialisation of CVac.
Further, the establishment of a $12 million funding facility (discussed
below) has largely addressed funding risk and ensures that phase
IIb/III pivotal trials can be progressed. The cost for phase IIb trials is
US$4 million and for phase III trials is estimated to be between US$7-9
million, with most of the expense for phase III trials expected to be
incurred in the latter stages of the Phase III trial timeframe.
The company had initially expected to conduct trials on ~340 patients
over three tranches, although based on discussions with the FDA, the
company may only need to conduct a randomised 60-patient trial. The
trial is likely to require 15 sites in the US and 15 sites in Australia &
New Zealand.

www.alphasecurities.com.au