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Medical science has made a significant number of breakthroughs over the past century. The average life span in western cultures has substantially increased. Heart disease and cancer have been amongst the most successful

Key Takeaway: science has made a significant number of breakthroughs over the past century. The average life span in western cultures has substantially increased. Heart disease and cancer have been amongst the most successful areas of drug discovery over the last 20 years. The diseases asso

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science has made a significant number of breakthroughs over the past century.
The average life span in western cultures has substantially increased. Heart
disease and cancer have been amongst the most successful areas of drug discovery
over the last 20 years. The diseases associated with aging have, however,
yet to be fully understood or effectively treated. Diseases of aging are in fact
diseases capable of being prevented or cured. They are no longer regarded as an
inevitable part of aging.
develop therapeutic drugs designed to treat the underlying causes of
degeneration of the brain as the aging process
Contents
Chairman's Letter 1
Review of Operations 2
Intellectual Property Report 5
Corporate Governance Statement 7
Directors' Report 12
Auditor's Independence Declaration 22
Income Statements 23
Balance Sheets 24
Statements of Changes in Equity 25
Cash Flows Statements 26
Notes to the Financial Statements 27
Directors' Declaration 58
Independent Audit Report 59
Shareholder Information 62
Corporate Information 64
Fellow Shareholders,
delighted to report on the progress of the Company over the past year. It has
proven to be a very productive year and the fruits of the focused efforts by our
scientists, managers and staff have been reflected in a number of important
value-adding announcements and events.
tough market conditions, Prana successfully pursued funding that will be used to
promote our drug development pipeline; reached several significant research
milestones; and was allowed or granted key patents for our leading compound,
PBT2, by the United States and European Patent Offices respectively. At the same
time, we continued to engage in discussions with major pharmaceutical companies
interested in helping Prana conduct large clinical trials with PBT2, for the
treatment of Alzheimer's Disease (AD).
specific goal of the Company has been to produce a drug to treat Alzheimer's
Disease. It is our hope and expectation that, in PBT2, we have that drug and
will meaningfully improve the lives of patients. Increasingly, PBT2 is
attracting the attention of scientists, pharmaceutical companies and investors
around the world. In July, Prana was very strongly represented at the
International Conference on Alzheimer's Disease (ICAD) held in Chicago. ICAD is
the largest and highest profile academic and industry event in Alzheimer's
Disease. Our lead drug for AD, PBT2, was highlighted in the prestigious Hot
Topics segment of the conference.
same week, the results of a clinical trial of PBT2 on patients with AD were
published in The Lancet Neurology journal. PBT2 was able to affect patients in
at least two important ways - the drug reduced the level of a toxic protein
(Abeta42) in patient's spinal fluid, and the patients receiving PBT2 improved
their performance in measures of Executive Function, an important aspect of
cognition. Executive Function loss is clinically observed in AD patients, even
at the very early stages of the disease. Patients on the trial who received a
placebo rather than the real drug did not show either of these
success has come at a very interesting, and in some ways challenging, time in
the global effort to market a drug to treat AD by stopping or very significantly
slowing its progression. Current drugs on the market do not do this, they merely
treat the existing symptoms for a limited period of time. A great deal of time,
money and effort has been spent through the global effort of a great many
companies attempting to reduce Abeta42. This year there have been several high
profile and disappointing results reported that failed to prove the so called
"Amyloid Hypothesis" - that Abeta is poisonous to brain cells and causes
Alzheimer's Disease. In very stark contrast to these reports, PBT2 is a drug
specifically designed to stop the actual toxicity of Abeta. The drug achieves
this by targeting metals in the brain, such as copper and zinc, which react with
Abeta to make it toxic. The clinical trial results on patients are very
encouraging and larger longer trials are now being planned.
deal of our enthusiasm around the potential of PBT2 comes from the growing body
of information around how the drug works. Another very important milestone
achieved in July was the publication in Neuron of the laboratory research behind
the Company has commented on the potential of its drug pipeline to benefit
patients with other diseases such as Parkinson's Disease, Huntington's Disease
and some types of cancer. All the programs are progressing well and we
anticipate new drug candidates entering in the development pipeline in the
coming year. In each disease we target, our opportunity arises from our
specialized knowledge of the role of metals in the development and progression
continue to keep you updated with announcements and I encourage you to visit our
website at www.pranabio.com to learn more about your Company.
face many challenges, but looking ahead, I am optimistic that we will find ways
to commercialize Prana's unique MPAC technology in order to help millions of
Alzheimer's sufferers who currently have no hope for a cure. Plans are under way
for PBT2 to be back in the clinic to be tested in more advanced clinical trials
and, with the success to date of PBT2 in AD, we now expect our other programs to
like to extend my thanks and appreciation to the very dedicated and hard working
team of Prana scientists, managers, staff and consultants, as well as to my
fellow directors on the Board. I also want to thank Prana's investors and
shareholders for your continued loyalty and support. I look forward to sharing
with all of you the rewards that are to come.
2008, Professor Rudolph Tanzi, Co-Founding scientist of Prana, was appointed by
the U.S. Senate Special Committee on Aging on the Future of Alzheimer's:
Breakthroughs and Challenges, to testify on Alzheimer's Disease as a growing
health care crisis. His testimony spoke to the available therapeutic approaches
in Alzheimer's Disease, where PBT2 is differentiated to others by working to
detoxify the Abeta protein in brain synapses as well as promoting the clearance
of the toxic Abeta from the brain. PBT2 is Prana's lead drug candidate for the
treatment of Alzheimer's Disease.
July 2008, the results of the Phase IIa trial in Alzheimer's Disease patients
treated with Prana's PBT2 were published in The Lancet Neurology Journal. The
published results described the significant decrease in Abeta protein levels in
the cerebrospinal fluid of patients treated with PBT2 at the 250mg dose compared
to patients on placebo. The published results also reported that at this same
dose patients showed significant improvement in two measures of cognitive
Executive Function compared with placebo, as assessed using the
Neuropsychological Test Battery (NTB).
Prana's Annual General Meeting in November 2008, the company reported on the
prospect of PBT2 being suitable for the treatment of Huntington's Disease as a
second neurological therapeutic application. Prana had commissioned a report
from two independent U.S. based clinical researchers being key opinion leaders
in the field of Huntington's Disease entitled, "The suitability and
recommendations for the clinical development of PBT2 in Huntington's Disease".
The report reviewed the pre-clinical animal modeling undertaken on PBT2 and the
encouraging signs of cognitive effect and clinical safety observed with PBT2
from the Phase IIa Alzheimer's Disease trial. The authors of the report
concluded that PBT2 was a suitable drug candidate for clinical development in
Huntington's Disease.
Last updated: Sep 28, 2009