2013 Apr 15 Annual Report 2012 - Phosphagenics

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Also in 2004 Vital Capital changed its name
to Phosphagenics, surrendered its PDF status
and focussed its efforts on the development of
technologies and solutions using its patented
Vitamin E Phosphate both as a superior delivery
system and as a dietary supplement. It was also
investigated as a drug to help to slow down
and prevent the development of atheroslerosis
(hardening of the arteries) as well as reduce
cholesterol.
In 2005 Phosphagenics pushed beyond the
accepted limit of size of molecules that are able
to be delivered transdermally without disruption
to the skin. Parathyroid hormone and Insulin were
molecules of a size that had previously never
been delivered through the skin. Phosphagenics
achieved this breakthrough. There was
tremendous interest in this project especially
as diabetes was a rapidly growing problem.
In 2006 the Company started a Phase 1
trial for insulin after encouraging pre clinical
results, and Nestle signed an agreement with
Phosphagenics to investigate its Vitamin E
product for helping with Metabolic Syndrome.
Animal trials using Phosphagenics product
(GTP0805) with cancer drugs showed
improvement in reducing cancer tumors.
In 2007 Insulin phase 1 trial results were
successful and a phase 1 oxycodone trial was
approved. Phosphagenics had decided to
implement an oxycodone development program
instead of the morphine patch upon which proof
of concept studies had been completed. Purely
in terms of annual sales, Oxycodone had become
the dominant opioid in the management of
chronic pain and was more potent than morphine.
In 2008 a phase 2 trial on Type 1 diabetics was
conducted with results in 2009 indicating success
at being able to deliver insulin transdermally.
However, a combination of a realisation of
the costs required to take insulin through to
a phase 3 and the commercial failure of Pfizer’s
non injectable insulin delivery drug Exubera
(which cost Pfizer around $2 billion in write
offs), meant that the opioid pain patch program
appeared as a better and more economically
achievable commercial program. In 2008
there were a number of early clinical programs
undertaken with a series of results announced
in the following year.
In 2009 Phosphagenics completed its first
commercial agreement for selling product into
the cosmetics industry by licensing Le Metier
de Beaute to use TPM ® in its high end range
of cosmetics sold through up market department
stores including Bergdorf Goodman and Neiman
Marcus .The company signed an agreement with
CSL to investigate TPM ® in helping to deliver
large proteins. The rest of 2009 saw the release
of results from earlier trials which all showed
encouragement. Retinoic Acid, Insulin with Type 1
diabetics, the oxycodone patch prototype, lidocaine
and diclofenac were results announcements that
provided further proof of the platform nature of the
technology and led to the strategy of taking some
of these further down the commercialisation path.
Meanwhile, Nestle’s assessment of the use of our
Vitamin E Phosphate product to address metabolic
syndrome was not sufficiently compelling for
Nestle to take the next step of commercialisation.
There were a number of interesting positive results
from the phase 2 equivalent trial but not enough
for them to take a positive commercial view.
In 2010 the Company refined its strategy to focus
attention on a single major pharmaceutical goal,
whilst pursuing opportunities that had the potential
to provide short term cash flows. Elixia ® as an in
house cosmetic brand was launched with a range
of natural and high performance formulations.
However, it wasn’t till the BodyShaper formulation
was launched in May 2011 that major stockists
showed interest. The launch through TVSN
and Myers was highly successfully exceeding
initial expectations. A deal with AS Watson in
July led to the Company looking to take Elixia ®
global. Expansions into Europe through Boots
created great expectation, but a subdued retail
environment and serious competitive pressures
meant that sales disappointed and have led to
internal structural changes for Elixia ® .
In 2011, after having secured 3M as a
development partner the Company was ready
to start clinical trials of its Oxycodone patch,
which it did late in 2011.
We reached agreement with MMA to develop a
product to solve the issue of mastitis in dairy cows
a multi billion dollar problem for farmers. We also
reached agreement with Themis for the development,
manufacture and marketing of a diclofenac product
(similar to Voltaren) to be sold in India.
PHOSPHAGENICS ANNUAL REPORT 2012