Opfrisser
Onderstaande persbericht van Clinuvel is van november 2006. Hierin schept de CEO Philippe Wolgen een duidelijk beeld van het bedrijf en geeft nog eens in het kort aan wat ze voor geheel 2007 nog op de rol hebben staan. Daarom dacht ik dat het niet verkeerd is om dit bericht op dit moment nog maar eens uit de stal te halen en hier te plaatsen.
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Attention ASX Company Announcements Platform
Lodgement of Open Briefing®
Clinuvel Pharmaceuticals Limited
Level 13
1 Collins Street
Melbourne, VIC 3000
Date of lodgement: 14-November-2006
Title:Open Briefing®. Clinuvel CEO Updates Outlook
Record of interview:
corporatefile.com.au
Clinuvel Pharmaceuticals Limited recently raised A$35.2 million in new equity
to fund the development program of CUV1647. The company’s financial
position is now transformed. What advances in clinical development and
strategy have been achieved?
CEO Philippe Wolgen
The company’s prospects have evolved very substantially in the last 12
months.
Firstly, I think it is important to note that the last twelve months of clinical
development have been built on a significant safety profile in the patients
treated. Since I joined Clinuvel we have redirected the clinical strategy of the
company, to become entirely focused on demonstrating efficacy for CUV1647
in a “registrable’ clinical indication. A key component of the changes was the
appointment of Dr Helmer Agersborg as Chief Scientific Officer. We revisited
the biochemical properties of CUV1647 and made the decision to apply
CUV1647 where the clinical demand was most evident. Also, I have worked
intensely with the existing Board for the company to benefit from their
experience in the industry.
Secondly, we’ve built a cohesive management and clinical team around our
lead drug candidate CUV1647, which takes responsibility for the program and
executes it accordingly. This team is pivotal in the continuous development of
CUV1647. I believe we have made significant progress by recruiting
physicians and opinion leaders in their field worldwide.
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Thirdly, through careful clinical trial design we have attained our milestones in
demonstrating the efficacy of CUV1647 in key indications such as
polymorphous light eruption (PLE) Phase IIb trials in Melbourne, the start of
erythropoietic protoporphyria (EPP) trials in Switzerland and the protocols
rewritten for the forthcoming trials.
Fourthly, we have ensured that we have communicated our strategy and
objectives consistently to investors in Australia and internationally.
corporatefile.com.au
What has been the value driver? Why have prospects improved?
CEO Philippe Wolgen
Unpredictably, a change in paradigm occurred where least expected during our
investigations into photobiology of skin cancer we learnt that the incidence of
skin cancer (SCC) and actinic keratosis (AK; pre-malignant sunspots) in fairskinned
organ transplant patients was significant. Research demonstrates that
organ transplant patients with skin type I and II (according to the Fitzpatrick
classification), have 65 to 100 times increased risk of developing skin cancer
following the organ transplant.
We believe that CUV1647 could play a role in reducing the rate of AK
development in organ transplant patients. We will commence clinical trials in
2007 with these patients.
corporatefile.com.au
In your address to shareholders at last week’s AGM you mentioned the clinical
funding requirement of A$54 million for the CUV1647 development program.
What is included in this estimate?
CEO Philippe Wolgen
Our latest prospectus contains an estimate of A$54 million to fund the clinical
program, including the program for continuous product development, costs of
clinical trials in PLE Phase II/III, AK Phase II, EPP Phase II/III, and other
clinical costs.
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At the AGM you also highlighted the significant progress made towards first
registration of CUV1647 in the last financial year. What trials are planned to
progress the development of CUV1647 during the 2007 financial year?
CEO Philippe Wolgen
At this stage our clinical program contains five activities for the foreseeable
future. However, I reiterate that in this business there are risks, which are
typical to the dynamic process of drug development. I believe that we have a
team with the right mindset to adapt to these dynamics and successfully achieve
our objectives.
Having said this, clearly the upside of taking a new drug to market must be
attractive from an investor’s perspective. As it currently stands, our immediate
targets are:
1. PLE trials planned in Q1/Q2 2007 in Europe;
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2. EPP trials planned in Q1/Q2 2007 in Europe and Australia;
3. Solar Urticaria (SU) trials planned in Q1/Q2 2007 in the UK and
Europe;
4. AK in immuno-compromised organ transplant patients, trials
planned mid 2007 in Europe and Australia; and
5. Obtaining an Investigational New Drug (IND) status in
preparation for our US clinical program.
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In the first fiscal quarter ended 30 September 2006, Clinuvel recorded a net
cash burn of A$2.9 million. What is the likely rate of cash burn for the
remainder of fiscal 2007?
CEO Philippe Wolgen
The A$2.9 million is a direct result of running a tight fiscal policy, but includes
the costs of disposing of the pharmaceutical distribution business EpiPharm.
The cash burn rate for the second and third quarters is projected to be close to
the figure in the first quarter. It is important to note, that our spend is focussed
on the clinical development of CUV1647.
corporatefile.com.au
What is the relevance of the recent patent filings for specific clinical
applications of CUV1647? Why has it been necessary to file new patents for
the use of CUV1647?
CEO Philippe Wolgen
Continuous patent filing is very much the norm in pharmaceutical development.
As discoveries in the application of CUV1647 are made, we will expand and
fortify the intellectual property position of Clinuvel to continue to build the
value of the company.
corporatefile.com.au
In your address to shareholders, you also mentioned a US presence with the
establishment of Clinuvel Inc. in San Francisco. What part will this presence
play in Clinuvel’s continuing development program?
CEO Philippe Wolgen
Our US office will position us closer to the US Food and Drug Administration
(FDA) and will facilitate the coordination of the US trials. It is essential to
have a presence on the ground in the US and this will also enhance the strength
of our clinical team headquartered in Melbourne.
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What are the key milestone achievements marking continued progress towards
first registration of CUV1647, which are being targeted during the 2007
financial year?
CEO Philippe Wolgen
Our key milestones, which we can be reasonably confident of achieving
include: interim results for the EPP trial currently being conducted in
Europe; commencement of Phase II/III trials in PLE subject to regulatory
approval; commencement of trials in organ transplant patients in Australia
and most likely in Europe.
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Above all, I see the thoughtful and continuous monitoring of the safety
profile for CUV1647 in human subjects a major milestone. Unlike the
building of any other business, I keep reminding my team that we are
working with and on humans. Safety of our lead peptide is a permanent
focus. We’ve adopted the mindset to look at each sa