Novogen Ltd - Report of Foreign Issuer
October 30 2007 - 6:55AM
Edgar (US Regulatory)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
______________________________________________
Form
6-K
REPORT
OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER
THE
SECURITIES
EXCHANGE ACT OF 1934
For
the
month of October, 2007
Commission
File Number
________________
Novogen
Limited
(Translation
of registrant’s name into English)
140
Wicks
Road, North Ryde, NSW, Australia
(Address
of principal executive office)
___________________________________
Indicate
by check mark whether the registrant files or will file annual reports under
cover of Form 20-F or Form 40-F.
Form
20-F
x
Form
40-F
o
Indicate
by check mark if the registrant is submitting the Form 6-K in paper as permitted
by Regulation S-T Rule 101(b)(l):
Note:
Regulation S-T Rule 101 (b)( I) only permits the submission in paper of a Form
6-K if submitted solely to provide an attached annual report to security
holders.
Indicate
by check mark if the registrant is submitting the Form 6-K in paper as permitted
by Regulation S-T Rule lO1(b)(7):
Note:
Regulation S-T Rule l01(b)(7) only permits the submission in paper of a Form
6-K
if submitted to furnish a report or other document that the registrant foreign
private issuer must furnish and make public under the laws of the jurisdiction
in which the registrant is incorporated, domiciled or legally organized (the
registrant’s “home country”), or under the rules of the home country exchange on
which the registrant’s securities are traded, as long as the report or other
document is not a press release, is not required to be and has not been
distributed to the registrant’s security holders, and, if discussing a material
event, has already been the subject of a Form 6-K submission or other Commission
filing on EDGAR.
Indicate
by check mark whether the registrant by furnishing the information contained
in
this Form is also thereby furnishing the information to the Commission pursuant
to Rule l2g3-2(b) under the Securities Exchange Act of 1934. Yes
o
No
x
If
“Yes”
is marked, indicate below the file number assigned to the registrant in
connection with Rule 12g3-2(b):
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant
has
duly caused this report to be signed on its behalf
by the undersigned,
thereunto duly authorized.
Novogen
Limited
(Registrant)
/s/ Ron
Erratt
Ronald
Lea Erratt
Company
Secretary
Date
26 October, 2007
Chairman’s
address
to
the Annual General Meeting of Novogen Limited
26
October, 2007
It
is
with pleasure that I present to you, our valued shareholders, my address for
the
2007 Annual General Meeting
I
propose
to focus on the progress made during 2006/2007 and outline some of the keys
steps planned for the year ahead designed to realise some of the future value
of
your Company. You could perhaps summarise the overall performance
this year as making steady progress in strengthening the underlining value
of
our intellectual property but again not seeing this value reflected in the
Company’s share price.
I
reflected last year that the biotech sector had become distinctly
unpopular. With the continued excitement around the resources boom as
the favoured area to take some exposure to risk together with the above average
returns flowing from blue chip stocks the biotech sector has perhaps fallen
to
an even lower ebb.
I
am
sometimes asked by shareholders what is the CEO and the management doing to
fix
the share price.
The
focus
the Board seeks from the management will continue to be to effectively manage
the development of our science, protect that science through comprehensive
patent application and enforcement, raise sufficient cash to move our
intellectual property towards commercialisation, develop a
licensing/collaboration strategy to fully realise the full commercial value
our
compounds and ultimately move towards a self funded biotech R&D
company. Along the way we have an obligation and desire to keep the
market fully informed. Through this communication process we seek to
build a better understanding throughout the business and investment community
of
the Company’s potential and underlying value.
We
are
always refining our approach to this broad task but at the same time are always
cautious not to oversell the true position or invest valuable funds on what
might be described as hype.
Although
it might be seen by some as stating the obvious it is at times necessary to
remind people that any more direct intervention in our attempts to
influence the share price could be both illegal and contrary to the best long
term interests of shareholders.
Not
withstanding these comments we have invested some additional funds and time
on
our public relations communication process this year and in particular we have
sought to augment the start to the Ovature trial with a comprehensive
information campaign targeting cancer sufferers, clinicians, clinical research
staff and hospital administrators about the benefits of participating in this
trial. More detail about Ovature will be included in following
presentations.
The
Ovature trial is of course the principal focus for our 72%US subsidiary Marshall
Edwards, Inc., and importantly we recently, post balance date, completed a
successful “PIPE” raising of US$16.45M which will underwrite our ability to
progress the Ovature trial. Significantly there was interest from new
investors in further compounds such as NV-196 and the option agreement Marshall
Edwards has for all of Novogen’s Oncology compounds.
Another
key event for Marshall Edwards this year was the appointment of Professor Bryan
Williams as that company’s non executive Chairman. Professor Williams
brings to the group a wealth of experience in medical research and in particular
his involvement as chairman of the department of cancer biology at the
prestigious Cleveland Clinic in the USA from 1991 to 2005 makes him ideally
qualified to oversee the strategic development of Novogen’s oncology pipeline
through Marshall Edwards, Inc.
The
strategic development for Marshall Edwards was also strengthened by the
appointment of the JPMorgan company as financial advisor. This
broadens our access to expert advice in the areas of licensing, business
collaboration and all forms of fund raising.
Glycotex
our 81% US subsidiary also has made good progress this year. The 2005
approval by the US Securities Exchange Commission (SEC) to proceed with a NASDAQ
public listing was a key step in our strategy to develop this different area
of
technology. We chose to delay that listing until some further
milestones were achieved with development of the science which are necessary
to
gain an Investigational New Drug (IND) approval from the US Food and Drug
Administration (FDA). This approval which we expect to receive during
the next quarter will greatly enhance our ability to conduct a successful
Initial Public Offering (IPO) which in turn will allow us to commence larger
scale clinical trials in the USA.
In
the
meantime a successful private raising of US$1.6M in return for 3.6% of the
company will allow us to progress all the necessary work to initiate the IPO
process.
In
the
OTC area, again post balance date, we have completed our strategy of moving
production of our active compounds to a contractor in
Switzerland. This will achieve significant cost savings contributing
to better product margins and importantly realising AUS$4.0M cash from the
sale
of our Wyong premises.
Further
cash benefits were achieved from this business through the successful
prosecution of our patents in North America leading to advantageous
settlements.
As
we
look ahead the key focus in 2008 will be on accelerating patient recruitment
into the Ovature trial which in turn will allow for an interim analysis of
the
trial data late next year. The ability to conduct an interim analysis
well before completion comes about because of our previously granted fast track
status and operation under a Special Protocol Approval (SPA) from the
FDA. Depending on the outcome of this analysis we may have the
ability to apply for a New Drug Approval (NDA) and move towards marketing
through a licence arrangement whilst the trial is still being
completed.
In
addition Marshall Edwards will progress an IND application for NV-196 known
as
Triphendiol. This will allow commencement of clinical trialling in
the USA most likely to treat pancreatic or cholangiocarcinoma (bile duct)
cancer. Triphendiol has shown positive pre clinical results in both
these cancers in
invitro
testing along with some Melanomas and all 3
areas have the potential to receive orphan drug status if the FDA formally
agrees that no effective treatments are currently available specifically for
these diseases. If such status were to be achieved this again offers
the opportunity for an accelerated path through the trial and approval
process.
Outside
the oncology area Novogen will continue its identification of new compounds
and
further progress those already identified to have potential in the anti
inflammatory and cardiovascular areas.
I
commend
your attention to a presentation to be made shortly by Dr. Cath Walker which
will give you some insight into this area and in particular the plans for
potential compounds in the treatment of anti inflammatory
disease. This year we completed some very encouraging animal studies
using our compound NV-17 and we can now move towards a phase 2 clinical trial
and to test the concept of FAIMS as a new class of anti inflammatory compound
without the risks of cardiovascular side effects.
I
thank
you for your attention and again thank all our shareholders for their patience
and support .I would like also to publicly thank all our staff who
achieve at a level equal to or better than that expected in large pharmaceutical
companies but under tight budget constraints and without the almost
unlimited resources and rewards associated with that industry. There
is no better measure of their contribution than the number and diversity of
exciting compounds moving toward commercialisation which stands Novogen apart
from so many biotech research companies.
Philip
Johnston
Chairman.
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