6-K: Report of foreign issuer [Rules 13a-16 and 15d-16]
Published on
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 February, 2006.
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
o
If
“Yes”
is marked, indicate below the file number assigned to the registrant in
connection with Rule 12g3-2(b):
82-
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
24 February, 2006
ASX
&
MEDIA
RELEASE
24
FEBRUARY, 2006
NOVOGEN
ADVANCES CLINICAL TRIAL PROGRAMS AND RETAINS
SOLID CASH POSITION
Pharmaceutical
company, Novogen Limited (ASX: NRT, NASDAQ: NVGN),
has made significant gains in its clinical trial program during the half year
to
31 December, 2005, with sufficient cash reserves to maintain the impetus of
its
research and development.
Consolidated
cash reserves are $42.4 million at 31 December,
2005.
Chief
Executive Officer of Novogen, Mr Christopher Naughton, said
the continuing strategy of the Novogen Group was to fund its research activities
through its US based therapeutically focused subsidiaries, whilst Novogen
Limited created the intellectual property to support the existing portfolio
of
compounds and developed the extensive pre-clinical drug pipeline.
“The
Group strategy is to consider licensing and partnering when
compounds are clinically advanced, such as with the anti-cancer drug
phenoxodiol, now entering phase III trials,” Mr Naughton said.
“Our
present cash reserve position ensures that we can resist the
need to seek prematurely outside partnerships for drug development and
pharmaceutical licensing.”
Mr
Naughton said the Group had made significant advances in its
research and development program during the half year.
The
Novogen Group of companies includes the Australian parent and
two US based subsidiaries, Marshall Edwards, Inc., and Glycotex, Inc.
Marshall
Edwards, is 87 per cent owned by Novogen and is
developing the Group’s lead anti-cancer compound, phenoxodiol, across a range of
different cancers and in combination with other anti-cancer drugs. Glycotex
which is 83 per cent owned by Novogen, is responsible for the development of
the
glucan wound healing program.
Among
research and development advances was the receipt of
research and clinical trial data demonstrating that phenoxodiol, had delayed
significantly tumour progression in men suffering from late-stage hormone
refractory prostate cancer.
Other
progress made with phenoxodiol during the period included
the announcement of an investigator sponsored clinical study of phenoxodiol
in
combination with docetaxel for women with recurrent ovarian cancer.
This
clinical study is to take place at Yale University School of
Medicine and is supported jointly by the multinational pharmaceutical company
Sanofi-Aventis and Marshall Edwards.
Researchers
from Yale University’s School of Medicine also
reported further updates on results of phenoxodiol on women with early-stage
cancer of the cervix and vagina.
In
addition, further progress has been made with the trans NV-04
cardiovascular program and the NV-52 anti-inflammatory clinical plan.
Glycotex
filed for an IPO with the US Securities Exchange
Commission during the period, and although formal approval was received, the
company opted to develop its glucan wound healing program further before
considering reissuing the prospectus later in 2006. Glycotex has appointed
Dr Reinhard Koenig as its chief executive officer, based in San
Francisco.
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Novogen
also increased its intellectual property suite during the
half year to 31 December, 2005, to a total of 51 patents with the addition
of
six new international patents across its drug development pipeline.
Total
revenue for the half year to December was $8.64 million,
compared with $9.59 million for the six months to 31 December, 2004.
Royalties
of approximately $0.7 million were received for the six
months in the form of milestone payments due under a licence agreement with
Archer Daniels Midland and $0.3 million due under a licence agreement with
Melbrosin.
The
majority of revenue is from sales of over the counter products
internationally contributing $6.4 million compared with $7.3 million in the
previous corresponding half year, with a contribution from interest earned
on
cash deposits.
Net
loss for the six months was $6.5 million, an increase of $1.6
over the half year to 31 December, 2004.
Novogen
is focused on research and development of drugs derived
from its phenolic technology platform. The Company manages its international
research and development programs utilising the expertise and clinical research
capabilities of universities and hospitals in Australia, the US and other key
international locations.
Under
U.S. law, a new drug cannot be marketed until it has been
investigated in clinical trials and approved by the FDA as being safe and
effective for the intended use. Statements included in this press release
that
are not historical in nature are "forward-looking statements" within the
meaning
of the "safe harbor" provisions of the Private Securities Litigation Reform
Act
of 1995. You should be aware that our actual results could differ materially
from those contained in the forward-looking statements, which are based on
management's current expectations and are subject to a number of risks and
uncertainties, including, but not limited to, our failure to successfully
commercialize our product candidates; costs and delays in the development
and/or
FDA approval, or the failure to obtain such approval, of our product candidates;
uncertainties in clinical trial results; our inability to maintain or enter
into, and the risks resulting from our dependence upon, collaboration or
contractual arrangements necessary for the development, manufacture,
commercialization, marketing, sales and distribution of any products;
competitive factors; our inability to protect our patents or proprietary
rights
and obtain necessary rights to third arty patents and intellectual property
to
operate our business; our inability to operate our business without infringing
the patents and proprietary rights of others; general economic conditions;
the
failure of any products to gain market acceptance; our inability to obtain
any
additional required financing; technological changes; government regulation;
changes in industry practice; and one-time events. We do not intend to update
any of these factors or to publicly announce the results of any revisions
to
these forward-looking statements.
A
copy of this release can be downloaded from
www.westbrookfin.com.au or
www.novogen.com
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