- Report of Foreign Issuer (6-K)
February 17 2009 - 6:06AM
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 February 2009
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):
o
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):
o
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
13 February, 2009
ASX
& MEDIA RELEASE
13
FEBRUARY, 2009
NOVOGEN
TO FOCUS ON ONCOLOGY PROGRAM
Sydney,
Australia, 13 February, 2009 – Australian pharmaceutical R&D company,
Novogen Limited (ASX:NRT NASDAQ:NVGV) today advised it would focus its
activities on its oncology program.
With the
current economic climate making capital raising for extended programs difficult,
Novogen is relying on its internal resources to concentrate on the expanding
oncology portfolio.
Along
with this decision, Novogen has taken several steps to reduce costs so that
existing cash reserves are devoted to maintaining the significant potential of
the oncology program.
Among
cost reduction measures are:
·
|
outsourcing
of the scale-up manufacturing of clinical stage
compounds:
|
·
|
putting
on hold the cardiovascular and anti-inflammatory
programs;
|
·
|
reducing
world wide staff numbers from 62 to
51;
|
·
|
implementing
fee and income reductions of 20 per cent for the board and executive
management.
|
Novogen
advises that its Group cash balance at 31 December, 2008 is approximately A$44
million which it considers appropriate to ensure the viability of the
Company.
As it
proceeds closer to commercialisation of its oncology R&D and when financial
market conditions become more favourable, Novogen will be in a better position
to fund work on the remainder of its intellectual property which is derived from
its isoflavonoid technology platform.
Novogen’s
business strategy is to take its R&D to a clinical stage where it has a
definable value and is saleable to an organisation which would undertake
commercialisation.
The
Novogen Group’s most advanced anti-cancer compound phenoxodiol is in advanced
clinical trials, and is licensed to Novogen’s 71 per cent owned subsidiary,
Marshall Edwards, Inc. Elements of the Novogen Group’s oncology
program which are conducted by Marshall Edwards include:
·
|
phase
III global trial of phenoxodiol to treat advanced ovarian
cancer;
|
·
|
phase
II trial in the US of phenoxodiol to treat prostate
cancer;
|
·
|
phase
I trial of phenoxodiol to treat cervical
cancer;
|
·
|
phase
I trial of triphendiol, a derivative of phenoxodiol, to treat bile duct
and pancreatic cancers and advanced melanoma, for which the FDA has
granted orphan drug status, and which is approved for entry into clinical
trialling in the US.
|
Separately,
Novogen has developed NV-128, the promising mTOR inhibitor, which has a
different pathway from phenoxodiol and triphendiol to achieving cancer cell
death. This opens up new opportunities in anti-cancer therapies and
the possibility of these compounds working synergistically.
Novogen
is maintaining its commitments to Glycotex, Inc., its US based wound management
subsidiary, and also continues to earn revenue from sales of consumer
healthcare products in Australia Canada and the UK and from thirteen licensees
worldwide.
Novogen
has 95 granted patents surrounding its intellectual property which establishes
significant value within the group and a pipeline for future R&D
activity.
About
Novogen Limited
Novogen Limited (ASX: NRT; NASDAQ:
NVGN) is an Australian biotechnology company that has patented isoflavone
technology for the treatment and prevention of degenerative diseases and
disorders. The Company coordinates an international clinical research and
development program with external collaborators, hospitals and
universities. For more information, visit
www.novogen.com
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 party
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.
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