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 Decenber, 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):
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
11 December, 2006
ASX
& MEDIA RELEASE
11
DECEMBER, 2006
NOVOGEN
LIMITED’S US PATENT ADVANCE FOR PHENOXODIOL
Novogen
Limited (ASX:NRT; Nasdaq:NVGN) advises that it has recently obtained allowance
in the United States for patent claims to pharmaceutical compositions of the
anti-cancer drug candidate phenoxodiol.
The
US
Patent and Trademark Office has allowed for grant claims to pharmaceutical
compositions and unit dose forms of various substituted isoflav-3-enes
(including phenoxodiol). The issue and publication fees have been paid and
the
US patent is expected to issue in the first half of 2007. The period of
exclusivity is anticipated to be at least until 2017.
When
granted, this patent will significantly add to the Novogen intellectual property
portfolio surrounding phenoxodiol, which already includes granted protection
for
certain pharmaceutical uses including the treatment of cancer, and pending
patent applications for manufacturing processes and modes of action. This
portfolio includes granted protection in the US, UK, Australia, Singapore,
New
Zealand, Hong Kong, Czech Republic, and Turkey and pending applications
elsewhere around the world.
The
rights to develop and commercialise phenoxodiol have been licensed to Novogen’s
US oncology subsidiary company Marshall Edwards Inc (Nasdaq:MSHL). Phenoxodiol
is now in a multi-national phase III clinical trial as a chemotherapy
resensitiser for advanced ovarian cancer and is known as the 'Ovature'
trial.
Marshall
Edwards Inc has recently appointed JPMorgan Securities of New York to coordinate
the international outlicensing and commercialisation strategies for
phenoxodiol.
About
phenoxodiol:
Phenoxodiol
is an investigational drug and, as such, is not commercially available.
Phenoxodiol is a novel-acting drug that inhibits key pro-survival signaling
pathways operating via sphingosine-1-phosphate and Akt. Inhibition of these
pathways leads to prevention of phosphorylation of key anti-apoptotic proteins
such as XIAP. Loss of activity of these proteins restores the ability of
chemoresistant tumor cells to undergo apoptosis in response to chemotherapy.
The
putative molecular target for phenoxodiol is a tumor-specific protein,
accounting for the highly selective nature of the drug.
About
Novogen
Novogen
is an Australian based biotechnology company in the business of research and
development of drugs derived from its phenolic technology platform. The Company
manages its research and development programs utilising the expertise and
clinical research capabilities of universities and hospitals in Australia,
USA
and Europe. Novogen’s drug program is researching and developing compounds for
the treatment of cancer, cardiovascular disease and anti inflammatory disease.
About
Marshall Edwards Inc:
Marshall
Edwards, Inc. (Nasdaq : MSHL) has licensed rights from Novogen Limited (Nasdaq
:
NVGN) to bring three oncology drugs - phenoxodiol, NV-196 and NV-143 - to market
globally. Marshall Edwards, Inc. is majority owned by Novogen, an Australian
biotechnology company that is specializing in the development of therapeutics
based on a flavonoid technology platform. Novogen, based in Sydney, Australia,
is developing a range of therapeutics across the fields of oncology,
cardiovascular disease and inflammatory diseases. More information on
phenoxodiol and on the Novogen group of companies can be found at
www.marshalledwardsinc.com and 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 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.
--ISSUED
FOR: NOVOGEN
LIMITED
LISTINGS: ASX
(CODE NRT), NASDAQ (CODE NVGN).
FOR
FURTHER
INFORMATION: CHRISTOPHER
NAUGHTON, MANAGING DIRECTOR, NOVOGEN LIMITED
TEL
(02) 9878 0088 http://www.novogen.com
ISSUED
BY : WESTBROOK
COMMUNICATIONS
CONTACT:
DAVID REID TEL (02) 9231 0922 OR 0417 217 157