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 May, 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
15 May, 2006
Contacts: Christopher
Naughton
Chief
Executive Officer
+61
2
8877 6196 (Australia)
David
Sheon,
For
Marshall Edwards, Inc.
202
518-6321
MARSHALL
EDWARDS, INC. LICENSES TWO ANTI-CANCER COMPOUNDS FROM NOVOGEN
LIMITED.
(Washington
DC; and Sydney Australia - May 15) - Novogen Limited and Marshall Edwards,
Inc.
(MSHL) have concluded a Licence Agreement for MSHL to develop and commercialise
the two oncology compounds NV-196 and NV-143.
NV-196
is
being developed initially in oral form for pancreatic and bile duct cancer
and
NV-143 is targeted for the treatment of melanoma, also in oral dosage
form.
MSHL
holds an option licence agreement with Novogen that entitles MSHL to make
the
first and last offer from Novogen for oncology compounds that have entered
human
clinical trials.
NV-196
is
in phase I human testing and qualifies as an option compound. MSHL has exercised
that option on the terms now agreed. NV-143 is in pre-clinical testing and
has
also now been in-licensed by MSHL.
The
terms
of the licences consist of a single upfront payment to Novogen of US$1million,
a
series of payments for each compound upon reaching the milestones of US
Investigational New Drug (IND) approval, entering human testing at phases
II and
III and receipt of a New Drug Application for marketing and a royalty on
sales
of five per cent. MSHL will fund the ongoing clinical programs and is
responsible for the commercial development of the drugs.
MSHL
is
also the licensee of the Novogen developed investigational anti-cancer drug
phenoxodiol that currently is in phase II trials for ovarian and prostate
cancer. MSHL is concluding the protocol for phenoxodiol to enter phase III
human
trialling for chemotherapy resistant ovarian cancer, the development program
for
which the US FDA has granted MSHL fast track status.
The
Chairman of MSHL, Professor Graham Kelly, said the in-licensing of NV-196
represented a significant addition to the anti-cancer portfolio of Marshall
Edwards, Inc.
“The
high
safety profile and effectiveness that these drugs have demonstrated in
pre-clinical studies, along with our positive clinical experience with the
related compound phenoxodiol, auger well for a successful clinical program.”
Professor Kelly said.
“The
oncology world is looking for an effective series of drugs that can be targeted
to specific cancers with the knowledge that they are effective and relatively
safe.
“With
this class of drugs we hope to be able to offer that combination of safety
and
effectiveness to patients,” Professor Kelly added.
Marshall
Edwards, Inc. (Nasdaq : MSHL) is a US clinical development oncology company
and
is majority owned by Novogen, an Australian biotechnology company that is
specialising in the development of therapeutics based on regulation of the
sphingomyelin pathway.
Novogen
Limited (ASX : NRT Nasdaq : NVGN), 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.