-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, IMu9f5Y27i/QJ90pfMRW+0761Dfq5TZEBCY4AhgvcOPW28ZNcyqtQ3npZW88E7eA FF9nkhiqNyeWLthhZTTRwQ== 0001075880-06-000029.txt : 20060515 0001075880-06-000029.hdr.sgml : 20060515 20060515080632 ACCESSION NUMBER: 0001075880-06-000029 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 1 CONFORMED PERIOD OF REPORT: 20060515 FILED AS OF DATE: 20060515 DATE AS OF CHANGE: 20060515 FILER: COMPANY DATA: COMPANY CONFORMED NAME: NOVOGEN LTD CENTRAL INDEX KEY: 0001075880 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 FISCAL YEAR END: 0630 FILING VALUES: FORM TYPE: 6-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-29962 FILM NUMBER: 06836982 BUSINESS ADDRESS: STREET 1: 140 WICKS RD STREET 2: NORTH RYDE CITY: NEW SOUTH WALES 2113 STATE: C3 ZIP: 2113 BUSINESS PHONE: 01161298780088 MAIL ADDRESS: STREET 1: 107 NORTH RYDE CITY: SYDNEY STATE: C3 ZIP: 1670 6-K 1 form6k20060515.htm FORM 6K 20060515 Form 6K 20060515

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.


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