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Biopharmaceuticals Oncology FDA

 News Release - August 25, 2006

Novogen Cash Reserves $25.4M, Phenoxodiol Receives US FDA Clearance for Phase III Human Trial

STAMFORD, Conn. and SYDNEY, Australia, Aug. 25 (HSMN NewsFeed) -- Pharmaceutical company Novogen Limited (Nasdaq: NVGN ; ASX: NRT ), has ended the 2005/06 financial year with solid cash reserves and US Food and Drug Administration (FDA) clearance for the final phase of human clinical testing of its lead anti-cancer drug, phenoxodiol.

Revenue for the year ended 30 June, 2006, was $13.9 million, a 3.2 percent improvement over the previous corresponding period of $13.4 million.

Cash reserves at 30 June, 2006 were $25.4 million, a decrease of $10.5 million over the year.

Research and Development (R&D) expenditure increased by $1.4 million to $9.1 million, from $7.7 million in the previous corresponding period.

The increased R&D expenditure mostly reflected costs associated with progressing the pre-clinical and clinical drug development program, and the scale-up and drug manufacturing process development costs for human clinical testing of phenoxodiol being conducted by Novogen's majority owned subsidiary, Marshall Edwards, Inc.

In May 2006, the US FDA granted Marshall Edwards, Inc. Special Protocol Approval for the phase III human clinical trial of phenoxodiol as a chemo- sensitizing agent in women with drug resistant ovarian cancer.

This form of approval by the FDA settles and agrees the clinical parameters which will permit commercialization of phenoxodiol if it meets its clinical objectives.

Novogen Managing Director, Mr. Christopher Naughton, said the group was now in a substantial growth phase with phenoxodiol approved to enter the final stage of clinical development prior to the application for product registration. The Group is also continuing to progress its pipeline of other drugs in various stages of advanced development.

"The key elements of Novogen's R&D strategy have been to progress the drug pipeline as far as possible and to surround it with strong patent protection before taking on a commercialization partner," Mr. Naughton said.

"While this entails considerable upfront expenditure, the result is the continued creation and preservation of substantial long term value for Novogen shareholders."

Mr. Naughton said a realistic measure of accruing value in the Company was the strength of its global patent portfolio, which had increased from 45 to 61 during the year.

Clinical development progress by the Novogen group during the year included the following:

* Yale University researchers in March 2006, reported data which revealed 74 percent of women patients treated with phenoxodiol as a chemo- sensitizing agent showed evidence of either tumor stability or shrinkage;

* Results in November 2005, from an Australian clinical trial of phenoxodiol in men with late stage hormone resistant prostate cancer showing significantly delayed tumor progression;

* Also in November Yale University reported encouraging results from clinical studies of phenoxodiol in women with cervical and vaginal cancer;

* Completion in March 2006, of a phase I clinical trial of the anti- inflammatory drug NV-52, for bowel disease, revealing it has potential as an oral therapy;

* Results in September 2005, of a phase Ib clinical trial of the experimental cardio-vascular drug trans-NV-04, demonstrating reductions in blood pressure and arterial stiffness in patients with compromised weight and heart health;

* Novogen granting in May 2006, an exclusive license to MEI for the development of two new anti-cancer drugs, NV-196 for the treatment of pancreatic and bile duct cancer, and NV-143 for a broader anti-cancer therapy.

Novogen group's loss after tax for the year ended 30 June 2006, was $9.3 million, an increase from $9.5 million for the previous corresponding period.

After balance date, Marshall Edwards, Inc. raised $18 million in addition to an associated line of equity credit of $15 million.

Novogen is involved in drug discovery and product development for disorders that are commonly associated with aging and coordinates an international clinical research and development program with external collaborators, hospitals and universities.

For more information see

Source: Novogen

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