Novogen Cash Reserves $25.4M, Phenoxodiol Receives US FDA Clearance for Phase III Human Trial
August 25 2006 - 10:36AM
PR Newswire (US)
STAMFORD, Conn. and SYDNEY, Australia, Aug. 25
/PRNewswire-FirstCall/ -- 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 http://www.novogen.com/. DATASOURCE: Novogen
Limited CONTACT: Mr. Christopher Naughton, Chief Executive Officer
or Mr. David Seaton, Chief Financial Officer, both of Novogen
Limited, (02) 9878 0088 or David Sheon of SciWords, LLC,
+1-202-518-6321, for Novogen Limited Web site:
http://www.novogen.com/
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