KZIA Kazia Therapeutics Ltd

STAMFORD, Conn., Aug. 29 /PRNewswire-FirstCall/ -- Pharmaceutical company Novogen Limited (NASDAQ:NVGN)(ASX:NRT), has ended the 2004/5 financial year with a lift in sales by its consumer products business and encouraging preliminary data from its advanced pharmaceutical clinical trial program. Revenue for the year was US $13.3 million (US $12.3 million) and included a five percent increase in sales of consumer products from $9.5 million to $10.1 million. The sales increase was the result of more targeted promotional programs emphasizing Novogen's product range as the most clinically trialed natural alternatives, and an extension of distribution channels in Australasia, the European Union and the United States. Cash reserves at June 30, 2005, were $35.5 million, a decrease of $8.3 million over the year. Cash was used primarily for research and development expenses of $7.7 million, an increase of $1.4 million from $6.2 million in the previous corresponding period. Funds were expended on the Novogen Group's human clinical trial program, including the anti-cancer drug, phenoxodiol, and cardiovascular and anti- inflammatory research and development. Phenoxodiol is currently being evaluated by Novogen's majority owned subsidiary, Marshall Edwards Inc. (NASDAQ:MSHL), in phase II clinical trials for the treatment of prostate cancer, ovarian cancer and squamous cell carcinomas (SCC) of the cervix, vagina and vulva. According to Novogen managing director, Mr. Christopher Naughton, the Group would continue to increase its commitment to research and development. "Our strong cash position and improved sales from our consumer products division ensure we will be able to maintain momentum with advanced research and development into isoflavones and pharmaceuticals based on our patented human phenolic hormone technology," Mr. Naughton said. During the year the Group made significant progress in the clinical development of phenoxodiol including: * In November 2004, MSHL was granted "fast track" status with the U.S. Food and Drug Administration (FDA) for its intended use as a chemo sensitizing agent in combination with pacitaxil or cisplatin in patients with recurrent late stage ovarian cancer that is resistant or refractory to platins and taxanes. * In January 2005, researchers from Yale University School of Medicine revealed that phenoxodiol considerably enhanced the ability of the drug docetaxel to kill human ovarian cancer cells in the laboratory. The researchers also found the effect of phenoxodiol-enabled 1/100th of the amount of docetaxel to be used as docetaxel alone on cells previously found to be resistant to docetaxel. * In January 2005, the U.S. FDA granted "fast track" status for oral phenoxodiol for prostatic adenocarcinoma that is resistant to both hormonal and cytotoxic chemotherapy. Under the FDA Modernization Act (1997), designation as a "fast track" product means that phenoxodiol is eligible for certain accelerated marketing approval programs although it does not ensure future regulatory approval. * In May 2005, preliminary results were received from the combination therapy trial for patients with late stage refractory ovarian cancer being conducted at Yale New Haven Hospital and the Royal Women's Hospital in Australia. These preliminary results revealed that 33 percent (12/36) of patients who were on combination therapy that included phenoxodiol experienced a complete or partial response. The Novogen Group was granted 10 patents during the 2004/5 financial year increasing to 45 the number of issued patents protecting its isoflavone technology and pharmaceutical drug pipeline. In January 2005, Novogen settled its patent infringement suit against the General Nutrition Corporation (GNC); Novogen received cash and the reinstatement of its consumer products in GNC's retail outlets. Novogen's operating loss attributable to shareholders for the year ended June 30, 2005, was $8.3 million compared with $8.2 million for the previous corresponding period, with the net loss after tax for the Group decreasing from $9.4 million to $9.2 million for the same period. 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. Phenoxodiol is an investigational drug and, as such, is not marketed in the U.S. 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 party 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. DATASOURCE: Novogen Limited CONTACT: Christopher Naughton of Novogen, or +011-612-98-78-00-88, or David Sheon, +1-202-518-6321, for Novogen

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