Healthcare Industry News: mTOR
News Release - February 13, 2009
Novogen to Focus on Oncology ProgramSYDNEY, AUSTRALIA--(Healthcare Sales & Marketing Network)--Feb 13, 2009 -- Australian pharmaceutical R&D company, Novogen Limited (ASX:NRT.AX ) (NasdaqGM:NVGN ) today advised it would focus its activities on its oncology program.
With the current economic climate making capital raising for extended programs difficult, Novogen is relying on its internal resources to concentrate on the expanding oncology portfolio.
Along with this decision, Novogen has taken several steps to reduce costs so that existing cash reserves are devoted to maintaining the significant potential of the oncology program.
Among cost reduction measures are: -- outsourcing of the scale-up manufacturing of clinical stage compounds;
-- putting on hold the cardiovascular and anti-inflammatory programs;
-- reducing world wide staff numbers from 62 to 51;
-- implementing fee and income reductions of 20 percent for the board and executive management.
Novogen advises that its Group cash balance at 31 December, 2008 is approximately A$44 million (US$29 million) which it considers appropriate to ensure the viability of the Company.
As it proceeds closer to commercialisation of its oncology R&D and when financial market conditions become more favourable, Novogen will be in a better position to fund work on the remainder of its intellectual property which is derived from its isoflavonoid technology platform.
Novogen's business strategy is to take its R&D to a clinical stage where it has a definable value and is saleable to an organization which would undertake commercialization.
The Novogen Group's most advanced anti-cancer compound phenoxodiol is in advanced clinical trials, and is licensed to Novogen's 71 percent owned subsidiary, Marshall Edwards, Inc. Elements of the Novogen Group's oncology program which are conducted by Marshall Edwards include: -- phase III global trial of phenoxodiol to treat advanced ovarian cancer;
-- phase II trial in the US of phenoxodiol to treat prostate cancer;
-- phase I trial of phenoxodiol to treat cervical cancer;
-- phase I trial of triphendiol, a derivative of phenoxodiol, to treat bile duct and pancreatic cancers and advanced melanoma, for which the FDA has granted orphan drug status, and which is approved for entry into clinical trials in the US.
Separately, Novogen has developed NV-128, the promising mTOR inhibitor, which has a different pathway from phenoxodiol and triphendiol to achieving cancer cell death. This opens up new opportunities in anti-cancer therapies and the possibility of these compounds working synergistically.
Novogen is maintaining its commitments to Glycotex, Inc., its US-based wound management subsidiary, and also continues to earn revenue from sales of consumer healthcare products in Australia, Canada and the UK and from thirteen licensees worldwide.
Novogen has 95 granted patents surrounding its intellectual property which establishes significant value within the group and a pipeline for future R&D activity.
About Novogen Limited
Novogen Limited is an Australian biotechnology company that has patented isoflavone technology for the treatment and prevention of degenerative diseases and disorders. The Company coordinates an international clinical research and development program with external collaborators, hospitals and universities. For more information, visit 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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