Marshall Edwards Awarded Key Patent for Compositions of Lead Oncology Drug Candidates

Dec 20, 2011

San Diego – Marshall Edwards, Inc. (Nasdaq: MSHL), an oncology company focused on the clinical development of novel therapeutics targeting cancer metabolism, announced today that the U.S. Patent and Trademark Office has issued a new patent, U.S. Patent No. 8,080,675, covering a number of the Company’s isoflavone-based compounds, including lead oncology drug candidates ME-143 and ME-344, and their pharmaceutical compositions. The patent is estimated to provide protection until March 2027.
“This patent represents another important milestone in our efforts to develop our lead drug candidates into valuable treatment options for patients with cancer,” said Daniel P. Gold, Ph.D., President and Chief Executive Officer of Marshall Edwards. “Furthermore, this demonstrates our commitment to further strengthening the intellectual property portfolio we acquired earlier this year, which will be essential for partnering any of our drug candidates and enhancing shareholder value.”

Marshall Edwards completed the acquisition of its isoflavone-based intellectual property portfolio, including worldwide rights to lead oncology drug candidates ME-143 and ME-344, from Novogen Limited in May 2011. The portfolio now includes 11 issued U.S. patents, at least 14 U.S. patent applications, at least 40 issued foreign patents and at least 80 foreign patent applications.

About Marshall Edwards

Marshall Edwards, Inc. (Nasdaq: MSHL) is a San Diego-based oncology company focused on the clinical development of novel anti-cancer therapeutics. The Company’s lead programs focus on two families of small molecules that result in the inhibition of tumor cell metabolism. The first and most advanced is a NADH oxidase inhibitor program that includes lead candidate ME-143. The Company initiated a Phase I clinical trial of intravenous ME-143 in patients with solid refractory tumors in September 2011 and expects final data from the trial by the second quarter of 2012. The second program is a family of mitochondrial inhibitors that includes lead candidate ME-344. The Company is currently conducting the necessary pre-clinical animal toxicity studies to support submission of an Investigational New Drug (IND) application for ME-344 in the first quarter of 2012. For more information, please visit

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 or differences in interpretation 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.