Marshall Edwards Issued New Patent for Use of Lead Drug Candidate ME-143 in Treating Cancer
Company Also Announces Two Japanese Patents Covering Lead Drug Candidates
Apr 25, 2012
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 Patent No. 8,163,795 covering the Company’s lead drug candidate ME-143 for use in treating cancer. The patent is expected to provide protection until September 2025.
The Company also announced that it has received notices of allowance from the Japanese Patent Office for two patents that cover the ME-143 and ME-344 compositions of matter, respectively, and their use in treating cancer.
“This key U.S. patent for ME-143 follows on the heels of a related patent for ME-344 as well as a composition patent for both compounds, solidifying the intellectual property position surrounding our two lead oncology drug candidates,” said Daniel P. Gold, Ph.D., President and Chief Executive Officer of Marshall Edwards. “As we prepare for our upcoming Phase II clinical trials, we believe our strong patent estate will help to facilitate our partnering efforts both in the U.S. and in high growth markets abroad."
Marshall Edwards owns exclusive worldwide rights to all of its drug candidates, including ME-143 and ME-344. The Company’s intellectual property portfolio now includes 15 issued U.S. patents, at least 12 additional U.S. patent applications, and more than 70 issued foreign patents and 50 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 therapeutics targeting cancer metabolism. The Company’s lead drug candidates, ME-143 and ME-344, have been shown in laboratory studies to interact with specific enzyme targets resulting in inhibition of tumor cell metabolism, a function critical for cancer cell survival. Marshall Edwards initiated a Phase I clinical trial of intravenous ME-143 in patients with solid refractory tumors in September 2011 and plans to present safety and pharmacokinetic data from the trial at the American Society of Clinical Oncology Annual Meeting in June 2012. The Company received approval of its Investigational New Drug application for ME-344 in April 2012 and is initiating a Phase I clinical trial of intravenous ME-344 in patients with solid refractory tumors. For more information, please visit www.marshalledwardsinc.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 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.