1 History Formerly known as Novet, Novogen Inc. is an Australian based company that was formed in 1992 by Professor Graham Kelly in Sydney. Professor Kelly set up the company with the purpose of the commercialisation of the Isoflavone drug technology, which forms the basis of the current R&D program. With private investors backing the idea from day one, Novogen was listed on the ASX in 1994. [1] By 1995, Novogen expanded its prescription only drugs division into non-prescription healthcare consumer products. Not only did this help build the company's experience and infrastructure in the logistics of product manufacture, but aided in the methods of testing and marketing for several key drugs released during the nineties, including Promensil in 1997 and Trinovin in 1998. [2] After receiving its first Australian government START grant of $2.79m in 1998 to develop the anti-cancer compound NV-06 (Phenoxodiol), Novogen continued to soar in the ranks of the biomedical world. This allowed Novogen to break into the US market with the approval of its products, and begin listing on the NASDAQ as NVGN on the 6th January 1999. [2] It was then in 2002, Novogen commenced work with Marshall Edwards Inc (MEI), a 65% owned US subsidiary of Novogen, to serve as a commercial vehicle for its anticancer drug technology. In December 2010, MEI was sold the rights to Novogens Isoflavone portfolio, in return for $US4 million worth of convertible stock in Marshall Edwards, to bring oncology drugs Phenoxodiol, Triphendiol and NV-128 to market globally. Another US subsidiary of Novogen, Glycotex Inc, is a privately held pharmaceutical company focused on discovering & developing drugs intended to accelerate wound healing & tissue repair in acute as well as chronic wounds. It is an 80.7% owned subsidiary of Novogen Limited and has been studying the effectiveness of GLYC-101 gel on wound healing. Glycotex has been able to submit promising final results of two completed Phase II clinical trials of the GLYC-101 gel, where they observed its effect on wound closure in patients undergoing carbon dioxide laser skin resurfacing. [4] More recently, Novogen announced the completion of the sale of its ‘non-core’ consumer products business to Pharm-a-Care Laboratories Pty Limited for a total sale price of $A10.1million. The Novogen board, which underwent an extensive review and makeover at the end of 2010, believe that the sources provided by the sale will aid greatly in therapeutic drug development opportunities. [5] Despite current poor market prices, Novogen continues to provide a substantial body of IP. With 27 issued, and 25 pending patents all across the world include Canada, USA and Europe, Novogen continues to be the leader in Isoflavone research. [6] [7] http://www.novogen.com/about/about0101.cfm?mainsection=01&subsection=01 Core Business Over the past two decades, Novogen has patented soy and red clover isoflavone technology, which serve as the platform in reversing the disease process of common degenerative diseases. Based on the natural phenomenon whereby plant flavonoids are able to regulate communication between cells and within cells, Novogen has developed drugs that allow ‘over-active’ signals to be switched off, and ‘under-active’ signals to be switched on. Given the complexity of degenerative diseases such as ovarian cancer and prostate cancer, it takes Novogen a period of 12 – 15 years to develop its drugs and even then, continues to conduct research on the behaviour of the drug. 3 [8]http://www.novogen.com/know/know0201.cfm?mainsection=02&subsection=03 Corporate Structure and key employees [9] As a company limited by shares with only 21 employees, Novogen Ltd is heavily managed by a board of non-executive directors who are overlooked by newly elected Chairman Mr WD Rueckert. Chairman - Mr WD Rueckert Following the resignation of former chairman and director Mr PA Johnston, Mr Rueckert was elected into position on 18 November 2010. His previous roles include director of MEI beginning 2007 until 2009, and was then re-elected as Director in March 2011. Mr Rueckert has held senior rolls since 1981, where he was President of United States Oil Company, a publicly traded oil exploration business. Along with his role in the Novogen company, Mr Rueckert is currently a Director of Chelsea Therapeutics Inc., a Nasdaq listed drug development company and Fairfield County Bank, a community bank in Ridgefield, Connecticut. CFO and Operations Manager - Mr MG Hinze Mr. Mark G. Hinze has been Chief Financial Officer of Novogen Limited since June 18, 2010 and also its Operations Manager since June 2010. Mr. Hinze has been with Novogen Group for over 10 years and previously held the position of Financial Controller. Prior to joining Novogen Mr. Hinze worked as the Finance and Administration Manager of Alpha Healthcare's Pathology division and also the Finance Manager for Diagnostic Pathology prior to its sale to Alpha Healthcare. Non-executive Director - Josiah T Austin Mr Austin is a United States resident and the largest shareholder in Novogen. He is managing member of El Coronado Holdings, LLC, a privately owned investment holding company, which invests in public and private companies and also runs and operates agricultural properties with his family. Mr Austin previously served on the Board of Directors of Monterey Bay Bancorp of Watsonville, California, and is a prior board member of New York Bancorp, Inc., and North Fork Bancorporation. During the last three years Mr Austin has served as Director of Goodrich Petroleum Inc. Along with Mr Josiah T Austin, Novogen announced the appointment of two new directors to its Board on the 20th September 2010. Mr Ross Youngman and Mr Peter White all have solid backgrounds encompassing investment and corporate finance, and aim to broaden the contributions of the board level to provide a fresh perspective on developing the companies direction. The Novogen board continue to work closely and proficiently with Executive board members of subsidiaries MEI and Glycotex, Inc. Market Behaviour Since it’s listing on the ASX in 1994, the behaviour of Novogen Ltd Share prices is a clear reflection of both successful and failed drug trials, a case of tax fraud, and a complete overhaul of the Board of Directors. [10] 5 In the early years of 2000, Novogen was successfully completing clinical trials of Phenoxodiol, the first known trial in humans of anti-cancer therapy targeting reactivation of the death receptors in a highly selective manner. With promising results, share prices peaked at $8.40 on 5/12/2003, at which time market capitalization of Novogen was $570m. However, founder and then CEO Professor Graham Kelly was soon to cause a major disruption in Novogen’s market behavior. Initially raided as part of the Wickenby investigation in 2005 by the ATO, he was later charged in 2010 for two counts of defrauding the commonwealth or a public authority and five counts of obtaining a financial advantage by deception.[11] Media released news of the ATO investigation in 2007, and caused a further blow to the Novogen shares, dropping to a low $1.05. Despite positive news released in 2008 that triphendiol may aid in treating pancreatic cancer, and safety of the Promensil drug in women with a history of breast cancer, shareholders were losing confidence in the company. Since 2009, there have been major changes to the Board of Directors at Novogen, which only highlights the instability of the Novogen Company. On June 2, 2010 Novogen shares collapsed by 50%, to 0.185 [12] following the revelation of disappointing phase II trials of Phenoxodiol treating Ovarian Cancer. With market capitalisation now at $17m, and a 52 week range in share price of 0.11 – 0.46, Novogens future is in doubt despite it being the leader in isoflavone technology. [13] References [1] Novogen Limited (2011) Company website retrieved 28/08/2011 http://www.novogen.com/about/about0101.cfm?mainsection=01&subsection=02 [2] Bioline International (1999) Autogen Limited - An Overview, Investee Profile: Alchemia, BIO SHARES, The Deloitte Biotech Index retrieved28/08/2011 [3] Edgar Online (2011) Form 10-k Commission File Number: 000-50484 retrieved 12/09/2011 http://google.brand.edgaronline.com/EFX_dll/EDGARpro.dll?FetchFilingHTML1?ID=3 908971&SessionID=ThuSHC9JmyZQEA7 [4] Novogen Limited (2011) Company announcement: Glycotex releases final phase ll clinical trials data plus results of mechanism of action study retrieved 10/09/2011 http://www.novogen.com/news/news0501.cfm?mainsection=05&subsection=03&new sid=368 [5] Life Scientist (2010) Novogen finalises IP sale deal with US subsidiary retrieved 08/09/2011http://www.lifescientist.com.au/article/372090/novogen_finalises_ip_sale _deal_us_subsidiary [6] Novogen (2011) Intellectual Property and Patents retrieved 09/09/2011 http://www.novogen.com/consumer_health/ippatents.html [7] http://www.novogen.com/about/about0101.cfm?mainsection=01&subsection=01 [8] http://www.novogen.com/know/know0201.cfm?mainsection=02&subsection=03 [9] Novogen Limited (2011) Novogen Limited Appendix 4E June, 2011 retrieved 09/09/2011 [10] ASX (2011) NRT, NOVOGEN ORD retrieved 12/09/2011 http://hfgapps.hubb.com/asxtools/Charts.aspx?asxCode=NRT&compare=comp_index &indicies=0&pma1=0&pma2=0&volumeInd=9&vma=0&TimeFrame=M10 [11] The Australian (2007) Papers 'link Novogen, tax haven' retrieved 12/09/2011 http://www.theaustralian.com.au/business/legal-affairs/papers-link-novogen-taxhaven/story-e6frg97x-1111114022436 7 [12] The Sydney Morning Herald (2010) Novogen stock slashed in half retrieved 10/09/2011 http://www.smh.com.au/business/novogen-stock-slashed-in-half-20100602wxbp.html [13] Investmart (2011) Novogen Limited retrieved 10/09/2011 http://www.investsmart.com.au/company_profile/summary/default.asp?function=pri nt&SecurityID=NRT&ExchangeID=ASX