July 22, 2013 Issue
The Most Powerful Name In Corporate News and Information
Dedicated to the Mission of Making a Meaningful Impact in the Lives of Patients Suffering from Diseases Caused by Aging and Obesity, NeoMedigen, Ltd. Uses the Well Constructed Strategy of Cutting Edge Innovation and R&D to Deliver Solutions
About NeoMedigen, Ltd. (BSX: 6NM):
The global healthcare environment is changing at a rapid pace. Healthcare is becoming more personalized treatments are becoming more targeted and economic pressures mean governments and healthcare systems are demanding increasingly cost-effective solutions to healthcare problems.
At Neomedigen, we are dedicated to our mission of making a meaningful impact in the lives of patients suffering from diseases that are caused by aging and obesity.
In 2012, we carried this mission forward through the issuance of publicly traded shares on the BSX (Bermuda Stock Exchange), the advancement of our commercial opportunities and the advancement of several key clinical pipeline programs that we believe have the potential to significantly help patients with diseases of aging.
We believe that scientific research is the key to achieving this, in collaboration with others who share our interest and our passion.
Within the overall
Neomedigen strategy, cutting-edge innovation is at the heart of what we do,
and our R&D strategy has been carefully constructed to deliver on our
promise to our patients, customers, and shareholders.
50 Main Street
Birmingham, AL 35213
conducted by: Lynn Fosse, Senior Editor, CEOCFO Magazine, Published – July
CEOCFO: Mr. White, your website indicates that NeoMedigen, Ltd. is doing innovations for life. Would you explain?
Mr. White: The global healthcare environment is changing at a rapid pace. Healthcare is becoming more personalized treatments are becoming more targeted and economic pressures mean governments and healthcare systems are demanding increasingly cost-effective solutions to healthcare problems. At NeoMedigen, we are dedicated to our mission of making a meaningful impact in the lives of patients suffering from diseases that are caused by aging and obesity. We are a biopharmaceutical company with intellectual property around small molecule formulation research and development in the areas of skin care, obesity and longevity. We currently have one formulation under patent application in the United States. The company's current focus is on the prevention of childhood obesity & aging skin. NeoMedigen's RezGen5 is designed to target childhood obesity which is one of the most serious public health challenges of the 21st century. Globally, in 2010 the number of overweight children under the age of five was estimated to be over 42 million. Close to 35 million of these are living in developing countries. Overweight and obese children are likely to stay obese into adulthood and more likely to develop non-communicable diseases like diabetes and cardiovascular diseases at a younger age. NeoMedigen's formulation for skin, NeoDerm/ND6 is specifically designed to reduce skin inflammation without the need for steroids and antibiotics. NeoMedigen is advancing a new class of therapeutics for diseases of aging. Our compounds are mimicking the benefits of a calorie restricted diet and exercise while lowering levels of glucose and insulin. It could be a real game changer, time and clinicals will tell. These drugs in development would treat one disease, but unlike drugs of today, they would prevent 20 others. In effect, they would slow aging.
CEOCFO: Would you tell us about RezGen5 and what is unique about that molecule?
Mr. White: The developmental focus from the start has always been to understand the mechanism of how DNA repair regulates age-associated diseases, and can become a core technology of how to control human diseases. RezGen5™ was tested in a panel of pre-pharma cell based assays by Brunswick Laboratories, which indicate a range of beneficial mechanisms. These results show great promise for RezGen5™ being used in the treatment of the following age related diseases such as dietary supplementation, or as a pharmaceutical treatment, to prevent (or improve an individual’s ability to resist) DNA damage, enhance DNA repair and stimulate immune function in diseases where these processes are central to the manifested disease state; e.g. ageing, cancer, obesity/metabolism cardiovascular disease and autoimmune disorders such as diabetes, rheumatoid arthritis and ulcerative colitis. Phase 1 clinicals represents the first time that RezGen5™ will be tested on humans either healthy volunteers or patients. The purpose of these studies are to study in a clinical setting the metabolism, structure-re-activity relationships, mechanism of action, and side effects of the drug/supplement in humans and to determine how effective RezGen5™ is in boosting immune systems, treating inflammation and its effect on increasing metabolism. DNA repair and sirtuin activation has recently emerged as an area of “hot” anti-ageing research. NEOM has begun to select new targets for its research to prove the importance of its molecule for a wide array of potential therapeutic targets. NEOM’s validated targets will go through the early stages of drug discovery with its synergized molecule RezGen5. This research will build upon understanding how cells repair DNA damage caused by daily ‘wear and tear’ in the environment – including ultraviolet rays and tobacco - to identify possible points of therapeutic intervention for cancer patients and potential new drugs - that block the repair of gene faults - could destroy cancer cells by preventing their ability to grow, divide and survive. Progression of ageing is associated with the deregulation of many genes involved in multiple pathways responsible for controlling cell growth and differentiation including cell cycle, programmed cell death, intra- and inter-cellular communication, and DNA repair processes. Discovery and development of new drugs at NEOM are based on the knowledge of DNA damage repair and SIRT1 modulation. While SIRT1 was the first in this family of enzymes to be discovered, considerable research is also under way on other members in this family, SIRTs 2-7. This speaks well for the molecular mechanism of DNA repair to be an effective target for developing medicines that would address directly controlling key critical factors in human aging, cancer and/or detrimental immunological factors and represents an attractive portfolio of potential drug targets for anti-ageing
CEOCFO: What is actually happening with RezGen5 that does not happen naturally or with other drugs?
Mr. White: There are five ingredients that make up the molecular non-competitive formulation, which are all naturally occurring. The way it works is that there is an enzyme activator that allows the molecule to reach the cell. One of the properties within the synergized molecule combats free- radicals around the cell wall and creates a defensive perimeter allowing other actions to take place, and starts destroying the free radicals that are constantly bombarding the cell wall. The next layer in the molecule activates the mitochondria, which is the energy center for the cell. When it activates that energy center, it allows the other ingredients that are part of the molecule to start repairing the cell wall. What we feel is happening is that it starts to repair the DNA that is actually in the cell. We have to do further research to prove the DNA repair. Human trials are the next mountain to climb. You can see things in a cellular environment that you might not see in human clinical trials, so again that is the next step up the ladder.
CEOCFO: Has the medical community paid attention or is it still too early in development?
Mr. White: The Neomedigen board of directors met two weeks ago and we established an independent scientific advisory council. The Director of the council is Dr. Joseph Baur. Dr. Baur made the original discovery of resveratrol activation of SIRT1, and he did that with Dr. David Sinclair of Harvard. A company was formed out of that discovery called Sirtris Pharmaceuticals, which was sold within eleven months of animal trials being completed for 780 million dollars. Dr. Baur is now the head of our scientific advisory council. Our assistant director Dr. Donald Ingram’s research has focused on nutritional and pharmacological interventions designed to slow the rate of aging and thus reduce the risk of age-related disease and functional decline at the Pennington Biomedical Research Lab at Louisiana State University. Dr. Baur’s lab on the campus of Penn University is part of the Perelman School of Medicine, and it is called the Baur Anti-Ageing Lab. The long-term goal of the Baur lab is to use models of lifespan extension, including CR, drugs, and longevity genes, to elucidate the basic mechanism(s) that drive aging in mammals, with the hope that this knowledge will lead to new therapeutic approaches to improve human health and longevity. We are very fortunate to have both of these well- respected researcher’s overlooking the science, so I think the scientific and medical community will begin to pay quite a bit of attention to Neomedigen over the coming year.
CEOCFO: What have you learned in past experiences that is most helpful as you develop the molecule and create the company?
Mr. White: I think you always have to look at the highest and best use for anything that you do to create value, whether it is in real estate or developing molecular formulations. I also like a small and nimble company with the ability to turn on a dime as needed. I think you have to be realistic about the economic targets you can hit. For instance, there is a difference between therapeutic dermatology and Alzheimer’s disease, from the standpoint of regulatory oversight. Therapeutic dermatology is an easier hill to climb for us in the short – term to create value. Over the long-term, because we are developing value across the board, you can always find additional uses for our molecular formulations. As we move forward building value in the company, we will start to utilize that capital to open up new areas of clinical research and development. You always walk before you run.
CEOCFO: Do you have a timetable and are you funded to start out?
Mr. White: Let me first speak to you about why Neomedigen Limited ticker symbol 6NM went public in Bermuda and then dual-listed it is stock on the Boerse Berlin in Germany. The advantages to going public in the early stages, rather than waiting, were substantial: Raise money faster and cheaper by increasing the "liquidity" factor for your investors; leverage a larger retention of ownership; leverage your personal return on investment as an owner by decreasing the amount of time it will take you to make money on your investment, increasing the valuation of your company, and changing the liquidity of your asset to a much more liquid form than that of a private company; grow your company faster by increasing your ability to attract "mergers", "acquisitions" and "strategic partners; grow your company by attracting top personnel without necessarily huge cash outlays; grow your company and make it more powerful by attracting top notch team members to your board of directors; grow your company by increasing its ability to compete for large corporate contracts; and, grow your business by increasing your status in the eyes of all those you do business with. The decision to go public early on could make you millions if not billions of dollars in the extra equity that you retain and do not give up to venture capitalists. We were a small company and were not adequately funded; we decided that the cost of going public and creating liquidity and capital for the company here in the United States was just too expensive. The typical cost for taking a company public is close to a million dollars in the US. We ended up spending US $200,000 to take our company public in Bermuda, and we are a Bermuda-based company. We are listed on the Bermuda Stock Exchange main board, and we have independent Bermuda directors. Bermuda is a well-known exchange for a myriad of industries and it opened up the ability for us to dual-list in Germany and Europe, where there is a smaller amount of micro-cap and small cap companies going public in this market relative to the United States. We are creating capital to start the clinicals this year. Our business model is to license that technology and product out to other companies. We are not a marketing company, we are a research and development company, and we will make money that way and reinvest it into additional research and development and clinical trials for our small molecule formulations.
CEOCFO: Assuming the results are as anticipated, are there any challenges on your radar screen?
Mr. White: The regulatory environment is always changing and is a concern. However, we have some very good consultants on board over for the expressed purpose of guidance through the regulatory hurdles that are always there when you are dealing with pharmaceutical products, whether you are talking about the United States or globally. Clinical trial risks are always daunting to overcome but we have a very low overhead relative to our competitors, and we go through a process which mitigate the risk out of our clinical trials. The most cognizant issues I face as a CEO of a publically traded biotech is creating value under budget and on time. If you look at our budgets online you will see burn rates as low as $123,000 per month. This is far better than the industry average.
CEOCFO: Why should people in the business and investment community pay attention to Neomedigen, Ltd.?
White: We are founded on the premise of patent-pending paradigm
shift technology in small molecule formulations as it regards RezGen5.
NeoMedigen is working from the solid foundation established by Dr. Pero over
the last 30 years. There are very few companies having DNA repair as a core
technology to exploit, and even fewer that have figured out how to protect
the major of human cells that are not dividing and growing. The company is
currently focusing its operational resources on clinical research at Harvard
Beth Israel Hospital, Penn University and UMASS Medical Center. The
clinicals will ascertain the highest and best use in the areas of immunity,
dermatology and nutrigenomics of NeoMedigen’s synergized molecular
formulation RezGen5. Neomedigen and its research partners are focused on
RezGen5 and how it can activate sirtuins and DNA repair capacity in vivo, in
order to take advantage of the recent advances demonstrating both in
dividing cells and, also non-dividing repair capacities involved in
modulating DNA repair compositions. NeoMedigen could potentially develop
additional indications and methods of delivery for RezGen5 and other
synergized molecular formulations. NeoMedigen has focused on developing many
novel small molecule activators of sirtuins and DNA repair. The company has
recently completed several early stage studies with the first generation
small molecule RezGen5. NeoMedigen, Preclinical studies performed at
Brunswick Laboratories’ with Rezgen5, has demonstrated potential importance
in multiple disease areas, including Type 2 diabetes and related
complications, cardiovascular, inflammatory and neurodegenerative diseases.
NeoMedigen is carrying its mission forward through the issuance of publicly
traded shares on the BSX and Boerse Berlin, the advancement of our
commercial opportunities and the advancement of several key pipeline
programs that I believe has the highest and best potential to reach into
three market areas pharmaceutical (therapeutic dermatology), OTC (aesthetic
dermatology) and CPG cosmetics. I believe that human clinicals are the keys
to achieving the full potential value. NeoMedigen’s cutting-edge innovation
and clinical strategy has been carefully constructed to mitigate risks and
deliver value to our shareholders now and in the future. The market for
anti-ageing dermatology products and processes is a very large one and
continues to grow. The global anti-aging market for the boomer generation
was worth $162.2 billion in 2008. This should reach 274.5 billion in 2013,
for compound annual growth rate (CAGR) of 11.1%. The disease segment
generated $66.0 billion in 2008. This is expected to grow at a CAGR of 12.5%
to reach $119.2 billion in 2013.The appearance segment generated $64.4
billion in 2008. This segment should increase to $105.4 billion in 2013, for
a CAGR of 10.4%. NeoMedigen has strong potential for value creation, derived
from three main sources: Mid-term Value Proposition—NeoMedigen foresees its
proprietary molecule discovery as a mid-term revenue-generating channel, via
out-licensing agreements with CPG and CPG cosmetic players in the industry;
Long-term Value Proposition—NeoMedigen’s core competencies include its R&D
expertise in formulating synergized molecules from discovery through
pre-clinical trials. The Company will rely on strategic partners’
capabilities to promote clinical trials, marketing, large-scale
manufacturing and commercialization; Potential Strategic Partners—NeoMedigen
is continuously seeking strategic partnerships for co-development,
out-licensing and commercialization of its intellectual property and
proprietary solutions, to combat diseases of ageing. Potential fields of
collaborations & licensing include: Obesity; Dermatology; and Immune
Support. NeoMedigen researchers will be working to translate this research
into a potential new class of pharmaceuticals to treat diseases of aging,
offering the ability for people to live longer, healthier lives. In line
with our business model, NeoMedigen adopts a VIPCo (Virtually Integrated
Pharmaceutical Cormpany) organization which focuses on accelerating R&D
advances in full compliance with pharmaceutical industry standards, and
building value by consolidating technology and product pipeline. To this
end, we outsource all non-core activities to selected top tier CMOs and CROs
worldwide. I firmly believe that Neomedigen will develop an identity as a
globally recognized company in the area of skin care and longevity. We are
not a cancer research company, but we are a longevity research and
development company, and that by all accounts is our mission.
“At NeoMedigen, we are dedicated to our mission of making a meaningful impact in the lives of patients suffering from diseases that are caused by aging and obesity.”- Philip White
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