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Executive Summary

Global and Expanding Problem.

According to the World Health Organization

(WHO), dengue is the world's...
Either way, any required regulatory pathway to market should be minimal and brief,
relatively speaking (no more than 3 yea...
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Uspi exec summary sept2013v2


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Transcript of "Uspi exec summary sept2013v2"

  1. 1. Executive Summary Global and Expanding Problem. According to the World Health Organization (WHO), dengue is the world's fastest-spreading tropical disease and represents a "pandemic threat" infecting an estimated 50 million people across all continents. The journal Nature recently reported that the rate of infection could be as many as 400 million annually worldwide, “making it more prevalent than malaria.”1 Dengue has recently reappeared again in the United States, in South Florida. However, presently there are no approved treatments or vaccines for dengue fever.2 We believe that we have the basis to develop the first world-wide, cost-effective solution, which also creates the potential for significant shareholder wealth. Where We Are and Where We Are Going. We are a development stage company. Our current development path next involves independent confirmation of our own internal proof of concept and preliminary dosage studies conducted over the past several years. We have already gathered anecdotal field reports from overseas, faith-based NGO groups showing effectiveness in treating local human populations within two days of the initial dosing and with no adverse side effects.3 We now plan to confirm the efficacy of our proprietary compound with independent, in vitro testing by a respected university with regard to all four strains of the dengue virus, such as the University of Florida (who has all four strains and with whom we have developed a preliminary testing protocol). From there, we plan to seek licensing of the intellectual property rights as a biopharma compound to a pharmaceutical company for further drug development as a Botanical Drug Products or explore a licensing arrangement with a nutraceutical company for manufacturing and distribution outside the U.S. Alternatively, we could continue the second round of preliminary safety and efficacy on our own. 1 The Global Distribution and Burden of Dengue – Nature, April 7, 2013. 2 A recent study shows that even in the lowest income countries, patients spend an average of USD $ 7.72 per dengue episode. The American Journal of Tropical Medicine and Hygiene, Health Economics of Dengue: A Systematic Literature Review and Expert Panel's Assessment, Mark E. Beatty, Philippe Beutels, [...], and Joel N. Kuritsky, 4 March 2011; 84(3): 473:488. This cost does not include governmental spending on medical treatments for these patients. We calculate that our manufacturing and packaging costs will allow profitability well within sight of the WHO’s target of treating patients suffering from tropical diseases at a product cost of $1.00 per day. 3 We also have obtained reports from a physician in the Philippines indicating the dengue dosing included in our patent application to be highly effective in relieving symptoms of dengue fever patients in as little as eight hours after the initial dosing. 226 Hillcrest St. Orlando, FL 32801 407-245-7383
  2. 2. Either way, any required regulatory pathway to market should be minimal and brief, relatively speaking (no more than 3 years we estimate). The FDA currently categorizes each of the two components of our proprietary compound as nutritional supplements, which current law allows to be sold if not making any medical claims. The two components of our proprietary dengue compound have been recognized and used safely in traditional eastern medicine. In no event does our business model currently contemplate any type of research and development spending at levels that might be associated with more traditional new investigational drugs. We have filed for patent protection regarding the use of our proprietary compound based on our current base of knowledge gathered over several years of research. Who We Are and What We Do. U.S. Phytotherapy, Inc., located in Orlando, Florida, researches and develops plant-based compounds for combating infectious diseases such as dengue fever, which represents our first target indication. Our team consists of: Bob Rosen, our founder, had medical training and spent his career as a serial entrepreneur. CEO Melody Giacomino, MBA, has fifteen years in the pharmaceutical and medical industry in both sales and marketing. Ed Harp, CPA, is our CFO. Our medical advisor Andreas Muhler, M.D., MBA has consulted with medical startups; his experience includes clinical trial design, and FDA regulatory approval processes. Medical advisor Jan Mintorovitch, Ph.D. (biochemistry) compiled our investigators brochure for the science and research required by ethics review boards at the clinical site locations. What We Need. USPI is looking for a capital investment to complete the pre-clinical proof of concept. Our more immediate needs for in vitro testing and additional short-term overhead expenses would be approximately $150,000. The ideal angel investor would also provide us with strategic value, and assist us in additional financings and future alliances. If we were to fully develop the commercial aspects of a new product as a nutraceutical, we estimate a total cost up to the point of commercialization of approximately $5 million and a time for completion under three years. Any product or path that we choose to pursue would also fit neatly into a milestone-based funding program. To date we have been entirely self-funded, and our current shareholders consist only of our current officers and directors. Contact: Melody Giacomino 321-505-1948 226 Hillcrest St. Orlando, FL 32801 407-245-7383