Paxerol™ Introduction – An Unmet Medical Need
Nocturia, the frequent need to urinate at night, afflicts 2.2B people. Our patented drug to prevent nocturia is a fixed dose extended release combination of safe drugs that reduces nocturia by 33-100%. We are seeking $2.6M to launch the drug in Europe Q1 2015 and complete one clinical trial before licensing our patents to a big pharma company in mid-2015. Since we are using low doses of known safe drugs for a new purpose, the FDA approval path is very fast.
Nocturia, a sometimes deadly condition, causes insomnia, fatigue, depression, and lower quality of life. It is linked to higher rates of heart disease, stroke, brain damage, and sometimes deadly hip fractures. In the US alone, exhaustion due to nocturia causes over $60B per year in lost work time. Twenty-five percent (25%) of nursing home operating costs are the result of urinary incontinence. No drug on the market today solves the problem of low nocturnal bladder capacity, the major issue for 76% of nocturia sufferers.
Featured Presenter: David A. Dill, CEO and President
Below detail & strategy summary.
Paxerol™ Introduction – An Unmet Medical Need
Nocturia, the frequent need to urinate at night, afflicts 2.2B people. Our patented drug to prevent nocturia is a fixed dose extended release combination of safe drugs that reduces nocturia by 33-100%. We are seeking $2.6M to launch the drug in Europe Q1 2015 and complete one clinical trial before licensing our patents to a big pharma company in mid-2015. Since we are using low doses of known safe drugs for a new purpose, the FDA approval path is very fast.
Nocturia, a sometimes deadly condition, causes insomnia, fatigue, depression, and lower quality of life. It is linked to higher rates of heart disease, stroke, brain damage, and sometimes deadly hip fractures. In the US alone, exhaustion due to nocturia causes over $60B per year in lost work time. Twenty-five percent (25%) of nursing home operating costs are the result of urinary incontinence. No drug on the market today solves the problem of low nocturnal bladder capacity, the major issue for 76% of nocturia sufferers.
A Unique Solution and Investment Opportunity
- Paxerol™ is a low dose combination of known safe drugs in extended release formulation
- 6 US patents already issued (worldwide coverage in process); expire in 2030
- 3 synergistic mechanisms of action inhibit PGE2 production; reducing bladder irritations
- Successful with 80% of those testing informally due to increased comfortable bladder capacity
- Effective in 30 minutes; no side effects when used as directed; reduces nocturia 33%-100%
- No new chemical entity, so need no Phase 1 safety tests and years of risk from unknown side effects
- Ethicor Pharma contract signed; launches in EU Q1 2015 as an unlicensed prescription “Special”
- One simple, quick Phase 2a trial before signing big pharma license Q3 2015
- Plan to return 100% of invested funds Q3 2015 upon license signing; massive potential thereafter
- We will earn $150M net income for each 1% of nocturia sufferers who use Paxerol
- Projected 10X return based on Ethicor contract; potential 400X return with big pharma license
- Need $2.6M to reach profitability after extensive due diligence and investment by Keiretsu Forum teams
A World Class Team
Our team includes leading professionals for all key tasks. In addition to the team below, we will use a contract research organization (CRO) to manage the double blind placebo controlled clinical trial and a manufacturer to provide clinical trial drugs supplies and drugs for sale through Ethicor starting in Q1 2015.
CEO, Founder and Seed investor
- David Dill, former IBM executive and CFO of 7 firms.
Strong Scientific Advisors
- Frank Rauscher, III, Ph.D., Chief Scientist, Dep. Director, Wistar Institute
- Khurshid Iqbal, Ph.D., Pharma Chemist, J&J, Hoffmann-LaRoche. Formulation/manufacturing expert.
Leading Clinical Trial Experts
- Tony DelConte, MD, led Enablex through FDA trials for Novartis
- Thomas Garvey III, MD, NIH, FDA, renowned drug safety expert
World Class Support
- Joy Barton, Ph.D., Novartis, Marquant Partners Licensing Agent, highly recommended by AstraZeneca
- Ed Allera, Buchanan Ingersoll, FDA Focused Lawyer
- Ping Wang, MD, Andrews Kurth, named to top 1000 patent lawyer list 2012/13
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