Wellesley Pharmaceuticals, LLC
A therapeutic development company
Monday, June 10, 2013
Embassy Suites, Chesterbrook, Pennsylvania (directions)
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About
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The Company - Wellesley Pharmaceuticals, LLC has developed a novel combination therapy to treat nocturia, or excessive urination at night. Wellesley was founded based on the discovery that a group of off-patent, FDA-approved drugs can be combined and reformulated to treat nocturia and other overactive bladder syndromes. Our innovative and proprietary formulations significantly reduce the chronic and dangerous unmet medical needs of those 55 and older whose sleep is regularly interrupted due to untimely urination urges. The FDA agreed that we can bypass Phase 1 safety testing with a 505(b)(2) drug application for this new use of proven safe drugs. The goal is to successfully complete Phase 2b testing of our product, Paxerol™, which will enable licensing of the IP to a major pharma company in 2014. The licensee will fund Phase 3 trials and take this low-risk, high-reward product to market by late 2015 or 2016.
Opportunity and Competition - The nocturia market is large and growing rapidly due to demographic trends. 65% of adults between the ages of 55 and 84 have nocturia at least a few nights per week and millions at younger ages suffer. The Company’s U.S. target market is over 100 million patients and the worldwide total is about 2.2 billion. No drugs on the market are focused on nocturia, but the 2 major over-active bladder drugs are Vesicare and Enablex, with 2010 sales of $1.5 billion. These drugs cause major side effects, including dry mouth (up to 35%), and constipation (up to 21%). Psychosis has also been reported. Efficacy can take months and for many it never happens. Studies have reported that 43-83% of their users abandon the drugs within 30 days. Due to side effects and low efficacy, they have fewer than 2 million users out of the 2.2 billion sufferers. With nocturia, awakening 2 to 6 times nightly for a bathroom visit is annoying, but each visit also has risk of insomnia and raises the odds of chronic diseases, such as heart disease and stroke. Multiple studies show increased morbidity/mortality associated with nocturia, ranging from fatigue and depression to increased rate of hip fractures (which triple overall 3 year death rates).
3 Major Issues
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Many variables can affect nocturia, including age, weight, sex, temporary medical issues, permanent medical issues, exercise, diet, drinking patterns, barking dogs, and annoying children and/or bed partners. In light of these many variables, what are the pros and cons of using a standing set of independent patient arms versus using a crossover clinical trial design that has every patient using each drug alternative for one week?
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How do the FDA combination drug rules apply to a product which is a low dose extended release combination of two OTC drugs? If drug A at 75mg reduces nocturia by 20% and drug B at 170mg reduces nocturia by 25%, then is it necessary to show that using both of them together at those doses reduces nocturia by 26% or 45% ? If together they reduce nocturia by 33%, would that suffice or is it necessary to show a dose response curve for each drug that displays the dose at which its efficacy is maximized?
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What investors would be most likely to have an interest in providing funding for Wellesley?
Program:
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6:30 - Cocktails & Dinner (Cash bar and special 2-entree buffet menu)
8:00 - , will deliver the Company's "Elevator"
Pitch to the Group
8:20 - A Panel will address 3 Major Issues for the Company
9:00 - Open discussion: members and guests
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Slides
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