The Tragic Implications of Nocturia
2.4 billion people suffer from Nocturia, the frequent need to urinate at night. Its sleep disturbance causes insomnia, fatigue, and depression. Fatigue leads to lack of exercise and depression leads to overeating, so most nocturia sufferers end up obese. Nocturia is accompanied by blood pressure spikes, which are dangerous for obese people, causing high rates of heart disease and stroke.
A 12-year study of 16,000 people tracked nocturia frequency versus life span. For older women, 68% without nocturia survived 12 years, but for those with 3 plus voids per night, 22% survived. The study suggests nocturia leads to thousands of deaths each day. Another study estimated that the costs of fatigue and missed work due to nocturia costs the US economy $215 billion/year.
76% of nocturia sufferers have low bladder capacity caused by excess prostaglandin production, which irritates bladders and makes a quarter full bladder feel ready to burst! No drug treats this, so Wellesley Pharmaceuticals can fill a huge unmet need by combining 2 drugs that work synergistically to reduce prostaglandins.
Acetaminophen and ibuprofen have half-lives of 1–2 hours, so the extended release formula is key to protect 9 hours. The 10 US patents, which cover the use of acetaminophen with any NSAIDs, should stop anyone from using their drug label or advertising the solution. Patents are method of use patents covering doses ranging from 5 to 2000 mg to ensure nobody can bypass them.
The Phase 2 results set records. 2.25x better than the best FDA approved drug, which was abandoned due to poor sales and bad side effects. OAB drugs reduce nocturia 15% with terrible side effects, but sell $4.5 billion per year. The drug provided 50–96% improvement to 23% of the patients and 25–50% for 38%, which is why an independent study listed the company as #1 among nocturia drugs.
In Phase 3 much better results are expected by including more women, one pill so less water will be taken, and excluding polyuria patients. At some point we hope to share nocturia management instructions, so that patients will experience the full benefits of the drug and advice. For many patients, lifestyle decisions are a major part of their problem.
The world’s leading nocturia authority, Dr. Weiss, saw results and wrote, “The study is stunning. Congratulations. It is a monumental achievement.” He said once the drug is FDA approved, it will be the go-to drug for all urologists.
The lead US licensing prospect expects multiple billions in the US alone. Royalty rates are usually in the 15% range. As an LLC there is no income tax to pay, so net income margins should reach 93%. That should provide an annual return of 6.6X each year just based on US sales. Our lead China prospect also expects to sell more than a billions dollars of the drug.
The key question is why none of the 1000 or more venture capital firms and family offices in the US that have been contacted have refused to support this drug. Can someone explain this disgusting indifference?