Mezzion is a rare disease pharmaceutical company, publically listed in 2012. The company is currently looking to bring to market the first chronic FDA approved treatment option, JURVIGO® (udenafil), for specific use in single ventricle congenital heart disease (SVHD) patients twelve and over who have undergone Fontan surgical palliation. Sadly, the average life expectancy for a Fontan patient is 35-45 and apart from JURVIGO® there are currently no other candidates in late clinical development directed to this patient population. The aim of JURVIGO® therapy is to preemptively slow down or arrest the secondary circulatory pathologies that are associated with the Fontan circulation, with a particular focus on peak exercise performance and liver fibrosis / cirrhosis.

FDA awarded the company both orphan disease status for the product and a pediatric rare disease designation. Equivalent status has been provided in the European Community.

Mezzion has undertaken extensive market research covering both payors and patients and has concluded that the global NPV for JURVIGO® is estimated at $6.7B. Our current estimated launch time is early 2027, achieving peak net sales of $2.5B by 2036 and patent protection through 2042. While the financial upside is significant, our primary motivation is to bring JURVIGO® to market as quickly as possible to provide Fontan patients with their first FDA approved therapeutic opportunity and hopefully inspire other companies to do the same.

In late May 2022 we had a pivotal Type B meeting with the FDA where we were provided not only a clear path to approval for our initial indication but one where we feel that we have a high likelihood of success based on the results already established in our pivotal phase 3 trial, FUEL.