Market Ready Products (Mastisol® Plus and NicoSwab™)
The Company has achieved FDA exemption on a topical, post-operative surgical adhesive product that is impregnated with the antibiotic bacitracin (Mastisol Plus). The product secures bandages to post-operative wounds while protecting against bacterial contamination. The data profile on this product shows superiority over the surgical adhesive without antibiotic.
Jaleva has also successfully completed pre-clnical and phase 1 clinical tests on a stable, transmucosal Nicotine Replacement Therapy (NRT) product (NicoSwab) that outperforms Nicorette Gum®, Quickmist® and Nasal Nicorette®. The product is ready for market launch in the $2.5B smoking alternative marketplace. Trial batches have been manufactured, and test marketing resulted in overnight success with the trial batch being sold-out and retailed in over 100 stores
Clinical Stage Topical Products
The Company’s patented resin technology safely keeps 100% of an active ingredient in place on the skin, while providing a controlled but increased rate of release of the active ingredient into the skin over a sustained period of time. As a result, Jaleva has consistently demonstrated that its topical formulations out-perform market leaders in many product categories.
The Company additionally has two clinical stage topical products. The first is a topical surgical prep product (Mast-R-Prep™) with phase 1 and 2 clinical trial data. Mast-R-Prep™ adheres to drapes and has a superior bacterial log-reduction profile over time compared to ChloraPrep®. The surgical prep arena is $2B worldwide. The Company has additionally completed phase 1 testing on a Topical Diclofenac product with pre-clinical results that show superiority over Voltaren® gel, and a phase 1 clinical trial that indicates statistical superiority over placebo. Novartis makes $700M in sales annually with Voltaren® gel in Europe.
Transmucosal Pipeline Products
The advantage of Jaleva’s transmucosal technology is that with a tiny drop placed on the inside of the cheek, medications can be delivered into the bloodstream reaching a maximum concentration on the order of minutes – much more quickly than with transdermal patches and pills, and even more quickly than inhalers and nasal sprays that are specifically designed for quick delivery of medications. The Company has worked to develop and license a deep pipeline of drug products focused on large markets in the CNS sector. The current formulations are designed to provide quick delivery of vardenafil for erectile dysfunction, alprazolam for anxiety, ondansetron for nausea, sumitriptan for migraines, fentanyl for pain. Many of these products have relatively short time-to-market regulatory pathways with the FDA and are being developed for subsequent distribution by potential licensees in the U.S.