Jaleva Pharmaceuticals, LLC (“Jaleva” or the “Company”) is a specialty pharmaceutical company that has developed a novel, resin based, drug delivery system that promotes transmucosal and topical delivery of medications more efficiently and effectively than currently known technologies.
Conventional transdermal technology has demonstrated the benefits of delivering drugs via the skin, but they only work for an extremely limited number of drugs, and even then the time it takes for the medication to reach maximum concentration in the bloodstream can be on the order of hours to days. This is because millions of dead skin cells form a protective barrier on the surface of the skin (the stratum corneum) that prevents most therapeutic molecules from passing through into the dermis and eventually into the bloodstream.
The advantage of Jaleva’s transbuccal 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 to an hour - 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.
Jaleva is engaged primarily in the research and development of its patented resin, trans-mucosal systemic delivery of active ingredients focused on the Central Nervous System (“CNS”) market place. The current formulations are designed to provide quick delivery of alprazolam for anxiety, ondansetron for nausea, sumitriptan for migraines, fentanyl for pain, and nicotine as an aid to smoking cessation. Jaleva has successfully completed pre-clinical tests on a stable transmucosal Nicotine Replacement Therapy (NRT) product.
Many topical dermatologic treatments use delivery vehicles such as powders, sprays, solutions, lotions, lacquers and creams to deliver an active ingredient to the skin. However, these delivery vehicles often lack effectiveness as the application of the product comes off easily once applied to an affected area of the skin. This, in combination with trapping of the active ingredient by the vehicle, results in poor delivery of the active medication. In contrast, the Company’s patented resin technology safely keeps 100% of an active ingredient in place on the skin, while also 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 has licensed two of its topical peri-operative products: Stayzon to a recognized U.S. pharmaceutical company and Mast-R-Prep to a major European pharmaceutical company. First sales in the marketplace from these licensing deals are slated to begin in the first quarter of 2012.
The Company’s technology has been developed in-house and the Company is profitable. The products developed by Jaleva for subsequent distribution by its licensees in the U.S. have relatively short time-to-market regulatory pathways with the FDA, ranging from a 90 day approval timeline for its 510k products to 10 month approval timeline for products requiring 505 (b)(2) approval.
