Jaleva’s ‘Nicofix’, a Transbuccal Nicotine Replacement Therapy Product, achieves outstanding test results

SAN DIEGO, CA, November 22, 2010 – Jaleva Pharmaceuticals LLC announces encouraging pre-clinical results for ‘NicoFix’, Jaleva’s proprietary Nicotine Replacement Therapy product currently under development.

BioTox Sciences has completed a pre-clinical pharmacokinetic trial measuring Nicotine levels in the blood serum of rabbits after buccal administration of ‘NicoFix’. Jaleva’s investigational product achieved a Nicotine Tmax (time of maximum concentration) of 5 minutes, and a Cmax of 11 ngs/mL. These PK parameters are ideal for a Nicotine Replacement Product.

Jaleva’s ‘NicoFix’ is the only Nicotine Therapy Replacement product in the world that we know of that offers such a quick Tmax. One small drop of ‘NiocoFix’ placed on the inside of the cheek, using a unit-dose applicator, provides very rapid absorption of nicotine into the bloodstream.

Smokers who are trying to cut down or quit smoking develop powerful nicotine cravings that lead them to smoke again. These cravings are not satisfied by current technology, such as Nicoderm patches, Nicorette gum or Commit Lozenges. Nicotine gums and lozenges can take upwards of 30 minutes to maximize delivery of nicotine to the bloodstream. Patches take even longer.

“Jaleva is going to distinguish itself in this marketplace with its trans-mucosal solution, which is placed comfortably in the mouth. We anticipate that further testing of NicoFix will demonstrate that the product will rapidly deliver nicotine in the system without the numerous side effects associated with gums, patches, lozenges and sprays currently available. Based upon the formulation of NicoFix, we expect it to be well tolerated in humans,” said Alex Battaglia, MD, PhD, Jaleva’s President. According to Dr. Battaglia, who coordinated the pre-clinical trial, Jaleva’s product ‘NicoFix’ is formulated to maximize Nicotine delivery to the bloodstream within 5-10 minutes. Further pharmacokinetic studies and clinical safety and efficacy studies are planned for humans in the near future.

“In this pre-clinical trial, we were able to confirm what was proven in vitro – administration of a small dose of NicoFix results in very rapid absorption in the bloodstream. This holds great promise for the further investigation of NicoFix as a smoking cessation product,” said Mordy Levine, Jaleva’s CEO.

“It provides an exciting and unique opportunity for any company invested in developing a novel product and delivery system useful in smoking reduction or cessation,” said Eva Beim, Chief Marketing Officer and Co-founder of Jaleva.

Jaleva is currently planning human phase I pharmacokinetic testing for its stable ‘NicoFix’ formulation.

Formed in 2003, Jaleva Pharmaceuticals LLC is a privately held firm. Jaleva is engaged in the research & development of resin-based vehicles that quickly deliver medications trans-mucosally to the bloodstream. It is developing formulations that treat such conditions as chronic breakthrough pain and migraines. Jaleva is also developing superior topical formulations that are under investigation for the treat arthritis, skin cancer, psoriasis and other dermatological conditions. Unlike any other technology, Jaleva’s patented resin delivery system provides very quick delivery of medication into the bloodstream and also maximizes delivery of active ingredients into the skin.

For inquiries regarding licensing of our products, please contact: Mordy Levine, CEO, 561–573–0094.

02-22-2011