Jaleva’s ‘Nicofix’, a Transbuccal Nicotine Replacement Therapy Product, Announces 2nd Round of Outstanding Test Results

SAN DIEGO, CA, February 22, 2011 – Jaleva Pharmaceuticals LLC announces a second round of excellent pre-clinical results for NicoFix, Jaleva’s proprietary Nicotine Replacement Therapy (NRT) product currently under development.

BioTox Sciences CRO has completed a pre-clinical pharmacokinetic (PK) trial measuring Nicotine levels in the blood serum of canines after buccal administration of NicoFix.  This trial showed that Jaleva’s investigational product achieved a Nicotine Tmax (time of maximum concentration) of less than 10 minutes, with the other critical PK values being bioequivalent to Nicorette Lozenge. This is the second preclinical trial that has shown these characteristics.  In addition, the PK values of ‘NicoFix’ closely mimic those of a cigarette. These characteristics position ‘NicoFix’ as possibly an ideal candidate for a Nicotine Replacement Product. The data indicates that Jaleva’s ‘NicoFix’ has the potential to become the only NRT with a Tmax of less than 10 minutes. Plans for human phase 1 PK trials are underway for submitting an Investigational New Drug (IND) application to the FDA.

Smokers who are trying to cut down or quit smoking develop powerful nicotine cravings that lead them to smoke again.  Breakthrough cravings commonly occur when smokers use current technology, such as Nicoderm patches, Nicorette gum or lozenges, due to delayed effect with those technologies.  Nicotine gums and lozenges can take up to 30 minutes to maximize delivery of nicotine to the bloodstream.  Patches take even longer.

Jaleva anticipates that by placing one small drop of ‘NiocoFix’ on the inside of the cheek, using a unit-dose applicator, it will be likely to achieve very rapid absorption of nicotine into the bloodstream.  Smoking cessation research indicates that rapid absorption of nicotine from an NRT into the bloodstream gives smokers the best chance of quitting, thereby avoiding the long-term side effects of smoking such as lung cancer and chronic obstructive pulmonary disease (COPD).

“When a smoker trying to quit experiences a craving, they do not want to wait 30 minutes for a gum or lozenge to kick in.  They want relief immediately so they won’t feel the urge to light another cigarette. ‘NicoFix’ has the potential to provide that relief”, said Eva Beim, CMO and Co-founder of Jaleva.

“Jaleva was able to confirm once again that NicoFix is an excellent candidate as the ideal NRT product – given its low Tmax and how it is likely able to mimic the PK profile of cigarettes.  It is very difficult for smokers to give up the habit when products currently on the market take 20-30 minutes to deliver maximum nicotine into the bloodstream,” said Alex Battaglia, MD, PhD, Jaleva’s President, Chief Science Officer and Co-founder.  “We are encouraged by the pre-clinical PK results and are excited to further study the drug in humans,” said Dr. Battaglia.

“We are excited because for the second time we were able to confirm a short Tmax that will position NicoFix to be a candidate as the NRT of choice.  And unlike gums or lozenges that have to be chewed or sucked for 20-30 minutes – frequently during the day, NicoFix is quick to apply and is likely to be quickly absorbed,” said Mordy Levine, Jaleva’s CEO.

Formed in 2003, Jaleva Pharmaceuticals LLC is a privately held company.  Jaleva is engaged in the research & development of resin-based vehicles that quickly deliver medications trans-mucosally to the bloodstream. In addition to ‘NicoFix’, Jaleva is developing formulations that treat such conditions as anxiety, chronic breakthrough pain and migraines.  The Company is also developing superior topical formulations that are under investigation to 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 contact: Mordy Levine, CEO, 561–573–0094.