SAN DIEGO, CA, November 21, 2011 – Jaleva Pharmaceuticals LLC announces pre-clinical pharmacokinetic (PK) results for two of its formulations, RelievaDrop Alprazolam and RelievaDrop Ondansetron. Both are in the family of Jaleva's quick relief products currently under development.

BioTox Sciences CRO has completed a series of pre-clinical pharmacokinetic (PK) trials measuring the levels of each of these two active ingredients in the blood serum of canines after buccal administration of RelievaDrop Alprazolam and RelievaDrop Ondansetron. These trials showed that Jaleva's investigational product achieved a Tmax (time to achieve maximum concentration) of 6 minutes for Alprazolam and 18 minutes for Ondansetron.

By applying one drop of RelievaDrop (with an active ingredient) on the inside of the cheek, using a unit-dose applicator, it achieves very rapid absorption of the active ingredient into the bloodstream.
Alprazolam (trade name: Xanax) is used to treat treat anxiety disorders and panic disorder. Ondansetron (trade name: Zofran) is used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy and surgery. The Tmax for the Alprazolam tablet is 60-120 minutes. The Tmax for the Ondansetron tablet is 90 minutes.

The rapid Tmax for RelievaDrop Alprazolam and RelievaDrop Ondansetron position them as ideal candidates for quick relief from these conditions. Injection or intravenous administration of these drugs may be the only other delivery mechanism providing immediate relief. In addition, injection or intravenous delivery requires administration by a clinician in a hospital or medical setting.

Plans for human phase 1 PK trials are underway for submitting an Investigational New Drug (IND) application to the FDA, as well as the comparable application to the MHRA in the United Kingdom.

"When a patient experiences an anxiety or panic attack, waiting 1 – 2 hours for their Xanax to provide a therapeutic effect, can seem like forever. Patients want relief as soon as possible under these difficult circumstances, and RelievaDrop Alprazolam has the potential to provide that relief," said Eva Beim, CMO and Co-founder of Jaleva. "When patients undergo chemotherapy, 90 minutes is a long time to wait for a reduction in post-chemo nausea. RelievaDrop Ondansetron has the potential to provide patients with a product that can reduce their nausea in 18 minutes – truly fast relief."

"Jaleva was able to confirm once again that the RelievaDrop delivery technology is an excellent way to deliver active ingredients to the bloodstream – given the short Tmax we have seen with our formulations time and time again. We are encouraged by the results and firmly believe that the quality of life for thousands of patients can be improved with RelievaDrop delivery," said Alex Battaglia, MD, PhD, Jaleva's President, Chief Science Officer and Co-founder.

"We are excited because we have been able to confirm a short Tmax in delivering active ingredients into the bloodstream on a consistent basis using our unique and easy to use resin technology. To my knowledge, there is no other delivery system that can achieve this fast delivery. RelievaDrop is quick and easy to apply," 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. Jaleva is developing formulations that treat such conditions as smoking cessation, 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.

For inquiries contact: Mordy Levine, CEO, 561–573–0094.

SAN DIEGO, CA, October 8, 2011 – Jaleva Pharmaceuticals LLC is pleased to announce that the FDA has confirmed the regulatory pathway for RelievaDrop, Jaleva’s proprietary transbuccal Nicotine Replacement Therapy (NRT) product currently under development.  The FDA confirmed that the pathway for RelievaDrop is a 505(b)(2) new drug application - subject to the expected bioequivalence/efficacy trials for the transbuccal route of administration.

This confirmation came several months after Jaleva’s scientific advice meeting with the MHRA, the UK regulatory agency.  At that meeting the MHRA confirmed that RelievaDrop would be a MAA under article 10 of the relevant EU Directive.  This MAA regulatory pathway does not require extensive non-clinical and clinical studies as required for a new active substance. 

In addition, the MHRA provided their feedback and confirmed that the proposed trials were acceptable for eventual MAA approval if their outcome was positive.  

“We are very excited about the recent responses from the FDA and MHRA,” said Mordy Levine, Jaleva’s CEO.  “Given the relatively short regulatory pathways, this product has the opportunity to be on the market in Europe within the next 24 months and thereafter in the US.“

Recent preliminiary pharmacokinetic (PK) data indicate that Jaleva’s investigational product achieved a Nicotine Tmax (time of maximum concentration) of 10 minutes, with the other critical PK values being bioequivalent to Nicorette Lozenge.   In addition, the PK values of Nicotine absorbed from RelievaDrop closely mimic those of a cigarette.

Jaleva’s RelievaDrop has the potential to become the only NRT with a Tmax of less than 10 minutes.  Nicotine gums and lozenges can take up to 30 minutes to maximize delivery of nicotine to the bloodstream.  
Jaleva anticipates that by placing one small drop of RelievaDrop 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. 

“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. RelievaDrop has the potential to provide that relief,” said Eva Beim, CMO and Co-founder of Jaleva.

“And unlike gums or lozenges that have to be chewed or sucked for 20-30 minutes throughout the day, RelievaDrop is quick to apply and is quickly absorbed," said Alex Battaglia, MD, PhD, Jaleva’s President, Chief Science Officer and Co-founder.

Plans for human phase 1 PK trials are underway as are plans for submitting an Investigational New Drug (IND) application to the FDA. 

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 RelievaDrop, Jaleva is developing formulations that treat other Central Nervous System conditions.  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.

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.

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.

Release issued 15th September 2008

SAN DIEGO, CA, September 15, 2008 – Jaleva Pharmaceuticals LLC announces that MICROBIOTEST has completed a clinical trial comparing Chloraprep to Mast-r-Prep, Jaleva’s proprietary, chlorhexidine-based, one-step surgical skin prep product.  The results were outstanding.  Mast-r-Prep safely killed more bacteria for a longer period of time than Chloraprep, the top CHG based skin prep product in the market. 

Jaleva’s Mast-r-Prep is the only one-step surgical skin prep product in the world that offers a combination of several desirable characteristics.  In contrast to other one-step surgical skin prep products, Mast-r-Prep has a long acting kill rate, is fast drying, easy to remove, has increased tackiness that promotes adhesion of drapes, and also utilizes a proprietary technology to trap and kill bacteria.

“In this clinical trial, we were able to confirm what was proven in vitro - that Mast-r-Prep truly has a long acting antibacterial kill rate.  Long acting kill rate has always been a concern for hospitals and physicians, so we were gratified to see superiority when measured out to the 96 hour time point." said Mordy Levine, Jaleva’s Chief Executive Officer.

According to Dr. Alex Battaglia, Jaleva President who coordinated the clinical trial, "Mast-r-Prep is a one-step, Chlorhexidine-based surgical skin prep that outperforms currently available surgical skin prep products.  It kills more bacteria for a longer period of time, but additionally has several unique characteristics that surgeons will appreciate.

First, surgical drapes adhere to Mast-r-Prep formulation better than currently available surgical skin prep products.  Its tackiness also makes Mast-r-Prep more easily detectable. 

Second, Mast-r-Prep dries faster and is more easily removed than currently available surgical skin prep products.  Once it dries, Mast-r-Prep not only kills bacteria for a longer period of time but also traps bacteria like fly paper and prevents the bacteria from migrating to the surgical wound.    

These unique properties and superior qualities will be desirable to surgeons and lead to a sizeable advantage over currently available surgical skin prep products."

“We believe that Mast-r-Prep will supplant the use of currently available surgical skin prep products given their liabilities as well as the desire expressed by surgeons for a product like Mast-r-Prep that meets all their needs.” says Mordy Levine.  "Not only does Mast-r-Prep have user-friendly qualities that surgeons will prefer over currently available surgical skin prep products, but we fully expect Mast-r-Prep to outperform and outlast currently available Chlorhexidine-based surgical skin prep products.”

“It provides an exciting and unique opportunity for any company invested in infection prevention in hospital and surgical environments,” said Eva Beim, Vice President and Co-founder of Jaleva.

Formed in 2000, Jaleva Pharmaceuticals LLC is a privately held firm.  Jaleva is a leader in the application of its patented resin technology for the improvement of topical medications.  Jaleva is engaged in the research & development of delivery vehicles for active ingredients that treat onychomycosis, psoriasis, heel fissures (cracked heels), athlete’s foot and other dermatological conditions.

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

Release issued 2nd June 2008

SAN DIEGO, CA, June 2, 2008 – Jaleva Pharmaceuticals LLC announces that MICROBIOTEST has completed Time Kill and MIC studies for Mast-R-Prep, the company's proprietary, chlorhexidine-based, one-step surgical skin prep product.  The MIC and Time Kill results were outstanding.  Mast-R-Prep outperformed a major Isopropyl Alcohol / Povidone-Iodine skin prep product already on the market. 

Jaleva’s Mast-R-Prep is the only one-step surgical skin prep product in the world that offers a combination of several desirable characteristics.  In contrast to other one-step surgical skin prep products, Mast-r-Prep has a long acting kill rate, is fast drying, easy to remove, has increased tackiness that promotes adhesion of drapes, and also utilizes a proprietary technology to trap and kill bacteria.

“We are pleased and are very encouraged to see that the independent findings demonstrated that Mast-R-Prep is a unique and superior product in its antimicrobial properties," said Mordy Levine, Jaleva’s Chief Executive Officer.

According to Dr. Alex Battaglia, Jaleva President who coordinated the Time Kill and MIC Testing, "Mast-R-Prep is a one-step, Chlorhexidine-based surgical skin prep that outperforms currently available surgical skin prep products.  It has several advantages and unique characteristics that surgeons will appreciate.

First, surgical drapes adhere to Mast-R-Prep formulation better than currently available surgical skin prep products. 

Second, it has a unique bacteria trapping effect that prevents bacteria from migrating to the surgical wound.  Additionally, its tackiness makes Mast-R-Prep more easily detectable.  Mast‑R‑Prep dries faster and is more easily removed than currently available surgical skin prep products. 

These unique properties and superior qualities will be desirable to surgeons and lead to a sizeable advantage over currently available surgical skin prep products."

“We believe that Mast-R-Prep will supplant the use of currently available surgical skin prep products given their liabilities, and the desire expressed by surgeons for a product like Mast-R-Prep that meets all their needs.” says Mordy Levine.  "Not only does Mast-R-Prep have user-friendly qualities that surgeons will prefer over currently available surgical skin prep products, but we fully expect Mast-R-Prep to outperform and outlast currently available Chlorhexidine-based surgical skin prep products in human efficacy testing scheduled over the next few weeks.”

Formed in 2000, Jaleva LLC is a privately held firm.  Jaleva is a leader in the application of its patented resin technology for the improvement of topical medications.  Jaleva is engaged in the research & development of delivery vehicles for active ingredients that treat onychomycosis, psoriasis, heel fissures (cracked heels), athlete’s foot and other dermatological conditions.

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

Release issued 2nd June 2008

SAN DIEGO, CA, June 2, 2008 – Jaleva Pharmaceuticals LLC announces that market research results from FRANKLIN COMMUNICATIONS indicate that Mast-R-Prep, the company's proprietary, chlorhexidine-based, one-step surgical skin prep, has the characteristics most desirable to general surgeons and orthopedic surgeons.

Jaleva’s Mast-R-Prep is the only one-step surgical skin prep product in the world that offers a combination of several desirable characteristics.  In contrast to other one-step surgical skin prep products, Mast-R-Prep has a long acting kill rate, is fast drying, easy to remove, has increased tackiness that promotes adhesion of drapes, and also utilizes a proprietary technology to trap and kill bacteria.

Participation included 100 respondents as follows: general surgeons (n=60) and orthopedic surgeons (n=40).  A subset of the independent findings included:

• Confirmation that both DuraPrep and ChloraPrep are the leading surgical skin prep products. Each is currently used by approximately two-thirds of the survey participants. One Step Povidione Iodine ranks a distant third, with current usage cited by 41% of all respondents.
• Ratings of Mast-R-Prep, based on the product profile provided, were exceptionally favorable. The 7-point scale used to measure surgeon interest resulted in a mean rating of 6.39, with approximately half of the respondents assigning the highest rating of “7”.
• Mast-R-Prep’s long-acting kill rate was the top-rated contributor to its positive reception. Its fast-drying property and easy post-op removal ranked second and third, respectively. These address perceived shortcomings of the iodine-based DuraPrep.
• The positive response to the convenience related attributes points to the potential shortcomings of ChloraPrep.

“We were able to measure 19 different characteristics of Surgical Skin Prep products, for all major products in this marketplace.  We were pleased to see that the independent findings showed Mast-R-Prep as a unique and superior product in both its antimicrobial properties as well as in its convenience related properties," said Mordy Levine, Jaleva’s Chief Executive Officer.

According to Dr. Alex Battaglia, Jaleva President who coordinated the Time Kill and MIC Testing, "Mast-R-Prep is a one-step, chlorhexidine-based surgical skin prep that outperforms currently available surgical skin prep products.  It has several advantages and unique characteristics that surgeons will appreciate.

First, surgical drapes adhere to Mast-R-Prep formulation better than currently available surgical skin prep products.

Second, it has a unique bacteria trapping effect that prevents bacteria from migrating to the surgical wound.  Additionally, its tackiness makes Mast-R-Prep more easily detectable.  Mast-R-Prep dries faster and is more easily removed than currently available surgical skin prep products.

These unique properties and superior qualities will be desirable to surgeons and lead to a sizeable advantage over currently available surgical skin prep products."

“We believe that Mast-R-Prep will supplant the use of currently available surgical skin prep products given their liabilities, and the desire expressed by surgeons for a product like Mast-R-Prep that meets all their needs.” says Mordy Levine.  "Not only does Mast-R-Prep have user-friendly qualities that surgeons will prefer over currently available surgical skin prep products, but we fully expect Mast-R-Prep to outperform and outlast currently available chlorhexidine-based surgical skin prep products in human efficacy testing scheduled over the next few weeks.”

Formed in 2000, Jaleva LLC is a privately held firm.  Jaleva is a leader in the application of its patented resin technology for the improvement of topical medications.  Jaleva is engaged in the research & development of delivery vehicles for active ingredients that treat onychomycosis, psoriasis, heel fissures (cracked heels), athlete’s foot and other dermatological conditions.

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