Post on 25-Jun-2015
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Kills Lice & Their Eggs in One 10-Minute Application
NON-CONFIDENTIAL
• Georgia, U.S.A. corporation
• Founded in 1987 by Ed Burklow
• Originally focus on development, marketing, and distribution of pharmaceuticals
• Evolved to focus on development of specialty products - Improve existing drugs through extended release
- Look for new uses for existing drugs 2
• Prefers to license marketing rights
• Eleven generic products approved/launched
• New Drug Application (NDA) filed and accepted
• Investigational New Drug (IND) in Phase 2
• Two pre-IND projects in early stage development
• Previous formulation history with West-Ward
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Lycelle® Head Lice Removal Kit
• Cytanyl 5® - highly purified form of Citronellyl Acetate
• Patents – Three (3) Issued by US Patent & Trademark Office
• Generally Recognized As Safe (GRAS) Ingredients
• Safety & Tolerability – Proven Through Multiple Studies
• Efficacy – Proven Through Multiple Studies
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Lycelle® Head Lice Removal Kit
Contents
• Gel – 118 ml bottle (labeled)
• Lice Comb
• Patient Instruction Sheet
• Outer Box
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Lycelle® Head Lice Removal Kit
Best Lice Product Available
• Non-Pesticidal
• Kills Live Lice
• Kills Lice Eggs
• In One 10-Minute Application
6 NON-CONFIDENTIAL
Lycelle® How Does It Work?
• Destroys Lipid, Waxy Outer Surface of Both Lice & Eggs
• Surface Regulates Moisture Levels Critical to Survival
• Results in Sudden Dehydration of Both Lice & Eggs
• Immediate Immobilization and then Death of Lice
• Terminates Development of Eggs
• Comb Removes Dead Lice & Eggs from Hair
7 NON-CONFIDENTIAL
Lycelle® Studies
Safety & Tolerability
• Dermal Absorption
• Dermal Irritation
• Dermal Toxicity
• Dermal Sensitization
• Oral Toxicity
• Acute Ocular Irritation
• Human Study
Efficacy
• Open Label Pilot
• Dose Ranging
• Phase II
• Versus Nix (Permethrin)
• Versus Nix & Ovide (Malathion)
• Versus Permethrin-Resistant Lice
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Lycelle® Head lice Removal Kit
100% Effectiveness in Less than 5 Minutes
Permethrin-Resistant Lice
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Registration Status
•Citronellyl Acetate is GRAS ingredient
•U.S. FDA considers lice combs as 510k class I devices
•Lycelle Kit registered as medical device in U.S. due to inclusion of lice comb
•Lycelle Kit should be consumer product in other countries due to GRAS ingredient
Comparison Versus MENA Lice Products
*LYCELLE*
The ONLY non-insecticidal lice products
that kills both lice and eggs in 10 minutes
Brand Corporation Molecule Application Time
Insecticide Kills Lice Kills Eggs
SPREGAL
BOTTU (MOROCCO) OMEGA PHARMA
ESDEPALLETHRINE PIPERONYL BUTOXIDE
30 minutes Yes
Synthetic Pyrethroid
YES
Partially Reapply 7-10 days
NYDA
POHL-BOSKAMP
DIMETICONE
8 hours
No Smothers & Suffocates
YES
Partially Reapply 8-10 days
ASCABIOL SANOFI PFIZER
BENZYL BENZOATE SULFIRAM
24 hours Yes CNS effects
YES Reapply 7 days
PARA
APPLIPHARM BOTTU (MOROCCO)
BIOALLETHRIN PIPERONYL BUTOXIDE
30 minutes
Yes Synthetic
Pyrethroid
YES
Partially Reapply 7-10 days
PARASIDOSE PHARMAGHREB GILBERT
PHENOTHRIN
45 minutes
Yes Synthetic
Pyrethroid
YES YES
LYCELLE Effcon Citronellyl Acetate
10 minutes No Dehydrates
YES YES
Lycelle® Head Lice Removal Kit
12 NON-CONFIDENTIAL
Lycelle® Head Lice Removal Kit
Distribution Rights Available
NON-CONFIDENTIAL
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To discuss this opportunity further please contact Effcon Laboratories, Inc.
Contact Information:
Robert C Sykora, RPh
Licensing Officer, Effcon Laboratories, Inc.
Office: 00 1 678 8626141
Email: bob.sykora@yahoo.com
About Effcon Laboratories, Inc:
Established in the 1980’s, Effcon Laboratories Inc is dedicated to the development or
improvement of pharmaceutical products that address unmet needs or are complaince
challenges for patients. From concept through development, Effcon provides its
commercial partners with best of breed pharmaceutical technology that physicians
worldwide respect and support. These mutually beneficial partnerships within the
pharmaceutical and bio-technology industries are what drives our strategy and our
business every day.