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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
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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
NON-CONFIDENTIAL
Lycelle
Head Lice Removal Kit
Contents Gel 118 ml bottle (labeled) Lice Comb Patient Instruction Sheet Outer Box
NON-CONFIDENTIAL
Lycelle
Head Lice Removal Kit
Best Lice Product Available Non-Pesticidal Kills Live Lice Kills Lice Eggs In One 10-Minute Application
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
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
NON-CONFIDENTIAL
Lycelle
Head lice Removal Kit
100% Effectiveness in Less than 5 Minutes Permethrin-Resistant Lice
NON-CONFIDENTIAL
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
Molecule
ESDEPALLETHRINE PIPERONYL BUTOXIDE DIMETICONE
Kills Lice
Kills Eggs
Partially Reapply 7-10 days Partially Reapply 8-10 days Reapply 7 days
YES
POHL-BOSKAMP
8 hours 24 hours
YES YES
SANOFI PFIZER
PARA PARASIDOSE
30 minutes 45 minutes
YES
PHARMAGHREB GILBERT
YES
LYCELLE
Effcon
Citronellyl Acetate
10 minutes
No Dehydrates
YES
YES
*LYCELLE* The ONLY non-insecticidal lice products that kills both lice and eggs in 10 minutes
NON-CONFIDENTIAL
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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 1980s, 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.
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