2. • 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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3. • 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
3
4. 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
4
NON-CONFIDENTIAL
5. Lycelle®
Head Lice Removal Kit
Contents
• Gel – 118 ml bottle (labeled)
• Lice Comb
• Patient Instruction Sheet
• Outer Box
5
NON-CONFIDENTIAL
6. 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
7. 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
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NON-CONFIDENTIAL
8. Lycelle®
Studies
Safety & Tolerability Efficacy
• Dermal Absorption • Open Label Pilot
• Dermal Irritation • Dose Ranging
• Dermal Toxicity • Phase II
• Dermal Sensitization • Versus Nix (Permethrin)
• Oral Toxicity • Versus Nix & Ovide (Malathion)
• Acute Ocular Irritation • Versus Permethrin-Resistant Lice
• Human Study
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NON-CONFIDENTIAL
9. Lycelle®
Head lice Removal Kit
100% Effectiveness in Less than 5 Minutes
Permethrin-Resistant Lice
9
NON-CONFIDENTIAL
10. 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
11. Comparison Versus MENA
Lice Products
Brand Corporation Molecule Application Insecticide Kills Lice Kills Eggs
Time
ESDEPALLETHRINE Yes Partially
BOTTU (MOROCCO)
PIPERONYL 30 minutes Synthetic YES Reapply 7-10
SPREGAL OMEGA PHARMA
BUTOXIDE Pyrethroid days
No Partially
POHL-BOSKAMP DIMETICONE Smothers & YES Reapply 8-10
NYDA 8 hours
Suffocates days
ASCABIOL 24 hours Yes YES Reapply 7
BENZYL BENZOATE CNS effects days
SANOFI PFIZER
SULFIRAM
BIOALLETHRIN Yes Partially
APPLIPHARM
PIPERONYL Synthetic YES Reapply 7-10
PARA BOTTU (MOROCCO)
BUTOXIDE 30 minutes Pyrethroid days
PARASIDOSE Yes
PHARMAGHREB PHENOTHRIN
GILBERT
45 minutes Synthetic YES YES
Pyrethroid
LYCELLE Effcon Citronellyl 10 minutes No YES YES
Acetate Dehydrates
*LYCELLE*
The ONLY non-insecticidal lice products
that kills both lice and eggs in 10 minutes
13. Lycelle® Head Lice Removal Kit
Distribution Rights Available
NON-CONFIDENTIAL
14. 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.
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