Lycelle (Effcon) Non-Pesticidal Head Lice Removal Kit (3)

1

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

4 NON-CONFIDENTIAL

Lycelle® Head Lice Removal Kit

Contents

• Gel – 118 ml bottle (labeled)

• Lice Comb

• Patient Instruction Sheet

• Outer Box

5 NON-CONFIDENTIAL

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

8 NON-CONFIDENTIAL

Lycelle® Head lice Removal Kit

100% Effectiveness in Less than 5 Minutes

Permethrin-Resistant Lice

9 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

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: [email protected]

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.