Head Lice Asphyxiation Product 2 Mike Precopio - President & CEO Summers Laboratories, Inc.
Head Lice Growing resistance Pesticide treatments Schools: No nit policies Family has to be treated Social stigma 3
Nonprescription Treatments Home Remedies Mayonnaise, Petroleum jelly immobilizes lice, messy to remove Olive oil incomplete asphyxiation Physical treatment Nit combing needs to be used with lice killing product OTC Treatments (RID, NIX) Pesticides Significant resistance 4
Current Prescription Treatments Lindane Pesticide Resistance Black box warning Ovide 8-12 hour application Malathion Toxicity Chemical odor Flammable 5
Growing Resistance to Current Treatments 6
Growing Activism Against Pesticides California ban of Lindane for agricultural and pharmaceutical use Government and Consumer Campaigns for Alternative Treatment Pesticide Action Network North America (PANNA) Alaska- Alaska Community Action on Toxics (ACAT) Illinois- Lobbyist/Safer Pest Control Project support to ban pharmaceutical Lindane Indiana- Hoosier Environmental Council Michigan- Ecology Center partnered with broad coalition of health professionals New York- Citizen s Environmental Coalition 7
Growing Trends Will Benefit Asphyxiator Product Public awareness Media coverage increased concern about pesticide usage Consumer demand Willingness to pay higher prices for organic foods Social movement Increasing activist groups 8
Head Lice Asphyxiator Development History Initial idea for product over 10 years ago Developed a simple physical solution versus an expensive to develop pesticide solution Water soluble, elegant product Incorporated Benzyl Alcohol All product ingredients are currently used in FDA approved Rx products 9
Strong Patent Position U.S. patent coverage until 2022 Composition of matter patent Method of use for topical treatment of lice Other U.S. patents pending Claims for compositions and methods for killing lice and nymphs 10
Advantage of Head Lice Asphyxiator First non-pesticide prescription head lice product No resistance Easy-to-use 10 minute application Repeat after 8 days Similar consistency to hair conditioner 11
Louse Life Cycle Female lives 3-4 weeks lays 10 eggs (nits) per day Nits incubated by body heat hatch in 7-10 days nymphs mature for 8.5-12 days mate female lay eggs Louse usually survives for less than 1-day AWAY from the scalp 12
Closed Lice Spiracles Closed Spiracles 13
Magnified Lice Spiracles Open Closed after exposure to tap water Closed after exposure to mayonnaise 14
Active Ingredient: Benzyl Alcohol Benzyl alcohol is commonly used to preserve topical and injectable products. At least 3 injectable products contain more than 5% benzyl alcohol benzyl alcohol CH 2 OH Benzyl alcohol is used as a preservative at levels of 1 to 5% in shampoos and other personal care products. Benzyl alcohol has a long history of safe usage in humans 15
Lice Death by Asphyxiation The breathing spiracle has remained open after exposure to product allowing the formulation to enter and clog the spiracle The occlusion of the honeycomb breathing interface is apparent 16
Lice Asphyxiation Trial Design Six clinical studies in the U.S. with Lice Asphyxiator (benzyl alcohol), 5% Emulsion Phase II and III clinical development program: 485 patients Treated with two 10-minute L.A. 5% treatments for an infestation of head lice Treatment: day 1 Treatment: day 8 Evaluation: day 22 17
Positive Phase III Results Evaluation 2 weeks after day 8 of treatment Analysis Population Lice Asphyx (n/n) Success Rate (%) Vehicle (n/n) Success Rate (%) Study 1 ITT 48/63 76.2 3/62 4.8 LOCF 52/61 85.2 7/61 11.5 PP 48/55 87.3 3/53 5.7 Study 2 ITT 48/64 75.0 16/61 26.2 LOCF 50/63 79.4 20/61 32.8 PP 45/58 77.6 17/57 29.8 ITT= intent to treat, LOCF= last observation carried forward, and PP= per protocol n= number of subjects successfully treated and N= number of subjects treated 18
Marketing Approach Market size Prescription: $52 million OTC: $100 million Total: $152 million Medical education Sales Representative Promotion PR Pediatrician, School Nurses, Patients, Associations 19 Source: IMS NPA Data
20 Product Timeline NDA filed FDA accepts filing PDUFA date Product launch April 15, 2008 Mid 2008 June 15, 2007 August 2007
Closing Remarks An effective topical preparation that kills by asphyxiation without chemical toxicity is badly needed. 21
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