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3100 Cote Vertu, Suite 240, St- Laurent, QC, CANADA Tel: 514-360-8737 Fax : 514-221-4311 www.findlayventures.com Executive Summary Differentiated/value-added products with barriers to competition An advanced Orally-Dissolving-Film (ODF) platform that has circumvented many of the technology’s previous limitations availing significantly more product possibilities. A biopharma company; leader in the R&D and manufacture (GMP and certified by Health Canada) of ODF and Gels; utilizes a pharmaceutical approach. ODF products offer enhanced consumer benefits; convenience, ease of use, increased compliance, and overall patient experience. Appropriate for many applications and a wide variety of active ingredients. (Dietary supplements, nutraceuticals, pharmaceuticals, over-the-counter medications, veterinary). portability, The Technology A delivery system designed to accommodate a wide variety of ingredients for immediate release upon administration to the oral cavity Thin films (50 to 150 microns) High loading (~60% of active) ≤150 mg total Actives can be liquid or solid Small surface area (4 to 15 cm2) Fast release (<15 sec) Multiple materials capability for wider array of product options: Pullulan (bacterial polysaccharide polymer) Cellulose-based Aliginates Pectin 3 Application / Administration 1. Targeted molecules incorporated in a highly soluble and fast-dissolving polymeric film strip 2. Film placed on or under tongue, or in buccal cavity 3. Film dissolves in 2-15 seconds 4. API can be absorbed under tongue, in buccal cavity, or via digestive tract An intra-oral delivery system May offer clinical advantages Intra-oral products are administered either on the tongue, sublingually, or via the buccal cavity. These highly vascularized mucosal areas allow some substances more direct access to blood circulation, providing direct systemic administration. This could potentially allow a faster onset of action and a reduction of side effects as the product bypasses the stomach and liver. While not all substances are permeable and accessible to the buccal mucosa, ODF prototypes have demonstrated some characteristics that may enable them to be buccally absorbed. Take anytime and anywhere “40% of consumers have difficulties taking pills and capsules”* Does not require water, spoon or any device to take. Immediate dissolution, drug/active ingredient delivery, and onset of action. Easy and convenient to take and administer - dissolves in mouth in 3-20 seconds. Portable and discreet. Can be dissolved in liquid (i.e.; tea, juice, water, baby’s feed-bottle, etc.). Particularly convenient for infants, children, the elderly, and anyone who may have difficulties in swallowing tablets. *Source: Pill-Swallowing Problems in America: a National Survey of Adults, by Harris Interactive, 2003 Technology Limitations Reducing Product possibilities significantly increased Previous Limitations Limitations Reduced Low loading of ingredients < 20mg Higher loading ~ 100mg Careful ingredients selection Most all ingredients categories now possible, e.g., all natural , pure extracts, microencapsulation, etc. Examples: Electrolyte Replacement: Sodium 50mg , Potassium 15mg PharmaGABA: 75mg CoQ10: 60mg Key features and Benefits of Technology Attributes Features 2-10 cm² (small) 100 μm (thin) Size Technology Attributes Absorption Mechanism Dose range possibilities up to 100 mg API Via blood vessels under tongue or in buccal cavity. Manufacturing Development Status Fast dissolution. Convenient to take “anytime, anywhere”. Can take/administer without water. Product works fast. Immediate absorption in circulatory system. Appropriate for patients who can’t or won’t take pills. Flexible. Can be used to deliver many active ingredients/drugs Appropriate for may applications; dietary supplements, nutraceuticals, pharmaceuticals, etc. Potential for reduced sideeffects, faster onset of action. Immediate absorption in circulatory system. Products can work better, faster, and with less side effects. Turnkey product; from GMP, Health Canada development to market. - Certified Fast product development manufacturing turnaround. facility. Pharmaceutical-like controls. Products ready for market. Other prototypes developed. Benefits 2-20 seconds (fast) Dissolution Platform technology Advantages Products fast to market. Meets and exceeds regulatory requirements. Product quality and consistency ensured. Late stage of development. May require PK; only for marketing. Regulatory Considered an oral dosage form by FDA and Health Canada Food, vitamins/dietary supplements, over-the-counter, and prescription ODF products are regulated as an alternative oral dosage forms to chewable tablets and orally disintegrating tablets. This requires that they comply to the regulations that apply to the underlying product`s/active`s regulatory pathway. The exception occurs when claims of alternative routes of administration, other than the oral route, are made, e.g., sublingual, buccal, and/or direct circulatory absorption. Examples of Consumer Accepted Products Consumer Acceptance 100% 80% 60% 40% 20% 0% Source: CIMA Labs Would Ask for ODT Would Purchase ODT Would Prefer ODT (40%) of adults experience difficulty swallowing pills People are trying alternative forms of medication, such as orally dissolving technology (chewable tablets, rapidly-dissolving tablets or film). The greatest importance underlying their decision are; Ease of transporting their pills (80%) 1.Ease of administration (78%) 2.No need for preparation (76%) 3.No need for water when swallowing pills (65%) 4.Better taste of the pill (61%) Culverhouse Center for Swallowing Disorders, University of South Florida College of Medicine "Never before has there been a broad, comprehensive study of this under-recognized problem, and the findings are disturbing," - Worth Boyce, Jr., M.D., Professor of Medicine, Hugh F. Culverhouse Chair in Esophagology, "It is alarming that so many Americans are challenged to swallow needed medications, and many are not adhering to the medication treatment recommended by their doctor”. , - Joy McCann , Director Source: 2004 PR Newswire Association LLC , 2004 Gale, Cengage Learning. All rights reserved. Harris Interactive(R) (http://www.harrisinteractive.com/) Clinical Evidence of Consumer Acceptance 85% prefer Vitamin-D Fast-Dissolving Film Strips over Vit.-D Drops Film strip improved compliance over solution, and resulted in fewer repeated dosages. A Randomized, open-label, Cross-over study comparing two Vitamin D Supplements for infants” Liquid versus fast-dissolving ThinsolTM film strip, Dr. Rodd and Dr. Weiler, McGill University, December 2009 41 patients with mean gestational age of 39 weeks, 6-week study. Number of responses Reasons for preferring strips 30 25 20 15 10 5 0 Easier to administer No mess No spit out Main reasons Full dose consummed Blue Type - Products on market Green Type Ready for market Red Type- Products developed - "close to market". Black Type - Products in advanced development ; proof-of-concept, prototype & samples completed. Product list - Dietary Supplements Pharmacological Class Active, Strength Sleep aid Melatonin, 3mg (all natural) Anemia, fatigue Vitamin B12, 1 mg Cough and Throat Menthol, 5mg and Oil Eucalyptus, 3 mg Cold and Flu Thyme oil, 5mg Maintain cardiovascular health Resveratrol, 25mg Vitamin (Infants, Toddlers) Vitamin D3 400 IU Vitamin (Adult) Vitamin D3 1000 IU Anti-Anxiety PharmaGABA 75mg Anti-oxidant, maintain cardiovascular health Coenzyme Q10, 60mg Maintain cardiovascular health Omega 3, 30mg Multi-vitamin Various vitamins Product list - Over-the-counter Pharmacological Class Active, Strength Teeth-whitening Hydrogen peroxide Energizing Caffeine 40mg Energizing, sexual dysfunction, well being Caffeine 25mg / Ginseng (ginsenosides 1mg) Appetite suppressant Crocus 20mg Laxative Senna- Sennoside, 5, 15 mg Nicotine Replacement Therapy Nicotine, 2mg Electrolyte replacement Electrolyte, 50mg Na et 15mg K Tissue reparation, Immune system Vitamin C 30 mg The facilities Health Canada Certified Manufacturing for Natural Products Facilitiy located within a concentration of Bio/Pharma/Vet industries in St. Hyacinthe, Quebec, Canada 15,000 sq ft manufacturing and R&D facilities Quality Control and R&D laboratory 40ft. casting and drying ovens Pilot R&D casting/drying oven Automated cutting & packaging equipment Cartoning and shrink wrapping equipment Key business benefits Differentiate, add-value to Product Category Take Competitors’ Sales Increase Barriers to Competition Film packaging – Portability & Flexibility Single carton Can contain 1 or 2 aluminium pouches Carton can have a flap with peg hole