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1. US Partner: Competitor or Complementary Player? 2. Single partner for several applications or multiple partners per each? 3. Funding options for research projects? PCCI January 19, 2009 Diana Mackie, Business Dev. Silvia G Codony, Clinical Research Contura International A/S (Archive Version)
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Contura Business Units For urinary incontinence Pipeline New applications of soft tissue filler technology For facial augmentation Contura is a medical technology company based in Denmark focused on developing, manufacturing and commercializing soft tissue fillers that enhance the quality of people’s lives
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2000: Contura established 2001: Aquamid ® granted the CE-marking for use in soft tissue facial augmentation 2003: Bulkamid ® granted the CE-marking for use in the treatment of female urinary incontinence 2004: Launch of Aquamid ® Reconstruction for lipoatrophy, rhinoplasty and volume correction 2006: FDA grants Aquamid ® I D E, allowing its use in a major comparative clinical trial in the United States 2007: Contura and ETHICON, a J & J company, sign agreement granting ETHICON exclusive worldwide distribution rights for Bulkamid ®. Contura’s United States subsidiary Contura Inc. established Contura awarded the Product Differentiation Innovation Award for Aquamid ® by Frost & Sullivan 2008: Clinical trial of Bulkamid ® in the United States begins New manufacturing facility completed Contura History and Milestones
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Aesthetic Filler Market Aquamid ® Positioning Aquamid ® Pivotal Clinical Trial Results Partnership Opportunity
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US Aesthetics Filler Market Total Aesthetics Medicine market size exceeds $13 Billion* –Surgical procedures$ 8.4 B –Non-Surgical procedures$ 4.8 B Non-Surgical Procedures market size, includes MD fees & product –Botox > $ 1 B –All soft tissue fillers $ 1 B Number of Procedures –Botox 4.6 M $350 M at office retail –Soft Tissue Fillers 1.5 M $350 M at office retail * Source: Data from 2007 ASAPS and the May 2008 Millenium Research Group Report
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Market Dynamics: Many New Introductions 2004 2005 2006 2007 2008 2009 Radiesse Elevess relaunch Restylane Sculptra Juvederm Evolence Artefill (Puragen), Perlane Prevelle ___▼_______▼________________▼_▼_▼_▼______▼_▼_▼▼__________► Sources: industry studies, publications, company information Hyaluronic Acid brands (HAs), Particle and Polymer brands (PPFs), Collagen brand
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After cannibalizing Collagen, HA growth was blunted. Number of procedures Source: ASAPS (ASPS data show same effect)
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Competitive Players Portfolio Approach in high gear Allergan: Botox + very successful launch of Juvederm line Mentor: PurTox + Prevelle Silk launch + PLEs (acquired by J&J) BioForm: Radiesse + Relaxed Expressions (RF technique alternative to neurotoxin) Medicis: Neurotoxin + Restylane line Artes Medical: Elevess (HA) + Artefill long duration filler (now in Chapter 7) Bundling promotions is a key factor for success and is believed to help hold physicians loyal to your line.
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Aesthetic Filler Market Aquamid ® Positioning Aquamid ® Pivotal Clinical Trial Results Partnership Opportunity
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US Aesthetics Filler Market Total Aesthetics Medicine market size exceeds $13 Billion* –Surgical procedures$ 8.4 B –Non-Surgical procedures$ 4.8 B Non-Surgical Procedures market size, includes MD fees & product –Botox > $ 1 B –All soft tissue fillers $ 1 B Number of Procedures –Botox 4.6 M $350 M at office retail –Soft Tissue Fillers 1.5 M $350 M at office retail * Source: Data from 2007 ASAPS and the May 2008 Millenium Research Group Report
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Market Dynamics: Many New Introductions 2004 2005 2006 2007 2008 2009 Radiesse Elevess relaunch Restylane Sculptra Juvederm Evolence Artefill (Puragen), Perlane Prevelle ___▼_______▼________________▼_▼_▼_▼______▼_▼_▼▼__________► Sources: industry studies, publications, company information Hyaluronic Acid brands (HAs), Particle and Polymer brands (PPFs), Collagen brand
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After cannibalizing Collagen, HA growth was blunted. Number of procedures Source: ASAPS (ASPS data show same effect)
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Competitive Players Portfolio Approach in high gear Allergan: Botox + very successful launch of Juvederm line Mentor: PurTox + Prevelle Silk launch + PLEs (acquired by J&J) BioForm: Radiesse + Relaxed Expressions (RF technique alternative to neurotoxin) Medicis: Neurotoxin + Restylane line Artes Medical: Elevess (HA) + Artefill long duration filler (now in Chapter 7) Bundling promotions is a key factor for success and is believed to help hold physicians loyal to your line.
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NeurotoxinCollagenHyaluronic Acids Longer Lasting AllerganYES Medicis(Pipeline)YES Mentor + JnJ (Pipeline)YES BioFormRelaxed Expressions YES Artes Medical YES Each company started from one box and has been acquiring to complete the portfolio
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Aquamid characteristics: - Non-degradable - Biocompatible, Non-migrational - Non-allergenic, atoxic - Homogeneous (no particles) - Exchanges water, salts and organic molecules with host tissue - Stored without refrigeration Mode of Action -Volumizer – No intended foreign body reaction -full integration and vascularization Aquamid Has Unique Properties and Benefits Aquamid is an injectable hydrogel consisting of 97.5% water and 2.5% cross-linked polyacrylamide (1 ml syringe/27G needle)
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Facial skin sags → Surgical Facelift Loss of subcutaneous fat tissue → volume filler “Boosting volume under the skin” Wrinkles & folds in lower face → dermal fillers Lines & wrinkles in upper face → neurotoxins AgeingAgeing Young Old New Trend: Volume Filling and Facial Sculpting
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Unique Benefits of Aquamid ® Versatile volumizer: well suited for volumizing and sculpting procedures. Directed to the subcutaneous tissue for immediate filling and lifting effect. Natural look and feel: The gel is homogeneous. Aquamid® does not induce inflammatory nodules or granulomas. Integrates completely with existing tissue. Lasting enhancement: non-resorbable and enduring augmentation. Clinical data demonstrate patient and investigator satisfaction that exceeds 90% after 5 years.
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Naso labial folds Lip augmentation Cheek contouring Mento labial folds Glabella filling Nose correction Chin augmentation Scar correction Facial augmentation to correct lipoatrophy Minor body contouring Aquamid ® Versatile in Applications
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Durability of augmentation Compatibility with tissue Evolence Soft Tissue Filler Positionings Artefill SculptraRadiesse Juvederm Restylane
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Aquamid ® Pivotal US Study Results Study Design Results Highlights –Effectiveness –Safety
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Study Design Aquamid ® – 210 subjects Restylane ® – 105 subjects Screening Treatment to Optimal Max 3 sessions 3M6M9M12M Treated area: nasolabial folds 13 Sites in the US – each with 19 - 33 subjects
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Pivotal Study Key Conclusions Successfully show that Aquamid ® is safe and effective for its intended use. Support the regulatory requirements for the PMA filing
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Market Outlook Flat to low growth through 1H 2009 due to economy and less DTC advertising for next 6 months – however Botox grew by 13% in a challenging Q4/2008 New aesthetic medicines will launch, about one per year. Premium place given to those that leverage a sales force in place and where bundling can occur Aquamid ® launch in 2010 should find an industry in growth again with receptive physicians and consumers.
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Partnership Opportunity Contura is seeking a US Marketing partner via a US/NA license to commercialize Aquamid ® to its target customers. The framework of a marketing plan is available and shows how Aquamid ® would roll out to experienced and trained physicians in soft tissue fillers Aquamid ® will sustain an appropriate price premium. Supply and further development to come from Contura A/S
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Other Potential Partners for Aquamid® Beyond Current Filler Competitors Therapeutic Dermatology FocusAesthetic Equipment/Device Focus Galderma Graceway American Laser Angiotech Pharma Merz Nycomed Cynosure New Star Lasers Obagi KIng PhotoMedex Syneron SkinMedica Stiefel Consumer Companies in OTC Derm ValeantP&G J&J DermaPlus DermaVance Schering-Plough Unilever
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