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Kelo-cote®.

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Presentation on theme: "Kelo-cote®."— Presentation transcript:

1 Kelo-cote®

2 Kelo-cote Agenda Market Pathogenesis Scar Management Kelo-cote profile
Clinical evidence Competitors SWOT Positioning: Targets Activity plan Strategy

3 Kelo-cote Epidemiology
Each year 100 MILLION PATIENTS worldwide acquire scars as a result of surgical procedures and trauma1. About 15 MILLION of these patients will suffer from abnormal scars in the form of HYPERTROPHIC SCARS and KELOIDS1. 1Sund B. New developments in wound care. London: PJB Publications, 2000: (Clinical Report CBS 836)

4 Kelo-cote Market Scars are treated in 55 million elective operations and 25 million operations following trauma1 Hypertrophic scars may develop in approximately 39% to 68% of patients after surgery (and in 33% to 91% of patients after burns)2,³ Keloid scars may develop in 5% to 15% of wounds⁴ In 2011  > 200 million incisions made in the world each year on children and adults5 Prevention is not a common procedure 1Sund B. New developments in wound care. London: PJB Publications, 2000: (Clinical Report CBS 836) 2Lewis WH, Sun KK. Hypertrophic scar: a genetic hypothesis. Burns. 1990;16:176-8. 3Niessen FB, Spauwen PH, Robinson PH, Fidler V, Kon M. The use of silicone occlusive sheeting (Sil-K) and silicone occlusive gel (Epiderm) in the prevention of hypertrophic scar formation. Plast Reconstr Surg. 1998;102: 4Cosman  B, Crikelair  GF, Ju  DM, Gqulin  JC, Lattes  R. The surgical treatment of keloids. Plast Reconstr Surg. 1961;27335- 358. 5 Longaker MT. Regenerative medicine: a surgeon's perspective. J Pediatr Surg Jan;45(1):11-7; discussion 17-8.

5 Kelo-cote Skin scarring
Scars result from the biological process of wound repair in the skin and other tissues when the dermis is damaged. The body forms new collagen fibers to mend the damage, resulting in a scar. The new scar tissue will have a different texture and quality to the surrounding tissue. Abnormal scars can cause unpleasant symptoms and be aesthetically distressing, disfiguring, and psychosocially and functionally disabling. Appropriate treatment depends on scar type and etiology.

6 Kelo-cote Abnormal Scars

7 Kelo-cote Hypertrophic vs Keloid

8 Kelo-cote Pathogenesis NORMAL WOUND HEALING
Normal skin wound healing is a highly complex cascade of local and systemic events and can be categorised into three: 1. Haemostasis and inflammation 2. Proliferation 3. Remodeling Shih B, Garside E, McGrouther DA, et al. Molecular dissection of abnormal wound healing processes resulting in keloid disease. Wound Repair Regen. 2010;18:139-53

9 Kelo-cote Pathogenesis
DYSREGULATED BALANCE BETWEEN PROLIFERATION AND REMODELING Theory: abnormal wound healing process, involving increased and prolonged proliferation phase, with an excess collagen deposition by fibroblasts, and delayed remodeling phase. Shih B, Garside E, McGrouther DA, et al. Molecular dissection of abnormal wound healing processes resulting in keloid disease. Wound Repair Regen. 2010;18:139-53

10 Kelo-cote Scar management
1º Line of treatment and prevention of scars Mustoe TA, Cooter RD, Gold MH et al. International clinical recommendations on scar management, Past Reconstrtr Surg 2002; 110:

11 Kelo-cote Scar management
Mustoe TA, Cooter RD, Gold MH et al. International clinical recommendations on scar management, Past Reconstrtr Surg 2002; 110:

12 Kelo-cote Scar management
Treatment 1º Line Characteristics 2º line Silicon sheets Decreases the volume and increases the elasticity of scars in 60 to 100% of cases Laser Expensive, effective, side effects (hyperpigmentation) Silicone gel Thin layer that dries, similar outcomes than SGS with better acceptability by patients1. Cryotherapy Application of liquid Nitrogen, recurrrence. Impregnated elastic sheet Aesthetics and uncomfortables. Surgery In complicated hypertrophic scars (infections) and in keloids ( as a 2nd line of treatment when corticoids, pressure etc. do not work) Compressive treatment Compressive costumes (Burn units) 20 – 24 hours a day. Radiotherapy Particulate radiation consisting of high speed electrons. Adverse effects: Hypo- and hyperpigmentation, erythema, telangiectasia*, and atrophy. Cortisone cream / injections Efficacy but second effects Hypopigmentation around the injection site, dermal atrophy, delayed wound healing , telangiectasia*, etc. Pharmaceutical therapies Example: 5-FU, Bleomicyn, Imiquimod, onion extract, Vitamin E. Telangiectasia*: permanent dilation of preexisting small blood vessels, creating focal red lesions 1Mustoe, T.A.: "Evolution of Silicone Therapy and Mechanism of Action in Scar Management", Aesthetic Plastic Surgery 2008; 32:82–92

13 Kelo-cote Product profile Kelo-Cote:
- Kelo-cote® is a patented topical silicone gel for the management and prevention of abnormal scars in the form of hypertrophic scars and keloids. - Kelo-cote® was acquired by Sinclair in September 2010 for France, Spain, Italy, Germany and UK from ABT, an American company. - Sinclair IS acquired global rights to product excluding US in December 2011. - Medical Device (Class I MD) - Composition: Polysiloxane , Silicon Dioxide. - Patented formulation

14 Kelo-cote Product profile Indications:
- Kelo-cote Advanced Formula Scar Therapy is intended for the management of old and new hypertrophic and keloid scars resulting from general surgical procedures, trauma, wounds and burns. - Kelo-cote is suitable for use in children and people with sensitive skin. Posology: - Application in thin layer on dry skin 2 times/day - Dry in 4 to 5 minutes - Treatment duration 2 to 3 months

15 Kelo-cote Product profile Presentations Kelo-cote 60 g.
Kelo-cote Spray 50 ml Kelo-cote Spray 100 ml

16 Kelo-cote Mode of action Mechanism of action theory

17 Kelo-cote Results EFFICACY for old and new scars Reduces redness
Softens , flattens and smoothes raised scars Relieves itching, discomfort and pain associated with scars

18 Kelo-cote Benefits Self-dries to an invisible, breathable sheet within 4–5 minutes Transparent, odourless gel Easy and painless to apply – no removal necessary Ideal for any irregular skin/scar surfaces, the face, moving parts (joints, flexures) and any size of scars No need to shave the area before application Direct continuous contact with skin provides improved scar management Cosmetics and sun block can be applied over dried Kelo-cote® No maceration

19 Kelo-cote History Kelo-cote® (ABT), Dermatix® (Valeant) and Scarfade® (Hanson) Prior to mid-2007 Dermatix® = Kelo-cote® (Polysiloxanes, Silicon dioxide) During 2007 the agreement between ABT and Valeant ended. Valeant then entered into a contract with Hanson Medical, Inc. to manufacture Dermatix® (different formulation), the same for Scarfade (US only) New Dermatix composition Polixylosanes, Dimethicone. The original formulation of the Kelo-cote® brand has not changed since issue of US patent on April 21, 1998. Kelo-cote® (ABT, now SinclairPhama), Dermatix® (Valeant Pharmaceuticals) and Scarfade® (Hanson Medical, Inc.) are three brand names of topical silicone gel intended for the management of abnormal scars. It is important to understand the history of each brand and the development pathway to clearly diferentiate between the current formulations of each and to accurately interpret all clinical studies conducted to date under the brand name Dermatix®. Prior to mid-2007, the brand known as Dermatix® was manufactured for Valeant Pharmaceuticals (Valeant) by Advanced Bio-Technologies, Inc. (ABT), using the identical patented formulation that ABT sells under the Kelo-cote® name. The only difference between these products during that time was the artwork on the tube and carton. During 2007, the agreement between ABT and Valeant ended, and the last shipment of Dermatix® using the Kelo-cote® formulation was on September 19, 2007. Valeant then contracted with Hanson Medical, Inc. (Hanson) to manufacture Dermatix® for them using a different formulation, the same that Hanson sells under the brand name Scarfade®. Valeant also developed two brand extensions, Dermatix® Ultra and Dermatix®C, which are combination products of silicones and other ingredients including Vitamin C, none of which are related to the patented Kelo-cote® formulation. The original formulation of the Kelo-cote® brand has not changed since issue of US patent on April 21, 1998. Valeant Pharma ABT Hanson

20 Kelo-cote Vs Dermatix Key points of differentiation between Kelo-cote® and the current formulation of Dermatix®(Hanson formula):

21 Kelo-cote Clinical evidence
Title: Scar Management: Observational study of 1522 patients using Kelo-cote® Objectives: Evaluate the efficacy of Kelo-cote® in treating redness, itchiness, pain, elevation and pliability of scars. 1522 patients Patient tolerability of Kelo-cote® treatment was also a key parameter assessed. Results: 80% of physicians rated Kelo-cote® as very good and good in relation to improvement in symptoms and in efficacy. 98% physicians rated tolerability of treatment as very good and good. Sepehrmanesh M. Observational study of 1522 patients using Topical Silicone gel. Kompendium Dermatologie 2006; 1:30–32

22 Kelo-cote Clinical evidence
Over 98% of physicians and patients rated tolerability as “good” or “very good” Sepehrmanesh M. Observational study of 1522 patients using Topical Silicone gel. Kompendium Dermatologie 2006; 1:30–32

23 Overall Efficacy rated as “good” or “very good” by over 81%
Kelo-cote Clinical evidence Overall Efficacy rated as “good” or “very good” by over 81% Sepehrmanesh M. Observational study of 1522 patients using Topical Silicone gel. Kompendium Dermatologie 2006; 1:30–32

24 Kelo-cote Clinical evidence Conclusions: Key messages:
The observational study demonstrates the effectiveness of the product, as proven by the relief of scar symptoms The product is highly tolerable in use, and both physicians and patients are satisfied with Kelo-cote Key messages: Efficacy, tolerability, Physician and Patient satisfaction Silicone gels have been used and recognised as 1st line treatment for scars for over 20 years Efficacious in reducing symptoms associated with abnormal scarring, it is successful in the treatment of all scars, old or new and on any skin type and various injuries including surgery, trauma and burns Very successful mono-therapy i.e. without any concomitant therapy Tolerability: Patients and physicians evaluated tolerability as “very good” or “good” representing high consistency in the evaluations Physicians and Patient satisfaction: Patient compliance is very high Sepehrmanesh M. Observational study of 1522 patients using Topical Silicone gel. Kompendium Dermatologie 2006; 1:30–32

25 Kelo-cote Clinical evidence
Title: Efficacy and Tolerability of a Novel, Silicone Gel for Scar Treatment Objectives: Evaluation of efficacy and collection of safety data in clinical parameter of scars: Redness, pain, hardness, elevation and itchiness following treatment with Kelo-cote®. 111 patient surveillance study Different scar types at different ages were evaluated. Results: Patients: Efficacy 80.1% rated as very good Investigators: Efficacy 75.7% rated as very good Patients: Tolerability 89.2% rated as very good Investigators: Tolerability 84.2% rated as very good. Sebastian G et al. Effectiveness and compatibility of silicone gel with the treatment of different scars. Act Dermatol 2004; 30

26 Kelo-cote Clinical evidence
1. Kelocote significanty reduces all the key measurements using the Vancouver Scar Scale (VSS) Sebastian G et al. Effectiveness and compatibility of silicone gel with the treatment of different scars. Act Dermatol 2004; 30

27 Kelo-cote Clinical evidence
RESULTS BY SCAR TYPE Sebastian G et al. Effectiveness and compatibility of silicone gel with the treatment of different scars. Act Dermatol 2004; 30

28 Kelo-cote Clinical evidence RESULTS BY AGE OF SCARS
Sebastian G et al. Effectiveness and compatibility of silicone gel with the treatment of different scars. Act Dermatol 2004; 30

29 Kelo-cote Clinical evidence Conclusions: Key messages:
The efficacy of Kelo-cote® silicone gel is comparable with other topical scar therapies in the treatment of hypertrophic scars and keloids Silicone gel sheets have been recommended as first line therapy for the prevention and therapy of hypertrophic scars and keloids despite aspects of compliance for discomfort Kelo-cote® silicone gel provides easy handling and comfort to scar management Key messages: Efficacy on Old and New Scars: Improvement of scar symptoms using Kelo-cote® In the treatment of hypertophic and keloid scars Kelo-cote® significantly reduces all the key scar measurements using the Vancouver Scar Scale (VSS) The efficacy of Kelo-cote® silicone gel is comparable with silicone gel sheets in the treatment of hypertrophic scars and keloids but Kelo-cote® is easier to use which enhances patient compliance and the prospect of an aesthetically acceptable scar. Sebastian G et al. Effectiveness and compatibility of silicone gel with the treatment of different scars. Act Dermatol 2004; 30

30 Kelo-cote Clinical evidence
Title: Clinical Evaluation of a New, Self-Drying, Silicone Gel in the Prevention of Hypertrophy in New Scars: A Preliminary Report Objectives: Verify the efficacy Kelo-cote® vs the conventional treatments (pressure garments, intralesional steroids, or traditional silicone gel sheeting). 160 patient Rate of fresh surgical scars and patient compliance were also key parameters assessed. Prospective, randomized, parallel-group 80 patients with Kelo-cote® / 80 patients had no treatment unless they showed signs of hypertrophy Patients evaluated over a 6 month period Patients were evaluated following the excision of benign or malignant skin lesions (Also included scar revision and cosmetic surgery) Signorini M, Clementonil MT. Clinical evaluation of a new self-drying silicone gel in the treatment of scars: A preliminary report. 2007; Aesth Plast Surg 31:183–187

31 Kelo-cote Clinical evidence
Results: 67% of patients who used Kelo-cote® had no scar 72% of patients who used no treatment had a scar 25% of patients who used no treatment had hypertrophic scars or Keloids The majority (26%) of the scars that did form on the Kelo-cote® arm were mildly hypertrophic Scar classified as: Grade 1 - Normal skin Grade 2 - Mildly hypertrophic Grade 3 - Elevated (hard, dark pink to dark red) Grade 4 - Very elevated (very hard, red to brown colour, outside wound margins) Signorini M, Clementonil MT. Clinical evaluation of a new self-drying silicone gel in the treatment of scars: A preliminary report. 2007; Aesth Plast Surg 31:183–187

32 Kelo-cote Clinical evidence
Conclusions: Self-drying silicone gel is appealing because no fixation is required; it is invisible when dry; and sun blocks, makeup, or both can be applied in combination Friction by clothes also may contribute to early removal of the silicone film. These features suggest that the reported product could currently be the most recommendable agent for scar treatment, especially in visible areas Key Messages: Effectiveness: Improvement of scar symptoms. Tolerability: No side effects such as maceration, rashes or infections Physician and patient satisfaction: No fixation is required; it is invisible when dry; and sun block, cosmetics, or both can be applied in combination. The most recommendable agent for scar treatment, especially in visible areas. Signorini M, Clementonil MT. Clinical evaluation of a new self-drying silicone gel in the treatment of scars: A preliminary report. 2007; Aesth Plast Surg 31:183–187

33 Polyurethane Sheets / Tape
Kelo-cote Competitors Plant Based Extracts Silicone Gels Creams & Lotions Polyurethane Sheets / Tape Corticoids Silicone Sheets

34 Kelo-cote Competitors PLANT EXTRACTS SILICONE GEL SHEETS
No clinical efficacy Shown to create irritation Expensive treatment regimen as multiple daily applications Limited patient compliance SILICONE GEL SHEETS Similar efficacy Create maceration, itching, dermatitis Require fixation Poor patient compliance Unsightly Need to wash regularly Expensive treatment regimen CREAMS AND LOTIONS Provide moderate hydration No clinical evidence May cause irritation SILICONE GELS KC patented Formula KC most clinical Evidence Some stain clothes Some remain tacky

35 Kelo-cote Competitors With Silicone 100% Silicone Without Silicone

36 Kelo-cote Competitors Dermatix gel: Main competitor Clinical studies
+ - - Management of keloid /Hypertrophic scars Clinical studies Dry in 4-5 minutes Lange rank of products (gel and sheets) Well know brand in Spain, Italy and France. Direct sales - High price Formula changes Not high promotion (sales force) France 15gr. 60gr. Sheet clear Sheet fabric Spain 15 gr. Italy 60 gr. Germany 15gr. 60gr. UK 15gr. 60gr. Sheet clear Sheet fabric

37 Kelo-cote SWOT Analysis
STRENGTHS - Good brand identity Large and complementary range Unique formula silicon gel patented Non-invasive application compared to steroids injections used for old scars No side-effects Home treatment Easy to use Colorless (invisible) Odorless encourage treatment compliance Cosmetics and sun block can be applied over dried Kelo-cote® WEAKNESSES We do not have Kelo-cote studies. Clinical studies are under DERMATIX brand. We cannot prove our superiority of Kelo-cote (No comparative studies) Derms don´t seem very interested Not for hospital use Not be applied to open or fresh wounds Burns area : with spray ref, only 6 weeks treatment for 180cm2 Price strategy: cost effectiveness ratio is key for launch

38 Kelo-cote SWOT Analysis
OPPORTUNITIES - Large scar market - No UV on the market - Aesthetic takes importance and become a systematic request after surgery procedure despite of the quality of the stitches, cicatrization is a long-term process. few competitors: most of them on silicone wound-dressing only one on silicone gel (Dermatix) - High public prices on the market currently THREATS - Multiples targets - High price - We need to have a specific plan of action in order to deliver the right message to the right target: In Spain: Plastic Surgeons, derms In France: Derms , hospitals, Pharmacies In Italy: Plastic surgeons In Germany: Derms, Plastic surgeons In UK: Derms, Plastic surgeons, hospitals - KOLs are waiting for « something » on cicatrization environment with clinical proofs - Avoid final consumer - Minimize pharmacist role -Competitors on field with high notoriety

39 Kelo-cote Targets Patients Scaring risk group: 10-30 age group
Women are more than twice as likely as men to purchase scar products Children are also treated with scar reduction products more frequently than men. (55% women, 30% children, 15% men) Abnormal scars: Black people, Latins Data: Galileo Patients

40 Kelo-cote Influential targets Plastic surgeons Dermatologist
Message, concept and visual must represent Stronger scientific concept than beauty concept Credible product (consistent formula) Safety and efficacy, clinical evidence Higher patient compliance with Kelo-cote than with sheets Quick to dry and patented formula Dermatologist Message, concept and visual must represent More scientific concept than beauty concept Recommendation by plastic surgeons Safety and efficacy, clinical evidence Different mode of action to other products on the market Pharmacist

41 Kelo-cote Key Visuals

42 Kelo-cote Key Visuals

43 Kelo-cote Activities MATERIALS PROJECTS CONFERENCES

44 Kelo-cote Materials iPad : Target: Plastic surgeons and derms 5 slides
Clinical studies / results Graphics and pictures Pathology Management of scars Clinical evidence Product information

45 Kelo-cote Materials Brochures - Target: pharmacies
- Product information - Recommended by experts - Mechanism of action - Mode of use Kakemono (banner) Display

46 Kelo-cote Materials Sachets: - Target: Plastic surgeons and derms
- Presentation: 0,5 g. - Leaflet for the patient: - Product information and way to use. Patient brochure : - What are scars - Product information - Recommended by experts - Mechanism of action - Mode of use Mode of use : «Like a grain of rice» «Like a drop» thin cover to get dry

47 Kelo-cote Projects PROJECTS Projects:
Target: Plastic surgeons and derms Objetive: Get involve the doctors in scars management E.g.: Ask them to share pictures of scars for articles to be published on our website PROJECTS

48 Kelo-cote Conferences
Conferences / Congresses Target: Plastics surgeons and Derms Objective: Present them Kelocote, prescriptors, contact KOL. CONFERENCES

49 Kelo-cote Strategy Strategy KOL support: Plastic surgeons and Derms
Legitimacy of Kelo-cote: Kelo-cote is internationally recommended as the first line of treatment for the prevention and treatment of Hypertrophic scars and Keloids Differenciation from DERMATIX (Mode of action, patient compliance, efficacy, easy to use)

50 Kelo-cote Potential Issues
Controversy Kelocote Vs Dermatix Clinical Studies under the Dermatix brand Old lists: Dermatix still list in pharmaceutical books as ABT formulation New target: Plastic surgeons Derms: are not very interested, less surgeries, new procedures without scar formation.

51 KELOCOTE Summary

52 CONTACT US


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