1. - Allergika
Transcription
1. - Allergika
Business Opportunity in Dermatology ALLERGIKA Pharma GmbH Information Memorandum for International Cooperation I. ALLERGIKA Profile In 1991 ALLERGIKA Pharma GmbH was founded as a privately owned German pharmaceutical company based near Munich. ALLERGIKA is the leading company of Anti Dust Mite Products in Germany. The name ALLERGIKA® is one of the main assets of the company and represents a unique program: ALLERGIKA® stands for the company ALLERGIKA® stands for the umbrella trademark ALLERGIKA® stands for the products ALLERGIKA® stands for the product indications and applications ALLERGIKA® is identification for the patients The ALLERGIKA® trademark is registered worldwide. ALLERGIKA employees 60 people, thereof 20 sales reps for dermatologists, pediatricians and pharmacies, one key account manager hospital and one key account manager pharmacy. The company’s total sales is approximately 6 Mio. EUR. In 2006 ALLERGIKA has started with the development, marketing and distribution of its dermatological products, so called ALLERGIKA® Therapeutic Skin Care Line. ALLERGIKA® TSC Line is one of the most successful dermatological OTC product lines in Germany with an increasing rate of more than 30% in total and up to 200% per product. ALLERGIKA® TSC Products have a distribution rate of more than 20% in German pharmacies. Chart 1: Successful sales development of the ALLERGIKA® TSC Line 2 I. ALLERGIKA Profile ALLERGIKA® Therapeutic Skin Care (TSC) Line is clearly positioned in the field of skin diseases. The name ALLERGIKA® Therapeutic Skin Care underlines the positioning close to the dermatological therapy. Chart 2: Positioning of the ALLERGIKA® TSC Line The promotion of ALLERGIKA® TSC Line is focused on dermatologists and pediatricians in private offices and hospitals. ALLERGIKA promotes and sells its ALLERGIKA ® TSC Products exclusively to pharmacies (franchise business) and via wholesalers to pharmacies. ALLERGIKA® Therapeutic Skin Care is very well acknowledged and accepted by doctors and pharmacists as well as patients. ALLERGIKA® Eyelid Cream ranks No.1 in its market segment in Germany! ALLERGIKA® Lipolotio Urea 5% ranks already 3rd on the German market! Both products belong to the top selling products. No.1 Since 2008 ALLERGIKA has started to internationalize its ALLERGIKA® Therapeutic Skin Care products with the successful launch in Austria, Hungary, Luxemburg, Morocco and Saudi Arabia. 3 II. ALLERGIKA Market All over the world more than 30% of the population is affected by allergies with an increasing tendency up to 50% in the next twenty years. Allergies are quite often a multimorbide occurance. They are characterized by the so called “Atopic March”. Chart 3: Distribution of allergic diseases in Europe (Source: WHO 2005) Allergic Skin that means skin diseases related with eczema (e.g. neurodermatitis and contact eczema) with a distribution rate of 13% are the most frequent allergic disease worldwide! Chart 4: Distribution of Allergic Diseases (Source: ISAAC, uniklinikum-giessen.de, 2008) Dry skin is the main symptom of many skin diseases. More than 25% of the population worldwide are suffering on dry skin. They are also a target for ALLERGIKA® TSC Line. 4 III. ALLERGIKA Basic Therapy of Eczema and Dry Skin Skin diseases are diagnosed and treated in the first instance by dermatologists and pediatricians in private practices and hospitals. In the International Guideline for the treatment and prevention of eczema and dry skin of the European Academy of Dermatology and Venereology (EADV 2013) the Basic Therapy with emollients and cleansing products plays an important role and are recommended or prescribed by dermatologists complementary to their therapy with steroids, antibiotics or antiseptics. The requirements for the Basic Therapy according to the International Guideline are as follows: 1. Allergen Avoidance 2. Active Ingredients 3. Medical Galenic Formulation ALLERGIKA® Therapeutic Skin Care Products fulfill the strict requirements of the International Guideline and is therefore the ideal partner for the dermatological therapy. ALLERGIKA® helps to reduce pharmaceuticals like steroids. Chart 5: International Guidelines for treatment of atopic eczema and dry skin to graded severity (EADV 2013) 5 IV. ALLERGIKA Therapeutic Skin Care: Summary of ALLERGIKA´s USPs 1. ALLERGIKA has developed together with international key opinion leaders four ALLERGIKA® Therapeutic Concepts “from top to toe” for allergic patients: Concept I: Concept II: Concept III: Concept IV: Sensitive and atopic skin Dry skin Sensitive atopic and dry skin of Baby & Kids Sun intolerance ALLERGIKA offers with these concepts the only and most comprehensive program especially for allergic patients on the market. 2. ALLERGIKA® offers with Dermifant® the only skin care concept for babies and kids from “First Day”. 3. ALLERGIKA® TSC Line is consequently produced - 100% free of perfumes, preservatives (also parabens) and dyes - 100% free of natural allergens - 100% free of the 328 most frequent allergens as listed by the German Contact Dermatitis Group 4. ALLERGIKA® Therapeutic Skin Care Products are produced exclusively in Germany in pharmaceutical quality. 5. ALLERGIKA® Therapeutic Skin Care Products are clinically tested on atopic skin with very high skin tolerance. 6. ALLERGIKA® Therapeutic Skin Care Products are used and recommended by leading German dermatological hospitals. 6 IV. ALLERGIKA Therapeutic Skin Care: Product Overview Chart 6: ALLERGIKA® Therapeutic Skin Care Program (The ALLERGIKA® Core Products are highlighted in red) Concept I Concept II Concept III Concept IV . 7 V. ALLERGIKA® Core Products for the main dermatological indications ALLERGIKA offers the ideal Basic Therapy for the dermatological treatment of eczema and dry skin according to the International Guideline. In the following table the main dermatological indications from top to toe are pointed out. ALLERGIKA can provide for each indication a suitable product. These products are the ALLERGIKA® Core Products which are mostly recommended and/or prescribed by dermatologists. Nevertheless the allergic patient need a whole program which should be provided by the pharmacy (Chart 6). Chart 7: ALLERGIKA® Core Products for the main dermatological indications (Recommendation by Prof. Enk, University of Heidelberg) Pos. Localisation Main dermatological Indication ALLERGIKA® Core Products for Basic Therapy 1 Scalp / Hair Scalp eczema, Seborrhoic eczema ALLERGIKA® Mild Shampoo 2 Eyelid Periorbital dermatitis, Eyelid eczema, Airborne dermatitis ALLERGIKA® Eyelid Cream 3 Local areas Subacute eczema ALLERGIKA® Primrose Oil Cream 20% 4 Face Sebostasis ALLERGIKA® Facial Cream Urea 5% 5 Hand Fissured chronic hand eczema, psoriasis palmaris ALLERGIKA® Cream Urea 5% 6 Hand (Atopic) hand eczema ALLERGIKA® Soft Hand Cream 7 Body Sebostasis,mild atopic eczema ALLERGIKA® Lipolotio Urea 5% 8 Body Dehydration eczema, xerosis, diabetic skin ALLERGIKA® Lipolotio Urea 5%F 9 Body Psoriasis, Ichthyosis ALLERGIKA® Lipolotio Urea 10% 10 Body Sensitive, atopic skin prone to redness and acute itching ALLERGIKA® Hydrolotio Sensitive 11 Body Sensitive, atopic skin and chronic eczema ALLERGIKA® Lipolotio Sensitive 12 Body Sensitive, atopic skin ALLERGIKA® Bath & Shower Gel Mild 8 VI. ALLERGIKA TSC Line: Regulatory Affairs 1. ALLERGIKA Pharma GmbH is a pharmaceutical company certificated according to QMS ISO 9001:2000. 2. In respect to the regulatory requirements ALLERGIKA® Therapeutic Skin Care products are defined as cosmetics according to the European Cosmetic Directive 1223/2009 valid in all EU countries. ALLERGIKA® products are registered in all EU countries via CPNP procedure. 3. In countries outside the EU similar registration requirements exist. For this purpose ALLERGIKA can provide a comprehensive product documentation: • • • • • Technical record Stability data Preservation challenge tests Skin tolerance tests even on atopic skin Safety reports 4. Registration of ALLERGIKA® Therapeutic Skin Care may take 3-7 months depending on the country outside the EU. 9 VII. ALLERGIKA TSC Line: Clinical Documentation ALLERGIKA® Therapeutic Skin Care products are excellent documented ! 1. The therapeutical efficacy of all main active ingredients like Urea, Glycerol, Evening Primrose oil, Polidocanol, Allantoin and Bisabolol haven been proven. They are dermatological recommended and clinically documented. 2. All products have been tested on atopic skin with excellent results. 3. For all core products clinical trials with at least 20 patients on atopic skin over 4 weeks demonstrate excellent therapeutical results. 4. Clinical trials of ALLERGIKA® Basic cream and ointment (pharmaceuticals with German registration) in the interval therapy of eczema with steroids prove the clinical efficacy and steroid sparing effect. 5. Clinical trials of ALLERGIKA® Eyelid cream and Lipolotio urea 5% are still going on (27 patients over 4 weeks; barrier effect). 6. Comprehensive clinical documentation is available. 7. ALLERGIKA® Therapeutic Skin Care products are used and recommended from leading dermatological hospitals in Germany since nearly 10 years. 10 VIII. ALLERGIKA TSC Line: International Business Opportunity The ALLERGIKA® Therapeutic Skin Care product portfolio by its nature is based on the prescription and/or recommendation by doctors and pharmacists. ALLERGIKA® Therapeutic Skin Care is doctor and pharmacy oriented. It is part of the dermatological therapy of doctors. As a consequence the ALLERGIKA® Therapeutic Skin Care program should be promoted to dermatologists, pediatricians in private offices and in hospitals in the first instance. It is the strategic objective of ALLERGIKA Pharma GmbH to internationalize its unique ALLERGIKA® Therapeutic Skin Care program with regional and/or national partners all over the world. ALLERGIKA Pharma GmbH is looking for cooperation partners to which ALLERGIKA® Therapeutic Skin Care may be synergistic or complementary to its existing product portfolio (e.g. topical steroids) and/or an option for a future company strategy. ALLERGIKA Pharma GmbH offers: 1. A sustainable, long term business opportunity in a big and fast growing market 2. Unique ALLERGIKA® program with a worldwide registered trademark 3. High Quality products „Made in Germany“ 4. Exklusive, long term Distribution Agreement with attractive margins 5. Advertising, promotion and sales force training support 11 VIV. Coordinates In the event that you consider ALLERGIKA® Therapeutic Skin Care as an alternative business opportunity and/or a strategic company option, please contact ALLERGIKA Pharma GmbH as follows: Mr. Hartmut Bannert, President, CEO email: bannert@allergika.de. Mobile: +49 172 985 1406 Mrs. Stefanie Edler, Business Development Manager email: edler@allergika.de. Mobile: +49 177 915 4401 ALLERGIKA Pharma GmbH, Bürgermeister-Seidl-Str.8 D-82515 Wolfratshausen / Germany phone +49 81 71 42 25 7 fax +49 81 71 42 25 82 4 www.allergika.de info@allergika.de 12