LICENSING PRESENTATION September 2013 Tristram Lake Head of Licensing and Sales Neogen N.V.
CONTENTS The aim of this presentation is to communicate to you... Our mission Our vision Who we are What we do How we do it
Who are we? Developments International Alter Pharma N.V. Neogen Dev. Interntational SP NSP GSP Steac Developments International
our Basic idea We cover niche, overlooked and local markets with focus on older molecules, along with alternative forms and strengths when possible Neogen Generic Companies wishing to extend their Portfolio No skills or willingness to undertake developments Inlicensing of products
Roadmap 2 – 4 years Core competences Market intel Product selection Finished dose development Dossier compilation Submission & registration Supply & support API development Sales & marketing Core competences Market intel Qualification & management of 3rd party CMO’s Patent search Commercial scale production Formulation Stability testing Risk assessment Regulatory strategy Lab scale batches
Dosage FORMs Injectables: In-house development. EU CMOs Oral forms: 3rd party development or dossier update manufacturing outsourced in Europe and Asia BE performed if necessary Other forms: creams, sprays Developed and manufactured in EU based CMOs Supported by clinical study if necessary
SELECTION PRODUCT Opportunity driven Focus on niche products (turnover < EUR 20 million or available only in limited number of countries). 25 projects completed or in final development stages Approx. 60 other projects in pipeline Several products already launched
WIN Business Model License and long term supply agreement Dossier fee Supply price model adapted to product and territory Registration support Supply chain management Ex-works
COMPANY FIGURES Team of circa 30 people located in Belgium, Denmark, France, Hungary, Ireland, Netherlands 2012 turnover EUR 14 mio. 5 products launched in 30 countries License and Supply deals signed for ANZAC, Canada, China, Europe, LATAM, MENA, RSA, Russia/CIS, SAE, US > 120 License and Supply deals signed > 70 clients Distribution deals done in non-regluated markets
OUR STRENGTHS Multicultural team, allowing local focus with global perspective Strong expertise in: product selection dossier development licensing-out supply of product to the pharma industry Dynamic, fast and pragmatic decision process
Advantages of partnering with Us Full Regulatory Support: before, during and after granting MA Supply Chain Management Continuos Competitive Sourcing: API + Manufacturer Sourcing Strategy: 2 APIs sources + 2 Manufacturers (Asia, EU) Flexibility and speed Outsourcing advantages Fast moving, dynamic company with global experience
CONTACT Tristram Lake Head of Licensing NEOGEN N.V. Square Marie Curie 50 – 1070 Anderlecht – Belgium tristram.lake@neogen.be - licensing@neogen.be