1 Polymeric nanoparticles in drug delivery: overcoming barriers to reach the market VIII Jornadas de Aplicaciones Industriales de la Nanotecnología

2 A drug delivery company VIII Jornadas de Aplicaciones Industriales de la Nanotecnología

3 Polymeric nanoparticles VIII Jornadas de Aplicaciones Industriales de la Nanotecnología

4 Business model Basic Nanoscience Research Application Development Preclinical Studies Clinical StudiesCommercial Product Nanomedicine application in development Nanomedicine Clinical Investigations Commercial Nanomedicine Products LABORATORYMARKET VIII Jornadas de Aplicaciones Industriales de la Nanotecnología

5 Key points to overcome the barrier EFFICACY AND SAFETY COMPETITIVE ADVANTAGE INTELLECTUAL PROPERTY REGULATORY ISSUES SCALE-UP AND PRICE VIII Jornadas de Aplicaciones Industriales de la Nanotecnología

6 Polymeric nanotechnology for drug delivery Superior product benefit Increased bioavailability Controlled release Enhanced solubility Robust stability profile VIII Jornadas de Aplicaciones Industriales de la Nanotecnología

7 Favorable conditions for collaboration Intellectual property rights until 2032 PCT/EP2012/ Nanoparticles comprising esters of poly (methyl vinyl ether-co-maleic anhydride) and uses thereof PCT/EP2013/ Nanoparticles comprising a vegetable hydrophobic protein and a water miscible non-volatile organic solvent and uses thereof VIII Jornadas de Aplicaciones Industriales de la Nanotecnología

8 Smooth regulatory pathway All excipients are GRAS listed Very well known excipients: water, ethanol, propylene glycol... Widely used in a diverse range of pharmaceutical formulations GRAS: Generally Recognized as Safe VIII Jornadas de Aplicaciones Industriales de la Nanotecnología

9 Easy and cost-effective production No volatile organic solvents Avoids the use of special equipment and techniques Production using standard processes of solution preparation Low cost of goods ensures excellent profit margin VIII Jornadas de Aplicaciones Industriales de la Nanotecnología

10 Successful case 1: minoxidil Minoxidil Hair Loss Treatment Irritant excipient Patent protected Easy development Low price VIII Jornadas de Aplicaciones Industriales de la Nanotecnología

11 Successful case 1: minoxidil VIII Jornadas de Aplicaciones Industriales de la Nanotecnología

12 Successful case 2: mucosal vaccination Nano- vaccine for aquiculture No marketed product Vaccination by immersion bath Suitable for food use Patent protected Low price VIII Jornadas de Aplicaciones Industriales de la Nanotecnología

13 Successful case 2: mucosal vaccination VIII Jornadas de Aplicaciones Industriales de la Nanotecnología Mucosal immunization with antigens- loaded nanoparticles induces long lasting immunity

14 To take home VIII Jornadas de Aplicaciones Industriales de la Nanotecnología

15 Contact details Controlled releasing of molecules Enhancing of residence time Drug targeting Drug isolation from incompatible excipients Increasing bioavailability of hydrophobic or hydrophilic molecules Improving stability Increasing drug solubility PK modification LET US HELP YOU IN… Ricardo Palacios, PhD, MBA Business Development Director Ricardo Palacios, PhD, MBA Business Development Director Plaza Ceín, 5 Nave 14B | Polígono industrial Mocholí Noaín – Navarra | SPAIN VIII Jornadas de Aplicaciones Industriales de la Nanotecnología