Innovation in spray and aerosol drug delivery technologies

Transcription

1 Innovation in spray and aerosol drug delivery technologies MedTech & Pharma Innovation at the interface Pierre Carlotti - October 30, 2014

2 What makes Aptar Pharma successful? Size matters: part of Aptargroup (12,400 staff) APTAR PHARMA 2013 KEY FIGURES 2 Global leader and preferred pharma partner Track record Specialized in proprietary, innovative and patient-focused drug delivery solutions (sprays, aerosols and recently injectables ) Strongly focused on Innovation Global manufacturing footprint Worldwide leader in Nasal drug delivery devices Worldwide leader in pmdis (inhalers) Global player in Injectables Net sales: 709 M$ # Employees: 3,050 Our products are regulated as Constituents of Combination Products

3 MedTech vs Pharma: some market data (1) 3 MedTech is a diversified market in terms of applications MedTech is a concentrated market: top 15 players ~ 83% ww sales (> Pharma)

4 MedTech vs Pharma: some market data (2) 4 Few common players with Pharma

5 MedTech vs Pharma: some market data (3) 5 MedTech market is about half the size of Pharma Rx with comparable % growth

6 (Portable) Spray and Aerosol drug delivery technologies Technical devices (# parts, # materials ) achieving multiple key functions e.g. contain, protect, meter a dose of drug formulation, deliver it, at target site, in the form of a well-defined spray / aerosol Mainly Constituents of Combination Products Associated with a variety of drug formulation formats (solutions, suspensions, dry powders, pressurized gaz, preservative-free ) Majority of mechanical devices (no electronics) Intuitive and simple User-device interface (selfadministration) 6

7 (Portable) Spray and Aerosol drug delivery technologies Local and Systemic drug delivery pathways Variety of diseases/therapies (Rx): Allergies, Asthma, COPD, Hormones, Pain, Migraine, Diabetes Highly regulated in EU and USA ; emerging markets are increasing regulations rapidly as well Generic entries are more recent vs other drug dosage forms 7 Large device manufacturing volume market (> 1B devices p.a.)

8 Listen to and leverage voice of Key Stakeholders Clients Users / Patients (mainly self-administration) Regulators Partners Suppliers Payers 8

9 What does Innovation means? 9 The only visible innovation is the interface with the drug product (+ service activities) What is «inside» the device (active ingredient(s), formulation, device mechanism ) is often not visible to users and HC professionals Innovative drug delivery devices become enabling technologies if they contribute (at a high degree) to: Superior performance (mechanical / functional) Safe(r) drug delivery enhanced adherence Easy (-ier) patient experience enhanced adherence Fast track market approval (for the drug product) Cost-effective while being robust enhanced adherence

10 Is there a way to measure Innovation in Pharma (Rx)? 10 Clinical superiority? Price premium (drug / treatment)? Cost-benefit ratio (drug / treatment)? Patient and HCP preference? # patents (APIs, formulations, devices, process )? # scientific publications? R&D Pipeline? # NMEs? # collaborative programs with academia and start-ups? Acquisitions of start-ups by PharmaCos? # novel drug products on the market? % revenues corresponding to novel drug products? # of key players on a given market segment? Size / $$$ of drug product portfolio per therapy? Image and Reputation? Drug product The Drug Delivery Device can be a strong contributor / differentiator! Business Unit / Company

11 Listen to and leverage voice of Clients (Rx) Innovators (PharmaCos, Biotechs, Academia ) Generic Makers Specialty PharmaCos / 505B2 CMOs Global vs Regional 11

12 Listen to and leverage voice of Clients Innovators Performance (in vitro) & Quality Improved clinical performance (eg deposition pattern in the airways) Safety of supply (PharmaCos) Reputation (track record) Reactivity (Biotechs) Main drivers for Innovation: - High performance devices (dose, spray ) - Optimized User Interface - IP protection - Product Differentiation 12

13 Listen to and leverage voice of Clients Generic Makers BioEquivalence Fast-track data packages (CMC) Experience & Regulatory support Reducing Total Cost of Ownership Main drivers for Innovation: - Analytical testing capabilities - Manufacturing Excellence - Reactive supply chain - Service activities - Lower CoGs 13

14 Listen to and leverage voice of Clients Specialty PharmaCos / 505B2 Improved clinical performance: PK vs existing delivery route(s), side effects One stop shop Regulatory support Main drivers for Innovation: - Human Factor Engineering - R&D capabilities User-Device interface optimized to patient profile and clinical outcome - IP portfolio / exclusivities 14

15 Listen to and leverage voice of Clients CMOs Safety of supply Cost-Effective Main drivers for Innovation: - Service - Reactive supply chain - Partnership 15

16 Listen to and leverage voice of Clients Regional vs Global Global Organization, Quality System Market trends (Local vs Global) Local teams & support Support in relation to local regulatory environment Solutions adapted to local markets/needs Local marketing, R&D, manufacturing, sourcing capabilities (suppliers) 16

17 Listen to and leverage voice of Users Patients (self-administration) Healthy people (preventive nasal spray vaccination) Care givers HealthCare Practitioners Relatives, Third Parties (paediatric, elderly, emergency ) Intuitive and simple User-Device interface studies, trainings Pharmacists 17 Other point of sales

18 Listen to and leverage voice of Regulators Ensuring Safety and Efficacy Highly regulated countries Less regulated regions Therapy patient profile delivery route Patient adherence features Medical Devices (510K, CE) Constituent of combination products Guidances 18

19 Listen to and leverage voice of Partners and Suppliers Drug formulations Primary drug containers Inert and compliant (pack) materials Add-ons eg edose Counters Filling processes Validation processes Metrology QC instruments and methodologies 19

20 Listen to and leverage voice of Payers Cost/Benefit ratio Reimbursement schemes Drug formularies (US) Hospital supplies (China) Point of (drug product) sales Switches Rx OTC (patient becomes a consumer) Compliance monitoring? 20