Drug Delivery Evolution. Akan Oton Director of Business Development Board Member, Applied Drug Delivery Institute

Transcription

1 Drug Delivery Evolution Akan Oton Director of Business Development Board Member, Applied Drug Delivery Institute

2 The Global Leader in Development Solutions & Advanced Delivery Technologies Our Clients Drug, Biologic, OTC & VMS Companies 83 top 100 pharma 41 top 50 biotech Where We Work Discovery & Design Clinical Testing Product Supply 450+ in pipeline 7000 on market What We Provide Development Solutions (25%) Advanced Delivery Technologies (75%) 50% of NMEs 1 80% Top 200 drugs 1 1 Catalent has touched 50% of new innovator drugs approved by the US FDA since 2004, and in 2012 touched 80% of the top 200-selling drug compounds 1

3 Our Global Capabilities OSDrC is a registered trademark of Sanwa Kagaku Kenkyusho Co. 2

4 Starting Thoughts Products are the currency of the pharmaceutical business Product value is determined by who pays OTC -> The Consumer Rx -> Insurance company & Medicare Products under development have changed over the years because of Consumer Preference (OTC) & Managed Care Pressures (Rx) Cost and difficulty of developing drugs has changed how companies develop drugs and have forced specialization The Role of Drug Delivery, Collaborators and Technology Licensing has evolved as well 3

5 Top Changes Impacting the Industry Fixed R&D Budgets Greater emphasis on improved patient health outcomes Increased regulatory scrutiny Longer development times and shorter exclusivity The dawn of personalized medicine Patients becoming empowered payers 7 out of every 10 prescriptions filled in the U.S. are for generics Lack of formulary reimbursement for non-payer friendly drugs Growing technological complexity needs increased expertise Driving Pharma to consider new ways of doing business 4

6 New Product Dynamics Branded Drugs experience competition from Generics faster than ever before Longer development times Less patent life Average Years Post-Launch Exclusivity Period before generics (source: Business Insights) Replacing lost revenue requires continual investment & more efficient use of R&D Dollars FDA Approvals of New Drugs vs. R&D Spend (source: FDA, Phrma) Beginning in 2010 however, more drugs began to be approved after years of stagnation R&D Spend (Billions) - PhrmA members FDA Drug Approvals (NME) Pharma Companies are gaining more approvals at the same overall R&D costs! 5

7 More Drugs are a result of Pharma s focus on Specialty Areas, Better Products & Smarter Investments Pharma has begun to focus on Specialty therapeutic areas such as Oncology & Orphan Drugs KEY FAQS Number of Projects with Orphan Drug Designations (source: Phrma) Large Molecules, Biologics and Drug Delivery enabled products Four Reasons: 1. Economics - Managed Care willing to pay premium in specialty areas 2. Time to market Orphan and Oncology Products often fast tracked 3. Longer Exclusivity - Difficult to Genericize Biologics or complex dosage forms Clinical Probability of Success By Phase Source: 2012 Thomas Reuters CMR Guide Ph 1 to Phase 2 Ph 2 to Phase 3 Phase 3 to Submission New Biologic Entity 69% 32% 82% New Chemical Entity 44% 14% 74% 4. Probability of Approval Higher Approval Rates for Biologics Continued Specialization and Focus on Niche Therapeutics going forward 6

8 Industry History - Late 80s & 90s: The Blockbuster & the Me Too s Pain Celebrex GI - Prilosec, Aciphex Statins - Lipitor, Zocor Blood Thinners - Plavix Antipsychotics - Seroquel Pharma Companies Raced to Develop Similar Molecules In large patient populations 7

9 Industry History 1990 s & 2000 s Emergence of Drug Delivery for Life Cycle Management STRATEGIES TECHNOLOGIES EXAMPLES Add ER Technology to reduce Dose Extended Release Formulations Oral Controlled Release Microspheres & depot formulations Change Form for Patient Convenience Fast Dissolve Technologies Oral Dispersing tablets Identify New Chemical Substance New Salts & Forms of Molecules Co-Crystals technologies Salt Screening Add Novel Delivery Technology Solubilization Technologies NanoCrytals Change Device Devices Dry Powder Inhalers 8

10 Industry History 1990 s & 2000 s Key Companies Provided Specialized Solutions COMPANY TECHNOLOGIES Alza Acquired by J&J Extended Release OROS Technology Alkermes Long acting Injections Microspheres & depot formulations Elan Acquired by Alkermes Extended Release & Nanotechnology SODAS technology NanoCrystals technology RP Scherer Now Catalent Pharma Solutions Solubilization Technologies Fast Dissolve Technologies Softgels ZYDIS technology 9

11 Industry Today - Healthcare trends drive innovation Megatrend Economic Impact Drug Delivery partner Global Demand Global market growing to $975 BB by %+ growth in emerging markets and biologics There is opportunity to grow with this market Healthcare Costs Economic Growth Healthcare budgets are stretched putting pressure on market pricing for pharmaceutical products and driving use of low cost generics, store brands and complementary medicine There is a need to provide value to all stakeholders in the value chain Focus on Better Outcomes Evidence Based Medicine Premium pricing for products that improve Standard of Care. Consumers will pay for convenience. Innovation drives payors, consumers, patients, physicians to pay for Better Treatments. Better treatments are needed to gain market share and improve patient outcomes Drug Delivery must deliver value and improved outcomes 10

12 Past 24 months in Pharma. an exciting time for innovative new drugs Cystic Fibrosis treatment KALYDECO is the first and only FDAapproved CFTR potentiator Novel Prostate Cancer therapy for resistant patients previously on Docetaxil Targeted Breast Cancer Therapy with significant improvement in Progression Free Survival Novel Once Daily COPD treatment Next ADVAIR January 2012 August 2012 Feb 2013 May 2013 Each Product represents a significant Improvement in Clinical Outcomes or patient adherence 11

13 Drug Delivery Evolution HISTORICAL Few NCE s employing Drug Delivery technology at launch Drug Delivery used primarily in me-too products for LCM Primarily Self Developed by Pharma and manufactured by Pharma TODAY NCE s employing Drug Delivery to achieve better outcomes Lifecycle products not favored by Managed Care More Collaborations, Partnerships and Outsourcing Need for Robust Solutions at the right price This shift has required collaboration earlier in the development process 12

14 Collaborations all across the Development cycle between Pharma, Solutions Providers, Universities, etc. Preformulation First-in-man clinical supplies Clinical trial materials Commercial Supply: Oral, Parenteral, Inhaled Preclinical Phase I Phase II Phase III Commercial Salt/crystal screening, formulation and tox vehicle screening Dose Form & Delivery Technology Selection Bioavailability Solutions, Therapeutic Profile and Patient Adherence Improvements Product optimization, scale up, validation Line Extensions Dose Improvements Global Launch Supply Back-Up Supply Comprehensive Expert Analytical and Lab Services + Regulatory support 13

15 Looking Forward - Additional Areas for Drug Delivery & Drug Optimization Drug optimization to address major unmet needs Shifting from professionally administered drugs to self-administered Developing a vaccine so that it can be administered orally Non-Invasive Approaches to large molecule delivery Patient compliance challenges in pediatrics, geriatrics & mental health Further formulation improvement of Oral Drugs Increases patient adherence (e.g. QID to BID) Better solubility, permeation, and absorption of drugs Designing payer-friendly drugs Patient adherence will continue to increase in importance Improve therapeutic efficacy / reduce adverse side effects 14

16 Characteristics of Successful Drug Delivery Innovation Typically Enabled by collaborations to reach market. from university to technology developers to early stage companies to large pharma Uniquely enable improved clinical outcomes let us achieve what we couldn t do before, not just another tool They are cost effective for global markets. Allow pharma to market products globally 15

17 Final Thoughts The 5 Key Messages Products are the currency of the pharmaceutical business Product Value is determined by who pays OTC -> The Consumer Rx -> Insurance company & Medicare Products must Improve Patient Outcomes Cost and difficulty of developing drugs has forced Specialization The Role of Drug Delivery is to Enable Better Treatments 16

18 Questions? 17

19 Resources for Students & Young Professionals in Life Sciences

20 The Catalent Institute: Improving Treatments for Patients Connecting Collaborating Creating Advocating Industry & Academia Organizations, Industry, Academia Drug Delivery Resources & Research For Patients, Providers & Innovators 19

21 3 rd Annual Global Academic Competition Underway.Enter to Win $2000 (5 winners) Supporting Life Science leaders of tomorrow Competition jointly sponsored by AAPS Global reach to 91 AAPS student chapters, 2500 students, 35 countries Write a review articles on 1 of 8 topics posing good questions for future research Entries due 3/28/14, 5 winners will be selected by May 2014 For more information visit: 20

22 Upcoming Educational Symposia When: March 27, 2014 Where: Basel, Switzerland, Novartis Campus, 125 participants What: Overcoming Bioavailability Challenges Who: 4 co-sponsors: 3M, BASF, NOVARTIS & HOVIONE; Also Presenting: Agere, U of Saarland, & Formac also presenting When: June 12, 2014 Where: St. Paul, Minnesota, 3M Innovation Center, 100 participants What: Innovation Showcase - Advanced Drug Delivery Approaches for Small and Large Molecules Who: Drug delivery experts from Catalent, Xhale, Hovione, 3M, & Lipp Life Sciences, LLC REGISTER TO 21

23 Download the Catalent Institute Oral Drug Delivery Guide Creating educational resources on drug delivery To obtain a copy of the Oral Drug Delivery Reference Guide, please visit the Catalent Institute website: 22

24 Join Our Community! We Know Drug Delivery & Welcome Your Involvement We offer. Educational events visit our website for locations & dates at: Annual academic competition cosponsored with AAPS for additional details visit our website Annual landscape survey on drug delivery launches Q1 Educational resources: Oral Drug Delivery Reference Guide available for free download on our website 2013, Catalent Applied Drug Delivery Institute, All Rights Reserved