Teva Pharmaceutical Industries Limited · TASE:TEVA
Teva Pharmaceutical Industries — Technical Presentation (October 2013)
72 slides from Teva Pharmaceutical Industries's technical presentation, Oct 9, 2013
Slide 1: Teva R&D in Focus - Respiratory Webinar for the investment community
Teva R&D in Focus - Respiratory Webinar for the investment communityOctober 8th, 2013
Slide 2: Teva's Safe Harbor Statement
Teva's Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act of 1995 This document contains forward-looking statements, which express the current beliefs and expectations of management. Such statements are based on management’s current beliefs and expectations and involve a
Slide 3: Teva R&D in Focus webinar series
Teva R&D in Focus webinar series
Slide 4: Teva R&D in Focus: schedule
Teva R&D in Focus : schedule Other Placeholder: 4 High-value Gx NTEs CNS (MS) Respiratory October 8, 2013 December 5, 2013 Early 2014 Early 2014
Slide 5: Teva R&D Strategy
Teva R&D Strategy Establish leadership in High-value Gx Build a unique platform for NTEs Sustain and leverage strengths in CNS Achieve leading presence in Respiratory
Slide 6: Teva R&D in Focus - Respiratory: speakers
Teva R&D in Focus - Respiratory: speakers Tushar Shah, M.D.Senior Vice President, Head of Global Respiratory R&D20 years in respiratory R&D roles6 years at Teva, 5 in Altana, 9 at GSK Numerous INDs, 8 NDA submissions (incl. Advair) Hans LuijendijkVice President, Head of Global Respiratory Commercial
Slide 7: Agenda
Agenda Teva Respiratory today our strategy ICS/LABA class Teva's role R&D approach capabilities pipeline Teva-MicroDose Platform RSV program Commercial implications
Slide 8: Teva Respiratory today – the topline
Teva Respiratory today – the topline A broad-based R&D Strategy: 10 clinical stage programs Targeting all major drug classesProprietary devices addressing unmet needsAB-rated strategy in US13 submissions in next 5 yearsTargeting classes with aggregate value of $20BStrong growth expected: From a $1B
Slide 9: Agenda
Agenda Teva Respiratory today our strategy ICS/LABA class Teva's role R&D approach capabilities pipeline Teva-MicroDose Platform RSV program Commercial implications
Slide 10: Teva Respiratory today: a ~$1B business (excl. generics)
Teva Respiratory today: a ~$1B business (excl. generics) ~$1B 2013E 2012 * Qnasl® in US, local brands in EU $856M Qvar® ProAir® Other* Other* Qvar® ProAir®
Slide 11: Teva: A significant player in respiratory today
(Gp:) #4 Teva: A significant player in respiratory today WW Sales ($) #5 Source: IMS MIDAS Q2’13 Asthma and COPD ‘R3’, Teva sales excluding generics US Sales ($) #4
Slide 12: Strong track record in US market
Strong track record in US market Strong brand performance: ProAir® (with dose counter): #1 in albuterol category (52% share*)Qvar®: #2 in inhaled corticosteroid(ICS) category (28% share*)Qnasl®: non-aqueous nasal spray for allergic rhinitis (recently launched) An integrated approach: Product differe
Slide 13: Agenda
Agenda Teva Respiratory today our strategy ICS/LABA class Teva's role R&D approach capabilities pipeline Teva-MicroDose Platform RSV program Commercial implications
Slide 14: Our Strategy in Respiratory
Our Strategy in Respiratory Enhance value of existing brands (Qvar® and ProAir®): Introduce next-generation based on novel inhalersEnter new high-value drug classes in Asthma/COPD: Launch differentiated products based on novel inhalersExpand geographically: All EU countries, significant ROW marketsE
Slide 15: We are developing products in all major drug classes
We are developing products in all major drug classes ICS/LABA Antichol/ ß-agonist SABA: Short Acting ß2-AgonistLABA : Long Acting ß2-AgonistICS: Inhaled Corticosteroids LAMA : Long-Acting Muscarinic Antagonists WW market: $32B (12 months ending in Q2/2013) Source : IMS MIDAS Q2 2013 Reslizumab ProAi
Slide 16: Multiple approaches to address unmet needs
Multiple approaches to address unmet needs Differentiated products based on innovative devices Novel molecules AB-rated Teva-MicroDose Spiromax®
Slide 17: Current inhaled therapy: significant limitations
Current inhaled therapy: significant limitations Inappropriate inhaler use(device errors / coordination) Inadequate adherence (% of prescribed doses taken) Reduced effectiveness Patients under-utilize inhaled medicines with negative health outcomes
Slide 18: Inappropriate inhaler use: prevalent and associated with poor clinical outcomes
Inappropriate inhaler use: prevalent and associated with poor clinical outcomes Giraud et al. Eur Respir J 2002; 19: 246–251 Asthma Instability Score* % of the population n=3709p <0.0001 * Asthma Instability Score is a composite index of: Symptom frequency / Rescue medication / Nocturnal awaking/ Ex
Slide 19: Improving inhaled therapy
Improving inhaled therapy - Simpler intuitive inhalers- Consistency across inhalers - Reduced dosing frequency- Monitoring Inappropriate inhaler use(device errors / coordination) Inadequate adherence (% of prescribed doses taken) PROBLEMS SOLUTIONS
Slide 20: Spiromax®: designed to be simple and intuitive
Spiromax®: designed to be simple and intuitive 1 Open 2 Inhale 3 Close Intuitive Easy to use Easy to educate
Slide 21: Spiromax®: preferred by patients
Spiromax® : preferred by patients 21 No preference 65% Preference: Spiromax® vs. Diskus® N=17 71% Preference: Spiromax® vs. Turbuhaler® N=63 GFK Research, August 2013 (market study conducted in EU, sponsored by Teva) No preference
Slide 22: Device has significant influence on prescribing
Device has significant influence on prescribing 22 How would you rank the influence of delivery device over your prescribing decision?* * Pulmonologist survey, Jefferies Research, 2013 1 No impact 6.7 10 Very significant impact "An old but well-known drug in a new, more reliable inhaler is probably
Slide 23: Broad use of a single device reduces patient errors
23 Broad use of a single device reduces patient errors 23 Body: Most patients on maintenance therapy also use albuterol (rescue) Using different devices significantly increases errors* We will offer maintenance and rescue medication in similar devices To From FS Spiromax ® ProAir® Spiromax® Maintena
Slide 24: Agenda
Agenda Teva Respiratory today Our Strategy ICS/LABA class: Teva's role R&D approach: Capabilities, pipeline Teva-MicroDose: Platform, RSV program Commercial implications
Slide 25: ICS/LABA is the largest respiratory drug class
ICS/LABA is the largest respiratory drug class 25 SABA: Short Acting ß2-Agonist LABA : Long Acting ß2-Agonist ICS: Inhaled Corticosteroids LAMA : Long-Acting Muscarinic Antagonists Source : IMS MIDAS Q2 2013 ICS/LABA Antichol/ ß-agonist LAMA ICS SABA Anti- cytokines LABA
Slide 26: ICS / LABA class: market evolution
ICS / LABA class: market evolution 26 Differentiated ICS/LABA products will generate significant sales from 2014 No AB-rated Advair® before 2018 Other Placeholder: 26 Differentiated ICS/LABA AB-rated Advair® & Symbicort® (US) Advair® Symbicort® Foster®, Dulera® (Gp:) $14B (Gp:) 2018 (Gp:) 2013 (Gp:)
Slide 27: Differentiated ICS/LABA
27 Differentiated ICS/LABA DuoResp (EU) Same molecules as Symbicort ® FS Spiromax (US) FS Spiromax (EU) Same molecules as Advair® 2013 2015 First ICS/LABA Spiromax® submitted in EU 2 additional ICS/LABA Spiromax® submissions in 2015 (Gp:) $14B (Gp:) 2018 (Gp:) 2013 (Gp:) 2023 AB-rated Advair® & Symb
Slide 28: We are developing AB-rated Advair® and Symbicort®
28 (Gp:) 2013 (Gp:) 2023 AB-rated Advair® AB-rated Symbicort® Title: We are developing AB-rated Advair® and Symbicort®, and will submit an AB-rated Advair® in 2017 (Gp:) 2018 (Gp:) 2013 (Gp:) 2023 Advair® Symbicort® Foster®, Dulera® AB-rated Advair® & Symbicort® (US) Differentiated ICS/LABA (Breo®/R
Slide 29: Summary
29 Summary We are targeting key opportunities in ICS/LABA Unmet medical needs addressed via proprietary devices Focused AB-rated strategy in the US Similar approach in key existing and emerging classes (ICS, LAMA, LAMA/LABA, etc.) 29 T
Slide 30: Agenda
Agenda Teva Respiratiory today Our strategy ICS/:ABA market: Teva's role R&D approach: Capabilities, pipeline MicroDose: Platform, RSV program Commercial implications 30
Slide 31: R&D Approach
31 R&D Approach Other Placeholder: Capabilities, track record, pipeline Deep-dive into 3 programs: DuoResp® Spiromax® ProAir® Spiromax® FS Spiromax® Perspective on draft FDA guidelines Other Placeholder: 31
Slide 32: Capabilities
32 Capabilities Leading MDI manufacturer globally: 55 million units/yr Global respiratory R&D site network: 250 employees, $100M’s invested in infrastructure Unique skill set in CMC, Clinical, Regulatory Recent track record: QNASL® – FDA approval (one review cycle) ProAir® dose counter – FDA approva
Slide 33: Deep pipeline: clinical programs
33 Title: Deep pipeline: 10 clinical programs ; 5 in Phase II, III O ther Placeholder: 33 * BAI : breath actuated inhaler – designed as simple and intuitive device based on MDI DuoResp Spiromax Asthma, COPD ProAir Spiromax QVAR BAI Reslizumab Fluticasone Propionate Spiromax Salmeterol MDI 2:1 1:1 LA
Slide 34: R&D Approach
34 R&D Approach Other Placeholder: Capabilities, track record, pipeline Deep-dive into 3 programs: DuoResp® Spiromax® ProAir® Spiromax® FS Spiromax® Perspective on draft FDA guidelines Other Placeholder: 34
Slide 35: R&D Approach
35 Title: R&D Approach Other Placeholder: Capabilities, track record, pipeline Deep-dive into 3 programs: DuoResp® Spiromax® ProAir® Spiromax® FS Spiromax® Perspective on draft FDA guidelines 35
Slide 36: DuoResp® Spiromax®
36 DuoResp® Spiromax® Other Placeholder: ICS/LABA - maintenance therapy Same molecules as Symbicort®(Budesonide/Formoterol) Intuitive Spiromax device with dose counter Achieved bioequivalence according to EU guidelines Submitted in EU in 1/2013 (centralized procedure) Other Placeholder: 36
Slide 37: DuoResp® Spiromax®: bioequivalence to Symbicort® achieved in all parameters
37 Title: DuoResp® Spiromax®: bioequivalence to Symbicort® achieved in all parameters Other Placeholder: 37 0.80 1.25 1.06 0.96 0.80 1.25 1.12 0.98 0.80 1.25 1.05 0.98 0.80 1.25 1.16 0.98 0.80 1.251.01 0.91 0.80 1.251.08 0.96 0.80 1.25 1.02 0.94 0.80 1.25 1.04 0.95 Bioequivalence interval PK ratio a
Slide 38: Spiromax®: preferred by physicians vs. Turbuhaler®
38 Spiromax®: preferred by physicians vs. Turbuhaler® 38 76% Undecided N=181 Which is a better device? GFK Research, August 2013 (market study conducted in EU, sponsored by Teva)
Slide 39: R&D Approach
| R&D Approach Taz =" Capabilities, track record, pipeline = Deep-dive into 3 programs: = DuoResp® Spiromax® = ProAir® Spiromax® = FS Spiromax® = Perspective on draft FDA guidelines 39
Slide 40: R&D Approach
39 R&D Approach Other Placeholder: Capabilities, track record, pipeline Deep-dive into 3 programs: DuoResp® Spiromax® ProAir® Spiromax® FS Spiromax® Perspective on draft FDA guidelines 39
Slide 41: ProAir® Spiromax® - Status
41 Title: ProAir® Spiromax® - Status Other Placeholder: Successfully completed Phase I and II studies Completing Phase III (four clinical trials) and two pediatric phase 1 and 2 trials this year NDA submission under 505(b)(2): Mid-2014 41
Slide 42: R&D Approach
42 R&D Approach Other Placeholder: Capabilities, track record, pipeline Deep-dive into 3 programs: DuoResp® Spiormax® ProAir® Spiromax® FS Spiromax® Perspective on draft FDA guidelines Other Placeholder:
Slide 43: FS Spiromax®
43 FS Spiromax® Other Placeholder: ICS/LABA - maintenance therapy Same molecules as Advair® (Fluticasone/Salmeterol) Intuitive Spiromax device with dose counter Device consistency with rescue medication Improved therapeutic index demonstrated in Phase II 43
Slide 44: Salmeterol dose-ranging in FS Spiromax®: FEV1 improvement
44 300 200 100 0 Data on file, Teva Pharmaceuticals Time (hr) Baseline-adjusted FEV1 (mL) 0.5 1 2 3 4 5 6 9 12 Salmeterol 5 different salmeterol doses in FS Spiromax® (fluticasone/salmeterol) administered : Salmeterol component increasing: 0, 6.25, 12.5, 25, 50 mcg Fluticasone component was constant
Slide 45: FS Spiromax® provided similar bronchodilation with four-fold lower salmeterol dose
45 45 300 200 100 0 Data on file, Teva Pharmaceuticals Time (hr) Baseline-adjusted FEV1 (mL) 0.5 1 2 3 4 5 6 9 12 FS Spiromax® 100 mcg fluticasone /12.5 mcg salmeterol Advair® 100 mcg fluticasone /50 mcg salmeterol Title: FS Spiromax® provided similar bronchodilation with four-fold lower salmeterol
Slide 46: FS Spiromax®: same effective dose - 40% of the systemic exposure
46 FS Spiromax®: same effective dose - 40% of the systemic exposure Other Placeholder: 46 = 0.4 *systemic exposure : AUC [0-t] pg hr/mL Systemic exposure*…. FS Spiromax® 100 mcg fluticasone /12.5 mcg salmeterol Advair® 100 mcg fluticasone /50 mcg salmeterol (40%)
Slide 47: FS Spiromax®: Improves lung delivery
47 FS Spiromax®: Improves lung delivery Same clinical effect as Advair® achieved with significantly lower dose Leading to less systemic exposure Improved therapeutic index Other Placeholder: 47
Slide 48: FS Spiromax® - Status
Title: FS Spiromax® - Status Other Placeholder: Initiating Phase III early 2014 NDA submission under 505(b)(2) in 2015 Other Placeholder: 48
Slide 49: R&D Approach
Title: R&D Approach Other Placeholder: Capabilities, track record, pipeline Deep-dive into 3 programs: DuoResp® Spiromax® ProAir®Spiromax® FS Spiromax® Perspective on draft FDA guidelines Other Placeholder: 49
Slide 50: New FDA draft guideline removes a key obstacle to approval of AB-rated Advair®
Title: New FDA draft guideline removes a key obstacle to approval of AB-rated Advair® Other Placeholder: 50 Dose response pharmaco-dynamics DOABLE Single 4-week bioequivalence study HIGHLY CHALLENGING Prior requirements Draft Guideline
Slide 51: Rest of guideline remain the same
Title: Rest of guideline remain the same Other Placeholder: 51
Slide 52: Developing AB-rated products will still be difficult
Title: Developing AB-rated products will still be difficult Other Placeholder: 52 Body: CMC challenges: Developing a new dry powder device that matches Diskus® Demonstration of robust stability Need to achieve this at commercial scale PK and PD bioequivalence challenges In EU, slightly simpler guide
Slide 53: We are aggressively developing an AB-rated Advair®
We are aggressively developing an AB-rated Advair® Other Placeholder: 53 Based on internally developed blister-based device Expected to meet FDA guidelines for comparability to Advair Diskus® Leverage our considerable expertise and knowledge Working with fluticasone, salmeterol, and lactose Developi
Slide 54: Teva is perfectly situated to succeed in AB-rated respiratory products
Teva is perfectly situated to succeed in AB-rated respiratory products Multiple programs underway: AB-rated Advair® AB-rated Symbicort® Others
Slide 55: Agenda
Teva Respiratory today Our strategy ICS/LABA market: Teva's role R&D approach: Capabilities, pipeline Teva-MicroDose: Platform, RSV program Commercial implications
Slide 56: Nebulizers: used to treat the young and the elderly
Nebulizers: used to treat the young and the elderly Other Placeholder: 56 Inhalers (Gp:) Nebulizers Young children & the elderly More able patients
Slide 57: Current nebulizers have significant limitations
Current nebulizers have significant limitations Other Placeholder: Considerable effort to prepare dose Long dosing time (5-20 minutes) No feedback Inefficient and inexact dosing Large and bulky Most use mains electricity Cleaning is cumbersome Other Placeholder: 57
Slide 58: Teva-MicroDose is designed to be a unique type of nebulizer
Teva-MicroDose is designed to be a unique type of nebulizer Other Placeholder: 58 Other Placeholder: Dose preparation not needed Fast dosing: 30 seconds Feedback (LED) Exact and efficient dose Battery operated Small and portable Remote monitoring Easy to clean
Slide 59: Teva-MicroDose: preferred delivery modality for young children and the elderly
Teva-MicroDose : preferred delivery modality for young children and the elderly Other Placeholder: 59 Inhalers Young children & the elderly More able patients Teva-MicroDose Physicians surveyed* would switch to a Teva-MicroDose device: 77% of their poorly-controlled patients currently on nebulizer 4
Slide 60: Teva-MicroDose: potential to be a preferred device for some patients currently treated with inhalers
Inhalers Young children & the elderly More able patients Title: Teva-MicroDose: potential to be a preferred device for some patients currently treated with inhalers Teva-MicroDose * National Analysts Worldwide, Global survey, Fall 2012, 81 MDs Physicians surveyed* would switch to a Teva-MicroDose de
Slide 61: Pipeline based on Teva-MicroDose device
Pipeline based on Teva-MicroDose device Other Placeholder: MDT637 (RSV) - enters phase II Multiple pre-clinical programs 61
Slide 62: Respiratory Syncytial Virus (RSV): a large unmet need
Respiratory Syncytial Virus (RSV): a large unmet need Other Placeholder: A major disease in young children Most frequent cause of hospitalization of infants and young children in industrialized countries 85 000 to 144 000 RSV-associated hospitalizations of infants in US each year A major problem in
Slide 63: MDT637
MDT637 Small molecule targeting the RSV fusion protein Delivered to lungs in Teva-Microdose device Developed for treatment of RSV infection in infants Potential additional indications to study: Prophylaxis in infants Elderly (primarily COPD patients) 63
Slide 64: Antiviral activity demonstrated in a highly predictive preclinical model
Antiviral activity demonstrated in a highly predictive preclinical model Cotton rats inoculated on Day 0 ; viral titers assessed on Day 4 MDT637 reduced viral load by 2.3 log1 In comparison, ribavirin reduced viral load by 1.25-1.35 log in same model2 64 1. Antiviral Res. 2005; 68: 18-26. Data for R
Slide 65: Phase I program successfully concluded
Phase 1 program successfully concluded Low systemic exposure No pulmonary adverse events No clinically significant changes in pulmonary function, ECG, laboratory values, vitals or physical exam 65 Single Ascending Dose (Healthy) Multiple Ascending Dose (Healthy) Single Ascending Dose (Asthmatics) No
Slide 66: MDT-637: next steps
MDT-637 : next steps Phase 2a studies to begin in 4Q3013 NDA submission 2017 66
Slide 67: Summary
Summary Strong capabilities and infrastructure Deep pipeline: 10 clinical stage programs Spiromax® : significant clinical data, platform validated Teva-MicroDose: game changing platformfor children & elderly AB-rated Advair®: submission in 2017 67
Slide 68: Agenda
Teva Respiratory today Our strategy ICS/LABA market: Teva's role R&D approach: Capabilities, pipeline Teva-MicroDose: Platform, RSV program Commercial implications
Slide 69: Expected submissions 2013-2017
5 years ; 13 submissions 69 2013 2014 2015 2016 2017 DuoResp Spiromax (EU) Advair AB-rated (US) FS MDI (EU) FS Spiromax (EU) FS Spiromax (US) ICS / LABA ProAir Spiromax (US) SABA Fluticasone Spiromax (US) Qvar BAI (US) ICS LAMA BAI (US) LAMA BAI (EU) LAMA Microdose RSV Reslizumab IV Reslizumab SC Ne
Slide 70: Expected total respiratory revenue
Expected total respiratory revenue 70 $1B $2B $4B Today (2013) In 5 years (2018) In 10 years (2023) $1B $2B $4B Currently marketed brands + pipeline
Slide 71: R&D in Focus: Respiratory – the bottom line
R&D in Focus: Respiratory – the bottom line A broad-based R&D Strategy: 10 clinical stage programs Targeting all major drug classes Proprietary devices addressing unmet needs AB-rated strategy in US 13 submissions in next 5 years Targeting classes with aggregate value of $20B Strong growth expected:
Slide 72: Thank you
Thank you
Teva Pharmaceutical Industries — Technical Presentation (October 2013) on 6ix