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Dymista ® in 90 minutes *Carr et al. A novel intranasal therapy of azelastine with fluticasone for the treatment of allergic rhinitis. J Allergy Clin Immunol.

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Presentation on theme: "Dymista ® in 90 minutes *Carr et al. A novel intranasal therapy of azelastine with fluticasone for the treatment of allergic rhinitis. J Allergy Clin Immunol."— Presentation transcript:

1 Dymista ® in 90 minutes *Carr et al. A novel intranasal therapy of azelastine with fluticasone for the treatment of allergic rhinitis. J Allergy Clin Immunol. 2012; 129(5): 1282-1289. Leung et al. MP29-02: A major advancement in the treatment of allergic rhinitis. J Allergy Clin Immunol. 2012; 129(5): 1216.

2 Agenda Introduction Unmet medical need in Allergic Rhinitis and the patient perspective Dymista ® : the drug of choice for the treatment of Allergic Rhinitis Dymista ® versus commercially available first line therapy Wrap-up and discussion

3 Unmet medical need with current Allergic Rhinitis therapy: SCUAD Up to 20% of Allergic Rhinitis patients receiving an optimal pharmacologic treatment (according to guidelines) still present with severe symptoms These patients are ascribed to Severe Chronic Upper Airway Disease (SCUAD) Bousquet et al, 2009 & 2010 Before Controlled SCUAD n=586 Median score GlobalSleepPracticalEyeEmotions

4 Unmet medical need with current allergic rhinitis (AR) therapy Patients use multiple therapies to achieve AR symptom control −As many as 90% of patients in a recent survey - despite the fact that there is limited evidence to support this practice −60% of all AR patients are “very interested” in finding a new medication and 25% are “constantly” trying different medications to find one that “works” There is a clear need for a new and more effective therapy Canonica et al, 2007; Schatz, 2007; Mullol et al, 2009; Demoly et al, 2002; Bousquet et al, 2012; Bousquet et al, 2008; Marple et al, 2007 Up to 90% of patients already take 2 or more rhinitis medications CanonicaSchatzBousquetDemolyMullol % of Patients

5 Can Dymista ® change the landscape of AR management? Fast relief: SABA Sustained relief : LABA Preventer: ICS Unmet medical need −Most patients were taking SABA, LABA and ICS −Convenient treatment needed to simplify asthma management as per recommendations Fast relief: SABA Sustained relief : LABA Preventer: ICS Unmet medical need −Most patients were taking SABA, LABA and ICS −Convenient treatment needed to simplify asthma management as per recommendations Fast relief: anti-histamines Sustained & most effective relief: intranasal corticosteroids Unmet medical need −Changing face of the disease −20% SCUAD −75% of patients on unproven combination therapy −More effective therapies urgently needed Fast relief: anti-histamines Sustained & most effective relief: intranasal corticosteroids Unmet medical need −Changing face of the disease −20% SCUAD −75% of patients on unproven combination therapy −More effective therapies urgently needed ….to the same extent as that seen in asthma management Asthma Landscape Many asthmatics now on LABA/ICS formulations Dymista ® a new paradigm for Allergic Rhinitis management Rhinitis Landscape SABA: short-acting beta-agonist; LABA: long-acting beta-agonist; SCUAD: severe chronic upper airway disease

6 Unmet medical need in Allergic Rhinitis and the patient perspective

7 The Allergy Epidemic The financial cost of allergy in Europe alone has been estimated at 100 billion euro/year EU Summit Report, 2008 Allergies becoming more severe Anaphylaxis increased 7 fold Allergies are continuously rising, affecting 50% of all Europeans by 2015

8 The clinical picture of allergic rhinitis is changing European Survey –67.2% = moderate or severe –42.5% = persistent disease SCUAD - approx. 30% of AR patients Shift from ‘mild’ to ‘moderate/severe’ Allergic Rhinitis Shift to mixed forms of Allergic Rhinitis More patients are becoming poly- sensitized Evolution of treatment-resistant phenotypes Severe Chronic Upper Airway Disease (SCUAD) Evolution of treatment-resistant phenotypes Severe Chronic Upper Airway Disease (SCUAD) Canonica et al, 2007; Settipane, 2001; Mosges & Klimek, 2007; Bousquet et al, 2009 Pie chart: data refers to non-infectious rhinitis; AR: Allergic Rhinitis Allergic Non-allergic Mixed

9 In Sweden, the cost of rhinitis is €2.7 billion/yr in terms of lost productivity Valovirta et al, 2008, Hellgren et al, 2010 The patient voice allergy survey Allergic Rhinitis impacts negatively patients’ activities High socioeconomic costs Intermittent (n=1257) Patients with moderate to severe impact (%) Sport/ exercise Visiting friends HolidayIndoor activities Public transport WorkSleepGoing out Outdoor activities Persistent (n=2305)

10 Allergic Rhinitis impacts patients’ sleep & emotional well-being Up to 52% of AR patients do not feel rested after sleep Up to 49% wake up during the night Up to 32% have difficulty getting to sleep AR has a significant emotional impact in 77% of persistent AR and 66% of intermittent AR patients Valovirta et al, 2008 AR: Allergic Rhinitis The patient voice allergy survey Persistent (n=2305) Intermittent (n=1257) Patients with moderate to severe impact (%) % of Patients Severe Moderate Mild Absent Not feeling rested on waking Disturbed sleep Difficulty going to sleep TiredIrritablePoor Conc. Self Conscious

11 Allergic Rhinitis impacts school performance Comparing adolescents’ exam performance during ‘mock’ examinations (conducted in winter) with formal exam in summer − Current symptomatic hay fever associated with 50% increase in risk of dropping exam grade between winter and summer − For those taking hay fever medications risk increased by 40% − And those taking sedating medications risk increased by 70% Walker et al, 2007 What is actually achieved?

12 Allergic rhinitis is commonly associated with co-morbidities Individuals with active rhinitis symptoms are 1.5-4.5 times more likely to suffer from co-morbid conditions including: –Asthma –Otitis media –Sinusitis –Eczema –Food and insect bite allergies –Migraine and Depression Up to three quarters of asthmatics have allergic rhinitis and these patients are more likely to have uncontrolled asthma More patients with rhinitis have uncontrolled asthma Derebery et al, 2008; Vandenplas et al, 2008 % of patients with uncontrolled asthma No rhinitis Allergic rhinitis Non-allergic rhinitis

13 Patients reporting severe rhinitis exhibit the worst asthma control – on a par with current smokers Based on a survey of 4,429 patients prescribed ICS in 83 UK general practices Multiple logistic regression: predicting poor control (ACQ score >1.25) Clatworthy J, Price D et al. Prim Care Resp J 2009 ICS: inhaled corticosteroid Rhinitis predicts poor control of asthma

14 The majority of patients with Allergic Rhinitis felt irritable, tired and miserable in 2006 as well as in 2010 AIA, Allergies in America survey; AR, Allergic Rhinitis; NASAL, Nasal Allergy Survey Assessing Limitations. Impact of current Allergic Rhinitis therapy on real life measures have not improved Respondents (%) IrritableTiredEmbarrasedMiserable NASAL 2010 (n=400) AIA 2006 (n=2500) Depressed

15 What do allergic rhinitis patients want and how do they treat their symptoms? 1,000 Allergic Rhinitis patients completed the survey −254 mild −746 moderate/severe patients (total nasal symptom score [TNSS]) ≥8/12, (incl. congestion score ≥2) −Recruited through a patient panel The survey included questions on respondents’ −Treatment −Episode duration −Impact of symptoms on productivity −Other questions Results from a new health survey including 1,000 patients Pitman et al, 2012

16 What do Allergic Rhinitis patients want? Discrete choice experiments are based on the premise that any good or service can be described by its characteristics (or attributes) Secondly, the extent to which an individual values a good or service can be described in terms of the levels of these characteristics The technique involves presenting individuals with choices of scenarios described in terms of attributes and associated levels Participants are asked to choose their preferred scenario Introduction to the world of Discrete Choice Experiments

17 What do Allergic Rhinitis patients want? Patients were presented with 7 product characteristics: 1.Maximum symptom relief (mild, moderate, complete) 2.Time to maximum relief (3, 7, 14 days) 3.Time to first dose benefit (0.5, 3, 8 hours) 4.Risk of side effects (2%, 5%, 10%) 5.Administration method (tablet, nasal spray, both) 6.Frequency of medication (once, twice, three times/day) 7.Monthly out-of-pocket cost (£15, £30, £45). Patients were asked to imagine that they paid the full cost of this prescription medication Patients were presented with 19 pairs of ‘potential Allergic Rhinitis products’ (based on the above characteristics) and asked to choose between them We asked them using a Discrete Choice Experiment (DCE)

18 An Example Choice Set Patients were presented with 19 of these and asked to pick ‘A’ or ‘B’

19 DCE Results: moderate to severe SAR patients Patients want more efficacious treatments which provide complete or substantial treatment relief Patients where willing to pay £43 to receive such a medication CI: confidence interval; WTP: willingness to pay DCE: discrete choice experiment; SAR: Seasonal Allergic Rhinitis Treatment efficacy drives patient preference for rhinitis treatment

20 DCE Results: mild SAR patients Even patients with mild AR symptoms wanted more efficacious treatments Patients where willing to pay £28 to receive such a medication Treatment efficacy drives patient preference for rhinitis treatment CI: confidence interval; WTP: willingness to pay DCE: discrete choice experiment; SAR: Seasonal Allergic Rhinitis

21 Implications of Discrete Choice Experiment Results INS: intranasal steroid; OTC: over the counter

22 New results from a health utilisation survey including 1,000 patients An average symptom SAR episode lasts 12.5 days for moderate/severe patients and 9.8 days for mild patients Patients with mild SAR have 6 episodes per year Patients with moderate/severe SAR have 8 episodes per year Work is negatively impacted by over 90% of patients AR: Allergic Rhinitis Symptom episodes are short but occur many times during the season with a negative impact Impact on work productivity % of Patients Productivity impacted 10% 20% 30% 40% 50% 60% 70% 80% 90% Unable to… No impact

23 New results from a health utilisation survey including 1,000 patients Two thirds of all patients incl. in the survey reported using ≥ 2 AR medications −70.5% of moderate to severe −56.1% of mild patients The need for faster and more effective treatment was the primary reason for co-medicating −True for both moderate/severe and mild patients Pitman et al, 2012; AR: Allergic Rhinitis Most patients use multiple therapies to control their symptoms Faster and more effective reduction of nasal and ocular symptoms are the treatment targets of drug development % moderate/severe patients on 2 ≥ AR medications TotalIncreased nasal efficacy Increased ocular efficacy Faster nasal response Faster ocular response Other % of Patients

24 Conclusions The clinical picture of Allergic Rhinitis is changing to more severe and mixed forms Allergic rhinitis has a negative impact on virtually every aspect of patients’ lives Most patients use multiple therapies in an attempt to achieve faster and better symptom control Patients with Allergic Rhinitis want more efficacious treatments which provide complete or substantial treatment relief Faster and more effective nasal and ocular symptom control are the future drug development targets

25 Dymista ® : the drug of choice for the treatment of Allergic Rhinitis

26 The ARIA guidelines Intranasal corticosteroids are considered the most effective treatment for Allergic Rhinitis There is a need for high-quality, direct head-to-head comparison studies to further substantiate current treatment recommendations (European Medicines Agency) Bousquet et al, 2008; Brozek et al, 2010; Carr et al, 2012; Hampel et al, 2010 ARIA: allergic rhinitis and its impact on asthma MEDA’s Clinical Development Programme represents to date the largest body of evidence directly comparing first-line therapies for Allergic Rhinitis

27 Dymista ® : A snapshot What is it? −Dymista ® is a novel intranasal formulation of Azelastine hydrochloride and Fluticasone propionate in one nasal spray (total daily dose: 548/200 µg) Where is it approved? −Dymista ® has been approved by the FDA in May 2012 −Dymista ® has been approved by the EU in January 2013 −Licensing authority registration conditions differ from country to country

28 Dymista ® : a novel intranasal formulation of intranasal Fluticasone propionate and Azelastine hydrochloride 4 phase III, multi-centre, randomised, double-blind, placebo-controlled, parallel group trials (SAR trials) One long-term open-label safety study (chronic rhinitis trial) In all, 4,617 patients Objectives: −To directly compare the efficacy and safety of Dymista ® with Azelastine and Fluticasone propionate nasal sprays in patients with moderate-to-severe SAR −To assess the long-term safety of Dymista ® in patients with chronic rhinitis Overview of Clinical Development programme Hampel et al, 2010; Carr et al, 2012; ; Price et al, 2012; SAR: seasonal allergic rhinitis

29 Dymista ® clinical programme summary Hampel et al, 2010; Carr et al, 2012; Price et al, EAACI, 2012 FP: fluticasone propionate; ITT: intent to treat The largest body of evidence directly comparing the effectiveness of anti-rhinitis medications

30 Dymista ® study design: Seasonal Allergic Rhinitis Studies NS: nasal spray; TNSS: Total Nasal Symptom Score; TOSS: Total Ocular Symptom Score; bid: twice daily Hampel et al, 2010; Carr et al, 2012 Dymista ® NS Fluticasone propionate NS Azelastine NS Placebo Day 7 Screening Day 1 Randomisation Day 7 Visit Day 14 Visit Symptom qualification period Daily TNSS/TOSS Daily Assessment (AM & PM) Placebo run-in 1 spray/nostril bid

31 Dymista ® trial patients ≥ 12 years old with a ≥ 2-year history of Seasonal Allergic Rhinitis (SAR) Positive skin prick test to relevant pollen Moderate-to-severe SAR −Defined by ARIA guidelines −Defined by baseline rTNSS, nasal congestion scores and rTOSS At randomisation patients demonstrated: −Baseline rTNSS of 18-19 (max =24) −Baseline rTOSS of 11-12 (max =18) Patients had moderate to severe Seasonal Allergic Rhinitis ARIA: Allergic Rhinitis and its impact on asthma; rTNSS: reflective total nasal symptom score; rTOSS: reflective Total Ocular Symptom Score; Hampel et al, 2010; Hampel et al, 2010; Carr et al, J Allergy Clin The majority of randomized patients with Allergic Rhinitis have moderate-to-severe disease

32 Endpoints Reflective total nasal symptom score [rTNSS] (AM + PM) −Maximum score = 24 Reflective total ocular symptom score [rTOSS] (AM + PM) −Maximum score = 18 Individual nasal and ocular symptoms −Nasal: congestion; itching; rhinorrhoea; sneezing −Ocular: itching, redness, watering rTNSS by patient baseline severity Substantial treatment response (requested by EMA) −50% reduction from baseline in rTNSS −≤ 1 point remaining for EACH nasal symptom (i.e. complete/almost complete symptom relief) Hampel et al, 2010; Carr et al, J Allergy Clin

33 rTNSS baseline ranges were: MP4002: 18.19-18.61; MP4004: 18.22-18.59; MP4006: 19.37-19.51 MP4002: † p=0.034 vs Dymista ® ; ‡ p=0.001 vs Dymista ® ; * p<0.001 vs Dymista ® ; MP4004: † p=0.038 vs Dymista ® ; ‡ p=0.032 vs Dymista ® ; * p<0.001 vs Dymista ® ; MP4006: † p=0.029 vs Dymista ® ; ‡ p=0.001 vs Dymista ®; * p<0.001 vs Dymista ® AZE: Azelastine; FP: Fluticasone propionate; rTNSS: reflective Total Nasal Symptom Score Carr et al, J Allergy Clin Consistent benefit of Dymista ® across “ALL SEASONS” Dymista ® 5.615.545.53 FP4.714.554.89 AZE4.234.544.82 PLA2.923.033.4 Spring Autumn Spring & Summer LS Mean Change from Baseline in rTNSS MP4002MP4004MP4006

34 Significantly greater baseline rTNSS reduction rTNSS: reflective Total Nasal Symptom Score; FP: Fluticasone propionate; AZE: Azelastine; PLA: placebo Carr et al, J Allergy Clin MP4002 (n=831)MP4004 (n=776) † p=0.034 vs Dymista ® ; ‡ p=0.002 vs Dymista ® † p=0.038 vs Dymista ® ; ‡ p=0.032 vs Dymista ® AZEFPAZEFP ∆ Placebo LS Mean Change from Baseline rTNSS ∆ Placebo LS Mean Change from Baseline rTNSS

35 Significantly greater baseline rTNSS reduction rTNSS: reflective Total Nasal Symptom Score; FP: Fluticasone propionate; AZE: Azelastine; PLA: placebo Carr et al, J Allergy Clin MP4006 (n=1971) Meta-analysis (n=3398) † p=0.029 vs Dymista ® ; ‡ p<0.016 vs Dymista ® † p=0.001 vs Dymista ® ; ‡ p<0.001 vs Dymista ® AZEFPAZEFP ∆ Placebo LS Mean Change from Baseline rTNSS ∆ Placebo LS Mean Change from Baseline rTNSS

36 Better clinical benefit was observed from the first day of assessment and was sustained * p <0.001 vs all active treatments; † p ≤ 0.015 vs Dymista ® ; ‡ p ≤ 0.050 vs Dymista ® Dymista ® (n=848) ;AZE: Azelastine (n=847); FP: Fluticasone propionate (n= 846); Placebo (n= 857); rTNSS: reflective Total Nasal Symptom Score Carr et al, J Allergy Clin FP PLA rTNSS (LS Mean Change from Baseline) Day AZE Start

37 * p≤0.0008 vs Dymista ® ; † p≤0.0047 vs Dymista ® ; ‡ p=0.0125 vs Dymista ® Dymista ® (n=848) ;AZE: Azelastine (n=847); FP: Fluticasone propionate (n= 846); Placebo (n= 857) Carr et al, J Allergy Clin Dymista ® targets all the different nasal symptoms of Allergic Rhinitis AZE ∆ Placebo LS Mean Change from Baseline: individual symptom score FP CongestionRhinorrheaSneezingItch

38 † p=0.0073 vs Dymista ® ; ‡ p=0.0379 vs Dymista ® Dymista ® (n=848) ;AZE: Azelastine (n=847); FP: Fluticasone propionate (n= 846); Placebo (n= 857) Carr et al, J Allergy Clin Dymista ® targets all the different ocular symptoms of Allergic Rhinitis AZE FP ∆ Placebo LS Mean Change from Baseline: individual symptom score ItchWateryRedness

39 Effective even in more severe patients * p ≤0.0001 vs all active treatments; † p <0.04 vs Dymista ® ; ‡ p< 0.01 vs Dymista ® rTNSS: reflective Total Nasal Symptom Score; RQLQ: Rhinitis Quality of Life Questionnaire; FP: Fluticasone propionate; AZE: Azelastine; PLA: placebo Carr et al, J Allergy Clin AZE FP PLA rTNSS (LS mean change from baseline) rTNSS ≤ 18.9rTNSS > 18.9RQLQ ≤ 3.9RQLQ > 3.9

40 Substantial treatment response with Dymista ® AZE: Azelastine; FP: Fluticasone propionate ; PLA: placebo Carr et al, 2012. Responder rate = % of patients who achieved the specified response Day rTNSS 50% response Responder Rate (%) AZE FP PLA Start

41 Complete treatment response with Dymista ® AZE: Azelastine; FP: Fluticasone propionate ; PLA: placebo Carr et al, 2012. Responder rate = % of patients who achieved the specified response rTNSS (≤1 point for all symptom scores) Day Responder Rate (%) AZE FP PLA Start

42 These results have been published in JACI ‘Prior to MP29-02 [Dymista ® ], no clinical development program has demonstrated additional benefit over two currently recommended first-line AR therapies in moderate-to-severe patients’ ‘Patients with moderate-to-severe SAR achieved better control and were controlled earlier with MP29-02 [Dymista ® ] than with recommended medications according to guidelines’ ‘The results are consistent among different parameters, including ocular symptoms, and across various allergy seasons’ ‘’MP29-02 [Dymista ® ]provided benefits for all patients, providing significantly greater symptom relief than Fluticasone propionate or Azelastine monotherapy regardless of disease severity’ Take home messages Carr et al, 2012 JACI: Journal of Allergy & Clinical Immunology; AR: Allergic Rhinitis; SAR: Seasonal Allergic Rhinitis

43 Editors’ choice J Allergy Clin Immunol ‘MP29-02 [Dymista ® ]: A major advancement in the treatment of Allergic Rhinitis’ ‘MP29-02 [Dymista ® ]: can be considered the drug of choice for the treatment of Allergic Rhinitis’ AR: Allergic Rhinitis

44 Dymista ® versus commercially first line therapy

45 The treatment effect of Dymista ® becomes even more striking when comparing it to commercially-available FP – the Meda Fluticasone propionate preparation masks the ‘real world’ effects of Dymista ® Dymista ® versus commercially available first line therapy

46 The importance of Study MP4001 Hampel et al, 2010; Carr et al, 2012; Price et al, EAACI, 2012 FP: fluticasone propionate; ITT: intent to treat

47 Hampel et al, 2010; Carr et al, 2012 AZE: azelastine; FP: fluticasone propionatel; rTNSS: reflective total nasal symptom socre; Data presented as LS mean change from baseline delta placebo with 95% CI Dymista ® is more effective in reducing nasal AR symptoms compared to commercially available first-line therapy Not commercial available first line therapy Commercially available first line therapy FPAZE LS Mean Change from Baseline in rTNSS (Delta placebo) † p<0.0001 vs Dymista ® ; ‡ p=0.0031 vs Dymista ®

48 Patients treated with Dymista ® experience significant relief from all their nasal symptoms Better than intranasal Fluticasone or Azelastine Dymista ® (n=153); FP: Fluticasone propionate (n=151); AZE: azelastine (n=152) Hampel et al, 2010. Results expressed as LS mean change from baseline (delta placebo) with 95% CI † p=0.0034 vs Dymista ® ; ‡ p=0.0001 vs Dymista ® † p=0.0240 vs Dymista ® ; ‡ p=0.0033 vs Dymista ® Nasal CongestionNasal Itch LS Mean Change from Baseline (Delta placebo) AZEFPAZEFP LS Mean Change from Baseline (Delta placebo)

49 Patients treated with Dymista ® experience significant relief from all their nasal symptoms Dymista ® (n=153) FP: Fluticasone propionate (n=151); AZE: azelastine (n=152) ; Hampel et al, 2010. Results expressed as LS mean change from baseline (delta placebo) with 95% CI Better than intranasal Fluticasone and Azelastine † p=0.0678 vs Dymista ® ; ‡ p<0.0001 vs Dymista ® † p=0.0009 vs Dymista ® ; ‡ p<0.0001 vs Dymista ® RhinorrheaSneezing AZEFPAZEFP LS Mean Change from Baseline (Delta placebo) LS Mean Change from Baseline (Delta placebo)

50 Dymista ® (n=153); FP: Fluticasone propionate (n=151); AZE: azelastine (n=152); rTOSS: reflective Total Ocular Symptom Score; SAR: Seasonal Allergic Rhinitis; Hampel et al, 2010; Data presented as LS mean change from baseline delta placebo with 95% CI Dymista ® is also more effective than intranasal steroids in treating the symptoms of conjunctivitis Approx 90% of SAR patients also experience eye symptoms during the season Patients treated with Dymista ® experienced significantly better ocular symptom relief than those treated with fluticasone with a relative difference of 58% † p=0.0022 vs Dymista ® ; ‡ p=0.0706 AZEFP LS Mean Change from Baseline in rTOSS (Delta placebo)

51 Hampel et al, 20120 Dymista ® (n=153); FP: Fluticasone propionate (n=151); AZE: azelastine (n=152) ; Data presented as LS mean change from baseline delta placebo with 95% CI Better than intranasal Fluticasone or Azelastine Patients treated with Dymista ® experience significant relief from all their ocular symptoms † p=0.0001 vs Dymista ® ‡ p=0.0127 vs Dymista ® † p=0.0218 vs Dymista ® ‡ p=0.2923 vs Dymista ® † p=0.0044 vs Dymista ® ‡ p=0.0372 vs Dymista ® Watering Itching Redness AZEFPAZEFPAZEFP LS Mean Change from Baseline (Delta placebo)

52 † p=0.0013 vs Dymista ® ; ‡ p=0.0004 vs Dymista ®; Dymista ® (n=153); FP: Fluticasone propionate (n=151); AZE: azelastine (n=152); Data on file rT7SS: Total of 7 symptom scores (All nasal pluis all ocular symptoms); Data on file; Results expressed as LS mean change from baseline (delta placebo) with 95% CI Better than intranasal Fluticasone or Azelastine Dymista ® most effectively treats the entire rhinitis symptom complex (both nasal & ocular symptoms) AZEFP rT7SS LS Mean Change from Baseline (Delta placebo)

53 AR: allergic rhinitis; AZE: Azelastine; FP: Fluticasone propionate; rTNSS: reflective Total Nasal Symptom Score Data on file; Results expressed as LS mean change from baseline (delta placebo) with 95% CI Most AR patients have moderate-to-severe disease Dymista ® : the most effective option regardless of severity Most severe patientsModerate/ severe patients LS Mean Change from Baseline In rTNSS (Delta placebo) AZEFP AZEFP † p=0.0436 vs Dymista ® ; ‡ p=0.0035 vs Dymista ® Dymista ® (n=77); FP (n=64); AZE (n=68) † p=0.0188 vs Dymista ® ; ‡ p=0.0002 vs Dymista ® Dymista ® (n=76); FP (n=87); AZE (n=84)

54 Dymista ® is also more effective for those patients with moderate/severe ocular symptoms rTOSS: reflective total ocular symptom score; ITT: intent to treat; AZE: Azelastine; FP: Fluticasone propionate; BL: baseline. Data on file; Results expressed as LS mean change from baseline (delta placebo) with 95% CI More severe patients BI TOSS ≥ 8 ITT † p=0.0022 vs Dymista ® ; ‡ p=0.0706 vs Dymista ® Dymista ® (n=153); FP (n=151); AZE (n=152) † p=0.0012 vs Dymista ® ; ‡ p=0.0456 vs Dymista ® Dymista ® (n=128); FP (n=125); AZE (n=118) LS Mean Change from Baseline In rTOSS (Delta placebo) AZEFPAZEFP

55 Dymista ® : superior in providing faster and substantial symptom relief (≥ 50% reduction in nasal symptoms) More Dymista ® patients achieve substantial symptom relief (1 in every 2 patients) And achieve this level of control up to 6 days faster than either FP or AZE Relevance: A substantial response with up to 6 day’s time advantage over first-line therapy is relevant since an AR episode lasts 12.5 days on average Substantial nasal symptom reduction is achieved by more Dymista ® patients and up to 6 days earlier than existing first-line therapy Bachert et al. EAACI 2011, AZE: Azelastine; FP: Fluticasone propionate; PLA: placebo; AR: allergic rhinitis Responder rate = % of patients with a 50% or more reduction in Total Nasal Symptom Score Responders rate (%) PLA Day 6 days AZE FP

56 Dymista ® : More patients will be symptom-free than first-line therapy 1 out of 6 Dymista ® patients achieve complete or near-to- complete symptom relief Relevance: Complete symptom relief is what patients want 80 million allergic rhinitis sufferers around the world could become symptom-free with Dymista ® AZE: Azelastine; FP: Fluticasone propionate; PLA: placebo Data on file; Responder Rate = % of patients with a score of ≤ 1 for every nasal symptom AZE FP PLA Responders rate (%) Day

57 Dymista ® is the drug that patients want Patients want more effective therapy and are willing to pay £43 to receive such medication (DCE results) Two thirds of all patients incl. in the survey reported using ≥ 2 AR medications −Faster and more effective reduction of nasal and ocular symptoms was the primary reason for co-medication Results of the health survey Dymista ® represents the drug which patients want AR: Allergic Rhinitis; DCE: discrete choice experiment Pitman et al, 2012 % moderate/severe patients on ≥ 2 AR medications TotalIncreased nasal efficacy Increased ocular efficacy Faster nasal response Faster ocular response Other % of Patients

58 MP4001 Conclusions The efficacy of Dymista ® is more apparent compared to commercially- available first line therapy (than not commercially available comparators used in studies MP4002, MP4004 and MP4006 [i.e. the JACI publication]) Dymista ® is more effective than commercially first-line therapies in combating overall nasal symptoms (rTNSS), overall ocular symptoms (rTOSS) as well as each of the individual symptoms Dymista ® provides benefits for all patients, providing significantly greater symptom relief vs FP or AZE regardless of disease severity More Dymista ® patients achieved substantial nasal relief and achieved it earlier. 250 million patients will experience substantial symptom relief while 80 million patients will have no symptoms and feel themselves “cured” Dymista ® versus marketed comparators AR: Allergic Rhinitis; rTNSS: reflective Total Nasal Symptom Score; rTOSS: reflective total ocular symptom score; FP: Fluticasone propionate; AZE: Azelastine

59 Wrap up and Discussion

60 Can Dymista ® change the landscape of AR management? Fast relief: SABA Sustained relief : LABA Preventer: ICS Unmet medical need −Most patients were taking SABA, LABA and ICS −Convenient treatment needed to simplify asthma management as per recommendations Fast relief: SABA Sustained relief : LABA Preventer: ICS Unmet medical need −Most patients were taking SABA, LABA and ICS −Convenient treatment needed to simplify asthma management as per recommendations Fast relief: anti-histamines Sustained & most effective relief: intranasal corticosteroids Unmet medical need −Changing face of the disease −20% SCUAD −75% of patients on unproven combination therapy −More effective therapies urgently needed Fast relief: anti-histamines Sustained & most effective relief: intranasal corticosteroids Unmet medical need −Changing face of the disease −20% SCUAD −75% of patients on unproven combination therapy −More effective therapies urgently needed ….to the same extent as that seen in asthma management Asthma Landscape Many asthmatics now on LABA/ICS formulations Dymista ® a new paradigm for Allergic Rhinitis management Rhinitis Landscape SABA: short-acting beta-agonist; LABA: long-acting beta-agonist; SCUAD: severe chronic upper airway disease


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