A world leader in allergy immunotherapy

Transcription

1 A world leader in allergy immunotherapy R&D and Business Briefing New York, May 2014 ALK R&D and Business Briefing

2 Agenda 13.00: ALK An emerging speciality pharma company with a global growth strategy 13.30: Allergy Immunotherapy Treating the cause of allergic rhinitis and asthma 14.05: The US The next opportunity 14.55: Break 15.05: House Dust Mite tablets Treating the world s most prevalent allergy 16.05: Japan and the emerging markets Future growth opportunities 16.15: R&D with a commercial focus Globalising the tablet portfolio, expanding into asthma 16.20: Closing remarks and open Q&A Afterwards: Drinks reception 2 ALK R&D and Business Briefing

3 House Dust Mite development programme Unmet medical need and the role for AIT Professor Moisés A. Calderón MD PhD Director of Clinical Trials Unit Section of Allergy and Clinical Immunology Imperial College London ALK R&D and Business Briefing

4 HDM Respiratory Allergic Disease: Unmet need and the role of AIT Professor Moisés A. Calderón MD PhD Section of Allergy and Clinical Immunology ALK R&D Business Briefing New York, May 21 st ALK R&D and Business Briefing

5 Geographical variation in the prevalence of sensitivity to aeroallergens in Europe European Community Respiratory Health Survey I 18,102 adults (20-44 years age); 35 centres Allergens Sensitised D pt Grass Cat Birch37.4% Alter Olive Clad Parie Ragw Belgium France % Iceland Ireland % % Italy % Norway % Spain % Sweden The Netherlands % United Kingdom % ALK R&D and Business Briefing Bousquet PJ et al. Allergy 2007; 62: Bousquet PJ et al. Ann Epidmiol 2010; 20:

6 Geographical distribution of D. pteronyssinus and D. farinae mite species North hemisphere Dermatophagoides pteronyssimus Dermatophagoides farinae 6 ALK R&D and Business Briefing Colloff MJ. Dust mites. CISCO 2009

7 Allergic Rhinitis 49% of Rhinitics are HDM Allergic Bauchau V and Durham. SR. Eur Respir J 2004; 24: Allergic Asthma Between 50-85% of Asthmatics are HDM Allergic Nelson RP et al. J Allergy Clin Immunol 1996; 98: Platts-Mills TAE et al. J Allergy Clin Immunl 1989; 83: Gregory LG et al. Trends in Immunol 2011; 32: ALK R&D and Business Briefing

8 The prevalence of HDM respiratory allergic disease is a global challenge Patients affected by allergic rhinitis worldwide 1, millions Global prevalence of asthma 3, millions >50% allergic patients have HDM allergy 5 1. EFA Book on respiratory allergies. Valovirta E, 2012, p Brozak et al., Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines: 2010 Revision. 3. WHO, Asthma fact sheet no. 307, May GINA. Pocket Guide for Asthma Management and Prevention, Accessed Chen et al. Hypoallergenic Der p 1/Der p 2 combination vaccines for immunotherapy of house dust mite allergy. J Allergy Clin Immunol. 2012;130(2): ALK R&D and Business Briefing

9 Asthma and Allergic Rhinitis are often co-morbid diseases Up to 40% patients with allergic rhinitis are reported to have concomitant asthma Up to 90% patients with asthma are reported to have concomitant allergic rhinitis 9 ALK R&D and Business Briefing

10 Allergen Immunotherapy for Rhinitis IMMUNOTHERAPY SCIT SLIT All allergens 1 8 studies SCIT 187 / Placebo 189 I 2 = 86% House Dust Mites 1 7 studies SLIT 173 / Placebo 175 I 2 = 83% All allergens 2 49 studies SLIT 2333 / Placebo 2256 I 2 = 81% House Dust Mites 2 9 studies SLIT 232 / Placebo 232 I 2 = 93% Favours AIT Favours placebo 1 Calderon MA et al. Cochrane Database of Systematic Reviews 2014, No.: CD [In press] 10 ALK R&D and Business Briefing 2 Radulovic S et al. Cochrane Database Syst Rev Dec 8;(12):CD

11 Allergen Immunotherapy for Asthma IMMUNOTHERAPY SCIT SLIT All allergens 1 34 studies SCIT 727 / Placebo 557 I 2 = 73% House Dust Mites 1 12 studies SLIT 247 / Placebo 161 I 2 = 77% All allergens 2 9 studies SLIT 150 / Placebo 153 I 2 = 64% House Dust Mites 2 4 studies SLIT 55 / Placebo 53 I 2 = 79% Favours AIT Favours placebo 1 Abramson MJ et al. Cochrane Database Syst Rev Aug 4; (8): CD ALK R&D and Business Briefing 2 Calamita Z et al. Allergy 2006; 61:

12 Assessment of AIT formulations in HDM-Rhinitis SCIT n=7 SLIT n=15 Gabriel 1977 Blainey 1984 Pichler 1997 Varney 2003 Dokic 2005 Riechelmann 2010 Yukselen 2012 Tari 1990 Mungan 1999 Passalacqua 1998 Guez 2000 Bahceciler 2001 Marcucci 2004 Tonnel 2004 Passalacqua 2006 Pham-Thi 2007 Tseng 2008 O Hehir 2009 Bush 2011 Bozek 2012 De Bot 2012 Yukselen ALK R&D and Business Briefing Calderon MA et al. J Allergy Clin Immunol 2013; 132(6):

13 Assessment of AIT formulations in HDM-Rhinitis SCIT n=7 SLIT n=15 Total Adults Children Patients 397 (7 studies) Total 365 (6 studies) Adults 32 (1 study) Children Primary Efficacy Outcome 958 (15 studies) 390 (8 studies) 568 (7 studies) Symptom score T4SS Combined score VAS + Doctor s assessment Nasal Symptom scores T4 / T5 / T7 / T8SS Combined score Eyes-Nose-Lung Symptoms Treatment duration (months) Dose of Der p 1 major allergen Maintenance 7ug 30 ug Cumulative ug Safety Maintenance ug Cumulative 55 37,900 ug Poor reporting Mild local and systemic reactions Only 1 case anaphylaxis reported Use of adrenaline reported Better reporting Better safety profile Mainly local reactions No anaphylaxis reported 13 ALK R&D and Business Briefing Calderon MA et al. J Allergy Clin Immunol 2013; 132(6):

14 Assessment of AIT formulations in HDM-Asthma SCIT n=19 SLIT n=14 Smith 1972 D Souza 1973 Gaddie 1976 Warner 1978 BTA 1979 Buchanan 1981 Blainey 1984 Pauli 1984 Bousquet 1985 Franco 1995 Peroni 1995 Olsen 1997 Pichler 1997 Maestrelly 2004 Ameal 2005 Blumberga 2006 Garcia-Robaina 2006 Wang 2006 Yukselen 2012 Giovane 1994 Bousquet 1999 Mungan 1999 Pajno 2000 Bahceciler 2001 Ippoliti 2003 Marcucci 2005 Lue 2006 Niu 2006 Pham-Thi 2007 Tseng 2008 Bush 2011 Yukselen 2012 Devillier ALK R&D and Business Briefing Calderon MA et al. J Allergy Clin Immunol 2013; 132(6):

15 Assessment of AIT formulations in HDM-Asthma Total Adults Children SCIT n=19 Patients 987 (19 studies) Total 744 (15 studies) Adults 243 (4 studies) Children Primary Efficacy Outcome Symptom Scores Daytime T3/T4/T6SS VAS HDM PD 20 FEV 1 FEV 1 Self improvement Doctors improvement SLIT n= (14 studies) 607 (4 studies) 503 (10 studies) Symptom scores Medication scores Well-controlled asthma Day and night-time Symptoms Daytime T3SS Rhinitis Symptoms Asthma and Rhinitis Symptoms Treatment duration (months) Dose of Der p 1 major allergen Maintenance ug Cumulative ug Safety Poor reporting Serious systemic reactions reported (exacerbation of asthma) Use of adrenaline reported Maintenance 0.8 1,010 ug Cumulative ,700 ug Better reporting Better safety profile Mainly local reactions No anaphylaxis reported 15 ALK R&D and Business Briefing Calderon MA et al. J Allergy Clin Immunol 2013; 132(6):

16 Recommendations of AIT for HDM allergy ARIA Conditional (weak)* recommendation SCIT/SLIT adults: moderate quality evidence SCIT/SLIT children: low quality evidence Brożek J et al. ARIA Revision J Allergy Clin Immunol 2010;126: * Applying GRADE Implications for patients, clinicians and policy makers. 16 ALK R&D and Business Briefing

17 Recommendations of AIT for HDM allergy GINA AIT should be considered only after strict environmental avoidance and pharmacological intervention GINA global strategy for asthma management and prevention: updated ALK R&D and Business Briefing

18 Unmet needs on HDM AIT RCT well-powered studies Defined populations Adults and children Phenotypes Control of asthma disease Adequately allergen exposure Well defined outcome measures Well characterized allergen extracts

19 House Dust Mite development programme Development plan and key clinical trials data Henrik Jacobi Executive Vice President, Research & Development ALK R&D and Business Briefing

20 House dust mite allergy Perennial allergy Strong link to asthma Early onset and occurrence in life UK birth cohort trial* 13% sensitised to HDM at age 4 years 50% subsequently developed asthma 8x higher risk of developing asthma if sensitised to HDM *Source: Arshad et al. Pediatrics

21 The HDM SLIT-tablet The largest clinical development program ever on the efficacy and safety of immunotherapy in HDM allergic rhinitis and asthma 5,097 4, subjects in phase phasei-iii II/III I 21

22 The HDM SLIT-tablet The largest clinical development program ever on the efficacy and safety of immunotherapy in HDM allergic rhinitis and asthma 386 subjects in phase I 5,097 subjects in phase I-III 2,574 2,137 4,711 subjects in subjects in asthma rhinitis phase II/III trials 22

23 The HDM SLIT-tablet Five efficacy studies have been completed and all have met their primary endpoint Phase I Phase II Phase III MT-01 MT-03 P008 TO MT-02 (efficacy in AA) P003 (efficacy in AR) MERIT (efficacy in AR) MITRA (efficacy in AA) TO-203-AR (efficacy in AR) TO-203-AA (efficacy in AA) P001 (efficacy in AR) 23

24 MT-02 Efficacy in allergic asthma 6 SQ-HDM (n=156) N = SQ-HDM (n=159) 1 SQ-HDM (n=146) Duration in weeks: Placebo (n=143) ICS adjustment Baseline Assessment Primary efficacy analysis: Reduction in ICS ICS adjustment Efficacy Assessment 24 EudraCT Number: ;

25 MT-02 Primary endpoint Mosbech H et al. J Allergy Clin Immunol 2014; in-press Data on file, ALK; 25

26 P003 Efficacy in allergic rhinitis 12 SQ-HDM (N = 42) N=124 6 SQ-HDM (N = 41) Placebo (N = 41) Screening Treatment Weeks: Randomisation EEC session End of treatment Primary endpoint: total rhinitis symptoms score at 24-week challenge ClinicalTrials.gov Identifier: NCT

27 P003 Primary endpoint Total rhinitis symptoms score n.s (20%) p= (18%) p= (30%) p<0.001 Baseline 8 weeks 16 weeks 24 weeks Placebo 6 SQ-HDM 12 SQ-HDM Placebo n = 41 6 SQ-HDM n= SQ-HDM n = (27%) p= (49%) p<0.001 AAAAI abstract: Nolte H et al. 2014; Journal of Allergy and Clinical Immunology;133(2)(Supplement):AB

28 P003 Primary endpoint Total rhinitis symptoms score n.s (20%) p= (18%) p= (30%) p<0.001 Baseline 8 weeks 16 weeks 24 weeks Placebo 6 SQ-HDM 12 SQ-HDM Placebo n = 41 6 SQ-HDM n = SQ-HDM n = (27%) p= (49%) p<0.001 AAAAI abstract: Nolte H et al. 2014; Journal of Allergy and Clinical Immunology;133(2)(Supplement):AB

29 P003 Primary endpoint Total rhinitis symptoms score n.s (20%) p= (18%) p= (30%) p<0.001 Baseline 8 weeks 16 weeks 24 weeks Placebo 6 SQ-HDM 12 SQ-HDM Placebo n = 41 6 SQ-HDM n = SQ-HDM n = (27%) p= (49%) p<0.001 AAAAI abstract: Nolte H et al. 2014; Journal of Allergy and Clinical Immunology;133(2)(Supplement):AB

30 P003 Primary endpoint Total rhinitis symptoms score n.s (20%) p= (18%) p= (30%) p<0.001 Baseline 8 weeks 16 weeks 24 weeks Placebo 6 SQ-HDM 12 SQ-HDM Placebo n = 41 6 SQ-HDM n = SQ-HDM n = (27%) p= (49%) p<0.001 AAAAI abstract: Nolte H et al. 2014; Journal of Allergy and Clinical Immunology;133(2)(Supplement):AB

31 The HDM SLIT-tablet Two European Phase III studies, MITRA and MERIT, have been completed and both met their primary endpoint Phase I Phase II Phase III MT-01 MT-03 P008 TO MT-02 (efficacy in AA) P003 (efficacy in AR) MERIT (efficacy in AR) MITRA (efficacy in AA) TO-203-AR (efficacy in AR) TO-203-AA (efficacy in AA) P001 (efficacy in AR) 31

32 32 MITRA

33 MITRA Efficacy in allergic asthma 12 SQ-HDM (N=282) N=834 6 SQ-HDM (N=275) Placebo (N=277) Period 1 Screening Period 2 Treatment maintenance Period 3 ICS reduction Randomisation Period 2A 2B 3A 3B End of trial Daily diary: Symptoms, PEF, medication ICS 50% reduction ICS 100% withdrawal EudraCT Number:

34 MITRA Primary endpoint Time to first moderate or severe asthma exacerbation during period 3 (ICS reduction/withdrawal) The definition of an asthma exacerbation was fulfilled if the subject experienced one or more of the protocol-defined criteria, and it led to change in treatment The baseline values (referred to in the criteria) were the mean values during the last 14 days of the individual subject s screening period 34

35 MITRA Definition of a moderate exacerbation Criteria a)-d) defined a moderate exacerbation: a) nocturnal awakening(s) due to asthma requiring SABA for 2 consecutive nights or increase o 0.75 from baseline in daily symptom score on 2 consecutive days b) increase from baseline in occasions of SABA use on 2 consecutive days (minimum increase: 4 puffs/day) c) 20% decrease in PEF from baseline on at least 2 consecutive mornings/ evenings or 20% decrease in FEV1 from baseline d) visit to the emergency room/trial site for asthma treatment not requiring systemic corticosteroids 35 35

36 MITRA Definition of a severe exacerbation Criteria e)-f) defined a severe exacerbation: e) Need of systemic corticosteroids for the treatment of asthma symptoms for at least 3 days f) Emergency room visit because of asthma, requiring systemic corticosteroids or hospitalisation for more than 12 hours because of asthma 36 36

37 MITRA Main selection criteria HDM-induced allergic asthma of at least 1 year Documented reversible airway obstruction Use of ICS in accordance with the GINA Guideline step Dose of ICS after switching to budesonide: mcg Asthma control questionnaire (ACQ) score Corresponding to partly controlled asthma at randomisation FEV 1 70% of predicted value 37

38 MITRA Demography 100% was sensitised to HDM 66% was also sensitised to other allergens than HDM 32% was treated with pharmacotherapy at inclusion according to GINA Guideline step 4 38

39 MITRA Analysis of primary endpoint Time to first moderate or severe asthma exacerbation during period 3 6 SQ-HDM vs. placebo 12 SQ-HDM vs. placebo Primary efficacy endpoint HR* [CI 95% ] % risk reduction p-value HR* [CI 95% ] % risk reduction p-value Time to first asthma exacerbation (FAS) 0.69 [0.49;0.96] 31% [0.47;0.93] 34% *Pre-defined relevant effect size: HR 0.70, corresponding to a % risk reduction 30% 39

40 Time to first asthma exacerbation Placebo 6 DU Placebo 12 DU 6 SQ-HDM 12 SQ-HDM Primary endpoint Probability % risk reduction a 12 SQ.HDM: 34%, p= SQ-HDM : 31%, p=0.028 a : estimated by hazard ratio 0.00 Placebo 6 SQ-HDM 6 DU 12 SQ-HDM 12 DU Time (days)

41 41 MERIT

42 MERIT Efficacy in allergic rhinitis 12 SQ-HDM (N = 318) N = SQ-HDM (N = 336) Placebo (N = 338) Period 1 Baseline Period 2 Treatment maintenance Efficacy assessment 15 days Randomisation 10 months 2 months End of trial 1-week diary periods Daily diary EudraCT Number:

43 MERIT Primary endpoint Primary endpoint: The primary endpoint was the average total combined rhinitis score (TCRS) during the last 8 weeks of treatment. Symptoms: Runny nose Blocked nose Sneezing Itchy nose Maximum score: 12 Medication: Desloratadine Budesonide Maximum score: 12 Maximum TCRS: 24 43

44 MERIT Main selection criteria Moderate to severe persistent HDM allergic rhinitis (with or without asthma) with symptoms despite using symptomatic treatment Total daily rhinitis symptom score of at least 6 (out of 12), or a score of at least 5 with one symptom being severe, during 8 days of the 15-days baseline period Use of symptomatic medication during 8 days of the 15-days baseline period Presence of 1 of the following items due to HDM allergic rhinitis baseline period: 1. Sleep disturbance 2. Impairment of daily activities, leisure and/or sport 3. Impairment of school or work 44

45 MERIT Demography 46% had concomitant asthma 100% was sensitised to HDM 68% was also sensitised to other allergens than HDM 42% had severe and 58% moderate disease at baseline according to the m-aria Guideline criteria 45

46 MERIT Analysis of primary endpoint The trial confirmed efficacy of both administered doses Endpoint Treatment group Absolute difference to placebo* [95% CI] p-value Placebo - - TCRS 6 SQ-HDM 1.18 [0.45;1.91] SQ-HDM 1.22 [0.49;1.96] *Pre-specified relevant difference was 1 46

47 MERIT - Analysis of primary endpoint Total Combined Rhinitis Score % reduction 43% reduction Total combined rhinitis score First visit after randomisation End of trial efficacy evaluation Placebo 12 SQ-HDM 47

48 MERIT - Analysis of primary endpoint Total Combined Rhinitis Score % reduction 42% reduction Total combined rhinitis score First visit after randomisation End of trial efficacy evaluation Placebo 6 SQ-HDM 48

49 Time course analysis of Total Combined Rhinitis Score Total combined rhinitis score 266 days 266 days Weeks with treatment Weeks with treatment Placebo 12 SQ-HDM Placebo 6 SQ-HDM Error bars: Standard error of difference in adjusted means 49

50 50 The vision

51 HDM allergy and ALK s vision One HDM SLIT-tablet daily induces immunological tolerance and provides clinical benefit in both allergic asthma and allergic rhinitis 51

52 Questions & discussion Please raise your hand, then wait until a microphone reaches you 52 ALK R&D and Business Briefing

53 Agenda 13.00: ALK An emerging speciality pharma company with a global growth strategy 13.30: Allergy Immunotherapy Treating the cause of allergic rhinitis and asthma 14.05: The US The next opportunity 14.55: Break 15.05: House Dust Mite tablets Treating the world s most prevalent allergy 16.05: Japan and the emerging markets Future growth opportunities 16.15: R&D with a commercial focus Globalising the tablet portfolio, expanding into asthma 16.20: Closing remarks and open Q&A Afterwards: Drinks reception 53 ALK R&D and Business Briefing

54 International markets Partnerships, collaborations and expansion plans Jens Bager President and CEO ALK R&D and Business Briefing

55 Beyond the US opportunity Globalising a proven portfolio For selected emerging markets (not disclosed) Existing markets Markets of specific interest: Argentina, Australia, Brazil, eastern Europe, Russia, South Korea and Turkey 55 ALK R&D and Business Briefing

56 Japan: An unfolding opportunity The most allergic market in the world Emerging AIT market Japan: Market profile ~50m allergic patients ~3,000 specialists Allergy prevalence higher than EU and USA Dominated by HDM and Japanese cedar AIT currently almost non-existent as a treatment option 30% of population has one or more allergy Antihistamine sales: USD 1.3 billion Main allergies: HDM and Japanese cedar 56 ALK R&D and Business Briefing

57 Torii partnership for Japan Building on existing expertise Terms of the partnership Covers HDM and Japanese cedar SLITtablets Torii currently markets SCIT/SLIT drops but no SLIT-tablets launched yet Positive Phase III trial results from HDM tablet in March 2014 Potential launch in 2016 The only AIT company in Japan: 500 reps SCIT HDM licensed for market-building 57 ALK R&D and Business Briefing

58 China: An important emerging market for AIT Nearly 200 million allergic, up to 38 million severe cases Collaboration to fuel growth Eddingpharm: fast-growing specialty pharma with respiratory expertise Triples ALK s sales presence in China now up to 100 reps 7 year collaboration, subject to performance Covers sales and distribution of: Soluprick SQ diagnostic for HDM allergy Alutard SQ SCIT for HDM allergy HDM is China s most common allergy, affecting ~100 million AIT is gaining recognition and growing 58 ALK R&D and Business Briefing

59 Abbott collaboration for further expansion Abbott joins Merck, Torii and Eddingpharm in focusing on AIT Expands reach of portfolio A global healthcare company with expertise in diagnostics and pharmaceuticals Covers selected emerging markets Abbott gains rights to distribute and commercialise SLIT-tablet portfolio Grass, ragweed, tree and HDM Launches from 2017 onwards ALK is market authorisation holder and responsible for product supply 59 ALK R&D and Business Briefing

60 Agenda 13.00: ALK An emerging speciality pharma company with a global growth strategy 13.30: Allergy Immunotherapy Treating the cause of allergic rhinitis and asthma 14.05: The US The next opportunity 14.55: Break 15.05: House Dust Mite tablets Treating the world s most prevalent allergy 16.05: Japan and the emerging markets Future growth opportunities 16.15: R&D with a commercial focus Globalising the tablet portfolio, expanding into asthma 16.20: Closing remarks and open Q&A Afterwards: Drinks reception 60 ALK R&D and Business Briefing

61 Research and Development Key priorities and upcoming news Henrik Jacobi Executive Vice President, Research & Development ALK R&D and Business Briefing

62 AIT: A vision for the future Rhinoconjunctivitis Asthma Primary Prevention Prevention of Asthma MAP GAP 62 ALK R&D and Business Briefing

63 GAP trial: GRAZAX Asthma Prevention Preventing the progression of allergic disease Asthma prevention trial Initiated in 2010, completes in 2015 Assesses effect of GRAZAX on risk of developing asthma compared to placebo Potential new offering in the use of allergy immunotherapy Trial design Randomisation End of treatment End of trial GRAZAX Placebo Pan-European paediatric trial Multi-national, multi-centre trial: 101 sites in 11 European countries Patients: 812 children aged 5-12 with grass allergy but no asthma Screening Treatment period Follow-up ALK R&D and Business Briefing

64 Major pipeline events Scheduled events Status Europe North America Japan Regulatory filing for HDM SLIT-tablet Launch of HDM SLIT-tablet GRASTEK approved and launched in Canada GRASTEK approved and launched in the USA RAGWITEK approved and launched in the USA Merck s initiation of HDM SLIT-tablet Phase III RAGWITEK launch in Canada HDM Phase III results in North America Japanese cedar SLIT-tablet Phase I trial Initiation of Phase II/III trial with Japanese cedar SLIT-tablet Completion of HDM SLIT-tablet (rhinitis) Phase III Completion of HDM SLIT-tablet (asthma) Phase III Submission of HDM SLIT-tablet filing H2 ~ H2 H2 ~ ALK R&D and Business Briefing

65 Agenda 13.00: ALK An emerging speciality pharma company with a global growth strategy 13.30: Allergy Immunotherapy Treating the cause of allergic rhinitis and asthma 14.05: The US The next opportunity 14.55: Break 15.05: House Dust Mite tablets Treating the world s most prevalent allergy 16.05: Japan and the emerging markets Future growth opportunities 16.15: R&D with a commercial focus Globalising the tablet portfolio, expanding into asthma 16.20: Closing remarks and open Q&A Afterwards: Drinks reception 65 ALK R&D and Business Briefing

66 Conclusion Followed by open Q&A session Jens Bager President and CEO ALK R&D and Business Briefing

67 A clear strategy Strong progress on delivering our vision R&D investments have delivered a proven SLIT-tablet portfolio Global network of partnerships and collaborations Manufacturing scale-up to meet FDA standards and SLIT-tablet demand Continued focus on profitability Clear position as a leader in AIT 67 ALK R&D and Business Briefing

68 From strategic vision to commercial returns Major developments ahead Driving for profitability in Europe Realising the opportunity in North America Seizing the unfolding opportunity in Japan HDM SLIT-tablet in final stages of clinical development A global product for a worldwide allergy Enhancing ALK s position in China Expanding into emerging markets Exploring the potential of AIT in allergic asthma and asthma prevention 68 ALK R&D and Business Briefing

69 Questions & discussion Please raise your hand, then wait until a microphone reaches you 69 ALK R&D and Business Briefing

70 Agenda 13.00: ALK An emerging speciality pharma company with a global growth strategy 13.30: Allergy Immunotherapy Treating the cause of allergic rhinitis and asthma 14.05: The US The next opportunity 14.55: Break 15.05: House Dust Mite tablets Treating the world s most prevalent allergy 16.05: Japan and the emerging markets Future growth opportunities 16.15: R&D with a commercial focus Globalising the tablet portfolio, expanding into asthma 16.20: Closing remarks and open Q&A Afterwards: Drinks reception 70 ALK R&D and Business Briefing

71 Thank you for your attention Read more: Investor Relations: Per Plotnikof Head of Investor Relations Phone: Company presentation : May 2014