Eli Lilly and Company

Transcription

1 Eli Lilly and Company Ixekizumab Phase 2 Psoriasis Data Investment Community Discussion April 10, 2012

2 Safe Harbor Provision This presentation contains forward-looking statements that are based on management's current expectations, but actual results may differ materially due to various factors. The company's results may be affected by such factors as the risks and uncertainties in pharmaceutical research and development; competitive developments; regulatory actions; litigation and investigations; business development transactions; economic conditions; and changes in laws and regulations. For additional information about the factors that affect the company's business, please see the company's latest Forms 10-K and 10-Q filed with the Securities and Exchange Commission. The company undertakes no duty to update forward-looking statements. 2

3 Psoriasis Background Autoimmune disorder affecting the skin Roughly 7.5 million people in the U.S. have psoriasis; the most prevalent chronic autoimmune disorder 1 Estimated that roughly 17% of these patients have moderate-to-severe e o e e plaque psoriasis 1, requiring systemic therapy Underlying pathology of the disorder is not fully known but it is characterized by skin inflammation and infiltration by immune cells Inflammation thought to be linked to T-cell mediated immune response Interleukin-17A (IL-17) 17), a proinflammatory cytokine, is found in elevated levels in lesional psoriatic skin 1 National Psoriasis Foundation, About Psoriasis, Accessed Feb. 10,

4 Ixekizumab Profile Humanized digg4 monoclonal l antibody Binds to and neutralizes IL-17A (IL-17) High affinity and specificity for IL-17A Administered via subcutaneous injection 4

5 Study Design Study Population Moderate-to-severe chronic plaque psoriasis for at least 6 months Total of 142 patients; study sites in the U.S. and Denmark Randomized, d double-blind, bli d placebo-controlled, ll parallel l group study Doses (all subcutaneous): Placebo (n=27) ixekizumab 10 mg (n=28) ixekizumab 25 mg (n=30) ixekizumab 75 mg (n=29) ixekizumab 150 mg (n=28) Injection regimen: weeks 0, 2, 4,8, 12, 16 5

6 Endpoints and Measures Primary endpoint: Proportion of patients with at least 75% reduction in Psoriasis-Area-and- Severity-Index (PASI) scores (PASI 75) at 12 weeks Secondary measures included d (among others): PASI 90 (at least 90% improvement in PASI score) PASI 100 (100% improvement in PASI score) spga (static Physician Global Assessment) of 0 or 1 (clear or minimal disease) spga of 0 (clear of disease) Nail Psoriasis Severity Index (NAPSI) Psoriasis Scalp Severity Index (PSSI) 6

7 Baseline Characteristics Ixekizumab Characteristic a Placebo (N = 27) 10 mg (N = 28) 25 mg (N = 30) 75 mg (N = 29) 150 mg (N = 28) p-value b Age, years 45 ± ± ± ± ± Gender, male, n (%) 14 (52) 16 (57) 18 (60) 19 (66) 14 (50) 0.77 Weight, kg 92 ± ± ± ± ± Duration of psoriasis a, years 15 ± ± ± ± ± Previous systemic therapy, n (%) 13 (48) 12 (43) 9 (30) 6 (21) 10 (36) 0.22 BSA 19 ± ± ± ± ± PASI 16.5 ± ± ± ± ± spga 3.3 ± ± ± ± ± PSSI, (n) NAPSI, (n) 19.6 ± ± ± ± ± 12.0 (21) (21) (24) (18) (22) 35.0 ± 28.1 (17) 41.9 ± 44.8 (13) 34.9 ± 37.7 (10) 45.0 ± 46.9 (10) 46.5 ± 51.7 (10) DLQI 11.4 ± ± ± ± ± a Data presented in mean ± SD, unless otherwise mentioned, b p values are for comparisons across all treatment arms 7

8 PASI 75 At least 75% Improvement in PASI Scores from Baseline 100 % of Subjects Placebo LY 10 mg SC LY 25 mg SC LY 75 mg SC LY150 mg SC Treatment Arm %of patients at 12 weeks LY 150 mg 82 LY 75 mg 83 LY 25 mg 77 LY 10 mg 29 Placebo Weeks LY: ixekizumab SC: subcutaneous injections : treatment days p<0.05 versus placebo 8

9 PASI 90 At least 90% Improvement in PASI Scores from Baseline 100 Placebo Subject60 % of ts LY 10 mg SC LY 25 mg SC LY 75 mg SC LY150 mg SC Treatment Arm %of patients at 12 weeks LY 150 mg 71 LY 75 mg 59 LY 25 mg 50 LY 10 mg 18 Placebo Weeks LY: ixekizumab SC: subcutaneous injections : treatment days p<0.05 versus placebo 9

10 PASI % Improvement in PASI Scores from Baseline 100 Subjects60 % of Placebo LY 10 mg SC LY 25 mg SC LY 75 mg SC LY 150 mg SC Treatment Arm %of patients at 12 weeks LY 150 mg 39 LY 75 mg 38 LY 25 mg 17 LY 10 mg 0 Placebo LY: ixekizumab SC: subcutaneous injections : treatment days Weeks p<0.05 versus placebo 10

11 spga 0 Clear of Disease 100 Subject60 of s % Placebo LY 10 mg SC LY 25 mg SC LY 75 mg SC LY 150 mg SC Treatment Arm %of patients at 12 weeks LY 150 mg 46 LY 75 mg 38 LY 25 mg 20 LY 10 mg 7 Placebo Weeks LY: ixekizumab SC: subcutaneous injections : treatment days p<0.05 versus placebo 11

12 NAPSI Scores Nail Psoriasis Severity 100 Mean % Change Fr rom Baselin ne Placebo LY 10 mg SC LY 25 mg SC LY 75 mg SC LY 150 mg SC Weeks Treatment Arm Mean % change from baseline at 12 weeks LY 150 mg -49 LY 75 mg -57 LY 25 mg -24 LY 10 mg 14 Placebo 7 LY: ixekizumab SC: subcutaneous injections : treatment days p<0.05 versus placebo 12

13 PSSI Scores Scalp Psoriasis Severity ine Mean % Change From Basel Placebo LY10 mg SC LY 25 mg SC LY 75 mg SC LY 150 mg SC Treatment Arm Mean % change from baseline at 12 weeks LY 150 mg -85 LY 75 mg -95 LY 25 mg -87 LY 10 mg -43 Placebo -30 Weeks LY: ixekizumab SC: subcutaneous injections : treatment days p<0.05 versus placebo 13

14 Adverse Events Ixekizumab Placebo (N = 27) 10 mg (N = 28) 25 mg (N = 30) 75 mg (N = 29) 150 mg (N = 28) Total number of adverse events, n Serious adverse events At least 1 adverse event, n (%) 17 (63) 21 (75) 21 (70) 17 (59) 13 (46) Infections and infestations 7 (26) 12 (43) 9 (30) 9 (31) 8 (29) Nasopharyngitis c 5 (19) 3 (11) 3 (10) 3 (10) 4 (14) Upper respiratory infection 1 (4) 1 (4) 3 (10) 1 (3) 1 (4) Injection site reaction (10) 1(3) 2(7) Headache 1 (4) 4 (14) 4 (13) 1 (3) 1 (4) Allergy/hypersensitivity 2 (7) 1 (4) 1 (3) 2 (7) 1 (4) 14

15 Additional Safety Information No serious adverse events observed No significant change in mean neutrophil counts and no Grade 3 or 4 neutropenia observed Two basal cell skin carcinomas reported in one patient with a history of basal cell carcinoma; no other cancers observed Larger, longer-term studies are required to more fully characterize the safety profile of ixekizumab 15

16 Current Plans One Phase 3 trial ongoing in psoriasis: Initiated in December 2011 Randomized, double-blind, placebo-controlled Patients with chronic moderate-to-severe plaque psoriasis ~1,300 patients in the U.S., Canada, Europe, Japan and Australia Ixekizumab dosing mimics exposures at 75 mg and 150 mg doses in Phase 2 study Primary endpoints include spga 0or1andPASI75 Two additional Phase 3 trials in psoriasis to begin this year Evaluating options to study ixekizumab as a potential treatment for other autoimmune conditions such as psoriatic arthritis, ankylosing spondylitis and rheumatoid arthritis 16