Jefferies Healthcare Conference. June 25, 2008

Transcription

1 Jefferies Healthcare Conference June 25, 2008

2 Safe Harbor Statement Except for the historical information set forth herein, the matters set forth in this presentation,including without limitation statements regarding our anticipated future success in drug discovery and development, growing product pipeline and strategy, strong cash position, plans and expected timelines for advancing our drug candidates through preclinical and clinical trials, potential therapeutic and commercial value, including attributes and indications of our drug candidates, the anticipated cash burn, intentions to commercialize drug candidates ourselves and intentions to enter into a strategic partnership, contain predictions, estimates and other forwardlooking statements. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including the risk that results of clinical trials may be unsuccessful or insufficient to meet applicable regulatory standards, the high degree of risk associated with drug development, the uncertainty of the FDA approval process, the ability to enroll sufficient numbers of subjects in its clinical trials, the impact of competition and technological advances, the results of further scientific research, unanticipated delays, the ability of Incyte to compete against parties with greater financial or other resources, greater than expected expenses, economic factors, unanticipated or unpredictable expenses relating to litigation or strategic activities, our ability to obtain additional capital when needed, risks related to product candidates that are in-licensed, risks related to obtaining effective patent coverages for our products and other risks detailed from time to time in Incyte s reports filed with the Securities and Exchange Commission, including our Form 10-Q for the quarter ended March 31, 2008 and our filings with the SEC. Incyte disclaims any intent or obligation to update these forward-looking statements.

3 Incyte Today Expanding and maturing pipeline in several therapeutic areas: Oncology Inflammation Diabetes Highly productive R&D team that has progressed multiple proprietary small molecule compounds into clinical testing Proof-of-concept results achieved in several lead programs Strategic development and commercial plan Retain programs with well-defined markets that we can develop on our own Establish partnerships for compounds that address primary care markets or require lengthy development programs Solid cash position $219 million as of 3/31/08

4 Incyte s Clinical Pipeline Target Incyte Compound Indication Phase I Phase II Phase III JAK INCB18424 (oral) Myelofibrosis PV / ET* Multiple myeloma Prostate cancer Rheumatoid arthritis Psoriasis INCB18424 (topical) Psoriasis INCB28050 (preclinical) Lead follow-on HSD1 INCB13739 Type 2 diabetes INCB20817 Type 2 diabetes HM74a INCB19602 Type 2 diabetes Sheddase INCB7839 Multiple solid cancers Breast cancer CCR2 INCB8696 Multiple sclerosis PF (Pfizer) Osteoarthritis pain CCR5 INCB9471 HIV INCB15050 HIV *Polycythemia vera / Essential thrombocythemia

5 INCB18424: Summary of Recently Presented Phase I/II Results in Myelofibrosis Patients (ASCO 2008) Well tolerated at clinically active doses reversible thrombocytopenia is the dose limiting toxicity manageable with dose reduction (or if necessary, dose interruption) in most patients Demonstrates marked and durable improvement in spleen size Demonstrates marked and durable improvement in constitutional symptoms Results in striking reduction in systemic cytokine levels 5

6 How Important Is Spleen Reduction? Idiopathic Myelofibrosis,Ronald Hoffman,,University of Illinois College of Medicine; Organomegaly with muscle wasting in end stage MF patient Ninety percent of MF patients present with an enlarged spleen; 50% present with an enlarged liver Multiple complications including: significant discomfort loss of mobility early satiety difficulty breathing portal hypertension Increased cytokine production associated with extramedullary hematopoesis in the spleen: profound fatigue cachexia fever night sweats pain

7 INCB18424 Results in Rapid and Profound Reduction in Spleen Size (ASCO 2008) mg BID 24 Patients with Palpable Spleen or Liver 10 mg BID 12 Patients with Palpable Spleen or Liver Spleen Size, cm N=11 N=8 N= N=17 N=9 N= Days on Therapy NOTE: Data is censored after a dose change or dose interruption 7

8 Effect of Dose Reductions on Maintenance of Spleen Size Reduction (ASCO 2008) N=6 Spleen size, cm N=6 N=6 N=3 0 Baseline On 25 mg BID 1 Mo Post 3 Mo Post Mean + SEM for N=6 Changing dose to 25 mg QD 8

9 Improvement in Constitutional Symptoms (ASCO 2008) 25 mg BID 10 mg BID MFSAF Score (Maximum = 10) N=14 N=10 N=7 N=11 N=8 N=8 Fatigue Night Sweats Pruritis 0 Baseline 1 Mo 3 Mo Baseline 1 Mo 3 Mo Baseline 1 Mo 3 Mo Baseline 1 Mo Baseline 1 Mo Baseline 1 Mo Includes only patients with assessment for all time points 9

10 INCB18424: Next Steps Prospectively evaluate and select clinical endpoints Submit Special Protocol Assessment Present additional Phase II results at ASH

11 INCB18424: Summary of Recently Presented Phase IIa Results in Rheumatoid Arthritis Patients (EULAR 2008) INCB18424 at 15 mg BID was safe and very well tolerated in RA patients for 28 days: 12 treated, 4 placebo ACR20/50/70/90 responses achieved in 75%-50%-25%-17% of treated patients Individual parameters of the ACR score demonstrated similar trends of improvement Clinical activity seen as early as 1 week of dosing Oral treatment with INCB18424 has the potential to be more effective than currently available RA therapy, including injectable biologicals Additional doses of INCB18424 are currently being evaluated in this ongoing Phase IIa trial: 5 mg BID, 25 mg BID and 50 mg QD

12 Efficacy of 15 mg BID in Rheumatoid Arthritis (EULAR 2008) % with ACR Score D % of Subjects with ACR Scores on Day 28 75% 50% 25% 17% 50% Active Placebo N=12 N=4 Treatment 0% 0% 0% ACR 20 ACR 50 ACR 70 ACR 90

13 Improvement Seen in All ACR Parameters (EULAR 2008) % Improvement on Day % Improvement in Parameter (SEM) Tender Joint Count Swollen Joint Count ESR CRP Subject's Pain Assessment Subject's Global Assessment Physician's Global Assessment HAQ 0

14 INCB13739: Summary of Phase IIa Results in Type 2 Diabetic Patients (ADA 2008) 100 mg INCB13739 BID was safe and well tolerated over 28 days in patients with type 2 diabetes mellitus INCB13739 therapy led to statistically significant improvements in: hepatic insulin sensitivity plasma LDL-cholesterol plasma total-cholesterol Trends for improvements also observed in fasting plasma glucose, peripheral insulin sensitivity, plasma triglycerides, blood pressure INCB13739 has the potential to target multiple macrovascular risk factors in concert in patients with type 2 diabetes mellitus INCB13739 is currently being studied in a dose-ranging Phase IIb study in T2D patients whose glucose levels are not adequately controlled by metformin monotherapy

15 INCB13739: Primary Clamp Endpoints (ADA 2008) Mean change from baseline (mg/kg/min) mg/kg/min P= mg/kg/min P= PBO (3) INCB (15) PBO (4) INCB (14) End-of-study analysis, PP EGP (Low Insulin) Rd (High Insulin)

16 INCB 13739: Secondary Glucose, Lipid Endpoints (ADA 2008) P=0.075 P=0.007 P= PBO-adjusted FPG change from baseline (LS Mean; mg/dl) -80 All subjects FPG > 160 mg/dl PBO-adjusted change from baseline (LS Mean; mg/dl) (15A/4P) CHOL LDL TG HDL End-of-study analysis, PP

17 Steady Stream of Clinical Data Target Incyte Product Indications Expected Clinical Event Timing JAK INCB18424 (oral) Myelofibrosis Present Ph I/IIa results ASH 2H08 Initiate registration trials 4Q08/1Q09 PV / ET Top-line Ph IIa data ASH 2H08 Multiple myeloma Top-line Ph II data 2H08 Prostate cancer Top-line Ph II data 2H08 Rheumatoid arthritis Present Ph IIa data ACR 2H08 Initiate Ph IIb trial 2H08 INCB18424 (topical) Psoriasis Present Ph IIa data EADV 2H08 INCB28050 (preclinical) Lead follow-on Complete Ph I trials 2H08 HSD1 INCB13739 Type 2 diabetes Complete Ph IIb trial Mid-09 INCB20817 Type 2 diabetes Complete Ph I trial 1H08 HM74a INCB19602 Type 2 diabetes Top-line Ph IIa data 2H08/1H09 Sheddase INCB7839 Breast cancer Present top-line Ph II data 2H08 CCR2 INCB8696 Multiple sclerosis Complete Ph I trial 1H08