Photocure ASA · OSL:PHO
Photocure ASA — Technical Presentation (May 2012)
23 slides from Photocure ASA's technical presentation, May 31, 2012
Slide 1: Visonac Phase 2b Clinical Trial Results
Visonac® Phase 2b Clinical Trial Results May 31, 2012
Slide 2: Introduction
Introduction • Visonac® (methyl aminolevulinate) is a key late stage asset within the Photocure pipeline • Visonac is non-systemic • Dual mechanism of action – kills P acnes and decreases sebum production • Clinical experience gained in >400 patients • Phase 2b clinical trial initiated in July ’11 –
Slide 3: Program
Program • Acne – Disease State and Market Dynamics – Grete Hogstad, Vice President, Strategic Marketing • Results of phase 2b Trial – David Pariser, MD, Principal Investigator Professor of Dermatology, Eastern Virginia Medical School, Norfolk, Virginia Former President of the American Academy of Der
Slide 4: Acne – Disease State and Market Dynamics
Acne – Disease State and Market Dynamics Grete Hogstad 4
Slide 5: Acne – The Disease
Acne – The Disease • Acne is a high prevalence disease – 120 million patients afflicted in US and top 5 EU markets – Impacts 80-90% of young people • Continues through age 20-40 – 95% of patients seek medical advice • Clinical studies demonstrate that acne has a greater impact on emotional state and
Slide 6: Acne an Attractive Market
Acne an Attractive Market Leading Dermatology Markets Forecast, 2012 est • Acne is a large and growing segment in ACNE Dermatology PSORIASIS DERMATITIS – 3rd largest segment in Dermatology SKIN INFECTIONS MISCELLANEOUS – Represents 17% of the overall dermatology Global Acne Market Forecasts 2010 -20
Slide 7: High Unmet Need in Acne
High Unmet Need in Acne • High unmet need in the segment of moderate to Sales, Billions severe acne 0,25 Topicals – Current mainstay of therapy are oral, systemic 0,35 Isotretinoin antibiotics, retinoids, combinations 0,3 Oral Antibiotics Other Orals – Value of this segment ~$900 million globally 2,
Slide 8: Preparations to Secure Optimal Market Access
Preparations to Secure Optimal Market Access • Pricing and reimbursement • Expand clinical trials • Expand Key Opinion Leader network • Sales force sizing and targeting • Packaging and supply – Including lamp distribution and service • Finalize strategy ex-US Photocure’s US Commercial Operation layi
Slide 9: Phase 2b study of photodynamic therapy with Visonac cream in acne vulgaris
A double blinded, prospective, randomized, vehicle controlled multi-center study of photodynamic therapy with Visonac cream in patients with acne vulgaris David Pariser, MD 9
Slide 10: Trial Designed Based on Previous Clinical Experience
Trial Designed Based on Previous Clinical Experience • Red light selected as optimal wavelength to adequately penetrate sebaceous glands • Selection of optimal dose and incubation time based on degree of accumulation of fluorescence in both sebaceous glands Wavelength dependent penetration of light
Slide 11: Acne Inclusion Criteria
Acne Inclusion Criteria • High degree of acne severity due to numerous inflammatory lesions – IGA score 4 • Most of face involved, with comedones, numerous papules and pustules, and/or few nodules (<4) • Lesion count: – 25-75 inflammatory lesions (papules, pustules, and nodules) – 20-100 non-inflamm
Slide 12: Clinical Trial Design
Clinical Trial Design • Patients randomized to either Visonac cream plus red light illumination or Control (vehicle cream plus red light illumination) (2:1) – Independent review of eligibility of all patients at baseline • 1.5 hour incubation with occlusion followed by red light illumination – (632
Slide 13: Patient Demographics
Patient Demographics Demographics Visonac (N=100) Control (N=53) Mean age, years 18.6 18.6 Age 12-17 years 59 (59.0%) 35 (66.0%) Females/Males 44 / 56 22 / 31 (44.0% / 56.0%) (41.5% / 58.5%) Skin type: I-III 73 (73.0%) 39 (73.6%) IV 15 (15.0%) 7 (13.2%) V-VI 12 (12.0%) 7 (13.2%) Received systemic tr
Slide 14: Efficacy Results - Inflammatory Lesions
Efficacy Results - Inflammatory Lesions Reduction in number of inflammatory lesions Percent reduction of from baseline to week 12 inflammatory lesions at week 12 0 50% -2 45% -4 40% P=0.006 P=0.003 -6 35% -8 30% Visonac Visonac 25% -10 Control Control 20% -12 15% -14 10% -16 5% -18 0% Baseline Week
Slide 15: Efficacy Results - Improvement in Severity of Acne
Efficacy Results - Improvement in Severity of Acne Percentage of patients with reduced acne severity IGA scale 50% P=0.013 45% 40% 35% 30% 25% 20% Visonac Control 15% 10% 5% 0% Week 2 Week 4 Week 6 Week 12 15 Defined as an improvement of at least 2 grades on the IGA scale
Slide 16: Example of Reduction in Acne Severity Grade
Example of Reduction in Acne Severity Grade Week 12 Baseline 6 weeks after last treatment 16
Slide 17: Efficacy Results – Non-Inflammatory Lesions
Efficacy Results – Non-Inflammatory Lesions 0 -2 P=0.853 -4 -6 Visonac -8 Control -10 -12 -14 Baseline Week 2 Week 4 Week 6 Week 12 Significant and Comparable Results in Both Groups 17
Slide 18: Safety and Tolerability
Safety and Tolerability • No serious adverse events were reported • Most common adverse events reported were local pain and erythema • Pain – mild and transient Visual Analogue Score – Measured by Visual Analogue Score (0 – 10) during Scale illumination – Visonac mean = 3.4 during 1st illumination –
Slide 19: Summary of Clinical Trial Results
Summary of Clinical Trial Results • Visonac demonstrated efficacy versus control – Statistically significant reduction in inflammatory lesions – Statistically significant higher treatment success rate as defined by reduction in acne severity grade – Non-inflammatory lesions were reduced in both arms
Slide 20: Clinical Development Plan
Clinical Development Plan Inger Ferner Heglund 20
Slide 21: Phase 3 Development Plan
Phase 3 Development Plan • PHO will complete development and registration for both US and EU, leveraging its expertise with previous drug-device approvals • Continue discussions with regulatory authorities to finalize phase 3 study design – Number of subjects, duration of follow up, others 2 H 2012
Slide 22: Concluding Remarks and Q&A
Concluding Remarks and Q&A Kjetil Hestdal 22
Slide 23: Concluding Remarks
Concluding Remarks • Photocure Technology™ to solve high unmet needs of patients and consumers worldwide • Results of the phase 2b trial are significant and position Photocure to advance into the global phase III registration trials • Demonstrates the continued commitment to deliver on the milestone