Orion Oyj Class A · OMXHEX:ORNAV
Orion Oyj Class A — Investor Day (May 2019)
32 slides from Orion Oyj Class A's investor day presentation, May 22, 2019
Slide 1: R&D – The key engine for profitable growth
R&D – The key engine for profitable growth Christer Nordstedt SVP, Research & Development
Slide 2: Disclaimer
Disclaimer This presentation contains forward-looking statements which involve risks and uncertainty factors. These statements are not based on historical facts but relate to the Company’s future activities and performance. They include statements about future strategies and anticipated benefits of
Slide 3: Strategic goals
Strategic goals Deliver late-stage Build Maximize value portfolio early portfolio of assets Innovation system Competence base Therapy area work Capital Markets Day of Orion Corporation © Orion Oyj 22 May 2019 3
Slide 4: Achieving more in R&D
Achieving more in R&D Late stage Research Early development development Target Hit to Lead Lead Candidate Phase I Phase II Phase III identification generation optimisation selection, and validation preclinical development 8‒24 mo. 12‒24 mo. 18‒36 mo. 12‒24 mo. 12‒14 mo. 12‒36 mo. 18‒48 mo. Collabora
Slide 5: More focused R&D
More focused R&D Building long-term growth in R&D Innovation system helping patients with unmet needs Competence base Key actions: Therapy area work ● Increase the number of promising research projects Changes over the last 2 years ● Extend beyond small molecules in R&D ● Restructured R&D from proce
Slide 6: Focus areas of Orion’s R&D
Focus areas of Orion’s R&D Proprietary products Animal Health Fermion • Central nervous system • Orion utilises the • APIs to Orion’s • Oncology R&D of proprietary proprietary products • Respiratory products to develop • Generic APIs (Easyhaler product family) new medicines for • Contract developmen
Slide 7: Orion’s key clinical drug development programs
Orion’s key clinical drug development programs Project Indication Phase Registration Easyhaler® tiotropium COPD Bioequivalence study Darolutamide 1) Prostate cancer (nmCRPC) I II III FDA Priority Review Darolutamide 1) Prostate cancer (mHSPC) I II III ODM-109 (oral levosimendan) ALS I II III ODM-203
Slide 8: Interesting non-clinical projects under investigation to ensure long-term success
Interesting non-clinical projects under investigation to ensure long-term success • Parkinson’s disease (PD), amyotrophic lateral sclerosis (ALS) CNS and chronic pain Therapy Area • Currently primarily symptomatic treatments • Common cancer types, such as steroid hormone-dependent Oncology prostate
Slide 9: R&D balancing between technical probability and commercial potential
R&D balancing between technical probability and commercial potential High Sweet Probability of technical success spot Low Low Commercial potential High Capital Markets Day of Orion Corporation © Orion Oyj 22 May 2019 9
Slide 10: Darolutamide (ODM-201) for prostate cancer
Darolutamide (ODM-201) for prostate cancer Prof. Heikki Joensuu VP, Therapy Area Oncology
Slide 11: Darolutamide: Invented at Orion, co-developed with Bayer
Darolutamide: Invented at Orion, co-developed with Bayer • A structurally unique androgen-receptor antagonist • Under development for the treatment of prostate cancer • Preclinical studies indicate a low risk for drug-drug interactions Enzalutamide Apalutamide Darolutamide* (Pfizer, Astellas) (Janss
Slide 12: Two Phase III studies with darolutamide ongoing: ARAMIS and ARASENS
Two Phase III studies with darolutamide ongoing: ARAMIS and ARASENS ARAMIS target population: Localized prostate cancer that no longer responds to chemical (or surgical) castration ARASENS target population: Overtly metastatic prostate cancer that is sensitive to chemical (or surgical) castration Ca
Slide 13: ARAMIS: Darolutamide vs. placebo in hormone-insensitive localized prostate cancer
ARAMIS: Darolutamide vs. placebo in the treatment of hormone-insensitive localized prostate cancer1 Median metastasis-free survival improved from 18 months (placebo) to 40 months (darolutamide) Darolutamide Placebo P < 0.001 Hazard ratio 0.41 1Fizazi K, Shore N, Tammela TL, et al. N Engl J Med 2019;
Slide 14: ARAMIS: Darolutamide vs. placebo in hormone-insensitive localized prostate cancer
ARAMIS: Darolutamide vs. placebo in the treatment of hormone-insensitive localized prostate cancer1 A strong trend for improved overall survival in favor of darolutamide Darolutamide ,,, Placebo P = 0.045 Hazard ratio 0.71 1Fizazi K, Shore N, Tammela TL, et al. N Engl J Med 2019;380:1235-46 Capital
Slide 15: Key messages from the ARAMIS trial
Key messages from the ARAMIS trial Fizazi K ym. NEJM 2019; 380:1235-46 • Darolutamide has substantial efficacy (like enzalutamide and apalutamide) • Darolutamide has an excellent safety profile: parallels placebo - No side effect occurred in >10% of the patients except fatigue (darolutamide 12%, pla
Slide 16: Capital Markets Day of Orion Corporation © Orion Oyj 22 May 2019
Capital Markets Day of Orion Corporation © Orion Oyj 22 May 2019 16
Slide 17: Oral levosimendan (ODM-109) in ALS
ORAL levosimendan (ODM-109) in ALS The REFALS phase 3 study
Slide 18: Levosimendan in Amyotrophic Lateral Sclerosis (ALS)
Levosimendan in Amyotropic Lateral Sclerosis (ALS) IV levosimendan (Simdax®) has been used for short-term treatment of acutely 1 decompensated severe chronic heart failure (CHF), since 2000 ALS is a rare, devastating, neurodegenerative disorder with few treatment options, 2 causing progressive weakn
Slide 19: The LEVALS phase 2 study of oral levosimendan
The LEVALS phase 2 study of oral levosimendan • Pilot crossover study to establish proof of concept • Primary endpoint (sitting slow vital capacity SVC) was negative but there was a significant change in supine slow vital capacity • Supine vital capacity correlates better with diaphragmatic weakness
Slide 20: The REFALS study of oral levosimendan in ALS
The REFALS study of oral levosimendan in ALS Objectives Methodology Efficacy endpoints ● Demonstrate benefit of oral ● Phase 3 randomised, double-blind, ● PRIMARY levosimendan on respiratory placebo-controlled Supine slow vital capacity at and overall function in ALS 12 weeks ● 450 patients with ALS
Slide 21: REFALS study progress
REFALS study progress 104 ALS centres in 14 countries • REFALS is an Orion study, • 1st patient randomised July 2018 • Patient accrual is rapid – Last patient randomisation is expected July 2019 – Last patient visit expected July 2020 – Study results 2nd half 2020 • REFALS-ES on schedule to accept 1
Slide 22: Update on CYP11A1 platform (ODM-208/209)
Update on CYP11A1 platform (ODM-208/209)
Slide 23: CYP11A1 inhibitors (ODM-208 and ODM-209)
CYP11A1 inhibitors (ODM-208 and ODM-209) ● First-in-class compounds CHOLESTEROL ● Orion leads the development in the world CYP11A1 INHIBITOR ● CYP11A1-inhibitors prevent the synthesis of ALL steroid hormones ● Glucocorticoids and mineralocorticoids need to be replaced during therapy PREGNENOLONE All
Slide 24: CYP11A1 inhibitors have wide potential indications
CYP11A1 inhibitors have wide potential indications ● Prostate cancer (1.3 million cases/year; the 2nd most common cancer in males in the world1) ● 70% of breast cancers (estrogen receptor-positive cancers; 1.5 million cases/year; the most common cancer in females1) ● Endometrial cancer of the uterus
Slide 25: Orion investigates CYP11A1 inhibitors in two first-in-human Phase I-II trials
Orion investigates CYP11A1 inhibitors in two first-in-human Phase I-II trials The CYPIDES trial (ODM-208) The STESIDES trial (ODM-209) • Advanced prostate cancer that • Advanced prostate cancer that progressed during ≥1 novel progressed during one or more novel hormonal therapy and hormonal therapy
Slide 26: Update on ODM-203 and ODM-207
Update on ODM-203 and ODM-207
Slide 27: Update on ODM-203 and ODM-207
Update on ODM-203 and ODM-207 ODM-203 ODM-207 • A tyrosine kinase inhibitor • A BET inhibitor (inhibits key (FGFRs and VEGF) oncogenes, such as Myc) • KIDES Phase I-II trial: • A unique structure • 84 patients, various types • BETIDES Phase I-II trial: of cancers • Various types of solid tumors • 9%
Slide 28: Update on Easyhaler development projects
Update on Easyhaler development projects
Slide 29: Orion continues investing in Easyhaler
Orion continues investing in Easyhaler® Tiotropium Easyhaler ● We are developing a new second entry product for COPD (Chronic obstructive pulmonary disease) indication ● Tiotropium Easyhaler is in bioequivalence studies ● We have utilized the learnings from budesonide-formoterol and salmeterol-fluti
Slide 30: Connected Easyhaler
Connected Easyhaler Our aim is to ● Increase treatment adherence ● Strengthen patient-physician relationships ● Reduce hospitalisations Improve disease control and Quality of Life Capital Markets Day of Orion Corporation © Orion Oyj 22 May 2019 30
Slide 31: Orion’s R&D vision for the future success
Orion’s R&D vision for the future success 1 Brain power and muscle combined with agility of A preferred partner for other pharma companies and Increased visibility within the academic community and a small biotech. research institutions. capabilities to recruit and retain “the best and the brightest
Slide 32: Thank you!
Thank you!