Slide 1: R&D Presentation for Investors after FY2016
R&D Presentation for Investors after FY2016
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: Focus areas of Orion's R&D
Focus areas of Orion’s R&D Proprietary Products Animal Health Fermion Orion Diagnostica • CNS Orion utilises the • APIs to Orion’s • QuikRead test • Oncology R&D of proprietary proprietary system • Respiratory products to develop products • GenRead test (Easyhaler® new medicines for • Generic APIs s
Slide 4: Together we can achieve more in R&D
Together we can achieve more in R&D Late stage Research Early development development Target Candidate Phase I Phase II Phase III Hit to Lead Lead identification selection, generation optimisation and validation preclinical development 12–24 mo 18–36 mo 8–24 mo 12–24 mo 12–14 mo 12–36 mo 18–48 mo Co
Slide 5: Clinical development pipeline
Clinical development pipeline 5 2017 R&D presentation for investors © Orion Corporation
Slide 6: Key clinical pharmaceutical development projects 1/2
Key clinical pharmaceutical development projects 1/2 Project Indication PHASE Registration Easyhaler® budesonide-formoterol Asthma, COPD BEq study 1) Registration2) Easyhaler® salmeterol-fluticasone Asthma, COPD BEq study 1) ODM-201 (androgen receptor antagonist) 3) Prostate cancer (nmCRPC) I II III
Slide 7: Key clinical pharmaceutical development projects 2/2
Key clinical pharmaceutical development projects 2/2 Project Indication PHASE Registration ODM-109 (oral levosimendan) ALS I II ORM-12741 (alpha-2c adrenoceptor antagonist) 5) Alzheimer’s disease I IIa ODM-104 (more effective COMT inhibitor) Parkinson’s disease I II ODM-203 (targeted FGFR+VEGFR inhi
Slide 8: ODM-201 (androgen receptor antagonist)
ODM-201 (androgen receptor antagonist) A novel second generation androgen receptor (AR) antagonist for the treatment of prostate cancer In collaboration with Bayer. 8 2017 R&D presentation for investors © Orion Corporation
Slide 9: ODM-201: Partnership with Bayer – Financial terms
ODM-201: Partnership with Bayer – Financial terms ● Orion and Bayer will jointly develop ODM-201, with Bayer contributing a major share of the costs of future development ● Bayer will commercialise ODM-201 globally and Orion has the option to co-promote ODM-201 in Europe ● Orion is eligible to recei
Slide 10: ODM-201 has a unique profile
ODM-201 has a unique profile Enzalutamide 19%* ODM-201 3% ** ARN-509 29%* Enzalutamide ARN-509 ODM-201 general structure Antagonism IC50 (nM) Proliferation AR affinity Compound AR AR AR VCaP Ki (nM) WT AR (F876L) (T877A) (W741L) IC50 (nM) Bicalutamide 12 150 218 957 Agonist Enzalutamide 86 155 Agoni
Slide 11: ODM-201: Phase III study ongoing in nmCRPC
ODM-201: Phase III study ongoing in non-metastatic castration resistant prostate cancer (nmCRPC) ODM-201 (androgen receptor antagonist) Prostate cancer (nmCRPC) I II III ● nmCRPC patients who are at high risk for developing metastatic disease are included (n=1,500) ● Primary endpoint ● ODM-201 over
Slide 12: ODM-201: Phase III study in mHSPC
ODM-201: Phase III study in metastatic hormone sensitive prostate cancer (mHSPC) ODM-201 (androgen receptor antagonist) Prostate cancer (mHSPC) I II III ● ARASENS is a randomized, double-blind, placebo-controlled multicenter study ● Approximately 1,300 patients will be randomized (1:1 ratio) to rece
Slide 13: ODM-203
ODM-203 A unique and selective dual FGFR+VEGFR inhibitor for FGFR-dependent tumors 13 2017 R&D presentation for investors © Orion Corporation
Slide 14: Angiogenic indications with altered FGFR signalling
Angiogenic indications with altered FGFR signalling Tumor type Genomic alterations of FGFRs and FGFs Breast (luminal) ~35% (FGFR1 amp, FGFR2 amp, FGFR4 amp, FGFs) NSCLC-SCC ~20% (FGFR1 amp, FGFR2 amp) Bladder (invasive) ~15% (FGFR3 fusions, FGFR1 amp, FGFs) Prostate ~14% (FGFR1 amp, FGFR2&3 fusions)
Slide 15: ODM-203 has strong in vivo antitumor activity
ODM-203 has strong in vivo antitumor activity ClinicalTrials.gov identifier: ODM-203 (targeted FGFR+VEGFR inhibitor) Solid tumours I II NCT02264418 Angiogenic kidney cancer model (Renca) 600 FGFR xenograft model (RT4) 500 400 300 200 100 0 0 2 4 6 8 10 12 14 16 18 20 Treatment day Vehicle control p.
Slide 16: ODM-207
ODM-207 BET protein inhibitor 16 2017 R&D presentation for investors © Orion Corporation
Slide 17: ODM-207
ODM-207 ODM-207 (BET protein inhibitor) Cancer I ● ODM-207 is an investigational small molecule that has a unique chemical structure designed to block the growth of cancer cells through potent and selective inhibition of BET family proteins. In preclinical studies, ODM-207 has shown antiproliferativ
Slide 18: ORM-12741 for Alzheimer's disease
ORM-12741 for Alzheimer’s disease alpha-2c adrenoceptor antagonist In collaboration with Janssen 18 2017 R&D presentation for investors © Orion Corporation
Slide 19: ORM-12741 – collaboration with Janssen
ORM-12741 – collaboration with Janssen ● Licence agreement announced on 19 December 2013 (includes ORM-12741 and other compounds) ● Orion received USD 31 million upfront payment which is mainly used against current ongoing additional Phase IIa study costs ● Orion is eligible to receive milestone pay
Slide 20: ORM-12741
ORM-12741 ● Highly potent and selective alpha-2C adrenoceptor antagonist Quality of Memory ● Rodent models predict beneficial effects on cognition and neuropsychiatric symptoms (NPS) Improvement ● Phase 1 studies (healthy subjects) – Possible to administer orally – Well tolerated – Displacement of a
Slide 21: Phase 2 study on efficacy of ORM-12741 in AD
Phase 2 study on efficacy of ORM-12741 in AD ClinicalTrials.gov identifier: NCT02471196 ORM-12741 (alpha-2c adrenoceptor antagonist) Alzheimer’s disease I IIa ● New formulation improving pharmacokinetic (PK) properties of ORM-12741 is used in the current Phase 2 study Objectives To evaluate efficacy
Slide 22: ODM-104
ODM-104 more effective COMT inhibitor 22 2017 R&D presentation for investors © Orion Corporation
Slide 23: New COMT-inhibitor ODM-104 for Parkinson's disease treatment
New COMT-inhibitor ODM-104 for Parkinson’s disease treatment ODM-104 (more effective COMT inhibitor) Parkinson’s disease I II ● In phase I, ODM-104 has been in well tolerated and superior to entacapone by improving COMT inhibition and levodopa pharmacokinetics in man ● Optimized carbidopa component
Slide 24: ODM-109
ODM-109 Oral levosimendan Best symptomatic treatment for Amyotrophic Lateral Sclerosis (ALS) 24 2017 R&D presentation for investors © Orion Corporation
Slide 25: LEVALS study - levosimendan in ALS patients
LEVALS study - levosimendan in ALS patients ODM-109 (oral levosimendan) ALS I II ● Although the trial did not achieve its primary objective (oral levosimendan did not improve respiratory function against placebo measured by Slow Vital Capacity), the findings were, however, promising. Based on the fi
Slide 26: Levosimendan for Low Cardiac Output Syndrome
Levosimendan for Low Cardiac Output Syndrome Partner Tenax Therapeutics 26 2017 R&D presentation for investors © Orion Corporation
Slide 27: Levosimendan development in the US by Tenax Therapeutics
Levosimendan development in the US by Tenax Therapeutics Levosimendan Low Cardiac Output Syndrome I II III ● Phase 3 LEVO-CTS trial evaluated the efficacy of levosimendan in reducing morbidity/ mortality in cardiac surgery patients with reduced ejection fraction ● According to the preliminary findin
Slide 28: Orion
Orion Building well-being. Together. 28 2017 R&D presentation for investors © Orion Corporation