Medicinova, Inc. · NASDAQ:MNOV
Medicinova — Investor Presentation (January 2009)
36 slides from Medicinova's investor presentation, Jan 12, 2009
Slide 1: Accelerating the global development and commercialization of innovative pharmaceuticals
Accelerating the global development and commercialization of innovative pharmaceuticals Exhibit 99.1
Slide 2: Forward-looking statements
Statements in this presentation that are not historical in nature constitute forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward- looking statements include, without limitation, statements regarding Medici
Slide 3: Corporate Overview: Development Company Focused on Differentiated Product Candidates
Development Company Focused on Differentiated Product Candidates • Unique access to differentiated, potentially high-value assets primarily from Japanese alliances New Approaches to Treat Serious Medical Conditions: • MN-221: IV Acute Exacerbations of Asthma candidate • Potential $500 M US opportuni
Slide 4: Business Model: Return On Investment
In-License: • Product candidates with significant clinical or preclinical data Conduct Proof-of-Concept Clinical Trials: • Conduct Phase I and Phase II clinical trials to demonstrate efficacy of compound Two Pathways Towards ROI After Phase II: 1. Continue internal development of compound towards co
Slide 5: Acute Exacerbations of Asthma
Definition: • Long-lasting and severe asthma episode that is not responsive to initial bronchodilator or corticosteroid therapy Market Opportunity: • Approximately 2 million emergency room visits in the US each year* • 500,000 hospitalizations in the US • Approximately 4,000 deaths annually in the U
Slide 6: MN-221: A New Approach to Treating Acute Exacerbations of Asthma
MN-221: A novel, highly selective 2- adrenergic receptor agonist Three Potential Advantages over current therapy 1. Better delivery system (IV) = Better Bioavailability 2. Greater selectivity for receptors in the lungs (better binding) 3. Partial agonist for receptor in the heart MN-221: A New Appro
Slide 7: Human Beta-Adrenergic Receptor Selectivity
Test Drug 1 IC 50 (M) 2 IC 50 (M) 2 -Adrenoceptor Selectivity (IC 50 for 1 / IC 50 for 2 ) Human Human -Adrenergic Receptor -Adrenergic Receptor Selectivity Selectivity Levalbuterol 7.40E-06 1.40E-06 5.3 Albuterol 9.40E-06 1.60E-06 5.9 Terbutaline 6.00E-05 6.50E-06 9.2 MN-221 5.90E-06 1.40E-07 42.4
Slide 8: Effect on Heart Rate: Combination of MN-221 & Albuterol in Dogs
Effect on Heart rate: Effect on Heart rate: Combination of MN-221 & Albuterol Combination of MN-221 & Albuterol in Dogs in Dogs
Slide 9: MN-221: Positive Phase IIa Data
MN-221-CL-004 Study Design • Randomized, placebo-controlled, double- blind, dose escalation • 23 subjects with mild-to-moderate stable asthma (FEV 60% predicted) • Doses tested (all for 15 minutes): • 0.35 µ g /min • 1.0 µ g /min • 3.5 µ g /min • µ g /min MN-221: Positive Phase IIa MN-221: Positive
Slide 10: Mean Change in FEV1 Study MN-221-CL-004
P = 0.0106 P = 0.0006 P < 0.0001 P < 0.0001 P < 0.0001 Mean Change in FEV Mean Change in FEV Study: MN-221-CL-004 Study: MN-221-CL-004 Mean Baseline: 77.83% 77.67% 76.78% 81.60% 74.66% 75.78% 78.07% 79.78% At 15 Minutes: 77.54% 79.45% 80.06% 85.74% 82.02% 83.90% 89.65% 88.04% % Predicted: -0.29% 1.7
Slide 11: Mean Change in FEV1 Study MN-221-CL-005
Mean Change in FEV Mean Change in FEV Study: MN-221-CL-005 Study: MN-221-CL-005 Mean Baseline: 69.4% Mean Baseline: 64.6% Mean: 81.5% Mean: 82.0% Placebo Mean Baseline: 68.6%
Slide 12: Phase II Interim Data Study MN-221-CL-006
Phase II Interim Data Phase II Interim Data Study: MN-221-CL-006 Study: MN-221-CL-006 • These reviews included data from a total of 18 of 36 planned patients with severe, acute exacerbations of asthma treated in emergency departments. • Decrease in the hospitalization rate from 50% to 10% with the a
Slide 13: MN-221: Next Steps
MN-221-CL-007: A randomized, double-blind, placebo-controlled Phase II clinical trial designed to evaluate the safety and efficacy of MN-221 in patients with severe, acute exacerbations of asthma • Approximately 35 clinical sites in North America, Australia and New Zealand • Enroll approximately 200
Slide 14: MN-221 Development Plan
MN-221 Development Plan MN-221 Development Plan Note: Development plans / timelines for MN-221 are subject to change *Anticipated commencement and completion dates based on current projections If we are successful in completing the double-blind Phase IIb clinical trial, we plan to conduct a Phase II
Slide 15: Multiple Sclerosis
Definition: Multiple sclerosis (MS) is an inflammatory demyelinating disease of the central nervous system (CNS), affecting approximately 500,000 people in the United States and 2 million people worldwide. There is no cure for the disease. Multiple Sclerosis Market: Over $8.2 B worldwide sales in 20
Slide 16: MN-166: A New Approach to Treating Multiple Sclerosis
MN-166: • Anti-inflammatory and neuroprotective properties in vitro and in vivo • Demonstrated effects on brain volume and lesion evolution to axonal damage • Targets primarily chronic aspects of multiple sclerosis • Oral administration Mechanisms of Action: Stimulates Neurotrophic Growth Factor Rel
Slide 17: Current Clinical Studies: MN-166-CL-001
Placebo-controlled, randomized, double-blind Phase II study: • Year 1 - 0, 10 mg tid, 20 mg tid • Year 2 - 10 mg tid, 20 mg tid • n ~ 100 MS patients/group @ 25 sites in Serbia, Ukraine, Belarus, Bulgaria and Romania Key inclusion criteria: • Males or females aged 18 to 55 years, with relapsing remi
Slide 18: MediciNova
v © MEDICINOVA
Slide 19: Chronic Efficacy Demonstrated: Effects on Brain Volume
Brain volume loss was significantly less (p=0.030) in patients receiving 60 mg per day of MN-166 for 24 months compared to the other treatment groups N=71 1.59 Chronic Efficacy Demonstrated: Chronic Efficacy Demonstrated: Effects on Brain Volume Effects on Brain Volume N=70 1.79 N=34 2.08 N=45 2.12
Slide 20: Reduction of Persistent Black Hole (PBH) Formation
Parameter Treatment Groups Placebo 30 mg/day 60 mg/day Number Patients w. New Lesions at Month 2 Total Number New Lesions in all Patients Total Number of Persistent Black Holes Proportion of Lesions Evolving to PBH 0.23 0.17 0.14 p Value - 0.036 0.004 New T1 gadolinium-enhancing or new T2 lesions we
Slide 21: Sustained Disability Progression
TREATMENT Disability Progression is defined as a sustained increase in EDSS (increase in EDSS 1 maintained for four consecutive months) Time Period Placebo to Active ( N=100 ) Active Drug [30 mg (N=94), 60 mg (N=98)] 2 Years 21/100 (21%) 20/194 (10.4%) Sustained Disability Progression Sustained Disa
Slide 22: Acute Efficacy Demonstrated: Time to First Relapse
Acute Efficacy Demonstrated: Acute Efficacy Demonstrated: Time to First Relapse Time to First Relapse Median 401 days Median 244 days P-Value: 0.044
Slide 23: MN-166: Next Steps
MN-166: NEXT STEPS MN-166: NEXT STEPS Seek Partnership for Further Development: MediciNova’s strategic objective for MN-166 is to secure a partner to advance the clinical development of MN-166, and MediciNova is actively pursuing that objective
Slide 24: Commercially-Attractive Diversified Portfolio
Commercially-Attractive Commercially-Attractive Diversified Portfolio Diversified Portfolio
Slide 25: Key Financials
Dual Listing: • MNOV (NasdaqGM), December 2006 • 4875 (Osaka – Hercules), February 2005 Cash, Cash Equivalents and Marketable Securities as of 6/30/08 : ~$47.5 M as of 9/30/08 Market cap as of 12/31/08: ~$19M Shares outstanding: 11.9 M Key Financials Key Financials
Slide 26: MediciNova
© MEDICINOVA
Slide 27: Investment Highlights
MN-221 (Acute Exacerbations of Asthma): • Proven mechanism of action • Highly selective with improved safety profile vs. standard of care • Positive Phase IIa efficacy data • Phase IIb study initiated by holding an Investigator’s meeting in January 2009 MN-166 (Multiple Sclerosis): • Both chronic an
Slide 28: Addendum: Additional Data
Addendum: Addendum: Additional Data
Slide 29: MN-221 Study Design
MN-221-Study 6 Design MN-221-Study 6 Design • Randomized, modified single-blind, dose escalation, placebo-controlled Phase II Study in acute asthma patients in EDs • Approx. 36 patients in 3 dose cohorts at 8 ED clinical sites • Doses: 16µg/min x15 (240µg) 30µg/min x15 (450µg) 16µg/min x15;8µg/min x
Slide 30: MN-221: Safety
MN-221: Safety MN-221: Safety Phase IIa Study Safety Findings: • No clinically significant cardiovascular, ECG, or vital sign changes, or other safety concerns, observed at doses up to 30 micrograms/minute for 15 minutes or any time point thereafter • 60 micrograms/minute infusion improved FEV1 sign
Slide 31: Unmet needs in current multiple sclerosis therapies
Description Efficacy (relapse rate) Current agents offer only 30-50% relapse reduction Neutralizing antibodies can diminish efficacy over time Progression (RRMS) –neurodegeneration leads to permanent functional disability No approved treatment for PPMS, SPMS AEs—including flu-like symptoms SAEs –Rar
Slide 32: Approved MS therapies: sales, sponsors and side effects
Approx. Sales 2007** Compound Sponsor Side Effects $3.3 Billion Copaxone® Teva & Sanofi-Aventis Pain, redness, swelling, itching, chest pain, weakness, infection, nausea, anxiety are most common, also heart palpitations and trouble breathing after injection $1.9 Billion Avonex® Biogen-Idec Depressio
Slide 33: Chronic Efficacy Demonstrated: Effects on Brain Volume
Brain volume changes are linked to axonal loss Chronic Efficacy Demonstrated: Chronic Efficacy Demonstrated: Effects on Brain Volume Effects on Brain Volume 1.20 A.5
Slide 34: Reduction of Persistent Black Hole (PBH) Formation, a Sign of Axonal Loss
Reduction of Persistent Black Hole (PBH) Formation Parameter Treatment Groups Placebo 30 mg/day 60 mg/day # Patients w. New Lesions at Month 2 # Patients w. 1 PBH (% of Pts. w. New Lesions) 41 (56.9%) 33 (51.6%) 28 (50%) Mean Proportion of Lesions Evolving to PBH 0.24 0.20 0.16 Median Proportion of
Slide 35: MN-166 was very well tolerated in Phase II study
• MN - 166 was very well tolerated in Phase II study: 89% (264 of 297) of subjects completed the first 12 months of the study 82.5% (245 of 297) of subjects completed the full 24 months of the study • Discontinuation due to adverse effects was infrequent (5.1% in mg/day for months, 2.1% in 30 mg/day
Slide 36: Safety Comparison with Other Oral Agents
Compound Sponsor Current Phase Safety Profile from Phase II trials MN-166 MediciNova Phase II Mild, transient GI upset FTY 720 Novartis Phase III Blood pressure Heart rate Dyspnea Liver enzymes Lymphopenia Cladribine Merck Serono Phase III Fever Nausea, Vomiting Leucopenia BG-12 Biogen-Idec Phase II