Medicinova, Inc. · NASDAQ:MNOV
Medicinova — Investor Presentation (March 2010)
27 slides from Medicinova's investor presentation, Mar 9, 2010
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 statements regarding MediciNova’s clinical trials
Slide 3: MediciNova Corporate Overview
MediciNova Overview: • Founded in September 2000 • Headquartered in San Diego, CA • Additional office in Tokyo, Japan • Dual-listing on NasdaqGM as MNOV and Osaka Securities Exchange as 4875 • $93.9 million Market Cap (NasdaqGM) as of 3/05/2010 Development Company Focused on Differentiated Product C
Slide 4: MN-221 for Exacerbations of Acute Asthma and COPD
Definition: • Acute Asthma Exacerbations: Long-lasting and severe asthma episodes that are not responsive to initial bronchodilator or corticosteroid therapies • COPD Exacerbations: Sustained worsening of the patient's condition, from the stable state and beyond normal day-to-day variations, that is
Slide 5: Acute Asthma Treatment Flow in Emergency Departments in the U.S.
525,000 Acute Asthma Treatment Flow in Acute Asthma Treatment Flow in Emergency Departments in the U.S. Emergency Departments in the U.S. 1,900,000 1,900,000 Patients receive standard of care in Emergency Department Positive Response ~51% Continue therapy until patient is discharged Annual number of
Slide 6: MN-221: A New Approach to Treating Exacerbations of Acute Asthma & COPD
1. Improved Efficacy • Route of Administration (IV v. Inhalation) 2. Improved Safety • Higher selectivity for ß 2 receptor than ß 1 • Partial agonist for ß 1 receptor 3. Reduced Health Care Expenses MN-221: A New Approach to Treating MN-221: A New Approach to Treating Exacerbations of Acute Asthma &
Slide 7: Human ß-Adrenergic Receptor Selectivity
Test Drug ß 1 IC 50 (M) ß 2 IC 50 (M) ß 2 -Adrenoceptor Selectivity (IC 50 for ß 1 / IC 50 for ß 2 ) Human ß-Adrenergic Receptor Human ß-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.
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 in Dogs Combination of MN-221 & Albuterol in Dogs
Slide 9: MN-221 Clinical Trials
MN-221 Clinical Trials MN-221 Clinical Trials Completed Studies Completed Studies Ongoing Studies Ongoing Studies Study Study CL-004 CL-005 CL-006 CL-007 CL-010 Indication Indication Mild-to-moderate Asthmatics Moderate-to- Severe Asthmatics Acute Exacerbations of Asthma Acute Exacerbations of Asthm
Slide 10: MN-221-CL-004: Mean Change in FEV1
MN-221-CL-004: MN-221-CL-004: Mean Change in FEV Mean Change in FEV p < 0.05 p < 0.001 p < 0.05 p < 0.001
Slide 11: MN-221-CL-005: Mean Change in FEV1
MN-221-CL-005: MN-221-CL-005: Mean Change in FEV Mean Change in FEV Baseline: 64.6% Baseline: 69.4% 1 Hour: 82.0% 2 Hours: 81.5% Baseline: 68.6% Baseline: 68.6% 1 Hour: 70.5% 2 Hours: 71.2%
Slide 12: MN-221-CL-006: Mean Change in FEV1
MN-221-CL-006 MN-221-CL-006 Mean Change in FEV Mean Change in FEV Mean change in FEV from baseline was 5.27% higher in the MN-221 dose groups versus the placebo group
Slide 13: MN-221-CL-006: Hospitalization Rate by Treatment Group
MN-221-CL-006: MN-221-CL-006: Hospitalization Rate by Treatment Group Hospitalization Rate by Treatment Group MN-221 reduced the hospitalization rate by 45% Note: SOC means standard of care.
Slide 14: MN-221-CL-006: What have we learned?
What did we learn from the MN-221-CL-006 clinical trial? • There were no safety concerns with adding MN-221 to the standard of care. • There was a reduction in the hospitalization rate among patients treated with MN-221. • Overall, improvement in FEV was greater for patients receiving MN-221 than pl
Slide 15: MN-221-CL-007: Study Design
• Randomized, placebo-controlled, double-blind, multi-center Phase II clinical trial • patients with severe, acute exacerbations of asthma (FEV 50% predicted) at ~35 Emergency Department sites in US, Canada, Australia, and New Zealand • Dose Groups (~100 patients/group): • 1,200 µg MN-221 over hour
Slide 16: MN-221-CL-010 (COPD): Study Design
• Randomized, double-blind, placebo-controlled Phase Ib dose escalation study • 48 subjects with stable moderate-to-severe COPD (FEV 30% < 80% and FEV /FVC ratio < 0.7) at 6 sites in the US • Doses: • µg MN-221 over 1-hour (150 µg in minutes; µg in minutes) or placebo • µg MN-221 over 1-hour (300 µg
Slide 17: MN-166 for the Treatment of Multiple Sclerosis
MN-166 for Multiple Sclerosis (MS): • Oral administration • Multiple mechanisms of action, both neuroprotective and anti-inflammatory • MN-166 targets primarily chronic aspects of MS • Benign safety profile Mechanisms of Action: Potentially Neuroprotective • Inhibits nitric oxide and reactive oxygen
Slide 18: MN-166-CL-001 Phase II Study Design and Safety Profile
Placebo-controlled, Randomized, Double-blind Phase II Study: • Year 1 - Placebo, 30 mg/day, 60mg/day • Year 2 - 30 mg/day, 60mg/day • 297 patients (~100 patients/group) @ 25 sites in Serbia, Ukraine, Belarus, Bulgaria and Romania Key Inclusion Criteria: • Males or females aged 18 to 55 years, with r
Slide 19: MediciNova
MEDICINOVA ©
Slide 20: Slide 20
Slide 21: MN-166-CL-001 Study Results
P - Value: 0.04 P - Value: 0.035 MN-166-CL-001 Study Results MN-166-CL-001 Study Results P - Value: 0.026 P - Value: 0.004 P - Value: 0.0 9 P - Value: 0.0 8 Note: P-values listed on this slide compare placebo group to 60mg/day group of MN-166 Indicative of Potential Neuroprotective Effect: • Reduced
Slide 22: MN-166-CL-001: Efficacy Review (One Year)
MN-166-CL-001: MN-166-CL-001: Efficacy Review (One Year) Efficacy Review (One Year) Endpoints Indicative of Neuroprotective Effect (Chronic aspects of MS): Endpoints Relating to Acute Clinical Benefit:
Slide 23: Value to MediciNova: AV411 / Ibudilast
Value to MediciNova • AV411 is now part of MediciNova’s MN-166 program; both are ibudilast • API and drug product supply • 4 completed Phase I and Ib/IIa clinical trials • Open IND for ibudilast (Analgesia, Addiction) • Clinical & preclinical support for MN-166 program; dosing up to 100 mg/day • 2 m
Slide 24: MN-166: Opioid Withdrawal Trial Design/Endpoints
Trial Design/Endpoints MN-166: Ongoing clinical trial • Study Objective: Assess MN-166 safety/tolerability/PK and preliminary efficacy for opiate withdrawal in heroin-dependent subjects • Ongoing clinical trial run jointly by the New York State Psychiatric Institute and Columbia University in NYC (I
Slide 25: Commercially-Attractive Diversified Portfolio
COPD Asthma MS CNS Disorders Commercially-Attractive Commercially-Attractive Diversified Portfolio Diversified Portfolio COPD Asthma MS CNS Disorders
Slide 26: MediciNova
© MEDICINOVA
Slide 27: Investment Highlights: Near-Term Business Plan
Near-Term Business Plan: 1. Secure a global partnership for MN-166 2. Secure a regional partnership (ex-US/Japan rights) for MN-221 Clinical Milestones: 1. MN-221-CL-007 Phase II Study for Acute Exacerbations of Asthma • Anticipated completion 2H, 2010* 2. MN-221-CL-010 Phase Ib Study in Moderate-to