Medicinova, Inc. · NASDAQ:MNOV
Medicinova — Investor Presentation (January 2010)
29 slides from Medicinova's investor presentation, Jan 11, 2010
Slide 1: Accelerating the global development and commercialization of innovative pharmaceuticals
Exhibit 99.1 Accelerating the global development and commercialization of innovative pharmaceuticals
Slide 2: Forward-Looking Statements
Forward-Looking Statements 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 inc
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 • $85.7 million Market Cap (NasdaqGM) as of 12/31/2009 Development Company Focused on Differentiated Product
Slide 4: Pro Forma Stockholder Review
Pro Forma Summary of Securities Ownership Potential Financing from Avigen as of 12/31/2009 Acquisition Pro Forma Stockholder Review Pro Forma Stockholder Review Note: Assumes Second Payment Consideration in the amount of $1.1 million was paid at closing, that all convertible notes, including those i
Slide 5: 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 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 2 receptor than 1 • Partial agonist for 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 & COPD
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 Clinical Trials
MN-221 Clinical Trials MN-221 Clinical Trials Completed Studies Completed Studies Ongoing Studies Ongoing Studies 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 Asthma Moderate-t
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: 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 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-007: Study Design
• Randomized, placebo-controlled, double-blind, multi-center Phase II clinical trial • 200 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 1
Slide 15: 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: • 300 µg MN-221 over 1-hour (150 µg in 15 minutes; 150 µg in 45 minutes) or placebo • 600 µg MN-221 o
Slide 16: 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 17: MN-166 Phase II Study Design in Multiple Sclerosis
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 18: MediciNova
© MEDICINOVA
Slide 19: Slide 19
Slide 20: MN-166 Targets Primarily Chronic Aspects of MS
P-Value: 0.04 P-Value: 0.035 MN-166 Targets Primarily MN-166 Targets Primarily Chronic Aspects of MS Chronic Aspects of MS P-Value: 0.026 P-Value: 0.004 P-Value: 0.09 P-Value: 0.08 Note: P-values listed on this slide compare placebo group to 60mg/day group of M N -166 Indicative of Potential Neuropr
Slide 21: MN-166 Chronic Efficacy Demonstrated: Effects on Brain Volume
Brain volume changes are linked to axonal loss MN-166 - MN-166 - Chronic Efficacy Chronic Efficacy Demonstrated: Effects on Brain Volume Demonstrated: Effects on Brain Volume 1.20%
Slide 22: Reduction of Persistent Black Hole Formation
Parameter Treatment Groups Placebo mg/day mg/day Number Patients w. New Lesions (NL) at Month 2 Total Number of NLs in all Patients at Month Total Number of Persistent Black Holes (PBH) at Month 10 Percentage of Lesions Evolving to PBHs at Month 23% 17% 14% Percent Reduction from Placebo Group - 26%
Slide 23: Sustained Disability Progression
Disability Progression is defined as a sustained increase in EDSS (increase in EDSS 1 maintained for four consecutive months) Sustained Disability Progression Sustained Disability Progression 4.1% (49% Reduction) 5.3% (34% Reduction) 8.0% Sustained disability progression was significantly less likel
Slide 24: 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 Plot of Time to First Relapse by Treatment (ITT) Core (Year 1)
Slide 25: AV411: Value to MediciNova
AV411: Value to MediciNova • Both AV411 and MN-166 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 dosing up to 100 mg/day • 2 method of use patents issued in 2009
Slide 26: AV411: Opioid Withdrawal Trial Design/Endpoints
Trial Design/Endpoints AV411: Ongoing clinical trial • Study Objective: Assess AV411 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 (Inv
Slide 27: Commercially-Attractive Diversified Portfolio
Commercially-Attractive Commercially-Attractive Diversified Portfolio Diversified Portfolio
Slide 28: MediciNova
© MEDICINOVA
Slide 29: Near-Term Business Plan and Investment Highlights
Near-Term Business Plan: 1. Secure a global partnership for MN-166 (AV411) 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 Mod