Medicinova, Inc. · NASDAQ:MNOV
Medicinova — Merger or Acquisition (November 2009)
27 slides from Medicinova's merger presentation, Nov 17, 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
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: 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 (Kyorin, Kissei, Mitsubishi Tanabe Pharma, Meiji) New Approaches to Treat Serious Medical Conditions: • MN-221: Intravenous (IV) acute a
Slide 4: Merger Consideration
Merger Consideration • Each Avigen stockholder will have the option of receiving their pro rata allocation of cash or convertible notes aggregating approximately $37.0 million (~$1.24/share) , subject to potential upward and downward adjustments as set forth in the merger agreement: • First payment
Slide 5: Summary Securities Ownership Review (Fully Diluted Basis)
Summary Securities Ownership Review (Fully Diluted Basis) Pro Forma Stockholder Review Pro Forma Stockholder Review This pro forma ownership review is presented for illustrative purposes only and does not indicate actual ownership of MediciNova shares at any past, present, of future date. Actual own
Slide 6: 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 7: Placebo-controlled, randomized, double-blind Phase II study
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 8: MN-166 Targets Primarily Chronic Aspects of MS
Indicative of Potential Neuroprotective Effect: • Reduced brain volume loss • Reduced conversion of acute lesions to persistent black holes • Sustained disability progression was significantly less likely Acute Clinical Benefit: • Prolong time to relapse (by 127 days.) • Annualized relapse rate Prot
Slide 9: 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
Slide 10: 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 at Month Total Number of Persistent Black Holes at Month 10 Percentage of Lesions Evolving to PBH at Month 10 23% 17% 14% P-Value - 0.036 0.004 Reduction of Persi
Slide 11: 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% 5.3% 8.0%
Slide 12: 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 13: AV-411 Package: Additional Value from Avigen Deal
AV-411 Package: Value to Potential MN-166 Partnership • Both AV-411 and MN-166 are ibudilast • AV-411 preclinical data expected to support clinical package for MN-166. • Open IND for ibudilast • AV-411 trial supports MN-166 dosing up to 100 milligrams (mg) versus the maximum dosing of 60 mg in the P
Slide 14: MN-221 for Exacerbations of Acute Asthma and COPD
Definition: • Asthma Exacerbations: Long-lasting and severe asthma episode that is not responsive to initial bronchodilator or corticosteroid therapy • COPD Exacerbations: Sustained worsening of the patient's condition, from the stable state and beyond normal day-to-day variations, that is acute in
Slide 15: 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 16: 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 17: 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 18: 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 19: MN-221-CL-004: Mean Change in FEV1
p<0.05 p<0.0001 p<0.0001 p<0.0001 p<0.001 MN-221-CL-004: MN-221-CL-004: Mean Change in FEV Mean Change in FEV Baseline: 77.83% 77.67% 76.78% 81.60% 74.78% 75.78% 78.07% 79.78%
Slide 20: MN-221-CL-005: Mean Change in FEV1
Baseline: 64.57% Baseline: 69.35% Mean: 82.04% Mean: 81.47% Baseline: 68.64% Baseline: 68.64% MN-221-CL-005: MN-221-CL-005: Mean Change in FEV Mean Change in FEV Mean: 82.04% Mean: 81.47%
Slide 21: MN-221-CL-006: What have we learned?
What did we learn from MN-221-CL-006? • 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 placebo. • A dose of
Slide 22: 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%
Slide 23: MN-221-CL-007 Study Design
Study Design • Randomized, placebo-controlled, double-blind, multi-center Phase II clinical trial • patients with severe, acute exacerbations of asthma (FEV 50% predicted) at ~45 Emergency Department sites in US, Canada, Australia, and New Zealand • Dose Groups (~100 patients/group): • µ g in minute
Slide 24: MN-221-CL-010 (COPD)
MN-221-CL-010 (COPD) MN-221-CL-010 (COPD) Note: Development plans / timelines for MN-221 clinical trials are subject to change *Anticipated completion dates based on current projections • Doses: • 150 µg in 15 minutes followed by 150 µg in 45 minutes (1-hour infusion with a total dose of 300 µg) or
Slide 25: Commercially-Attractive Diversified Portfolio: Seeking Global Partner
COPD Asthma Seeking Global Partner Commercially-Attractive Commercially-Attractive Diversified Portfolio Diversified Portfolio COPD Asthma Seeking Global Partner
Slide 26: MediciNova
© a Baer] ao MEDICINOVA
Slide 27: Investment Highlights: Near-Term Business Plan
Near-Term Business Plan: 1. Secure a global partnership for MN-166/AV-411 combined package* 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 Pha