Medicinova, Inc. · NASDAQ:MNOV
Medicinova — Merger or Acquisition (September 2009)
48 slides from Medicinova's merger presentation, Sep 4, 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 statements regarding MediciNova’s clinical trial
Slide 3: Additional information about the transaction
This communication does not constitute an offer to sell or the solicitation of an offer to buy any securities or a solicitation of any vote or approval. This material is not a substitute for the registration statement/prospectus/proxy statement MediciNova, Inc. and Avigen, Inc. will file with the SE
Slide 4: 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: Intravenous (IV) acute asthma and COPD candidate • Potential $1 Billion+ c
Slide 5: Business Model: Return On Investment
In-License: • Novel, small-molecule product candidates with significant clinical or preclinical data packages and attractive market opportunities Conduct Proof-of-Concept Clinical Trials: • Conduct Phase I and Phase II clinical trials to demonstrate safety and efficacy of compound Two Pathways Towar
Slide 6: Avigen Transaction Overview
Avigen Avigen Transaction Overview Transaction Overview Transaction • • • Rationale • • • • Signed Definitive Merger Agreement with Avigen, Inc. on 8/20/2009. Following the completion of the transaction, Avigen will become a wholly-owned subsidiary of MediciNova. Anticipated closing will be 4Q, 2009
Slide 7: Avigen Transaction Overview: Merger Consideration
Avigen Avigen Transaction Overview Transaction Overview 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, subject to potential upward and downward adjustments as set forth i
Slide 8: Avigen Transaction Overview: Convertible Notes Consideration
Avigen Avigen Transaction Overview Transaction Overview Convertible Notes Consideration • 18-month maturity from the date of closing of merger (no early cash redemption). • Principal from the notes will be held in a trust account with principal invested in certain approved investment options. • The
Slide 9: Pro Forma Stockholder Review
Summary Securities Ownership Review (Fully Diluted Basis) (1) Assumes first payment consideration and second payment consideration aggregate $37.0 million and are both paid at closing and that MediciNova issues no shares or options from August 20, 2009 through the first conversion date of the conver
Slide 10: 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 billion worldwide sales i
Slide 11: Completed Clinical Study: MN-166-CL-001
Placebo-controlled, randomized, double-blind Phase II study: • Year 1 - 0, 10 mg three times a day (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,
Slide 12: MediciNova
v © MEDICINOVA
Slide 13: 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 14: 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 15: 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 16: 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 17: Additional Value from Avigen Deal: AV-411 Package
AV-411 Package • Both AV-411 and MN-166 are derived from 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 Phase 2 trial for MN-166.
Slide 18: 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.
Slide 19: 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 annual emergency room visits and 500,000 annual hospitalizations in the US • Approximately 2.7 million annual emergency room
Slide 20: MN-221: A New Approach to Treating Acute Exacerbations of Asthma
1. Improved Efficacy 2. Improved Safety 3. Reduced Health Care Expenses MN-221: A novel, highly selective - adrenergic receptor agonist; licensed from Kissei Pharmaceutical in 2004 Three Potential Advantages over current therapy MN-221: A New Approach to Treating MN-221: A New Approach to Treating A
Slide 21: Improved Efficacy
• MN-221 may improve efficacy over current standard of care due to its route of administration. • Currently patients who are struggling to breathe are given beta agonists in an inhaled formulation. • MN-221’s intravenous formulation allows MN-221 to access the beta receptors in the lungs without hav
Slide 22: Improved Safety
• MN-221 has a higher selectivity for the beta receptors than the beta receptors as compared with other beta agonists. • MN-221 is only a partial agonist for the beta receptor. • This may result in fewer cardiovascular side effects which are common with the current standard of care. 2) Improved Safe
Slide 23: Reduced Health Care Expenses
• Approximately 25% of patients who present to the emergency department with an acute exacerbation of asthma have to be hospitalized. • Based on clinical data obtained in our first emergency department-based study, patients treated with MN-221 in the emergency department may lower the hospitalizatio
Slide 24: 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 25: 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 26: MN-221 Phase II Study Designs
MN-221 Phase II Study Designs MN-221 Phase II Study Designs CL-004 CL-005 CL-006 CL-007 Type of Asthma Mild-to-moderate Moderate-to- Severe Acute Exacerbations Acute Exacerbations FEV (Entry Criteria) FEV 1 60% 75% FEV 1 40% FEV 1 55% FEV 1 50% Number Patients Number Sites ~45 Doses Tested compared
Slide 27: MN-221-CL-004: Mean Change in FEV1
MN-221-CL-004: MN-221-CL-004: Mean Change in FEV Mean Change in FEV (at 15 min.) (at 15 min.) Baseline: 77.83% 77.67% 76.78% 81.60% 74.78% 75.78% 78.07% 79.78%
Slide 28: 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 (at end of infusion) (at end of infusion) Mean: 82.04% Mean: 81.47%
Slide 29: 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 30: MN-221-CL-007 Study Design
Study Design • Randomized, placebo-controlled, double-blind, multi-center clinical trial • patients with severe, acute exacerbations of asthma (FEV 50% predicted) at ~45 Emergency Department sites in North America, Australia, and New Zealand • Dose: • 40 µg/min for 15 minutes;13.3 µg/min for 45 minu
Slide 31: MN-221: Expanded Indication – COPD Exacerbations
COPD patients are generally more ill than asthmatics with overall higher hospitalizations and mortality. Exacerbations of Chronic Obstructive Pulmonary Disease (COPD) are a sustained worsening of the patient's condition, from the stable state and beyond normal day-to-day variations, that is acute in
Slide 32: MN-221 Phase II Clinical Development Timeline
MN-221 MN-221 Phase II Program 1H 1H 2H 2H 1H 1H 2H 2H 1H 1H 2H 2H 1H 1H 2H 2H Acute Asthma CL-004 Dose Escalation CL-005 Prolonged Infusion CL-006 Single-Blind CL-007 Double-Blind * COPD Exacerbations To be determined MN-221 Phase II Clinical MN-221 Phase II Clinical Development Timeline Developmen
Slide 33: Commercially-Attractive Diversified Portfolio
Commercially-Attractive Commercially-Attractive Diversified Portfolio Diversified Portfolio
Slide 34: Key Financials
Dual Listing: • MNOV (NasdaqGM) • 4875 (Osaka – Hercules) Net Cash, Cash Equivalents and Marketable Securities: ~$40.7 million as of 6/30/09 Market cap as of 8/19/09: ~$85.5 million Shares outstanding: ~12 million Key Financials Key Financials
Slide 35: MediciNova
MEDICINOVA
Slide 36: Investment Highlights
MN-221 (Exacerbations of Asthma/COPD Exacerbations): • Proven mechanism of action • Highly selective with improved safety profile vs. standard of care • Positive Phase II efficacy and safety data for Acute Exacerbations of Asthma • Phase II study ongoing for Acute Exacerbations of Asthma MN-166 (Mul
Slide 37: Addendum: Additional Information
Addendum: Addendum: Additional Information • Avigen Transaction • MN-221 Data • MN-166 Data
Slide 38: Other potential benefits of convertible notes consideration
Other potential benefits that may accrue should Avigen’s shareholders elect to take convertible notes as merger consideration and subsequently convert these notes: • Increased liquidity in the U.S. markets: • Presuming that 100% of Avigen’s shareholders elect to receive convertible notes and convert
Slide 39: MN-221-CL-004 Study Design
Study Design • Randomized, placebo-controlled, double-blind, dose escalation study • subjects with mild-to-moderate stable asthma (FEV 60% predicted) at 4 sites • Patients are randomized to one of four different treatment groups (25% of patients on placebo for every dose level) • Each treatment sequ
Slide 40: MN-221-CL-004: Dose Treatment Groups
Eligible subjects were randomly assigned in a 1:1:1:1 ratio to 1 of 4 dose escalation treatment sequences: MN-221-CL-004: MN-221-CL-004: Dose Treatment Groups Dose Treatment Groups Group A Group B Group C Group D Visit 2 Placebo 0.35 µ g/min for 15 minutes 0.35 µ g/min for 15 minutes 0.35 µ g/min fo
Slide 41: MN-221-CL-005 Study Design
= Study Design • Randomized, placebo-controlled, single-blind, dose rate escalation study • subjects with moderate-to-severe stable asthma (FEV 40%, but 75% predicted) at 4 sites • Doses: • µg/min for 15 minutes followed by 8 µg/min for 105 minutes (2-hour infusion with a total dose of 1,080 µg) or
Slide 42: MN-221-CL-006 Study Design
Study Design • Randomized, placebo-controlled, modified single-blind, dose escalation study • patients with acute exacerbations of asthma (FEV = 55% predicted) at 8 Emergency Department sites • Doses: • µg/min for 15 minutes (240 µg) • µg/min for 15 minutes (450 µg) • 16 µg/min for 15 minutes; 8 µg/
Slide 43: MN-221 Safety Summary
MN-221 Safety Summary MN-221 Safety Summary Phase II Study Safety Findings: • No clinically significant cardiovascular, ECG, or vital sign changes, or other safety concerns, observed at doses up to 3840 micrograms in 4 hours. Safety Database: • MN-221 has been tested in almost 300 subjects in the US
Slide 44: MN-166 Chronic Efficacy: 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 45: MN-166 Reduction of Persistent Black Hole Formation
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 46: Approved MS therapies: sales and side effects
Approx. Sales 2008** Compound Sponsor Side Effects $2.3 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 $2.2 Billion Avonex® Biogen-Idec Depressio
Slide 47: 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 48: MN-166 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