Medicinova, Inc. · NASDAQ:MNOV

Medicinova — Investor Presentation (February 2011)

42 slides from Medicinova's investor presentation, Feb 7, 2011

  1. Slide 1: Accelerating the global development and commercialization of innovative pharmaceuticals

    Exhibit 99.1 Accelerating the global development and commercialization of innovative pharmaceuticals © MediciNova, Inc. 2011

  2. Slide 2: 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 include statements regarding M

  3. Slide 3: Corporate Overview: MediciNova, Inc.

    Corporate Overview: MediciNova, Inc. 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 • $62.2 million Market Cap (NasdaqGM) as of 2/01/2011 Development Compan

  4. Slide 4: Business Model: Return On Investment

    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 ef

  5. Slide 5: Management Team with Global Experience

    Management Team with Global Experience Years Leadership Background Experience Yuichi Iwaki, MD, PhD 35 Professor at USC, formerly Professor at CEO & President University of Pittsburgh; Advisor to JAFCO, Tanabe Michael Coffee 26 Avigen, Amarin Corp., Elan Pharmaceuticals, Chief Business Officer; N.A.

  6. Slide 6: Investment Highlights

    Investment Highlights Upcoming Near-Term Business Milestones: 1. Secure a global partnership for Ibudilast (MN-166/AV411) 2. Secure a strategic partnership for MN-221 Upcoming Clinical Milestones: 1. MN-221-CL-007 Phase II Study for Acute Exacerbations of Asthma • Anticipated completion in 2H, 2011*

  7. Slide 7: Ibudilast

    Ibudilast: • Neuropathic Pain • Multiple Sclerosis • Addiction

  8. Slide 8: Ibudilast for the Treatment of MS, Neuropathic Pain, & Drug Addiction

    Ibudilast for the Treatment of MS, Neuropathic Pain, & Drug Addiction Ibudilast (MN-166/AV411) • Oral administration • Safe and well-tolerated (approved in Japan/Korea with over 3.2 million exposures) patient • Mechanism(s) of Action primarily Inhibition of Macrophage Migration Inhibitor Factor (MIF

  9. Slide 9: Ibudilast (MN-166/AV411): Status for Each Indication

    Ibudilast (MN-166/AV411): Status for Each Indication Status for Chronic Pain: • MN-166/AV411 is enabled to go directly to Phase 2b clinical development • MN-166/AV411 mechanism of action is novel and thus complimentary current pain to treatments, and has both stand-alone and adjunctive utilities • M

  10. Slide 10: Ibudilast Neuropathic Pain Market Opportunity

    Ibudilast Neuropathic Pain Market Opportunity Total Rxsin 2009 Drug Company • Prevalence is approximately 4.2 (US) million neuropathic pain patients in Lyrica® Pfizer 9.1 Million the U.S. and million 40 worldwide ® Cymbalta Eli Lilly 14.7 Million • MN-166 has a different mechanism of action than cur

  11. Slide 11: Patent/Commercial Overview

    Patent/Commercial Overview Method of Use Composition of Matter © MediciNova, Inc. 2011 11

  12. Slide 12: Most Likely Scenario for Ibudilast's Development

    Most Likely Scenario for Ibudilast’s Development • Collaboration Structure with Pharma Partner: 1. Shared Risk 2. All indications; Ibudilast + Analogues 3. Option Agreement around Phase 2b Diabetic Peripheral Neuropathic Painand/orProgressive MStrialwithExclusive License, Development Milestones, Roy

  13. Slide 13: MN-221: Acute Exacerbations of Asthma and COPD

    MN-221: • Acute Exacerbations of Asthma • Exacerbations of Chronic Obstructive Pulmonary Disease (COPD)

  14. Slide 14: Acute Exacerbations of Asthma

    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 in the US • ~500,000 annual hospitalizations in the US • Average l

  15. Slide 15: Acute Asthma Treatment Flow in Emergency Departments in the U.S.

    Acute Asthma Treatment Flow in Emergency Departments (EDs) in the U.S. st nd Input: 1 line therapy in ED: 2 line therapy in ED: Hospitalization: 1,900,000 patients Patients receive SOC, Patients who do not Patients who do not with acute many while in the initially respond respond to SOC are exacerba

  16. Slide 16: Limitations of Current Therapies

    Limitations of Current Therapies What are the limitations of current therapies for acute exacerbations of asthma? Limitations of Inhaled Therapies: • Bronchoconstriction: inflammation andbronchoconstriction resultininsufficient air flow to get good drug deposition in the lungs • Mucus Plug Formation

  17. Slide 17: MN-221: Target Product Profile

    MN-221: Target Product Profile MN-221Indication:Treatment ofbronchospasms inpatients withacute exacerbations ofasthmaorCOPD.Itisadministered adjunctive tostandard of carebyintravenousinfusion. •A well-tolerated, potent,selective ß 2-agonistwhichisonlya partialagonistat ß 1. •A bronchodilating durati

  18. Slide 18: MN-221: A New Approach to Treating Acute Exacerbations of Asthma

    MN-221: A New Approach to Treating Acute Exacerbations of Asthma MN-221:A novel,highlyselectiveß 2- adrenergic receptoragonist Three potential advantages over current therapy: 1. Improved Efficacy • Route of Administration (IV v. Inhalation) 2. Improved Safety • Higherselectivity ß for 2 receptor ß

  19. Slide 19: Beta 2 agonist U.S. Market Overview

    Beta 2 agonist U.S. Market Overview © MediciNova, Inc. 2011 19

  20. Slide 20: MN-221 Phase II Study Designs in Asthma Indication

    MN-221 Phase II Study Designs in Asthma Indication MN-221-CL-004 MN-221-CL-005 MN-221-CL-006 MN-221-CL-007 Type of Stable Stable Acute Acute Asthma mild-to-moderate moderate-to-severeExacerbations Exacerbations FEV1 FEV1 60% 40% FEV1 75% FEV1 55% FEV1 50% (Entry Criteria) Number Patients 23 17 29 20

  21. Slide 21: MN-221-CL-006: Study Design

    MN-221-CL-006: Study Design Completed Phasetrial IIa in the Emergency Dept. • Randomized, placebo-controlled, single-blind, dose escalation study • 29 patients with acute exacerbations of asthma 1 55%(FEVpredicted) at 8 Emergency Department sites • Doses: • 16µg/min for 15 minutes (240 µg) • 30µg/mi

  22. Slide 22: MN-221-CL-006 Mean Change in FEV1 and Differences in Hospitalization Rate

    MN-221-CL-006 Mean Change in FEV 1 and Differences in Hospitalization Rate Mean change in FEV1 from baseline was 5.3% MN-221 reduced the hospitalization rate by 45% higher in the MN-221 dose groups versus the placebo group © MediciNova, Inc. 2011 22

  23. Slide 23: MN-221-CL-006: What have we learned?

    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,improvementin FEV1 wasgreaterforpatients receiving

  24. Slide 24: MN-221-CL-007: Study Design

    MN-221-CL-007: Study Design • Randomized, placebo-controlled, double-blind, multi-center Phase II clinical trial • Upto200patientswithsevere,acuteexacerbationsofasthma(FEV1 50%predicted) at multiple Emergency Department sites in the United States • Dose Groups (up to 100 patients/group): • 1,200µgof

  25. Slide 25: MN-221 Safety Summary

    MN-221 Safety Summary Safety Database: • MN-221 has been tested in almost 300 subjects in the US and Europe to date • No serious adverse events related to MN-221 were reported in any studies completed to date • No clinically significant cardiovascular, ECG, or vital sign changes, or other safety con

  26. Slide 26: MN-221 Patent Summary

    MN-221 Patent Summary • MediciNova has rights to a portfolio of patents and know-how related to MN-221, including composition of matter. • The U.S. patent for MN-221 has composition of matter and method of use claims and is set to expire no earlier than February 2017. • U.S. patent expiration does n

  27. Slide 27: MN-221 Potential Development Opportunity: Exacerbations of COPD

    MN-221 Potential Development Opportunity: •Exacerbations of COPD

  28. Slide 28: Chronic Obstructive Pulmonary Disease

    Chronic Obstructive Pulmonary Disease • Chronic obstructive pulmonary disease (COPD) is a progressive disease that causes airflow blockage and breathing-related problems. • COPD includes two main conditions: emphysema and chronic obstructive bronchitis. • Cigarette smoking is the leading cause of CO

  29. Slide 29: COPD Exacerbations

    COPD Exacerbations A COPD exacerbation is a sustained worsening of the Hospitalization rates amongst patient's condition, from the stable state and beyond Asthma and COPD patients normal day-to-day variations, that is acute in onset. Thousands COPD exacerbations are associated with a significant 1,9

  30. Slide 30: COPD: Current treatment paradigm in emergency department and hospital settings

    COPD: Current treatment paradigm in emergency department and hospital settings Represents leading drugs currently used Hospitalized patients follow the same treatment paradigm as in ER Initial treatment failure Other treatments Initial assessment Standard treatments and subsequent (not commonly used

  31. Slide 31: COPD Exacerbation Treatment Flow in Emergency Departments in the U.S.

    COPD Exacerbation Treatment Flow in Emergency Departments in the U.S. st nd Input: 1 linetherapyinED: 2 linetherapyinED: Hospitalization: 1,500,000 patients Patients receive SOC, Patients who do not Patients who do not with acute many while in the initially respond respond to SOC are exacerbations o

  32. Slide 32: MN-221-CL-010 (COPD) Study Design

    MN-221-CL-010 (COPD) Study Design • Randomized, double-blind, placebo-controlled dose escalation study • 48 subjects with stable moderate-to-severe Chronic Obstructive Pulmonary Disease(COPD)(FEV1 30%< 80%andFEV1/FVCratio< 0.7)at6 sites • Doses: • 10 µg/min for 15 minutes followed by 3.3 µg/min for

  33. Slide 33: MN-221-CL-010: Mean Change in FEV1

    MN-221-CL-010: Mean Change in FEV1 p = 0.0147 p = 0.0012 Baseline: Baseline: Baseline: Baseline: 50.31% 46.7% 46.6% 47.9% © MediciNova, Inc. 2011 33

  34. Slide 34: Addendum

    © MEDICINOVA Addendum

  35. Slide 35: MN-221-CL-004 Study Design

    MN-221-CL-004 Study Design • Randomized, placebo-controlled, double-blind, dose escalation study • 23 subjects with mild-to-moderate stable asthma 1 60%(FEV predicted) at 4 sites • Patients are randomized to one of four different treatment groups (25% of patients on placebo for every dose level)* •

  36. Slide 36: MN-221-CL-004: Mean Change in FEV1

    MN-221-CL-004: Mean Change in FEV1 © MediciNova, Inc. 2011 36

  37. Slide 37: MN-221-CL-005 Study Design

    MN-221-CL-005 Study Design • Randomized, placebo-controlled, single-blind, dose rate escalation study • 17 subjects with moderate-to-severe stable asthma 1 40%, (FEV but 75% predicted) at 4 sites • Doses: • 16µg/min for 15 minutes followed by 8 µg/min for 105 minutes (2-hour infusion with a total do

  38. Slide 38: MN-221-CL-005: Mean Change in FEV1

    MN-221-CL-005: Mean Change in FEV1 1 Hour: 2 Hours: 82.0% 81.5% 1 Hour: 2 Hours: 70.5% 71.2% Baseline: Baseline: Baseline: 69.4% 68.6% 68.6% Baseline: 64.6% © MediciNova, Inc. 2011 38

  39. Slide 39: MN-221 may improve efficacy over current standard of care due to its route of administration

    MN-221 may improve efficacy over current standard of care due to its route of administration Published evidence • It has been demonstrated that airway abnormalities extend from the proximal to the most distal airways in asthmatics, and in severe stable asthmatics it has been postulated that one reas

  40. Slide 40: MN-221 may result in fewer cardiovascular side effects than the current standard of care

    MN-221 may result in fewer cardiovascular side effects than the current standard of care • MediciNova has preclinical data and clinical data which demonstrates the safety of MN-221. • In summary, we have not seen clinically significant safety concerns with MN-221. • According to interviews of emerge

  41. Slide 41: MN-221 may reduce health care expenses by reducing the hospitalization rate

    MN-221 may reduce health care expenses by reducing the hospitalization rate • Since the average hospitalization cost is $6,477 in the US, the payor would save this amount for each hospitalization prevented. • Since US hospitals lose money on the typical asthma hospitalization due to low reimbursemen

  42. Slide 42: Commercially-Attractive Diversified Portfolio

    Commercially-Attractive Diversified Portfolio Addiction Pain/MS COPD Asthma © MediciNova, Inc. 2011 42

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