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USC, Formerly Prof. Pitt; Advisor to JAFCO, Tanabe Director, Avigen, Inc. Richard Gammans, PhD, MBA Richard Gammans, PhD, MBA Chief Development Officer 30 Incara, Indevus, BMS Kenneth W. Locke, PhD Kenneth W. Locke, PhD Chief Scientific Officer 23 Tanabe Research Laboratories USA, Indevus, Hoechst Shintaro Asako, CPA Shintaro Asako, CPA Chief Financial Officer 9 KPMG USA (Audit), Arthur Andersen USA Masatsune Okajima, CMA Masatsune Okajima, CMA VP, Head of Japanese Office 16 Daiwa Securities SMBC, Sumitomo Capital Securities, Sumitomo Bank Management Team with Global Management Team with Global Experience Experience MediciNova, Inc. 2008 27 MN 221 (Status Asthmaticus): Proven mechanism of action Highly selective with improved safety profile vs. standard of care Low risk / High reward proposition Positive efficacy data Low development costs to market Estimated $500 M market opportunity for MediciNova MN 166 (Multiple Sclerosis): Current treatment of MS represents significant unmet medical need Multi billion dollar market opportunity Both chronic and acute efficacy have been demonstrated in clinical studies Robust pipeline Six compounds with applications in multiple disease areas Unique access to other differentiated, high value assets Investment Highlights Investment Highlights
Current Clinical Studies: MN Current Clinical Studies: MN 166 CL 001 166 CL 001 22 MediciNova, Inc. 2008 Partnering Opportunities MN 001 (Bronchial Asthma) Phase III ready MN 001 (Interstitial Cystitis) Phase II ready MN 305 (Generalized Anxiety Disorder) Phase II ready MN 029 (Solid Tumors) Phase II ready MN 221 (Preterm Labor) Phase II ready MN 246 (Urinary Incontinence) Phase I ongoing MN 447 / MN 462 (Thrombosis) Preclinical Diversified Portfolio Diversified Portfolio 23 MediciNova, Inc. 2008 24 MN 221 for Status Asthmaticus Single Blind Phase IIb study to test efficacy commencement date: 1H 08 Results as early as 2H 08 Double Blind Phase IIb study to test efficacy commencement date: 1H 08 Results as early as 1H 09 Second Phase IIa study for extended dosing commencement date: 1H 08 Results as early as 2H 08 MN 166 for Multiple Sclerosis Announce Two Year Phase II Results expected 1H 08 Pursue Corporate Partnership Phase III ready 2H 08 Medicinova is constantly evaluating opportunities to partner MN 166 and additional programs Near Term Clinical Near Term Clinical Milestones Milestones MediciNova, Inc. 2008 25 Dual Listing: MNOV (NasdaqGM), December 2006 4875 (Osaka Hercules), February 2005 Limited liquidity due to low float Cash: $75.96 M as of 9/30/07 Market cap as of 1/03/07: ~$55.6 M Shares outstanding: 11.9 M Fully diluted shares outstanding: 14.0 M Key Financials Key Financials MediciNova, Inc. 2008 26 Leadership Years Experience Background Yuichi Iwaki, MD, PhD Yuichi Iwaki, MD, PhD CEO President 32 Prof.
Proven mechanism of action ( adrenergic agonist) 2. Rapid, reliable IV delivery (vs. inhaled / nebulized) 3. Safer (greater selectivity = fewer cardiovascular SE) 9 Competitive Advantages of Competitive Advantages of MN 221 MN 221 MediciNova, Inc. 2008 10 Phase IIa Design Randomized, placebo controlled, double blind, sequential dose escalation 23 subjects with mild to moderate asthma Primary objective To determine the efficacy of a single 15 minute treatment with intravenous MN 221 Secondary objective To determine the MTD (Maximum Tolerated Dose) Primary endpoint met in Phase IIa study completed October 2007 Achieved statistical significance in its primary endpoint of mean change in FEV1 from baseline at 15 minutes at doses of 3.5, 10, 16, and 30 micrograms/min of MN 221 compared to placebo No clinically significant cardiovascular, ECG or vital sign changes, or any other safety concerns observed at any dose tested 60 micrograms/min x 15 min (900 mcg) dose a possible MTD of MN 221 MN 221: Positive Phase IIa data MN 221: Positive Phase IIa data MediciNova, Inc. 2008 Change from Pre Infusion FEV1 at 15 min (ITT) Placebo .35 ug/min 1.0 ug/min 3.5 ug/min 10 ug/min 16 ug/min 30 ug/min MN 221 CL 002: Primary MN 221 CL 002: Primary Efficacy Variable Efficacy Variable 11 MediciNova, Inc. 2008 MN 221: Safety MN 221: Safety Phase IIa Safety Findings: No clinically significant cardiovascular, ECG or vital sign changes, or any other safety concerns observed at doses up to 30 micrograms/minute for 15 minutes or any time point thereafter 60 micrograms/minute infusion improved FEV1 significantly ( p 0.0001 ) without clinically significant cardiovascular, ECG, or vital sign changes; however, the safety trend led us to believe that this is a possible MTD and higher doses should not be tested Safety Database: MN 221 has been tested in over 300 subjects in the US and Europe to date Subjects have had infusions with no clinically significant adverse events at: 16 micrograms/minute for up to 4 hours and at lower doses for up to 24 hours 12 MediciNova, Inc. 2008 Commence Two Phase IIb study to test efficacy of MN 221 in Status Asthmaticus patients in the emergency room Single Blind (~32 patients) Anticipated commencement date: 1H 08 Results expected as early as 2H 08 Double Blind (~200 patients) Anticipated commencement date: 1H 08 Results expected as early as 1H 09 Commence second Phase IIa study (~20 patients) for extended dosing (4 hour infusion) Anticipated commencement date: 1H 08 Results expected as early as 2H 08 MN 221: Next Steps MN 221: Next Steps 13 MediciNova, Inc. 2008 14 MN 166 Overview MN 166 Overview Multiple Sclerosis Autoimmune disease Progressive loss of neuromuscular function Relapsing forms Progressive forms Damage to myelin sheath Damage to neuronal axon MediciNova, Inc. 2008 15 Multiple Sclerosis Market Approximately $6.2 B worldwide sales in 2005* Current Standard of Care: Beta interferons, Copaxone, Tysabri Administered either by intramuscular or subcutaneous injection or infusion MN 166: Anti inflammatory and neuroprotective properties in vitro and in vivo Stimulates Th2 cytokine production and neurotrophic factor release Cerebrovasodilator Inhibits leukotrienes, phosphodiesterases, Th1 cytokine production, nitric oxide and reactive oxygen species production Demonstrated effects on brain volume Targets both chronic and acute aspects of multiple sclerosis Oral administration MN 166 Overview MN 166 Overview *Source: MedAdNews, June 2006 MediciNova, Inc. 2008 Efficacy (relapse rate) Insufficient efficacy on relapses Most patients ultimately progress (disability/neurodegeneration) Neutralizing antibodies can diminish efficacy over time Neutralizing antibodies can diminish efficacy over time Uncomfortable and potentially dangerous AEs Rare but fatal PML with Tysabri Safety/ Tolerability All current drugs injectable (daily weekly) or infusion (monthly) Administration Increasing interest in combination therapies given insufficient efficacy with current core agents Black box on combination with Tysabri Combination Real neuroprotection would be groundbreaking Current treatments do not address disease progression Neuroprotection There are substantial unmet There are substantial unmet needs in the treatment of MS needs in the treatment of MS Description 16 MediciNova, Inc. 2008 Brain volume changes are linked to axonal loss 17 Chronic Efficacy Demonstrated: Chronic Efficacy Demonstrated: Effects on Brain Volume Effects on Brain Volume 1.20 MediciNova, Inc. 2008 MN 166 Similar Acute Efficacy to Current and Developing Treatments Anti inflammatory Outcomes: Pilot studies found reduced relapse rate and Th1 Th2 cytokine shift Prolong time to relapse ( 1yr.) Increased % relapse free (56%) Decreased T1 Gd lesion volume Reduces Relapses via Inhibiting Inflammation Phosphodiesterase IV and Leukotriene inhibitor Inhibits nitric oxide and reactive oxygen species production Inhibits Th1 cytokine production (IFN Y , TNF , IL 1 , IL 6) 18 P Value: 0.0438 P Value: 0.033 MN 166 Targets Both Chronic MN 166 Targets Both Chronic and Acute Aspects of MS and Acute Aspects of MS MediciNova, Inc. 2008 Phase III endpoint for certain FDA approved MS products 19 Acute Efficacy Demonstrated: Acute Efficacy Demonstrated: Time to First Relapse Time to First Relapse MediciNova, Inc. 2008 20 MN 166 was very well tolerated; 89% of subjects completed the first 12 months of the study Discontinuation for AE was infrequent (placebo 1, 30mg/d 2, 60 mg/d 3) Side effects were generally mild and self limiting No statistically significant adverse effects were observed No adverse laboratory or ECG findings GI side effects as a group were the only adverse events to occur at ~2 fold that of the placebo rate (placebo 7.8%, 30 mg/d 14.7%, 60 mg/d 22.2%) Tolerance to the GI side effects occurred rapidly (2 4 days) 12 serious adverse events were reported (placebo 4, 30 mg 2, 60 mg 6); all were not or unlikely to be attributable to treatment No deaths occurred in the study MN 166 Overview Safety MN 166 Overview Safety MediciNova, Inc. 2008 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 III H/A, Nasopharyngitis GI disorders Liver enzymes Laquinimod Teva Phase III Liver enzymes Arthralgia Fibrinogen Hemoglobin Safety Comparison with Other Safety Comparison with Other Oral Agents Oral Agents 21 MediciNova, Inc. 2008 Phase II placebo controlled, randomized, double blind study year 1 0, 10 mg 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, with relapsing remitting (RR) and/or secondary progressive (SP) Multiple Sclerosis with continued relapses; A definite diagnosis of relapsing MS using the new International Committee recommendations (MacDonald Criteria); One MRI scan taken two weeks prior to treatment start using a standardized MRI protocol with at least one Gd enhancing lesion; An EDSS score of 5.5 or less at the screening and baseline visits.
MediciNova, Inc. Source: MedAdNews, June 2006 MediciNova, Inc. 2008 4 In License: Product candidates with significant clinical or pre clinical data Proof of Concept Trials: Conduct Phase I and Phase II trials to demonstrate efficacy of compound in US Two Pathways Towards ROI After Phase II: Continue internal development of compound towards commercialization Seek partnership for compound Business Model: Business Model: Return On Investment Return On Investment MediciNova, Inc. 2008 5 NDA MN 221 Development Plan MN 221 Development Plan Note: Development plans / timelines for MN 221 are subject to change Anticipated commencement and completion dates based on current projections Filing as early as 2H 10 MediciNova, Inc. 2008 6 Anticipated commencement and completion dates based on current projections ** Phase III studies, as well as Bioequivalence and MTD studies, will be delayed until a corporate partnership is secured for MN 166 Phase II Phase III (EU)/* Phase III (USA)/* MN 166 Development Plan MN 166 Development Plan Pursuing Partnering Opportunities Note: Development plans / timelines for MN 166 are subject to change MediciNova, Inc. 2008 7 Definition Long lasting and severe asthma episode that is not responsive to initial bronchodilator or corticosteroid therapy MN 221: Novel, highly selective 2 adrenergic receptor agonist Greater selectivity Partial agonist for 1 receptor in the heart Full agonist for 2 receptor in the lungs Improved safety (fewer cardiovascular side effects) compared to older agonists IV formulation for acute hospital use Reliable and rapid delivery Positive Phase IIa results reported in October 2007 MN 221: A New Approach to MN 221: A New Approach to Treating Status Asthmaticus Treating Status Asthmaticus MediciNova, Inc. 2008 8 Market Opportunity Approximately 1.9 million emergency room visits in the US each year* 500,000 hospitalizations Approximately 4,000 deaths annually in the US* Potential $500 M market opportunity for MediciNova Current Standard of Care*: Beta agonists (all patients) Inhaled or nebulized Corticosteroids (66 77% of patients) IV or oral *Source: National Center for Health Statistics / CDC MN 221: Market Opportunity MN 221: Market Opportunity MediciNova, Inc. 2008 1.
You should not rely unduly on these forward looking statements, which speak only as of the date hereof. We undertake no obligation to update publicly or revise any forward looking statements discussed in this presentation. Forward Looking Statements Forward Looking Statements MediciNova, Inc. 2008 3 Development Company Focused on Low Risk Product Candidates Unique access to differentiated, high value assets primarily from Japanese alliances New Approaches to Treat Serious Medical Conditions: MN 221: IV Status Asthmaticus candidate Estimated $500 M US opportunity for MediciNova MN: 166: Oral Multiple Sclerosis candidate In 2005, approximately $6.2 B in worldwide MS therapeutic sales* Diverse Pipeline: Six compounds with applications in multiple disease areas Corporate Overview: Corporate Overview: MediciNova, Inc.
These forward looking statements may be preceded by, followed by or otherwise include the words believes, expects, anticipates, intends, estimates, projects, can, could, may, will, would or similar expressions. Actual results or events may differ materially from those expressed or implied in any forward looking statements due to various factors, including, without limitation, the risks and uncertainties inherent in clinical trials and product development and commercialization, such as the uncertainty in results of clinical trials for our product candidates, the uncertainty of whether the results of clinical trials will be predictive of results in later stages of product development, the risk of delays or failure to obtain or maintain regulatory approvals, our reliance on third parties and the timing, cost and design of future clinical trials and research activities, the timing of our expected filings with the FDA, the failure to execute strategic plans or strategies successfully, our collaborations with third parties, intellectual property and contract rights, and the other risks and uncertainties described in our filings with the Securities and Exchange Commission, including our annual report for the year ended December 31, 2006 and our subsequent periodic reports on Forms 10 Q and 8 K.
Accelerating the global development and commercialization of innovative pharmaceuticals January 2008 Exhibit 99.1 MediciNova, Inc. 2008 2 This presentation contains forward looking statements that involve risks and uncertainties. These forward looking statements include, but are not limited to, statements regarding our strategies and objectives, our plans for the development and commercialization of our product candidates, including development programs and clinical trials, our industry, our financial condition, liquidity and capital resources, the efficacy and potential benefits of our product candidates and other statements that are not historical facts.