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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* Completed Milestones in 2010: 1. Announced Positive MN 221 CL 010 Phase Ib Study Results in Moderate to Severe COPD Patients on March 17, 2010 3.
Kirk Johnson, Ph.D. Chief Scientific Officer 21 Avigen, Genesoft Pharmaceuticals, Chiron Corporation Michael Coffee Michael Coffee Chief Business Officer 26 Avigen, Amarin Corp., Elan Pharmaceuticals, N.A., Athena Neurosciences Masatsune Okajima, CMA Masatsune Okajima, CMA VP, Head of Japanese Office 19 Daiwa Securities SMBC, Sumitomo Capital Securities, Sumitomo Bank Management Team with Management Team with Global Experience Global Experience MediciNova, Inc. 2011 19 Upcoming Near Term Business Milestones: 1.
Option Agreement around Phase 2b Diabetic Peripheral Neuropathic Pain and/or Progressive MS trial with Exclusive License, Development Milestones, Royalties, Sales Milestones. Sustain NIDA sponsored Drug Addiction development Consider Investigator sponsored Neurological Trials 16 Most Likely Scenario for Most Likely Scenario for Ibudilast s Ibudilast s Development Development MediciNova, Inc. 2011 17 Commercially Attractive Commercially Attractive Diversified Portfolio Diversified Portfolio COPD COPD Asthma Asthma MS MS Pain/Addiction Pain/Addiction MediciNova, Inc. 2011 18 Leadership Years Experience Background Yuichi Iwaki, MD, PhD Yuichi Iwaki, MD, PhD CEO President 35 Professor at USC, formerly Professor at University of Pittsburgh; Advisor to JAFCO, Tanabe Shintaro Asako, CPA Shintaro Asako, CPA Chief Financial Officer 13 KPMG USA (Audit), Arthur Andersen USA Kirk Johnson, Ph.D.
Pain Composition of Matter AV1013 2 nd Generation Analogs Issued or allowed Pending AV1013 Enantiomer Key: Progressive MS Exp. 2018 Exp. 2025 Exp. 2027 MIF Inh. screen Exp. 2027 Ibudilast + Immunomodulator for MS Acute Sub chronic Pain Addiction MediciNova, Inc. 2011 Collaboration Structure with Pharma Partner: 1. Shared Risk 2. All indications; Ibudilast + Analogues 3.
Anticipated completion in 2H, 2011* MN 221 CL 007: MN 221 CL 007: Study Design Study Design 11 Note: Development plans / timelines for MN 221 clinical trials are subject to change *Anticipated completion date based on current projections MediciNova, Inc. 2011 12 Ibudilast (MN 166/AV411) Oral administration Safe and well tolerated (approved in Japan/Korea with over 3.2 million patient exposures) Mechanism(s) of Action primarily Inhibition of Microphage Migration Inhibitor Factor (MIF), PDE 4,10 inhibition; Attenuation of Glial Cell Activation Clinical Safety Preliminary Efficacy Completed Phase 2 Multiple Sclerosis Proof of Concept study (30 and 60 mg/d, predominately RRMS pts.) Completed Phase 1b/2a trial in Diabetic Neuropathic Pain (40 and 80 mg/d) Completed Phase 1b/2a clinical trial in Opioid Withdrawal Analgesia (40 and 80 mg/d) (Columbia Univ/NYSPI via NIDA funding) Ongoing Phase 1b Methamphetamine interaction trial (UCLA via NIDA funding) Additional Supporting Data 3 completed Phase 1 clinical trials Dosing up to 100 mg single dose 100 mg daily (50 mg twice/day) ~400 subjects treated with MN 166/AV411 to date (safe well tolerated) Ibudilast for the Treatment of MS, Ibudilast for the Treatment of MS, Neuropathic Pain, Drug Addiction Neuropathic Pain, Drug Addiction MediciNova, Inc. 2011 13 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 to current pain treatments, and has both stand alone and adjunctive utilities Majority of potential pharma partners are strategically committed to new pain therapies MN 166/AV411 has an attractive development timeline and long term exclusivity Status for Drug Addiction/Opioid Withdrawal: Announced positive safety/efficacy results from Phase 1b/2a study in Opioid Withdrawal (12/10) UCLA initiated Phase Ib study for Methamphetamine Addiction (9/10) Status for Multiple Sclerosis: MN 166/AV411 requires significant funding for future trials Phase 2 data were at doses that are below maximum utility Most attractive option may be Progressive MS which would require an additional Phase 2b clinical trial Ibudilast Ibudilast (MN 166/AV411): (MN 166/AV411): Status for Each Indication Status for Each Indication MediciNova, Inc. 2011 14 Ibudilast Ibudilast Neuropathic Pain Neuropathic Pain Market Opportunity Market Opportunity Drug Company Total Rxs in 2009 (US) Lyrica Pfizer 9.1 Million Cymbalta Eli Lilly 14.7 Million Neurontin (Gabapentin) Pfizer 23.4 Million Total 47.1 Million Neuropathic Pain Annual Market Opportunity: ~$8.0 Billion Prevalence is approximately 4.2 million neuropathic pain patients in the U.S. and 40 million worldwide MN 166 has a different mechanism of action than currently marketed neuropathic pain therapies MN 166 has potential to capture substantial market share in the neuropathic pain market *Source: SDI/Verispan, Lilly and Pfizer Quarterly Reports Approved indications: Lyrica: Neuropathic pain associated with diabetic peripheral neuropathy, post herpetic neuralgia, partial onset seizures, fibromyalgia; Neurontin: postherpetic neuralgia, partial seizures ; Cymbalta: Major Depressive Disorder, Generalized Anxiety Disorder, Diabetic Peripheral Neuropathic Pain, Fibromyalgia Market Value Calculated at Branded Prices MediciNova, Inc. 2011 15 Patent/Commercial Overview Patent/Commercial Overview Method of Use MS N.
CL 006, CL 007 located in emergency departments. MediciNova, Inc. 2011 MN 221 CL 006 MN 221 CL 006 Mean Change in FEV Mean Change in FEV 1 1 and and Differences in Hospitalization Rate Differences in Hospitalization Rate 10 Mean change in FEV 1 from baseline was 5.3% higher in the MN 221 dose groups versus the placebo group MN 221 reduced the hospitalization rate by 45% MediciNova, Inc. 2011 Randomized, placebo controlled, double blind, multi center Phase II clinical trial Up to 200 patients with severe, acute exacerbations of asthma (FEV 1 = 50% predicted) at multiple Emergency Department sites in the United States Dose Groups (up to 100 patients/group): 1,200 g of MN 221 over 1 hour (600 g in 15 minutes; 600 g in next 45 minutes) Placebo Patients will receive SOC treatment in addition to adjunctive treatment with MN 221 or placebo Primary efficacy endpoint will be improvement in FEV 1 (% predicted) at 3 hours The study is designed to have 80% power to detect a treatment difference of 5 percentage points in FEV 1 (% predicted) when comparing MN 221 + SOC to Placebo + SOC at a two sided a level of 0.05.
Reduces the hospitalization rate among patients treated with MN 221. No clinical adverse effects when added to standard of care (SOC). MediciNova, Inc. 2011 MN 221 Clinical Trials MN 221 Clinical Trials 9 Completed Completed Ongoing Ongoing Study Study CL 004 CL 005 CL 006 CL 010 CL 007 Indication Indication Mild to moderate Asthmatics Moderate to Severe Asthmatics Acute Exacerbations of Asthma Moderate to Severe COPD patients Acute Exacerbations of Asthma FEV FEV 1 1 (Entry Criteria) (Entry Criteria) FEV 1 60% 75% FEV 1 40% FEV 1 55% 80% FEV 1 30% FEV 1 50% Number of Number of Patients Patients 23 17 29 48 200 Number of Number of Sites Sites 4 4 8 6 ~20 Doses Tested Doses Tested Compared to Compared to Placebo Placebo 5.25, 15, 52.5, 150, 240, 450, 900 g over 15 min 1080 g over 2 hr; 1,125 g over 1 hr 240, 450 g over 15 min; 1080 g over 2 hr 300, 600, 1200 g over 1 hr 1200 g over 1 hr Note: CL 004, CL 005, CL 010 located in clinical sites.
It is administered adjunctive to standard of care by intravenous infusion. A well tolerated, potent, selective 2 agonist which is only a partial agonist at 1 . A bronchodilating duration of action that is longer than SABAs and shorter than LABAs. Provides additional bronchodilation when used in addition to the standard treatments of inhaled albuterol, inhaled ipratropium, and steroids.
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 7 MN 221: A New Approach to Treating MN 221: A New Approach to Treating Exacerbations of Acute Asthma COPD Exacerbations of Acute Asthma COPD MediciNova, Inc. 2011 8 MN 221: Target Product Profile MN 221: Target Product Profile MN 221 Indication: Treatment of bronchospasms in patients with acute exacerbations of asthma or COPD.
Limitations of Inhaled Therapies: Bronchoconstriction : inflammation and bronchoconstriction result in insufficient air flow to get good drug deposition in the lungs Mucus Plug Formation : mucus secretion and the formation of thick mucus plugs can cause persistent airflow limitation Albuterol Non Responders : not all patients benefit from albuterol Limitations of Current Intravenous Therapies: Safety : currently available options (e.g. epinephrine, terbutaline) have unacceptable cardiovascular risks at doses used MediciNova, Inc. 2011 MN 221: A novel, highly selective 2 adrenergic receptor agonist Three potential advantages over current therapy: 1.
Emergency Departments in the U.S. 1,900,000 1,900,000 Patients receive standard of care in Emergency Department Positive Response ~51% Continue therapy until patient is discharged Annual number of patients with acute exacerbations of asthma Non Responders ~49% Continue therapy for several hours Patient improves and is discharged Patient is hospitalized No Response 965,000 935,000 935,000 410,000 525,000 525,000 Source: Weber, Silverman et al, American Journal of Medicine, 2002, Volume 113; pp 371 *Patients who could potentially benefit from addition of MN 221 MediciNova, Inc. 2011 6 Limitations of Current Therapies Limitations of Current Therapies What are the limitations of current therapies for acute exacerbations of asthma?
MediciNova, Inc. Source: Internal MediciNova projections MediciNova, Inc. 2011 4 Definition: Long lasting and severe episodes that are not responsive to initial bronchodilator or corticosteroid therapies Market Opportunity: ~500,000 annual hospitalizations in the US for asthma Average length of stay for asthma hospitalization is 3.2 days Average cost for asthma hospitalization is $6,477 ~726,000 annual hospitalizations in the US for COPD ~119,000 deaths due to COPD Current Standard of Care (SOC): Inhaled Beta agonists, inhaled anticholinergics, and IV or oral corticosteroids MN 221 for Exacerbations of MN 221 for Exacerbations of Acute Asthma and COPD Acute Asthma and COPD COPD Discharged Hospitalized 72% 28% ~1.9 million Asthma 52% 48% ~1.5 million Hospitalization Rates Amongst Asthma and COPD Patients* *Source: National Center for Health Statistics / CDC, WHO website, Core Health indicators , 2006 National Hospital Discharge Survey, IMS Health s Disease and Condition Benchmarks PharMetrics Integrated Database, 1/2007 12/2008 5 Acute Asthma Treatment Flow in Acute Asthma Treatment Flow in Emergency Departments in the U.S.
You are cautioned not to place undue reliance on these forward looking statements, which speak only as of January 7, 2010. MediciNova disclaims any intent or obligation to revise or update these forward looking statements. MediciNova, Inc. 2011 3 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 $65.5 million Market Cap (NasdaqGM) as of 1/05/2011 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 asthma and COPD candidate Potential $1 billion+ combined market opportunity worldwide* MN 166: oral multiple sclerosis, neuropathic pain, drug addiction candidate 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 the risks and uncertainties inherent in clinical trials and product development and commercialization, such as the uncertainty in results of clinical trials for 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 approval, the risk of failure of the third parties upon whom MediciNova relies to conduct its clinical trials and manufacture its product candidates to perform as expected, the risk of increased cost and delays due to delays in the commencement, enrollment, completion or analysis of clinical trials or significant issues regarding the adequacy of clinical trial designs or the execution of clinical trials and the timing, cost and design of future clinical trials and research activities; the timing of expected filings with the FDA; MediciNova s failure to execute strategic plans or strategies successfully; MediciNova s collaborations with third parties; MediciNova s ability to realize the anticipated strategic and financial benefits from its acquisition of Avigen, Inc., to integrate the two ibudilast development programs and to pursue discussions with potential partners to secure a strategic collaboration to advance the clinical development of the combined development program; the availability of funds to complete product development plans and MediciNova s ability to raise sufficient capital when needed, or at all; MediciNova s ability to comply with the covenants in its financing agreements; intellectual property or contract rights; and the other risks and uncertainties described in MediciNova s filings with the Securities and Exchange Commission, including MediciNova s annual report on Form 10 K for the year ended December 31, 2009 and its subsequent periodic reports on Forms 10 Q and 8 K.
These forward looking statements include statements regarding MediciNova s clinical trials supporting the safety and efficacy of its product candidates and the potential novelty of such product candidates as treatments for disease, plans and objectives for clinical trials and product development, strategies, future performance, expectations, assumptions, financial condition, liquidity and capital resources.
MediciNova, Inc. 2011 Accelerating the global development and commercialization of innovative pharmaceuticals Exhibit 99.1 MediciNova, Inc. 2011 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.
Secured $15M Debt Financing from Oxford Finance Corp. on May 10, 2010 4. Announced Positive Safety and Efficacy data for Ibudilast (MN 166/AV411) Phase Ib/2a Study Results for Opioid Withdrawal and Analgesia on December 13, 2010 Investment Highlights Investment Highlights *Anticipated completion dates based on current projections