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Secure a global partnership for MN 166 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 1Q, 2011* 2. MN 166 Study for Opioid Withdrawal Anticipated completion in 2H, 2010* Completed Milestones: 1. Completed Avigen merger December 18, 2009 2.
Kirk Johnson, Ph.D. Chief Scientific Officer 20 Avigen, Genesoft Pharmaceuticals, Chiron Corporation Michael Coffee Michael Coffee Chief Business Officer 25 Chief Business Officer, Avigen, President of Elan Pharmaceuticals, North America Masatsune Okajima, CMA Masatsune Okajima, CMA VP, Head of Japanese Office 18 Daiwa Securities SMBC, Sumitomo Capital Securities, Sumitomo Bank Management Team with Management Team with Global Experience Global Experience MediciNova, Inc. 2010 14 Upcoming Near Term Business Milestones: 1.
IND s Analgesia division Neuropathic pain; Opioid Withdrawal MN 166 (Ibudilast) for the Treatment of MN 166 (Ibudilast) for the Treatment of MS, Neuropathic Pain, Drug Addiction MS, Neuropathic Pain, Drug Addiction MediciNova, Inc. 2010 11 Study Design: Study Objective: Assess MN 166 safety/tolerability/PK and preliminary efficacy for opiate withdrawal in heroin dependent subjects Ongoing clinical trial run jointly by the New York State Psychiatric Institute and Columbia University in NYC (Investigator IND study; MediciNova is not the sponsor) Trial to enroll ~30 patients (10 completers/cohort) Anticipated completion in 2H, 2010* MN 166 for Opioid MN 166 for Opioid Withdrawal: Withdrawal: Phase Ib/IIa Phase Ib/IIa Ongoing Clinical Trial Ongoing Clinical Trial Trial Design/Endpoints Week 1 2 3 Treatment Morphine (30 mg QID) and Placebo BID Morphine (30 mg QID) and Placebo BID or 20 mg BID of Ibudilast or 40 mg BID of Ibudilast Placebo BID or 20 mg BID of Ibudilast or 40 mg BID of Ibudilast Endpoints Safety, Tolerability, PK Safety, Tolerability, PK Withdrawal scores, Safety, Tolerability, PK Note: QID refers to taking the medication four times per day; BID refers to taking the medication twice a day *Anticipated completion date based on current projections MediciNova, Inc. 2010 12 Commercially Attractive Commercially Attractive Diversified Portfolio Diversified Portfolio COPD COPD Asthma Asthma MS MS Pain/Addiction Pain/Addiction MediciNova, Inc. 2010 13 Leadership Years Experience Background Yuichi Iwaki, MD, PhD Yuichi Iwaki, MD, PhD CEO President 34 Professor at USC, formerly Professor at University of Pittsburgh; Advisor to JAFCO, Tanabe Shintaro Asako, CPA Shintaro Asako, CPA Chief Financial Officer 12 KPMG USA (Audit), Arthur Andersen USA Kirk Johnson, Ph.D.
Anticipated completion 1Q, 2011* MN 221 CL 007: MN 221 CL 007: Study Design Study Design 9 Note: Development plans / timelines for MN 221 clinical trials are subject to change *Anticipated completion date based on current projections MediciNova, Inc. 2010 10 MN 166 Oral administration Safe and well tolerated (approved in Japan/Korea with over 3.2 million patient exposures) Mechanism(s) of Action primarily non selective PDE inhibition, Attenuation of Glial Cell Activation and Inhibition of Microphage Migration Inhibitor Factor (MIF) 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 Ongoing Phase 1b/2a clinical trial in Opioid Withdrawal; completion expected 2H, 2010 Additional Supporting Data 3 completed Phase 1 clinical trials Dosing up to 100 mg single dose 100 mg daily (50 mg BID) ~400 subjects treated with MN 166 to date (safe well tolerated) Open U.S.
CL 006, CL 007 located in emergency departments. MediciNova, Inc. 2010 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 8 Mean change in FEV 1 from baseline was 5.27% higher in the MN 221 dose groups versus the placebo group MN 221 reduced the hospitalization rate by 45% MediciNova, Inc. 2010 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 to100 patients/group): 1,200 g MN 221 over 1 hour (600 g in 15 minutes; 600 g in 45 minutes) Placebo Patients will receive Standard of Care (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 level of 0.05.
Improved Efficacy Route of Administration (IV v. Inhalation) 2. Improved Safety Higher selectivity for 2 receptor than 1 42.4 fold 2 selectivity (IC 50 1 / IC 50 2 ) Partial agonist for 1 receptor 3. Reduced Health Care Expenses 6 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. 2010 MN 221 Clinical Trials MN 221 Clinical Trials 7 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 ~35 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.
Emergency Departments in the U.S. 1,900,000 1,900,000 Positive Response ~51% Continue therapy until patient is discharged 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 Annual number of patients with acute exacerbations of asthma Patients receive standard of care in Emergency Department *Patients who could potentially benefit from addition of MN 221 MediciNova, Inc. 2010 MN 221: A novel, highly selective 2 adrenergic receptor agonist Three potential advantages over current therapy: 1.
MediciNova, Inc. Source: Internal MediciNova projections MediciNova, Inc. 2010 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 MediciNova, Inc. 2010 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 the date September 1, 2010. MediciNova disclaims any intent or obligation to revise or update these forward looking statements. MediciNova, Inc. 2010 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 $71.7 million Market Cap (NasdaqGM) as of 8/2/2010 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; 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, 10 K 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. 2010 Accelerating the global development and commercialization of innovative pharmaceuticals Exhibit 99.1 MediciNova, Inc. 2010 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.
Announced Positive MN 221 CL 010 Phase Ib Study Results in Moderate to Severe COPD Patients on March 17, 2010 3. Secured $15M Venture Debt from Oxford Finance Corp. on May 10, 2010 Investment Highlights Investment Highlights *Anticipated completion dates based on current projections