MediciNova, Inc. · NASDAQ:MNOV
MediciNova — Investor Presentation (March 2007)
24 slides from MediciNova's investor presentation, Mar 30, 2007
Slide 1: Accelerating the global development and commercialization of innovative pharmaceutical products
Exhibit 99.1 Accelerating the global development and commercialization of innovative pharmaceutical products © MediciNova, Inc. 2007
Slide 2: Safe Harbor Statement
Safe Harbor Statement This presentation may contain “forward looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include statements regarding the expected progress of the development of the Company’s product candidates and potential licens
Slide 3: Corporate Overview
Corporate Overview • US-based pharmaceutical development company: – Unique access to differentiated, high-value, lower-risk in-licensed assets from Japanese alliances – Focused on mid-to-late stage clinical development – Management team has global development/commercialization experience • Commercia
Slide 4: Business Model
Business Model Drug Development Research Late Preclinical Phase I Phase II Phase III Sales/ Marketing In-License: Partner: Commercialize: $ $$$$$ $$$$$$$$$$ • In-license high-value, differentiated small molecule product candidates at the late preclinical-early Phase II clinical development stage at
Slide 5: Proven Global Success of Drugs In-Licensed from Japan
Proven Global Success of Drugs In-Licensed from Japan Drugs discovered in Japan are being snapped up by Western companies: Drug Japanese Peak World-Wide Treatment Partner in U.S. (Date Launched) Discoverer Sales High Bristol-Myers Pravachol (1991) Sankyo $3.3 billion cholesterol Squibb Prevacid (199
Slide 6: Japanese Pharma Alliances
Japanese Pharma Alliances Japanese Pharmaceutical Company 2005 Sales ($M) • Unique access to mid-sized Japanese pharmaTakeda 10,208 companies with no U.S. and/or European Daiichi-Sankyo 8,330 Astellas 7,836 development capabilities Eisai 4,845 • Acquire rights to select, high quality compounds Sumit
Slide 7: Commercially-Attractive Diversified Portfolio
Commercially-Attractive 68 Years Compounds Diversified Portfolio 10 Indications Product candidate (indication) Preclinical Phase 1 Phase 2 Phase 3 Approval MN-001 (Bronchial asthma) MN-305 (Anxiety Disorders/Insomnia) MN-166 (Multiple sclerosis) MN-001 (Interstitial cystitis) MN-221 (Status Asthmati
Slide 8: 3 Near-Term Opportunities Show Pipeline Breadth and Value
3 Near-Term Opportunities Show Pipeline Breadth and Value • MN-001: Bronchial Asthma – Phase III initiated 4Q06 – Bonus indication: interstitial cystitis - in pivotal Phase II/III Product candidate (indication) Preclinical Phase 1 Phase 2 Phase 3 Approval – >$1B th5 year sales MN-001 (Bronchial asth
Slide 9: MN-001 (Asthma)
MN-001 (Asthma) Source KyorinPharmaceutical (2002) th Market Potential 5 yr sales > $1 B Advantages – Combined mechanism of leading brands (Singulair®, Zyflo® and Daxas®) with broader efficacy – Improved safety (no steroid-like side effects) – Convenience of oral administration (improved compliance)
Slide 10: MN-001 Competitive Advantages
MN-001 Competitive Advantages Potential First Line Therapy for the Treatment of Bronchial Asthma Anti- Steroid Safety Market Compound Dosing Inflammatory Sparing Issues Opportunity TID/BID; MN-001 QD in Yes Yes No > $3B development Singulair QD No No No $3B Accolate BID No No Liver toxicity < $90M Q
Slide 11: MN-001 Value-Added
MN-001 Value-Added At Acquisition • Large preclinical and early clinical database Value-Added • Elucidation of mechanism of action • cGMPmanufacturing (API and new formulation) • Expanded dose range (through Phase I testing) • Clinical proof-of-concept (in Phase II trial) • New composition of matter
Slide 12: MN-001 Key Data
MN-001 Key Data Proof-of-Concept in Mild-to-Moderate Asthmatics Mean FEV1 (L) Change from Baseline 0.5 Population: Intent-to-Treat (Observed Cases) 0.4 0.3 Statistically significant 0.2 improvement in mean 0.1 FEV1 after 4 weeks with 500 mg TID compared 0.0 to placebo (p=0.021; -0.1 p=0.021 p=0.058
Slide 13: MN-221 (Status Asthmaticus)
MN-221 (Status Asthmaticus) Source Kissei Pharmaceutical (2004) th Market Potential 5 yr sales ~ $500 M Advantages – Clinically-proven mechanism of action (highly selective 2-adrenergic receptor agonist) – Greater cardiovascular safety (less 1- adrenergic receptor stimulation) – More reliable, effec
Slide 14: MN-221 Competitive Advantages
MN-221 Competitive Advantages Proven Rapid Reliable Compound Dosing Mechanism Action Delivery Safety Issues MN-221 IV (Ph II) Yes Yes Yes No Inhaled; Cardiovascular ß-Agonists Yes Yes No nebulized (palpitations) Singulair IV (Ph III) No ? Yes No Zyflo IV (Ph I / II) No ? Yes Liver toxicity © MediciN
Slide 15: MN-221 Value-Added
MN-221 Value-Added At Acquisition • Large preclinical and early clinical database (in preterm labor) Value-Added • Initiated cGMP product manufacturing • Changed clinical dosing paradigm • Determined safety of new dosing paradigm (through Phase I testing) • New indicationStatus – Asthmaticus Next St
Slide 16: MN-221 Key Data
MN-221 Key Data Recovery from Ragweed-inducedBronchoconstrictionin Dogs 120 110 100 peak 90 response Vehicle 80 MN-221 (400 g/kg) 70 60 MN-221 (120 g/kg) 50 MN-221 ( 0 g/kg) 40 30 MN-221 (12 g/kg) 20 MN-221 g/kg) 10 0 baseline MN-221 (0.4 g/kg) 0 1 2 3 4 5 response Time after Injection (minutes) © M
Slide 17: MN-166 (Multiple Sclerosis)
MN-166 (Multiple Sclerosis) Source KyorinPharmaceutical (2004) th Market Potential 5 yr sales ~ $1 B Advantages – Oral treatment for MS – 16 years proven clinical safety and efficacy in inflammatory disorders (asthma, stroke) in Japan – Large preclinical and clinical database (3.2M patients treated;
Slide 18: MN-166 Competitive Advantages
MN-166 Competitive Advantages MN-166 Unmet Need Interferon Products More Intravenous or subcutaneous injection Oral convenient dosing (Injection site pain, swelling, and itching) Pilot clinical data Current relapse reduction rate is ~33% suggestive of 50% Greater efficacy (Significant market advanta
Slide 19: MN-166 Value-Added
MN-166 Value-Added At Acquisition • Large preclinical and clinical database • 16 years of clinical safety history • Pilot data in MS patients Value-Added • Completed first year of large (297-patient) clinical proof-of- concept Phase II study • Initiated cGMPAPI manufacturing Next Steps (in progress)
Slide 20: MN-166 Key Pilot Clinical Data
MN-166 Key Pilot Clinical Data Reduction of Relapse Rate Normalization of Serum Cytokine in 6 MS Patients Levels in 11 MS Patients 5 Cytokine % Change 4 IFN- -28 3 Th1 TNF- -35 2 1 IL-4 +119 Th2 0 IL-10 +64 Pre-Treatment Post-Treatment © MediciNova, Inc. 2007
Slide 21: MN-166 Key Phase II Data
MN-166 Key Phase II Data p-value Outcome Measure (pbo vs. 60 mg/d) Completers - annualized relapse rate: pbo - 0.8, 60 mg - 0.6 0.0752 (pbo - 42.7% vs. 60 mg - 60% with no relapses) Time to first relapse: Median for 60 mg > 1 year 0.0438 Median for pbo - 244 days % of subjects exacerbation-free for
Slide 22: Renewable Business Model: Two Newly-Acquired Product Opportunities
Renewable Business Model: Two Newly-Acquired Product Opportunities • Two novel cardiovascular th preclinical products acquired from Japanese 4 partner (Meiji Seika Kaisha, Ltd.) Product candidate (indication) Preclinical Phase 1 Phase 2 Phase 3 Approval • Modest investment with potentially large MN-
Slide 23: Management Team with Global Experience
Management Team with Global Experience Years LEADERSHIP Life Sciences Background Experience Yuichi Iwaki, MD, PhD 31 Prof. USC, Pitt; Advisor to JAFCO, Tanabe Executive Chairman, CEO Director, Avigen, Inc. Richard Gammans, PhD, MBA 29 Incara, Indevus, BMS Chief Development Officer Kenneth W. Locke,
Slide 24: MediciNova, Inc. Today
MediciNova, Inc. Today • Market-driven, commercially-focused mid-stagecompany pharma • Innovative business model: – Steady inflow of high-quality molecules, primarily from mid-size Japanese pharma – Focus on large, lucrative, underserved markets – Therapeutic & and molecular diversity lowers risk &