MediciNova, Inc. · NASDAQ:MNOV
MediciNova — Investor Presentation (May 2007)
30 slides from MediciNova's investor presentation, May 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: MN-221 (Status Asthmaticus)
MN-221 (Status Asthmaticus) Source Kissei Pharmaceutical (2004) Market Potential 5th 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, effect
Slide 9: Trends in Asthma
Trends in Asthma 1980 2000 2002 Outpatient visits 1,036,000 1,225,000 Emergency room 7,137,000 1,835,000 1,898,000 visits Physician office 9,332,000 12,692,000 visits Hospitalizations 408,000 465,000 484,000 Deaths 2,891 4,487 4,261 Total cost in 2004: $11.5 billion direct and $4.6 billion indirect
Slide 10: 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 11: Human Adrenergic Receptor Selectivity
Human -Adrenergic Receptor Selectivity 2-Adrenoceptor Adrenoceptor (IC50, M) Selectivity Drug 1 2 (IC50 for 1/IC50 for 2) MN-221 1.39 0.0224 62.1 Albuterol 5.63 1.56 3.61 (Salbutamol) S(-)-Propranolol 0.00127 0.00094 1.35 Displacement of [³H]-cyanopindolol or [³H]-CGP12177 binding in membrane prepar
Slide 12: Reduction in Bronchoconstriction
Reduction in Bronchoconstriction Recovery from Ragweed-induced Bronchoconstriction in 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 Inje
Slide 13: Phase IIa Study Outline
Phase IIa Study Outline • Study Objectives: – To determine the efficacy of a single 15-minutes treatment with intravenous MN- 221 in subjects with mild-to-moderate asthma. – To determine the efficacy of two sequential 15-minutes infusion of MN-221 separated by 20 minutes in subjects with mild-to-mod
Slide 14: MN-221 Value-Added/Next Steps
MN-221 Value-Added/Next Steps At Acquisition • Large preclinical and early clinical database (in preterm labor) Value-Added • Initiated cGMPproduct manufacturing • Changed clinical dosing paradigm • Determined safety of new dosing paradigm (through Phase I testing) • New indicationStatus – Asthmatic
Slide 15: MN-221 Summary
MN-221 Summary • Significant market opportunity (to $500M peak sales) • Improved selectivity for 2-adrenergic receptor over older agents • Improved safety (fewer cardiovascular side effects) compared to older -agonists • I.V. formulation (reliable and rapid delivery) • Recent composition and use pat
Slide 16: MN-166 (Multiple Sclerosis)
MN-166 (Multiple Sclerosis) Source KyorinPharmaceutical (2004) Market Potential 5th 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 17: MS Demographics and Market
MS Demographics and Market • Multiple sclerosis, an inflammatory disease of the central nervous system, affects 250,000 to 350,000 people in the U.S. and 2.5 million worldwide. • Relapsing-remitting MS is the most common type of the disease, affecting 6585% – of patients, and most patients with RRMS
Slide 18: MN-166 Competitive Advantages
MN-166 Competitive Advantages Unmet Need MN-166 Interferon Products Intravenous or subcutaneous injection More convenient dosing Oral (Injection site pain, swelling and itching) At least comparable Greater efficacy efficacy observed in Current relapse reduction rate is ~33% early trials Relative ben
Slide 19: Mechanism(s) of Action
Mechanism(s) of Action • Anti-inflammatory – Phosphodiesterase IV inhibitor – Leukotriene inhibitor – Inhibits nitric oxide and reactive oxygen species production – Inhibits Th1 cytokine production ,(IFN- TNF- , IL-1 , IL-6) • Neuroprotective – Stimulates Th2 cytokine production (IL-4, IL-10) – Stim
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: Phase II Clinical Protocol
Phase II Clinical Protocol • Phase II placebo-controlled, randomized, double-blind (monotherapy) study year 1 –0 (placebo), 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
Slide 22: Phase II Clinical Protocol
Phase II Clinical Protocol • Key Exclusion Criteria: – Treatmentwithsystemicimmunosuppressants (includinginvestigational treatments), suchas infliximab,natalizumab, cyclophosphamide, mitoxantrone,azothioprine, methotrexate, linomide, cyclosporine ordeoxysperagualinewithin6 monthsoftheWeek-2cranialMR
Slide 23: Key Phase II Clinical Outcome Data
Key Phase II Clinical Outcome Data p-value Outcome Measure (pbovs. 60 mg/day) Annualized relapse rate*: pbo- 0.8, 60 mg0.6 - (completers) 0.0752 pbo- 0.9, 60 mg0.7 - (ITT) 0.1106 Time to first relapse (ITT)*: Median for 60 mg > 1 year 0.0438 Median for pbo- 244 days % of subjects exacerbation-free f
Slide 24: Effects on Time to First Relapse
Effects on Time to First Relapse Time to first relapse (ITT): Median for pbo - 244 days, Median for 60 mg > 1 year, p=0.0438 Statistically Significant Approvable Phase3 endpoint © MediciNova, Inc. 2007
Slide 25: Key Phase II Radiological Data
Key Phase II Radiological Data* p-value Outcome Measure (ITT) (pbovs. 60 mg/day) % brainvolume change: 0.0352 pbo: -1.2%, 60 mg: -0.79% Cumulative volume of Gd-enhancing T1 lesions: 3 3 0.087 pbo- 2355 mm, 60 mg1927 - mm Cumulative number of active (Gd-enhancing (T1) and non-enhancing study- 01outco
Slide 26: Effects on Brain Volume
Effects on Brain Volume Effects of MN-166 on Change in Brain Volume (ITT) 0.00 Placebo -0.25 60 mg/day -0.50 -0.75 -1.00 -1.25 -1.50 Placebo 60 mg/day Treatment Group % brain volume change: pbo: -1.2%, 60 mg: -0.79%, p=0.0352 Brain volume loss is linked to disease progression © MediciNova, Inc. 2007
Slide 27: Key Phase II Safety Data
Key Phase II Safety Data • MN-166 was very well tolerated; 89% of subjects completed the first 12 months (core) of the study • Side effects were generally mild and self-limiting • No statistically significant adverse effects were observed • No laboratory or ECG findings • Mild, self-limiting GI side
Slide 28: MN-166 Summary
MN-166 Summary • Marketed product(forbronchial asthmaandcerebrovascular disorders) in Asia since 1989 • Extensive preclinical and clinical database: – Data from ~15,000 patients in clinical trial and post-marketing database – Extensive toxicology package, including carcinogenicity testing in one spe
Slide 29: 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 CEO & President Director, Avigen, Inc. Richard Gammans, PhD, MBA 30 Incara, Indevus, BMS Chief Development Officer Kenneth W. Locke, PhD 23 T
Slide 30: 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 &