Medicinova, Inc. · NASDAQ:MNOV
Medicinova — Investor Presentation (July 2007)
33 slides from Medicinova's investor presentation, Jul 24, 2007
Slide 1: MediciNova, Inc. 2007
© MediciNova, Inc. 2007 Accelerating the global development and commercialization of innovative pharmaceutical products Accelerating the global development and commercialization of innovative pharmaceutical products Exhibit 99.1
Slide 2: Safe Harbor Statement
Safe Harbor Statement 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 c
Slide 3: Corporate Overview
Corporate Overview U.S.-based pharmaceutical company developing and commercializing small molecule therapeutics sourced primarily from Japan Special relationships provide unique access to “untapped” source of novel therapeutics Broad, deep and advanced development pipeline with key market advantages
Slide 4: Innovative Business Model
Innovative Business Model IN-LICENSE high-value, differentiated small molecule product candidates from mid-sized Japanese pharmaceutical companies ADVANCE through proof-of-concept Phase II/III clinical trials MONETIZE assets at key value inflection points COMMERCIALIZE certain product candidates for
Slide 5: IN-LICENSE
IN-LICENSE Seek - Differentiated small molecules (NCEs) in late preclinical to early Phase II stage that: – Fill unmet medical needs – Offer competitive market advantages – Possess significant market potential Source - Mid-sized Japanese pharma ( e.g. , Kyorin, Kissei, Mitsubishi, Meiji) – Special r
Slide 6: Commercially-Attractive Pipeline
Commercially-Attractive Pipeline Product candidate (indication) Preclinical Phase 1 Phase 2 Phase 3 Approval MN-166 (Multiple sclerosis) MN-305 (Anxiety Disorders/Insomnia) MN-221 (Status Asthmaticus) MN-001 (Bronchial asthma) MN-001 (Interstitial cystitis) MN-029 (Solid tumors) MN-246 (Urinary inco
Slide 7: ADVANCE
ADVANCE Advance to next value inflection point (usually Phase II/III proof-of-concept) Cost-effective development through tightly–managed CROs Experience and expertise in U.S. and European drug development Successful advancement has brought new candidates into the portfolio and facilitates future in
Slide 8: MONETIZE
MONETIZE At value inflection point: Take selected assets forward to commercialization* ( e.g. , MN-221) Out-license to global or regional partner Form joint venture to develop asset(s) Royalty-based financing Multiple Opportunities to Realize Asset Value *pending FDA approval
Slide 9: MN-001: Opportunity to Monetize
MN-001: Opportunity to Monetize Novel, oral control medication for asthma Positive Phase II proof-of-concept data – Significant improvement in FEV1 – Excellent safety profile Once-a-day formulation in development (expected 08Q2) New composition of matter patent (expiry 2023)
Slide 10: COMMERCIALIZE
COMMERCIALIZE Commercialize selected product candidates in the U.S. ( e.g. , MN-166, MN-221)*. Asset selection is based on: Development time and costs Ability to sell with small, focused sales force (50-100 reps) Market potential *pending completion of clinical trials and FDA approval
Slide 11: MN-166 (Multiple Sclerosis)
MN-166 (Multiple Sclerosis) Source Kyorin Pharmaceutical (2004) Mechanism Neuroprotective + Anti-inflammatory Advantages - Oral treatment for MS - 17 year safety history in Japan (asthma, stroke) - New U.S. use patent Clinical Status - Positive Phase II results from one year treatment Milestones - F
Slide 12: MN-166: Next Generation Treatment for Multiple Sclerosis
MN-166: Next Generation Treatment for Multiple Sclerosis In an oral delivery form, MN-166 provides a high degree of safety with a broader ( neuroprotection + anti-inflammatory ) efficacy profile than interferons. Based on clinical and radiologic findings, MN-166 has the potential to modify disease p
Slide 13: Definition of next generation of MS treatment
Definition of next generation of MS treatment (abstracted from Neurology 68 (S3), 2007) Controlling inflammation is no longer sufficient Neuroprotection is a very important issue in MS and drugs that may provide neuroprotection are going to be very well received by the Neurology community The MRI me
Slide 14: MN-166
MN-166 Orally administered with new controlled- release dosage form in development Neuroprotective and Anti-inflammatory in replicated pre-clinical studies Safe – 17 years of clinical use with over 3 million exposures has not revealed rare, concerning safety issues – Toxicology package supporting Ja
Slide 15: Neuroprotection + Anti-inflammatory
Neuroprotection + Anti-inflammatory MN-166 may reduce both relapses (via anti-inflammatory effects) and disease progression (via neuroprotection)
Slide 16: MN-166: Clinical Efficacy
MN-166: Clinical Efficacy Demonstrated neuroprotective and anti- inflammatory effects in patients with relapsing MS Neuroprotective outcome: – Attenuated % brain volume loss (-.8% vs. -1.2%) Anti-inflammatory outcomes: – Pilot studies found reduced relapse rate and Th1 Th2 cytokine shift – Prolonged
Slide 17: Effects on Time to First Relapse
Effects on Time to First Relapse Phase III endpoint for certain FDA-approved MS products
Slide 18: Effects on Brain Volume
Effects on Brain Volume Brain volume changes are linked to axonal loss 1.2 0.79 0.2 0.4 0.6 0.8 1.2 1.4 Placebo 20mg, TID % Decrease in Brain Volume
Slide 19: Benefits VS Interferons
Benefits VS Interferons Unmet Need MN-166 Interferon Products More convenient dosing Oral Intravenous or subcutaneous injection (Injection site pain, swelling and itching) Greater efficacy At least comparable efficacy observed in early trials Current relapse reduction rate is ~33% Longer duration of
Slide 20: Benefits VS Oral Agents
Benefits VS Oral Agents Feature FTY 720 Cladribine BG-12 Laquinimod MN-166 Sponsor Novartis MerckSerono BiogenIdec Teva MediciNova Mechanism sphingosine-1- receptor agonist adenosine agonist, immunosuppressant fumaric acid deriv; NF k B inhibitor immuno- modulator inhibits PDE IV, leukotrienes and N
Slide 21: MN-221 (Status Asthmaticus)
MN-221 (Status Asthmaticus) Source Kissei Pharmaceutical (2004) Mechanism Highly selective -adrenergic receptor agonist Advantages - Clinically-proven MOA - Greater cardiovascular safety - Reliable, rapid route of administration (i.v.) Clinical Status - Well tolerated in Phase I - Phase II started 1
Slide 22: MN-221: Status Asthmaticus
MN-221: Status Asthmaticus Definition: Long-lasting and severe asthma episode that is not responsive to initial bronchodilator or corticosteroid therapy Market Opportunity: ~1.9 million emergency room visits in the U.S. each year* ~500,000 hospitalizations* ~4,000 deaths annually in the U.S.* Curren
Slide 23: MN-221: New Treatment Paradigm
MN-221: New Treatment Paradigm Proven mechanism of action ( - adrenergic receptor agonist) Rapid, reliable IV delivery (vs. inhaled/nebulized) Safer (greater selectivity = fewer cardiovascular side effects)
Slide 24: Human Beta-Adrenergic Receptor Selectivity
Human -Adrenergic Receptor Selectivity Drug Adrenoceptor (IC , M) -Adrenoceptor Selectivity (IC for /IC for ) MN-221 1.39 0.0224 62.1 Albuterol (Salbutamol) 5.63 1.56 3.61 S(-)-Propranolol 0.00127 0.00094 1.35 Displacement of [ H]-cyanopindolol or [ H]-CGP12177 binding in membrane preparations expre
Slide 25: MN-221 Phase IIa
MN-221 Phase IIa Phase IIa Proof-of-Concept Randomized, double-blind, placebo-controlled, sequential dose-escalation study Objectives: – Determine the efficacy of a single 15-minute treatment – Determine the efficacy of two sequential 15-minute treatments 22 mild-to-moderate asthmatics at 4 centers
Slide 26: Clear Development Path
Clear Development Path Clinical Plan: Phase IIa results anticipated 07Q4 Phase IIb results as early as 09Q1 Phase III (2 trials) results as early as 10Q2 Modest development costs (~$45M to NDA) Well-defined regulatory path – Acute dosing = short trials – Modest number of patients required for NDA (p
Slide 27: Favorable Commercial Metrics
Favorable Commercial Metrics Market addressable through focused sales force (50-100 reps) Significant market opportunity (~$500M) Rapid market penetration (could become new standard of care) High payer acceptance (due to potential reduction in hospitalizations)
Slide 28: MN-221 Competitive Advantages
MN-221 Competitive Advantages Compound Dosing Proven Mechanism Rapid Action Reliable Delivery Safety Issues -Agonists Inhaled; Nebulized Yes Yes No Cardiovascular (palpitations) Singulair IV (Ph III) No ? Yes No Zyflo IV (Ph I) No ? Yes Liver Toxicity MN-221 IV (Ph II) Yes Yes Yes No
Slide 29: Targeted Path to Commercialization
Targeted Path to Commercialization* MN-221 MN-166 *pending FDA approval **completed as early as † filing as early as
Slide 30: 2007 Milestones
2007 Milestones Clinical MN-166 – Positive Phase II (yr 1) results announced 3/07 MN-305 – Proof-of-concept Phase II results anticipated 07Q3 MN-221 – Proof-of-concept Phase II results anticipated 07Q4 Scientific MN-029 – Positive Phase I DCE-MRI results to be presented at ECCO (Barcelona, September
Slide 31: Financials
Financials Dual Listing: – MNOV (Nasdaq) – 4875 (Osaka (Hercules)) Cash: $98.1M as of 3/31/07 Sufficient cash through at least 12/31/08 Shares outstanding: 11.6M Market cap as of 7/20/07: ~$100M
Slide 32: MEDI@ NOVA
MEDI@ NOVA
Slide 33: Investment Highlights
Investment Highlights IN-LICENSE: Innovative business model ADVANCE: Rich mid- to late-stage clinical development pipeline with clear market advantages MONETIZE: Near-, mid- and longer-term realization of asset potential COMMERCIALIZE: MN-221 and MN-166 targeted for commercialization* by MediciNova