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8-K - FORM 8-K - MEDICINOVA INCd8k.htm
©
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. 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. 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. 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.
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.
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.
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 µg
over 15 min
1080 µg over  
2-hr;
1,125 µg over 
1-hr
240, 450 µg
over 15 min;
1080 µg over  
2-hr
300, 600, 1200
µg over  1-hr
1200 µg over  
1-hr
Note: CL-004, CL-005, CL-010 located in clinical sites.  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
µg
MN-221
over
1
hour
(600
µg
in
15
minutes;
600
µg
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.
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. 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.
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.
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.
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