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Form 8-K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

Date of report (Date of earliest event reported): March 9, 2010

 

 

MEDICINOVA, INC.

(Exact name of Registrant as Specified in Its Charter)

 

 

 

DELAWARE   001-33185   33-0927979

(State or Other Jurisdiction

of Incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

 

4350 LA JOLLA VILLAGE DRIVE, SUITE 950, SAN DIEGO, CA   92122
(Address of Principal Executive Offices)   (Zip Code)

Registrant’s telephone number, including area code: (858) 373-1500

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 

Item 7.01. Regulation FD Disclosure.

On March 9, 2010, MediciNova, Inc. (the “Registrant”) updated the slide presentation to be used by the Registrant at investor meetings. A copy of the revised slide presentation is attached hereto as Exhibit 99.1.

The information in this Current Report on Form 8-K being provided under this Item 7.01, including Exhibit 99.1 furnished herewith, is being furnished and shall not be deemed “filed” for any purpose of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of such Section. The information in this current report on Form 8-K shall not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits.

 

99.1  Slide Presentation of the Registrant.

 

2

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, MediciNova has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

Date: March 9, 2010

     MEDICINOVA, INC.
    By:   /s/    SHINTARO ASAKO        
    Name:   Shintaro Asako
    Title:   Chief Financial Officer

 

3

Slide Presentation
©
MediciNova, Inc. 2010
Accelerating
the global development
and commercialization of
innovative pharmaceuticals
Exhibit 99.1

©
MediciNova, Inc. 2010
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, 2008 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 March 5, 2010. MediciNova
disclaims any intent or obligation to revise or update these forward-looking statements.
Forward-Looking Statements
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
•
$93.9 million Market Cap (NasdaqGM) as of 3/05/2010
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 candidate; additional enabled neurological conditions
•
In 2008, over $8 billion in worldwide MS therapeutic sales**
Corporate Overview:
Corporate Overview:
MediciNova, Inc.
MediciNova, Inc.
**Source: Individual annual reports of leading MS companies, 2008
*Source:
Internal
MediciNova
projections

©
MediciNova, Inc. 2010
4
Definition:
•
Acute Asthma Exacerbations:
Long-lasting and
severe asthma episodes that are not responsive to
initial bronchodilator or corticosteroid therapies
•
COPD Exacerbations:
Sustained worsening of the
patient's condition, from the stable state and beyond
normal day-to-day variations, that is acute in onset
Market Opportunity:
•
Potential $1 billion+ combined market opportunity
worldwide* (acute asthma & COPD exacerbations)
Current Standard of Care (SOC):
•
Beta agonists -
Inhaled
•
Anticholinergics
-
Inhaled
•
Corticosteroids -
IV or oral
**Source: National Center for Health
Statistics / CDC, WHO website, “Core
Health indicators”
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:
Internal
MediciNova
projections

©
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
Patients receive
standard of care in
Emergency Department
Positive
Response
~51%
Continue therapy until
patient is discharged
Annual number of
patients with acute
exacerbations of asthma
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
*Patients who could
potentially benefit from
addition of MN-221

©
MediciNova, Inc. 2010
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
MN-221:
A
novel,
highly
selective
ß
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
ß
2
receptor
than
ß
1
•
Partial
agonist
for
ß
1
receptor
3.
Reduced Health Care Expenses

©
MediciNova, Inc. 2010
7
Human ß-Adrenergic Receptor
Human ß-Adrenergic Receptor
Selectivity
Selectivity
Test Drug
ß
1
IC
50
(M)
ß
2
IC
50
(M)
ß
2
-Adrenoceptor Selectivity
(IC
50
for ß
1
/ IC
50
for ß
2
)
Levalbuterol
7.40E-06
1.40E-06
5.3
Albuterol
9.40E-06
1.60E-06
5.9
Terbutaline
6.00E-05
6.50E-06
9.2
MN-221
5.90E-06
1.40E-07
42.4

©
MediciNova, Inc. 2010
Effect on Heart rate:                      
Effect on Heart rate:                      
Combination of MN-221 & Albuterol in Dogs
Combination of MN-221 & Albuterol in Dogs
8

©
MediciNova, Inc. 2010
MN-221 Clinical Trials
MN-221 Clinical Trials
9
Completed Studies
Completed Studies
Ongoing Studies
Ongoing Studies
Study
Study
CL-004
CL-005
CL-006
CL-007
CL-010
Indication
Indication
Mild-to-moderate
Asthmatics
Moderate-to-
Severe
Asthmatics
Acute
Exacerbations
of Asthma
Acute
Exacerbations
of Asthma
Moderate-to-
Severe
COPD patients
FEV
FEV
1
1
(Entry Criteria)
(Entry Criteria)
FEV
1
60%
75%
FEV
1
40% 
FEV
1
55%
FEV
1
50%
80%
FEV
1
30% 
Number of
Number of
Patients
Patients
23
17
29
200
48
Number of
Number of
Sites
Sites
4
4
8
~35
6
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
1200 µg over  
1-hr
300, 600, 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-004:                      
MN-221-CL-004:                      
Mean Change in FEV
Mean Change in FEV
1
1
10
p < 0.05
p < 0.001
p < 0.05
p < 0.001

©
MediciNova, Inc. 2010
MN-221-CL-005:                             
MN-221-CL-005:                             
Mean Change in FEV
Mean Change in FEV
1
1
11
Baseline:
64.6%
Baseline:
69.4%
1 Hour:
82.0%
2 Hours:
81.5%
Baseline:
68.6%
Baseline:
68.6%
1 Hour:
70.5%
2 Hours:
71.2%

©
MediciNova, Inc. 2010
MN-221-CL-006
MN-221-CL-006
Mean Change in FEV
Mean Change in FEV
1
1
12
Mean
change
in
FEV
1
from
baseline
was
5.27%
higher
in
the
MN-221 dose groups versus the placebo group

©
MediciNova, Inc. 2010
MN-221-CL-006:
MN-221-CL-006:
Hospitalization Rate by Treatment Group
Hospitalization Rate by Treatment Group
13
MN-221 reduced the hospitalization rate by 45%
Note: SOC means standard of care.

©
MediciNova, Inc. 2010
14
What did we learn from the MN-221-CL-006 clinical trial?
•
There were no safety concerns with adding MN-221 to
the standard of care.
•
There was a reduction in the hospitalization rate
among patients treated with MN-221.
•
Overall, improvement in FEV
1
was greater for patients
receiving MN-221 than placebo.
•
A dose of 1,200 µg
of MN-221 administered over one
hour
was selected for the MN-221-CL-007 clinical trial.
MN-221-CL-006:                 
MN-221-CL-006:                 
What have we learned?
What have we learned?

©
MediciNova, Inc. 2010
•
Randomized, placebo-controlled, double-blind, multi-center Phase II clinical trial
•
200
patients
with
severe,
acute
exacerbations
of
asthma
(FEV
1
50%
predicted)
at ~35 Emergency Department sites in US, Canada, Australia, and New Zealand
•
Dose Groups (~100 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
5
hours
•
The study is designed to have 80% power to detect a treatment difference of                              
5 percentage
points
in
FEV1
(%
predicted)
when
comparing
MN-221
+
SOC
to                       
Placebo + SOC at a two sided a-level of 0.05.
•
Anticipated completion in 2H, 2010*
MN-221-CL-007:
MN-221-CL-007:
Study Design
Study Design
15
Note: Development plans / timelines for MN-221 clinical trials are subject to change
*Anticipated completion date based on current projections

©
MediciNova, Inc. 2010
•
Randomized, double-blind, placebo-controlled Phase Ib
dose escalation study
•
48 subjects with stable moderate-to-severe COPD
(FEV
1
30% < 80% and FEV
1
/FVC ratio < 0.7) at 6 sites in the US
•
Doses:
•
300
µg
MN-221
over
1-hour
(150
µg
in
15
minutes;
150
µg
in
45
minutes)           
or placebo
•
600
µg
MN-221
over
1-hour
(300
µg
in
15
minutes;
300
µg
in
45
minutes)           
or placebo
•
1,200
µg
MN-221
over
1-hour
(600
µg
in
15
minutes;
600
µg
in
45
minutes)          
or placebo
•
Outcome
measures
–
descriptive
statistics
only
–
FEV
1
,
PK,
safety
•
Anticipated completion in 1H, 2010*
MN-221-CL-010 (COPD): 
MN-221-CL-010 (COPD): 
Study Design
Study Design
16
Note: Development plans / timelines for MN-221 clinical trials are subject to change
*Anticipated completion date based on current projections

©
MediciNova, Inc. 2010
17
MN-166 for Multiple Sclerosis (MS):
•
Oral administration
•
Multiple
mechanisms
of
action,
both
neuroprotective
and
anti-inflammatory
•
MN-166 targets primarily chronic aspects of MS
•
Benign safety profile
Mechanisms of Action:
Potentially Neuroprotective
•
Inhibits nitric oxide and reactive oxygen species production
•
Stimulates release of neuronal growth factors
•
Reduces demyelination
Anti-inflammatory
•
Inhibits
PDE’s
and
MIF,
leukotriene
release,
proinflammatory
cytokines
(TNFa,
IL-1b,
MCP,
IL-6)
•
Can increase IL-10 release
Current Standard of Care:
•
Beta
interferons
(Rebif
®
,
Avonex
®
,
Betaseron/Betaferon
®
),
Copaxone
®
,
Tysabri
®
•
Primary focus is on acute treatment of MS symptoms (i.e., relapse rate)
MN-166 for the Treatment of
MN-166 for the Treatment of
Multiple Sclerosis
Multiple Sclerosis

©
MediciNova, Inc. 2010
Placebo-controlled, Randomized, Double-blind Phase II Study:
•
Year 1 -
Placebo, 30 mg/day, 60mg/day
•
Year 2 -
30 mg/day, 60mg/day
•
297 patients (~100 patients/group) @ 25 sites in Serbia, Ukraine, Belarus,
Bulgaria and Romania
Key Inclusion Criteria:
•
Males or females aged 18 to 55 years, with relapsing remitting (RR) and/or
secondary progressive (SP) Multiple Sclerosis with continued relapses;
•
One MRI scan taken two weeks prior to treatment start using a standardized MRI
protocol with at least one Gd-enhancing lesion;
•
An Expanded Disability Status Scale (EDSS) score of 5.5 or less at the screening
and baseline visits.
Safety Profile:
•
89% (264 of 297) of subjects completed the first 12 months of the study
•
82.5% (245 of 297) of subjects completed the full 24 months of the study
•
Adverse effects reported more frequently in MN-166-treated than placebo-treated
subjects:  GI effects & depression
Completed Clinical Study:     
Completed Clinical Study:     
MN-166-CL-001
MN-166-CL-001
18

©
MediciNova, Inc. 2010
19
P-Value:  0.04
P-Value:  0.035
MN-166-CL-001 Study Results
MN-166-CL-001 Study Results
P-Value:
0.026
P-Value:  0.004
P-Value:  0.09
P-Value:  0.08
Note:  P-values listed on this slide compare placebo group to 60mg/day group of MN-166
Indicative of Potential Neuroprotective
Effect:
•
Reduced brain volume loss
•
Reduced conversion of acute lesions to persistent black holes
•
Sustained disability progression was significantly less likely (~50%)
Acute Clinical Benefit:
•
Prolong time to relapse (by 127 days.)
•
Annualized relapse rate
Protocol-Defined Primary Endpoint (Surrogate Endpoint):
•
No significant reduction in the cumulative number of active (gadolinium-enhancing (T1)
and non-enhancing new/enlarging (T2)) lesions on cranial MRI scans over 12 months of
treatment was observed
•
Positive trends were observed in volume of
gadolinium-enhancing (T1) lesions

©
MediciNova, Inc. 2010
20
MN-166-CL-001:
MN-166-CL-001:
Efficacy Review (One Year)
Efficacy Review (One Year)
Endpoints Indicative of Neuroprotective
Effect (Chronic aspects of MS):
Endpoints Relating to Acute Clinical Benefit:

©
MediciNova, Inc. 2010
21
Value to MediciNova
•
AV411 is now part of MediciNova’s
MN-166 program; both are ibudilast
•
API and drug product supply
•
4 completed
Phase
I
and
Ib/IIa
clinical
trials
•
Open IND for ibudilast
(Analgesia, Addiction)
•
Clinical & preclinical support for MN-166 program; dosing up to 100 mg/day
•
2 method of use patents issued in 2009; multiple filings in progress
•
Analog compounds behind ibudilast
•
First-generation development candidate:  AV1013 –
composition of matter patent issued
•
Second-generation dual target leads
Opioid
Withdrawal & Neuropathic Pain Indications
•
Ibudilast
is a good glial
cell attenuator in vitro and in the central nervous system (CNS) in vivo.
•
Glial
cell activation contributes to reward and withdrawal aspects of
opioids
and the
development and maintenance of neuropathic pain.
•
This may represent a new pharmocotherapy
approach for drug addiction and neuropathic pain.
Additional Value from Avigen
Additional Value from Avigen
Deal
Deal

©
MediciNova, Inc. 2010
22
MN-166: Ongoing clinical trial
•
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 mid-2010*
MN-166: Opioid
MN-166: Opioid
Withdrawal
Withdrawal
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
23
Commercially-Attractive
Commercially-Attractive
Diversified Portfolio
Diversified Portfolio
COPD
COPD
Asthma
Asthma
MS
MS
CNS Disorders
CNS Disorders

©
MediciNova, Inc. 2010
24
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
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
Alan Dunton, MD, PhD
Alan Dunton, MD, PhD
Clinical Development
Consultant & Board Member
27
CEO of Panacos & Metaphore; President of
the Janssen Research Foundation, a J&J
company

©
MediciNova, Inc. 2010
25
Near-Term Business Plan:
1.
Secure a global partnership for MN-166
2.   Secure a regional partnership (ex-US/Japan rights) for MN-221
Clinical Milestones:
1.   MN-221-CL-007 Phase II Study for Acute Exacerbations of Asthma
•
Anticipated completion 2H, 2010*
2.   MN-221-CL-010 Phase Ib
Study in Moderate-to-Severe COPD Patients
•
Anticipated completion in 1H, 2010*
3.   Ongoing MN-166
Study for Opioid
Withdrawal
•
Anticipated completion in mid-2010*
Investment Highlights
Investment Highlights
*Anticipated completion dates based on current projections
Note: Development plans / timelines for MN-221 clinical trials are subject to change