Form 8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 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 30, 2007

 


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:

 

¨ 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 30, 2007, Dr. Kenneth Locke, Chief Scientific Officer of MediciNova, Inc. (the “Registrant”), gave a presentation regarding the status of the Registrant’s development programs to attendees of the Registrant’s Annual Meeting of Stockholders. Attached as Exhibit 99.1 hereto and incorporated herein by reference in its entirety is a copy of Dr. Locke’s presentation.

The information in this Item 7.01, including the exhibits furnished herewith, is furnished pursuant to Item 7.01 and shall not be deemed “filed” for any purpose, including for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section. The information in this Item 7.01 of this Current Report on Form 8-K shall not be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act regardless of any general incorporation language in such filing.

 

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

 

Exhibit  

Description

99.1   Slide Presentation presented March 30, 2007

 

2


SIGNATURES

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

Dated: March 30, 2007.

 

MEDICINOVA, INC.
By:  

/s/ Shintaro Asako

  Shintaro Asako
  Chief Financial Officer

 

3


EXHIBIT INDEX

 

Exhibit No.  

Description

99.1   Slide Presentation presented March 30, 2007

 

4

Slide Presentation presented March 30, 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


©
MediciNova, Inc. 2007
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
licensing, collaboration and partnering plans.
These statements are based
on certain assumptions made by the Company’s management that are
believed to be reasonable at the time.  Such statements are subject to a
number of assumptions, risks and uncertainties, many of which are
beyond
the
control
of
the
Company,
including
results
of
clinical
studies,
interest of potential collaborators in the market and other risks and
uncertainties, including those described in the Company’s filings with the
Securities and Exchange Commission.  These assumptions, risks and
uncertainties could cause the Company’s actual results to differ materially
from those implied or expressed by the forward-looking statements.
Safe Harbor Statement
Safe Harbor Statement


©
MediciNova, Inc. 2007
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
Commercially-attractive clinical pipeline:
8 compounds in 10 different therapeutic indications;           
7 programs in Phase II or later
Key market advantages for each unique molecule
Multi-billion dollar collective market potential
Well-capitalized:
$212 M raised from inception; $104 M cash as of 12/31/06
Successful IPO ($122.5 M gross) on Osaka Securities Exchange (OSE; code:
4875) in February 2005
NASDAQ
listing
December
2006
(MNOV);
recent
NASDAQ
offering
(1
M
shares
@ $12) in February 2007 to introduce MNOV to new US shareholders
Corporate Overview
Corporate Overview


©
MediciNova, Inc. 2007
Business Model
Business Model
In-license high-value, differentiated small molecule product candidates at the late
preclinical-early Phase II clinical development stage at attractive terms from mid-sized
Japanese pharmaceutical companies
Add significant value through rapid advancement of product candidates through
proof-of-concept Phase II/III clinical trials
Secure strategic alliances at key value inflection points
Selectively retain and commercialize certain product candidates for maximum ROI
Sales/
Marketing
Phase III
Phase II
Phase I
Late Preclinical
Research
Drug Development
Partner:
$$$$$
Commercialize:
$$$$$$$$$$
In-License:
$


©
MediciNova, Inc. 2007
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
(Date Launched)
Treatment
Japanese
Discoverer
Partner in U.S.
Peak World-Wide
Sales
Pravachol
(1991)
High
cholesterol
Sankyo
Bristol-Myers
Squibb
$3.3 billion
Prevacid
(1995)
Heartburn
Takeda
Abbott
$4.3 billion
Aricept
(1997)
Alzheimer's
Eisai
Pfizer
$1.1 billion
Abilify
(2002)
Schizophrenia
Otsuka
Bristol-Myers
Squibb
$2 billion (a)
Crestor
(2003)
High
cholesterol
Shionogi
AstraZeneca
$4 billion (a)
(a) Analyst estimate
Source: the companies
Others: Pepcid (Merck), Cardizem (Aventis), Lupron (TAP), Atacand (AstraZeneca),
Biaxin (Abbott), Levaquin (J&J), Noroxin (Merck), Tequin (BMS) ….MORE


©
MediciNova, Inc. 2007
Japanese Pharma
Alliances
Japanese Pharma
Alliances
Unique access to mid-sized Japanese pharma
companies with no U.S. and/or European
development capabilities
Acquire rights to select, high quality compounds
in U.S. and select ex-U.S. markets
Favorable deal terms:
Modest milestone payments (e.g., no more than $1M
upfront)
Reasonable royalties (e.g., 14% maximum on U.S.
sales > $500M)
No stacking royalties (i.e., ~65/35% split with
originator on out-licensing)
Proven track record –
8 compounds acquired in 6
years
Self-renewing model
553
Kissei
602
Kyorin
618
Mochida
681
Kaken
741
Tsumura
759
Hisamitsu
842
Santen
995
Meiji
1,422
Kyowa-Hakko
1,320
Ono
1,563
Tanabe
1,812
Shionogi
2,129
Mitsubishi
2,540
Taisho
2,863
Chugai
2,874
Sumitomo
4,845
Eisai
7,836
Astellas
8,330
Daiichi-Sankyo
10,208
Takeda
2005 Sales ($M)
Japanese Pharmaceutical Company
MediciNova partner
Conduct US trials directly


©
MediciNova, Inc. 2007
Commercially-Attractive
Diversified Portfolio
Commercially-Attractive
Diversified Portfolio
6 Years
8 Compounds
10 Indications
6 Years
8 Compounds
10 Indications
Product candidate (indication)
Preclinical
Phase 1
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)
Phase 2
Phase 3
MN-246 (Urinary incontinence)
Approval
MN-221 (Preterm labor)
MN-447 & MN-462 (Thrombosis)


©
MediciNova, Inc. 2007
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
>$1B 5
th
year sales
MN-221: Status Asthmaticus
Phase II initiated 4Q06
Potential to change treatment paradigm
>$500M 5
th
year sales
MN-166: Multiple Sclerosis
Positive 297-patient Phase II;
Phase III to start 2H07
Capitalizes on market need for oral
medication
>$1B 5
th
year sales
Product candidate (indication)
Preclinical
Phase 1
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)
Phase 2
Phase 3
MN-246 (Urinary incontinence)
Approval
MN-221 (Preterm labor)
MN-447 & MN-462 (Thrombosis)
Product candidate (indication)
Preclinical
Phase 1
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)
Phase 2
Phase 3
MN-246 (Urinary incontinence)
Approval
MN-221 (Preterm labor)
MN-447 & MN-462 (Thrombosis)


©
MediciNova, Inc. 2007
MN-001 (Asthma)
MN-001 (Asthma)
Positive US Phase II results (12/05);    
Phase III initiated 4Q06
Milestones
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)
New US composition patent (market
exclusivity > 2023)
Advantages
5
th
yr sales > $1 B
Market Potential
Kyorin
Pharmaceutical (2002)
Source


©
MediciNova, Inc. 2007
MN-001 Competitive Advantages
MN-001 Competitive Advantages
< $90M
Liver toxicity
No
No
BID
Accolate
> $3B
No
Yes
Yes
TID/BID;
QD in
development
MN-001
< $10M
Liver toxicity
No
No
QID; BID in
clinical trials
Zyflo
No
Safety
Issues
$3B
No
No
QD
Singulair
Market
Opportunity
Steroid
Sparing
Anti-
Inflammatory
Dosing
Compound
Potential First Line Therapy for the Treatment of Bronchial Asthma


©
MediciNova, Inc. 2007
MN-001 Value-Added
MN-001 Value-Added
At Acquisition
Large preclinical and early clinical database
Value-Added
Elucidation of mechanism of action
cGMP
manufacturing (API and new formulation)
Expanded dose range (through Phase I testing)
Clinical proof-of-concept (in Phase II trial)
New composition of matter and method of manufacture patent
New indication –
Interstitial Cystitis (Ph II/III results 4Q06)
Next Steps (in progress)
Phase III clinical testing to establish market differentiation (oral controller with
anti-inflammatory activity, steroid-sparing)
Develop once-a-day dosage form


©
MediciNova, Inc. 2007
MN-001 Key Data
MN-001 Key Data
Mean FEV1 (L) Change from Baseline
Population: Intent-to-Treat (Observed Cases)
FEV1: Forced expiratory volume in the first second.
Note: Baseline is the Visit 3 pre-bronchodilator measurement.
p=0.021
p=0.058
p=0.305
Proof-of-Concept in Mild-to-Moderate Asthmatics
Statistically significant
improvement in mean
FEV1 after 4 weeks with
500 mg TID compared
to placebo (p=0.021;
intent-to-treat, observed
cases)
-0.5
-0.4
-0.3
-0.2
-0.1
0.0
0.1
0.2
0.3
0.4
0.5
Placebo
500mg TID MN-001
750mg BID MN-001
750mg QD MN-001


©
MediciNova, Inc. 2007
MN-221 (Status Asthmaticus)
MN-221 (Status Asthmaticus)
US Phase II 4Q06
Milestones
Clinically-proven mechanism of action
(highly selective
2
-adrenergic
receptor agonist)
Greater cardiovascular safety (less
1
-
adrenergic receptor stimulation)
More reliable, effective and rapid route
of administration (i.v. vs. inhaled)
Advantages
5
th
yr sales ~ $500 M
Market Potential
Kissei Pharmaceutical (2004)
Source


©
MediciNova, Inc. 2007
MN-221 Competitive Advantages
MN-221 Competitive Advantages
No
Yes
Yes
Yes
IV (Ph II)
MN-221
?
?
Yes
Rapid
Action
Yes
Yes
No
Reliable
Delivery
Liver toxicity
No
IV (Ph I / II)
Zyflo
No
No
IV (Ph III)
Singulair
Cardiovascular
(palpitations)
Safety Issues
Yes
Inhaled;
nebulized
ß-Agonists
Proven
Mechanism
Dosing
Compound


©
MediciNova, Inc. 2007
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 indication –
Status Asthmaticus
Next Steps (in progress)
Phase II proof-of-concept testing


©
MediciNova, Inc. 2007
MN-221 Key Data
MN-221 Key Data
Recovery
from
Ragweed-induced
Bronchoconstriction
in
Dogs
0
1
2
3
4
5
0
10
20
30
40
50
60
70
80
90
100
110
120
Vehicle
MN-221 (400
g/kg)
baseline
response
MN-221 (120
g/kg)
MN-221 (
0
g/kg)
MN-221 (12
g/kg)
MN-221
g/kg)
MN-221 (0.4
g/kg)
peak
response
Time after Injection (minutes)


©
MediciNova, Inc. 2007
MN-166 (Multiple Sclerosis)
MN-166 (Multiple Sclerosis)
Positive Phase II results 1Q07;
Phase III to start 2H07
Milestones
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; >15,000 in
formal clinical safety database)
New US use patent
Advantages
5
th
yr sales ~ $1 B
Market Potential
Kyorin
Pharmaceutical (2004)
Source


©
MediciNova, Inc. 2007
No neutralizing
antibodies
formed; no loss of
effect
Pilot clinical data
suggestive of 50%
reduction in
relapse
Oral
MN-166
Relative benefit gained from existing drugs may
decline over time -
possibly due to presence of
neutralizing antibodies
Current relapse reduction rate is ~33%
(Significant market advantage for a drug with a
relapse reduction rate of 50% or higher)
Intravenous or subcutaneous injection
(Injection site pain, swelling, and itching)
Interferon Products
Longer duration
of effect
Greater efficacy
More
convenient dosing
Unmet Need
MN-166 Competitive Advantages
MN-166 Competitive Advantages


©
MediciNova, Inc. 2007
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 cGMP
API manufacturing
Next Steps (in progress)
Phase III clinical testing
Develop once-a-day dosage form


©
MediciNova, Inc. 2007
Reduction of Relapse Rate
in 6 MS Patients
Normalization of Serum Cytokine
Levels in 11 MS Patients
Cytokine
% Change
Th1
IFN-
-28
TNF-
-35
Th2
IL-4
+119
IL-10
+64
0
1
2
3
4
5
Pre-Treatment
Post-Treatment
MN-166 Key Pilot Clinical Data
MN-166 Key Pilot Clinical Data


©
MediciNova, Inc. 2007
MN-166 Key Phase II Data
MN-166 Key Phase II Data
0.0352
% brain
volume change:
pbo: -1.2%, 60 mg: -0.79%
0.087
Cumulative volume of Gd-enhancing lesions:
pbo
-
2128 mm
3
, 60 mg -
1756 mm
3
0.033
% of subjects exacerbation-free for 1 year:
pbo
-
41%, 60 mg -
56.1%
0.0438
Time to first relapse:
Median for 60 mg > 1 year
Median for pbo
-
244 days
0.0752
Completers -
annualized relapse rate:
pbo
-
0.8, 60 mg -
0.6
(pbo
-
42.7% vs. 60 mg -
60% with no relapses)
p-value
(pbo
vs. 60 mg/d)
Outcome Measure


©
MediciNova, Inc. 2007
Renewable Business Model:
Two Newly-Acquired Product Opportunities
Renewable Business Model:
Two Newly-Acquired Product Opportunities
Two novel cardiovascular preclinical
products acquired from 4
th
Japanese
partner (Meiji Seika Kaisha, Ltd.)
Modest investment with potentially large
return in multi-$B cardiovascular market
MN-447 –
Antithrombotic
with novel
MOA (GPIIbIIIa/
v
3) affecting clot
formation
MN-462 –
Antithrombotic
with novel
MOA (carboxypeptidase
b inhibitor)
affecting clot lysis
Underscores ability to replenish pipeline
with innovative, high-value product
opportunities
Product candidate (indication)
Preclinical
Phase 1
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)
Phase 2
Phase 3
MN-246 (Urinary incontinence)
Approval
MN-221 (Preterm labor)
MN-447 & MN-462 (Thrombosis)
Product candidate (indication)
Preclinical
Phase 1
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)
Phase 2
Phase 3
MN-246 (Urinary incontinence)
Approval
MN-221 (Preterm labor)
MN-447 & MN-462 (Thrombosis)


©
MediciNova, Inc. 2007
Management Team
with Global Experience
Management Team
with Global Experience
Ligand, General Electric Medical
Systems, Hybritech, Molecular Biosystems
24
Lynn Terhorst, MBA
VP, Business Planning & Analysis
Clinical Advisors, D3 Capital,
Lippert/Heilshorn, Sutro
& Co.
24
Bonnie Feldman, DDS, MBA
VP, Investor Relations & Corporate     
Communications
15
8
22
29
31
Years
Experience
Daiwa Securities SMBC, Sumitomo Capital
Securities, Sumitomo Bank
Masatsune
Okajima, CMA
VP, Head of Japanese Office
KPMG USA (Audit), Arthur Andersen USA
Shintaro
Asako, CPA
Chief Financial Officer
Incara, Indevus, BMS
Richard Gammans, PhD, MBA
Chief Development Officer
Tanabe Research Laboratories USA,
Indevus, Hoechst
Kenneth W. Locke, PhD
Chief Business Officer
Prof. USC, Pitt; Advisor to JAFCO, Tanabe
Director, Avigen, Inc.
Yuichi Iwaki, MD, PhD
Executive Chairman, CEO
Life Sciences Background
LEADERSHIP


©
MediciNova, Inc. 2007
MediciNova, Inc. Today
MediciNova, Inc. Today
Market-driven, commercially-focused mid-stage pharma
company
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 & optimizes reward
Rich mid-
to late-stage clinical development pipeline:
6 years, 8 compounds, 10 indications
Small molecules with clear market advantages & strong IP
Multi-billion dollar market potential
Portfolio growth strategy: build to profitability through out-
licensing & retained commercial rights
Well-capitalized: poised for success