SEC Filing - MediciNova, Inc.

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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): November 10, 2008

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.

Representatives of MediciNova, Inc. (the “Registrant”) are scheduled to make a presentation at the Rodman and Renshaw 10^th Annual Healthcare Conference on November 10, 2008 at 11:35 a.m. Eastern time. A copy of the slide presentation to be used by the Registrant at this conference is attached hereto as Exhibit 99.1 to this Current Report.

The information in this Current Report, including Exhibit 99.1 furnished herewith, is being furnished and shall not be deemed “filed” for any purpose, including for 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 Current Report shall not be deemed 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 to this Current Report.

Item 9.01

Financial Statements and Exhibits.

(d)

Exhibits.


Exhibit		Description

99.1		Slide presentation of the Registrant

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.


	MEDICINOVA, INC.

Dated: November 10, 2008	By:	/s/ Shintaro Asako
		Shintaro Asako Vice President and Chief Financial Officer

EXHIBIT INDEX


Exhibit		Description

99.1		Slide presentation of the Registrant

Slide presentation

MediciNova, Inc. 2008

Accelerating

the global development

and commercialization of

innovative pharmaceuticals

Exhibit 99.1

MediciNova, Inc. 2008

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, without limitation, statements regarding MediciNova’s clinical trials supporting safety

and efficacy of 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, 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," "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, without limitation, 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; the availability of funds

to complete product development plans and MediciNova’s ability to raise sufficient capital when needed;

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, 2007 and its subsequent periodic reports on Forms 10-Q and 8-K. Undue reliance should not be

placed on these forward-looking statements, which speak only as of the date hereof. MediciNova disclaims any

intent or obligation to revise or update these forward-looking statements.

Forward-Looking Statements

MediciNova, Inc. 2008

Development Company Focused on Differentiated Product

Candidates

•

Unique access to differentiated, potentially high-value

assets primarily from Japanese alliances

New Approaches to Treat Serious Medical Conditions:

•

MN-221: IV Acute Exacerbations of Asthma candidate

•

Potential $500 M US opportunity for MediciNova

•

MN-166: Oral Multiple Sclerosis candidate

•

In 2007, over $8.2B in worldwide MS therapeutic

sales*

Corporate Overview:

MediciNova, Inc.

*Source: MedAdNews, July 2008

MNOV Headquarters:

San Diego, CA

Key Financials:

•

Dual listed company on NasdaqGM and Osaka Securities Exchange –

Hercules

•

~$27.2M Market Cap as of 9/30/08

•

~$55.8M Cash, Cash Equivalents and Marketable Securities as of 6/30/08

MediciNova, Inc. 2008

In-License:

•

Product candidates with significant clinical or preclinical data

Conduct Proof-of-Concept Clinical Trials:

•

Conduct Phase I and Phase II clinical trials to demonstrate

efficacy of compound

Two Pathways Towards ROI After Phase II:

Continue internal development of compound towards

commercialization

Seek partnership for further development of compound

MediciNova has focused its resources on its two prioritized product candidates, MN-221

and MN-166. Following completion of the Phase II trial of MN-166, MediciNova will not

pursue further significant clinical development of MN-166 until a partnership is secured. In

addition, MediciNova will pursue

a variety of initiatives to monetize its remaining product

candidates.

Business Model:

Return On Investment

MediciNova, Inc. 2008

Definition:

•

Long-lasting and severe asthma episode that is not responsive to initial bronchodilator

or corticosteroid therapy

Market Opportunity:

•

Approximately 2 million emergency room visits in the US each year*

•

500,000 hospitalizations in the US

•

Approximately 4,000 deaths annually in the US*

•

Potential $500 M market opportunity for MediciNova

Current Standard of Care (SOC):

•

Beta agonists (all patients) -

Inhaled or nebulized

•

Corticosteroids (66-77% of patients) -

IV or oral

*Source: National Center for Health Statistics / CDC

Acute Exacerbations of Asthma

MediciNova, Inc. 2008

MN-221: A

novel,

highly

selective

adrenergic

receptor

agonist

Three Potential Advantages over current therapy

Better delivery system (IV) = Better Bioavailability

Greater selectivity for

2 receptors in the lungs (better

binding)

Partial agonist for

receptor in the heart

MN-221: A New Approach to Treating

Acute Exacerbations of Asthma

MediciNova, Inc. 2008

Human

-Adrenergic Receptor

Selectivity

Test Drug

(M)

-Adrenoceptor Selectivity

(IC

for

/ IC

for

)

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. 2008

Effect on Heart rate:

Combination of MN-221 & Albuterol in Dogs

MediciNova, Inc. 2008

MN-221-CL-004 Study Design

•

Randomized, placebo-controlled, double-

blind, dose escalation

•

23 subjects with mild-to-moderate stable

asthma (FEV

60% predicted)

•

Doses tested (all for 15 minutes):

•

0.35

µg /min

•

1.0

µg /min

•

3.5 µg/min

•

10 µg/min

MN-221: Positive Phase IIa

Data

MN-221-CL-005 Study Design

•

Randomized, single-blind, placebo-controlled,

dose rate escalation

•

17 subjects with moderate-to-severe stable

asthma (40%

FEV

75% predicted)

•

Two doses tested:

•

µg /min

for

minutes

followed

µg /min

for

105

minutes

(2-hour

infusion

with toal

dose of 1,080 µg) or placebo

•

µg /min for 15 minutes followed by

15 µg/min for 45 minutes (1-hour infusion

with a total dose of 1,125 µg) or placebo

MN-221-CL-004 and MN-221-CL-005 Safety Data:

No clinically significant cardiovascular, ECG or vital sign changes, or other safety concerns

observed at any dose tested

•

16 µg/min

•

30 µg/min

•

60 µg/min

MediciNova, Inc. 2008

Mean Change in FEV

Study: MN-221-CL-004

Mean

Baseline:

77.83%

77.67%

76.78%

81.60%

74.66%

75.78%

78.07%

79.78%

At 15 Minutes:

77.54%

79.45%

80.06%

85.74%

82.02%

83.90%

89.65%

88.04%

Predicted:

-0.29%

1.78%

3.28%

4.14%

7.36%

8.12%

11.58%

8.26%

P = 0.0106

P = 0.0006

P < 0.0001

P = 0.11

P = 0.07

Placebo 0.35µg/min 1.0 µg/min 3.5µg/min 10µg/min 16µg/min 30µg/min 60µg/min

MediciNova, Inc. 2008

Mean Change in FEV

Study: MN-221-CL-005

Mean

Baseline:

69.4%

Mean

Baseline:

64.6%

Mean:

81.5%

Mean:

82.0%

Placebo Mean

Baseline:

68.6%

MediciNova, Inc. 2008

MN-221-CL-006:

Phase IIb

study commenced to test efficacy of MN-221 in acute exacerbations of

asthma patients (~36 patients in 8 sites) in the emergency department

•

Randomized, modified single-blind, placebo-controlled, dose escalation study

•

Doses:

16 µg/min x 15 min

(240 µg)

30 µg/min x 15 min

(450 µg)

µg/min

min;

8µg/min

105

min

(1,080 µg)

MN-221: Near-Term Clinical

Milestone

MediciNova, Inc. 2008

Definition:

Multiple sclerosis (MS) is an inflammatory demyelinating disease of the central nervous

system (CNS), affecting approximately 500,000 people in the United States and 2 million

people worldwide.

There is no cure for the disease.

Multiple Sclerosis Market:

Over $8.2 B worldwide sales in 2007*

Current Standard of Care:

•

Beta interferons (Rebif, Avonex, Betaserone), Copaxone

, Tysabri

•

Administered either by intramuscular or subcutaneous injection or infusion

Multiple Sclerosis

*Source: MedAdNews, July 2008

MediciNova, Inc. 2008

MN-166:

•

Anti-inflammatory and neuroprotective

properties in vitro

and in vivo

•

Demonstrated effects on brain volume and lesion evolution to axonal damage

•

Targets primarily chronic aspects of multiple sclerosis

•

Oral administration

Mechanisms of Action:

Stimulates Neurotrophic

Growth Factor Release

Inhibits nitric oxide and reactive oxygen species production

Inhibits Th1 cytokine production (IFN-

, TNF-

, IL-1

, IL-6)

Pilot studies found reduced relapse rate and Th1

Th2 cytokine shift

Phosphodiesterase

IV and Leukotriene

inhibitor

MN-166: A New Approach to

Treating Multiple Sclerosis

MediciNova, Inc. 2008

Placebo-controlled, randomized, double-blind Phase II study:

•

Year 1 -

0, 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 females aged 18 to 55 years, with relapsing remitting (RR) and/or

secondary progressive (SP) Multiple Sclerosis with continued relapses;

•

A definite diagnosis of relapsing MS using the new International

Committee

recommendations (MacDonald Criteria);

•

One MRI scan taken two weeks prior to treatment start using a standardized MRI

protocol with at least one Gd-enhancing lesion;

•

An EDSS score of 5.5 or less at the screening and baseline visits.

Current Clinical Studies:

MN-166-CL-001

MediciNova, Inc. 2008

MN-166 Effects Outcomes Related to Disease Progression in RRMS Patients

Clinical and MRI Outcomes:

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.)

MN-166 was very well tolerated in Phase II study:

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

GI adverse effects as a group and depression were the only adverse events to occur

more frequently in MN-166-treated than in placebo-treated subjects

P-Value: 0.044

P-Value: 0.030

MN-166 Targets Primarily

Chronic Aspects of MS

P-Value: 0.026

P-Value: 0.011

MediciNova, Inc. 2008

N=71 1.59

Chronic Efficacy Demonstrated:

Effects on Brain Volume

N=70 1.79

N=34 2.08

N=45 2.12

Percent Brain Volume Reduction

Percent Brain Volume Reduction (0 -

24 months)

Brain volume loss was significantly less (p=0.030) in patients receiving 60 mg

per day of MN-166 for 24 months compared to the other treatment groups

MediciNova, Inc. 2008

Parameter

Treatment Groups

Placebo

30 mg/day

60 mg/day

Number Patients w. New Lesions at Month 2

Total Number New Lesions in all Patients

426

338

315

Total Number of Persistent Black Holes

Proportion of Lesions Evolving to PBH

0.23

0.17

0.14

p Value

0.036

0.004

New T1 gadolinium-enhancing or new T2 lesions were defined as NL in the first

on-study MRI at month 2

Lesions that were hypointense and inactive at month 10 were PBH

Relative Risk (RR) of NL evolution to PBH was analyzed using a general linear

model with the error term from the Poisson distribution

Reduction of Persistent Black Hole

(PBH) Formation

MediciNova, Inc. 2008

TREATMENT

Time Period

Placebo to Active

(N=100)

Active Drug

[30 mg (N=94), 60 mg (N=98)]

2 Years

21/100 (21%)

20/194 (10.4%)

Disability Progression is defined as a sustained increase in EDSS

(increase in EDSS

1 maintained for four consecutive months)

Sustained Disability Progression

P-Value: 0.026

MediciNova, Inc. 2008

Acute Efficacy Demonstrated:

Time to First Relapse

Median 401 days

Median 244 days

P-Value: 0.044

MediciNova, Inc. 2008

MN-166: NEXT STEPS

Seek Partnership for Further Development:

MediciNova’s strategic objective for MN-166 is to secure a partner to

advance the clinical development of MN-166, and MediciNova is actively

pursuing that objective

MediciNova, Inc. 2008

Commercially-Attractive

Diversified Portfolio

MediciNova, Inc. 2008

Dual Listing:

•

MNOV (NasdaqGM), December 2006

•

4875 (Osaka –

Hercules), February 2005

Cash, Cash Equivalents and Marketable Securities as of 6/30/08 :

~$55.8 M as of 6/30/08

Market cap as of 9/30/08:

~$27.2 M

Shares outstanding:

11.9 M

Key Financials

MediciNova, Inc. 2008

Leadership

Years

Experience

Background

Yuichi Iwaki, MD, PhD

CEO & President

Prof. USC, Formerly Prof. Pitt;

Advisor to JAFCO, Tanabe

Richard Gammans, PhD, MBA

Chief Development Officer

Incara, Indevus, BMS

Shintaro Asako, CPA

Chief Financial Officer

KPMG USA (Audit), Arthur Andersen USA

Michael Kalafer, MD

Chief Medical Officer

Board Certified in Pulmonary Medicine, Critical

Care Medicine and Internal Medicine.

Associate Clinical Professorship of Medicine at

UCSD School of Medicine since 1985

Masatsune Okajima, CMA

VP, Head of Japanese Office

Daiwa Securities SMBC,

Sumitomo Capital Securities, Sumitomo Bank

Management Team with Global

Experience

MediciNova, Inc. 2008

MN-221 (Acute Exacerbations of Asthma):

•

Proven mechanism of action

•

Highly selective with improved safety profile vs. standard of care

•

Positive Phase IIa efficacy data

•

Near-term milestone: CL-006 results

MN-166 (Multiple Sclerosis):

•

Both chronic and acute efficacy have been demonstrated in clinical studies completed

to date

•

MediciNova seeking a partner to advance the clinical development of MN-166

Minimized Burn Rate:

•

Annual burn rate reduced compared to previous years as a result of focus on MN-166

and MN-221 development programs

•

For 9/30/2008 Cash, Cash Equivalents and Marketable Securities, reference Quarterly

Report on Form 10-Q filed 11/10/2008

Investment Highlights

MediciNova, Inc. 2008

Addendum:

Additional Data

MediciNova, Inc. 2008

A.1

MN-221-Study 6 Design

•

Randomized, modified single-blind, dose escalation, placebo-controlled

Phase II Study in acute asthma patients in EDs

•

Approx. 36 patients in 3 dose cohorts at 8 ED clinical sites

•

Doses:

16µg/min x15 (240µg)

30µg/min x15 (450µg)

16µg/min x15;8µg/min x105 (1,080µg)

•

Patients will receive Standard of Care (SOC) treatment in addition to

adjunctive treatment with MN-221 or placebo

•

Safety and efficacy (FEV1 and other) data will be summarized

•

No inferential statistical analysis

•

Help inform design of future, larger Phase III clinical trials

MediciNova, Inc. 2008

A.2

MN-221: Safety

Phase IIa

Study Safety Findings:

•

No clinically significant cardiovascular, ECG, or vital sign changes, or other safety

concerns, observed at doses up to 30 micrograms/minute for 15 minutes or any time

point thereafter

•

60 micrograms/minute infusion improved FEV1 significantly (p< 0.0001) without clinically

significant cardiovascular, ECG or vital sign changes; however, the safety trend led us to

believe that this is a possible MTD

Safety Database:

•

MN-221 has been tested in over 300 subjects in the US and Europe to

date

•

Subjects have had infusions with no clinically significant adverse events at:

•

16 micrograms/minute for up to 4 hours and at lower doses for up

to 24 hours

MediciNova, Inc. 2008

A.3

Description

Efficacy

(relapse rate)

Current agents offer only 30-50% relapse reduction

Neutralizing antibodies can diminish efficacy over time

Progression (RRMS) --neurodegeneration

leads to

permanent functional disability

No approved treatment for PPMS, SPMS

AEs—including flu-like symptoms

SAEs

–Rare, fatal PML and heptotoxicity

with Tysabri

Reports of significant FTY side effects (e.g. hepatotoxicity),

serious or fatal opportunistic infections, skin cancer

Safety/

tolerability

Injections –

daily up to weekly

Infusions --

monthly

Administration

Increasing interest in combination therapies given

incomplete efficacy with current “core”

agents

Black box on combination with Tysabri, REMS program

Combination

Historically, anti-inflammatory agents have shown little

impact on disease progression

Demonstrated neuroprotection, that is, reduction in disease

progression, would be groundbreaking

Neuroprotection

There are substantial unmet

needs in MS

MediciNova, Inc. 2008

A.4

Approx. Sales

2007**

Compound

Sponsor

Side Effects

$3.3 Billion

Copaxone®

Teva

Sanofi-Aventis

Pain, redness, swelling, itching, chest pain,

weakness, infection, nausea, anxiety are

most common, also heart palpitations and

trouble breathing after injection

$1.9 Billion

Avonex®

Biogen-Idec

Depression and Flu-like symptoms most

common, also liver injury, severe allergic

reactions, drop in red/white blood cell count

$1.7 Billion

Rebif®

Serono

& Pfizer

Depression and Flu-like symptoms most

common, also liver problems, injection site

problems, severe allergic reactions, trouble

breathing/loss of consciousness

$1.4 Billion

Betaseron®

Bayer

Lymphopenia, injection site reaction,

asthenia, flu-like symptoms are most

common, also necrosis at injection site

$343 Million

Tysabri®

Biogen-Idec

Infections, depression, pneumonia, acute

hypersensitivity reactions, appendicitis most

common, also liver damage, PML

Multiple Sclerosis Market*

*All these top selling drugs for MS are immunomodulators

**Source: MedAdNews, July 2008 and BIIB annual report 2007

MediciNova, Inc. 2008

A.5

Brain volume changes are linked to axonal loss

Chronic Efficacy Demonstrated:

Effects on Brain Volume

1.20

MediciNova, Inc. 2008

A.6

Reduction of

Persistent Black Hole (PBH) Formation

Parameter

Treatment Groups

Placebo

30 mg/day

60 mg/day

# Patients w. New Lesions at Month 2

# Patients w.

1 PBH (% of Pts. w. New Lesions)

41 (56.9%)

33 (51.6%)

28 (50%)

Mean Proportion of Lesions Evolving to PBH

0.24

0.20

0.16

Median Proportion of Lesions Evolving to PBH

0.17

0.08

0.04

Relative Risk (for Evolution to PBH) vs. placebo

0.74

0.63

p Value

0.074

0.011

New T1 gadolinium-enhancing or new T2 lesions were defined as NL in the first

on-study MRI at month 2

Lesions that were hypointense

and inactive at month 10 were PBH

Relative Risk (RR) of NL evolution to PBH was analyzed using a general linear

model with the error term from the Poisson distribution

Reduction of Persistent Black Hole (PBH)

Formation, a Sign of Axonal Loss

MediciNova, Inc. 2008

A.7

•MN-166 was very well tolerated in Phase II study:

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

•Discontinuation due to adverse effects was infrequent (5.1% in 60 mg/day for 24 months, 2.1%

in 30 mg/day for 24 months, 2.0% in placebo to 60 mg/day, 1.9% in placebo to 30 mg/day)

•Adverse effects were generally mild and self-limiting

•GI adverse effects as a group and depression were the only adverse events to occur more

frequently in MN-166-treated than in placebo-treated subjects

•Tolerance to the GI side effects occurred rapidly (2-4 days) and tended to occur early in

treatment whether MN-166 treatment was initiated in Year 1 or Year 2

•Mild-to-moderate depression was reported in 8 subjects; depression is common in MS

patients and was reported only towards the end of the study

•No significant increase in adverse laboratory or ECG findings was observed

•20 serious adverse events were reported; all were not

or unlikely

to be attributable to

treatment

•No deaths occurred in the study

MN-166 Overview-Safety

MediciNova, Inc. 2008

Compound

Sponsor

Current

Phase

Safety Profile

from Phase II trials

MN-166

MediciNova

Phase II

Mild, transient GI upset

FTY 720

Novartis

Phase III

Blood pressure

Heart rate

Dyspnea

Liver

enzymes

Lymphopenia

Cladribine

Merck

Serono

Phase III

Fever

Nausea,

Vomiting

Leucopenia

BG-12

Biogen-Idec

Phase III

H/A,

Nasopharyngitis

disorders

Liver

enzymes

Laquinimod

Teva

Phase III

Liver enzymes

Arthralgia

Fibrinogen

Hemoglobin

Safety Comparison with Other

Oral Agents

A.8