SEC Filing - MediciNova, Inc.

MEDICINOVA, INC.

Date: September 13, 2010

/s/ Shintaro Asako

Shintaro Asako

Vice President and Chief Financial Officer

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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): September 13, 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.

Representatives of MediciNova, Inc. (the “Registrant”) will be attending the Rodman and Renshaw Annual Global Investment Conference commencing on September 12, 2010 and are scheduled to make a presentation at such conference on September 13, 2010 at 3:40 p.m. Eastern time. The information to be presented by the Registrant at the conference and investor meetings 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.

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.

Slide Presentation

MediciNova, Inc. 2010

Accelerating

the global development

and commercialization of

innovative pharmaceuticals

Exhibit 99.1

MediciNova, Inc. 2010

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

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:

MediciNova, Inc.

*Source:

Internal

MediciNova

projections

MediciNova, Inc. 2010

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

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

Acute Asthma Treatment Flow in

Emergency Departments in the U.S.

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

410,000

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:

novel,

highly

selective

adrenergic

receptor

agonist

Three potential advantages over current therapy:

Improved Efficacy

•

Route of Administration (IV v. Inhalation)

Improved Safety

•

Higher selectivity for

receptor than

•

42.4 fold

selectivity (IC

/ IC

)

•

Partial agonist for

receptor

Reduced Health Care Expenses

MN-221: A New Approach to Treating

Exacerbations of Acute Asthma & COPD

MediciNova, Inc. 2010

MN-221 Clinical Trials

Completed

Ongoing

Study

CL-004

CL-005

CL-006

CL-010

CL-007

Indication

Mild-to-moderate

Asthmatics

Moderate-to-

Severe

Asthmatics

Acute

Exacerbations

of Asthma

Moderate-to-

Severe

COPD patients

Acute

Exacerbations

of Asthma

FEV

(Entry Criteria)

FEV

60%

75%

FEV

40%

FEV

55%

80%

FEV

30%

FEV

50%

Number of

Patients

200

Number of

Sites

~35

Doses Tested

Compared to

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

Mean Change in FEV

and

Differences in Hospitalization Rate

Mean change in FEV

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

•

200

patients

with

severe,

acute

exacerbations

asthma

(FEV

50%

predicted) at multiple Emergency Department sites in the United States

•

Dose Groups (up to100 patients/group):

•

1,200

µg

MN-221

over

hour

(600

µg

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

improvement

FEV

predicted)

hours

•

The study is designed to have 80% power to detect a treatment difference of

5 percentage

points

FEV

predicted)

when

comparing

MN-221

SOC

Placebo + SOC at a two sided

-level of 0.05.

•

Anticipated completion 1Q, 2011*

MN-221-CL-007:

Study Design

Note: Development plans / timelines for MN-221 clinical trials are subject to change

*Anticipated completion date based on current projections

MediciNova, Inc. 2010

MN-166

•

Oral administration

•

Safe

and

well-tolerated

(approved

Japan/Korea

with

over

3.2

million

patient

exposures)

•

Mechanism(s)

Action

primarily

non-selective

PDE

inhibition,

Attenuation

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

MS, Neuropathic Pain, & Drug Addiction

MediciNova, Inc. 2010

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

NYC

(Investigator

IND

study;

MediciNova

not

the

sponsor)

•

Trial to enroll ~30 patients (10 completers/cohort)

•

Anticipated completion in 2H, 2010*

MN-166 for Opioid

Withdrawal:

Phase Ib/IIa

Ongoing Clinical Trial

Trial Design/Endpoints

Week

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

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

Commercially-Attractive

Diversified Portfolio

COPD

Asthma

Pain/Addiction

MediciNova, Inc. 2010

Leadership

Years

Experience

Background

Yuichi Iwaki, MD, PhD

CEO & President

Professor at USC, formerly Professor at University

of Pittsburgh; Advisor to JAFCO, Tanabe

Shintaro Asako, CPA

Chief Financial Officer

KPMG USA (Audit), Arthur Andersen USA

Kirk Johnson, Ph.D.

Chief Scientific Officer

Avigen, Genesoft Pharmaceuticals, Chiron

Corporation

Michael Coffee

Chief Business Officer

Chief Business Officer, Avigen, President of Elan

Pharmaceuticals, North America

Masatsune Okajima, CMA

VP, Head of Japanese

Office

Daiwa Securities SMBC,

Sumitomo Capital Securities, Sumitomo Bank

Management Team with

Global Experience

MediciNova, Inc. 2010

Upcoming Near-Term Business Milestones:

Secure a global partnership for MN-166

Secure a strategic partnership for MN-221

Upcoming Clinical Milestones:

MN-221-CL-007 Phase II Study for Acute Exacerbations of Asthma

•

Anticipated completion 1Q, 2011*

MN-166

Study for Opioid Withdrawal

•

Anticipated completion in 2H, 2010*

Completed Milestones:

Completed Avigen merger December 18, 2009

Announced Positive MN-221-CL-010 Phase Ib Study Results in

Moderate-to-Severe COPD Patients on March 17, 2010

Secured $15M Venture Debt from Oxford Finance Corp. on May 10, 2010

Investment Highlights

*Anticipated completion dates based on current projections