SEC Filing - MediciNova, Inc.

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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): January 7, 2011

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 January 7, 2011, 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.

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.


	MEDICINOVA, INC.

Date: January 7, 2011	By:	/S/ SHINTARO ASAKO
	Name:	Shintaro Asako
	Title:	Chief Financial Officer

Slide Presentation of the Registrant

MediciNova, Inc. 2011

Accelerating

the global development

and commercialization of

innovative pharmaceuticals

Exhibit 99.1

MediciNova, Inc. 2011

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; MediciNova’s ability to comply with the covenants in its financing

agreements; 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 and 8-K. You are cautioned not to place undue

reliance on these forward-looking statements, which speak only as of January 7, 2010. MediciNova disclaims any intent or

obligation to revise or update these forward-looking statements.

MediciNova, Inc. 2011

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

•

$65.5 million Market Cap (NasdaqGM) as of 1/05/2011

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. 2011

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

Acute Asthma Treatment Flow in

Emergency Departments in the U.S.

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

410,000

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. 2011

Limitations of Current Therapies

What are the limitations of current therapies for acute exacerbations of

asthma?

Limitations of Inhaled Therapies:

•

Bronchoconstriction:

inflammation

and

bronchoconstriction

result

insufficient

air

flow

get

good

drug

deposition

the

lungs

•

Mucus

Plug

Formation:

mucus

secretion

and

the

formation

thick

mucus

plugs

can

cause

persistent

airflow

limitation

•

Albuterol

Non-Responders:

not

all

patients

benefit

from

albuterol

Limitations of Current Intravenous Therapies:

•

Safety:

currently

available

options

(e.g.

epinephrine,

terbutaline)

have

unacceptable

cardiovascular

risks

doses

used

MediciNova, Inc. 2011

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 ß

receptor than ß

•

Partial agonist for ß

receptor

Reduced Health Care Expenses

MN-221: A New Approach to Treating

Exacerbations of Acute Asthma & COPD

MediciNova, Inc. 2011

MN-221: Target Product Profile

MN-221 Indication: Treatment of bronchospasms

in patients with acute

exacerbations of asthma or COPD. It is administered adjunctive to standard of

care by intravenous infusion.

•

well-tolerated,

potent,

selective

-agonist

which

only

partial

agonist

•

bronchodilating

duration

action

that

longer

than

SABAs

and

shorter

than

LABAs.

•

Provides additional bronchodilation

when used in addition to the standard

treatments of inhaled albuterol, inhaled ipratropium, and steroids.

•

Reduces the hospitalization rate among patients treated with MN-221.

•

clinical

adverse

effects

when

added

standard

care

(SOC).

MediciNova, Inc. 2011

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

~20

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. 2011

MN-221-CL-006

Mean Change in FEV

and

Differences in Hospitalization Rate

Mean

change

FEV

from

baseline

was

5.3%

higher in the MN-221 dose groups versus the

placebo group

MN-221 reduced the hospitalization rate by 45%

MediciNova, Inc. 2011

•

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 to 100 patients/group):

•

1,200 µg

of MN-221 over 1 hour (600 µg

in 15 minutes; 600 µg

in next 45 minutes)

•

Placebo

•

Patients will receive 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

percentage

points

FEV1

predicted)

when

comparing

MN-221

SOC

to Placebo + SOC at a two sided a-level of 0.05.

•

Anticipated completion in 2H, 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. 2011

Ibudilast (MN-166/AV411)

•

Oral administration

•

Safe and well-tolerated (approved in Japan/Korea with over 3.2 million patient

exposures)

•

Mechanism(s) of Action primarily Inhibition of Microphage Migration Inhibitor Factor (MIF),

PDE-4,10 inhibition; Attenuation of Glial Cell Activation

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 (40 and

80 mg/d)

•

Completed Phase 1b/2a clinical trial in Opioid Withdrawal & Analgesia (40 and 80 mg/d)

(Columbia Univ/NYSPI via NIDA funding)

•

Ongoing Phase 1b Methamphetamine interaction trial (UCLA via NIDA funding)

•

Additional Supporting Data

•

3 completed Phase 1 clinical trials

•

Dosing up to 100 mg single dose & 100 mg daily (50 mg twice/day)

•

~400 subjects treated with MN-166/AV411 to date (safe & well-tolerated)

Ibudilast for the Treatment of MS,

Neuropathic Pain, & Drug Addiction

MediciNova, Inc. 2011

Status for Chronic Pain:

•

MN-166/AV411 is enabled to go directly to Phase 2b clinical development

•

MN-166/AV411

mechanism

action

novel

and

thus

complimentary

current

pain

treatments,

and has both stand-alone and adjunctive utilities

•

Majority of potential pharma

partners are strategically committed to new pain therapies

•

MN-166/AV411 has an attractive development timeline and long term exclusivity

Status for Drug Addiction/Opioid

Withdrawal:

•

Announced positive safety/efficacy results from Phase 1b/2a study in Opioid

Withdrawal (12/10)

•

UCLA initiated Phase Ib

study for Methamphetamine Addiction (9/10)

Status for Multiple Sclerosis:

•

MN-166/AV411 requires significant funding for future trials

•

Phase 2 data were at doses that are below maximum utility

•

Most attractive option may be Progressive MS which would require

an additional Phase 2b

clinical trial

Ibudilast

(MN-166/AV411):

Status for Each Indication

MediciNova, Inc. 2011

Ibudilast

Neuropathic Pain

Market Opportunity

Drug

Company

Total Rxs

in 2009

(US)

Lyrica

Pfizer

9.1 Million

Cymbalta

Eli Lilly

14.7 Million

Neurontin

(Gabapentin)

Pfizer

23.4 Million

Total

47.1 Million

Neuropathic Pain Annual Market

Opportunity:

~$8.0 Billion

†

•

Prevalence is approximately 4.2

million neuropathic pain patients in

the U.S. and 40

million worldwide

•

MN-166 has a different

mechanism of action than currently

marketed neuropathic pain

therapies

•

MN-166 has potential to capture

substantial market share in the

neuropathic pain market

*Source: SDI/Verispan, Lilly and Pfizer Quarterly Reports

Approved

indications:

Lyrica:

Neuropathic

pain

associated

with

diabetic

peripheral

neuropathy,

post

herpetic

neuralgia,

partial

onset

seizures,

fibromyalgia;

Neurontin:

postherpetic

neuralgia,

partial

seizures

;

Cymbalta:

Major

Depressive

Disorder,

Generalized

Anxiety

Disorder,

Diabetic

Peripheral

Neuropathic

Pain,

Fibromyalgia

†

Market Value Calculated at Branded Prices

MediciNova, Inc. 2011

Patent/Commercial Overview

Method of Use

N. Pain

Composition of Matter

AV1013

Generation

Analogs

Issued or

allowed

Pending

AV1013

Enantiomer

Key:

Progressive

Exp. 2018

Exp. 2025

Exp. 2027

MIF Inh.

screen

Exp. 2027

Ibudilast

Immunomodulator

for MS

Acute & Sub-

chronic Pain

Addiction

MediciNova, Inc. 2011

Collaboration Structure with Pharma

Partner:

Shared Risk

All indications; Ibudilast

+ Analogues

Option Agreement around Phase 2b Diabetic Peripheral Neuropathic

Pain

and/or

Progressive

trial

with

Exclusive

License,

Development Milestones, Royalties, Sales Milestones.

Sustain NIDA-sponsored Drug Addiction development

Consider Investigator-sponsored Neurological Trials

Most Likely Scenario for

Ibudilast’s

Development

MediciNova, Inc. 2011

Commercially-Attractive

Diversified Portfolio

COPD

Asthma

Pain/Addiction

MediciNova, Inc. 2011

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

Avigen, Amarin Corp., Elan Pharmaceuticals, N.A.,

Athena Neurosciences

Masatsune Okajima, CMA

VP, Head of Japanese

Office

Daiwa Securities SMBC, Sumitomo Capital

Securities, Sumitomo Bank

Management Team with

Global Experience

MediciNova, Inc. 2011

Upcoming Near-Term Business Milestones:

Secure a global partnership for Ibudilast (MN-166/AV411)

Secure a strategic partnership for MN-221

Upcoming Clinical Milestones:

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

•

Anticipated completion in 2H, 2011*

Completed Milestones in 2010:

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

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

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

2010

Announced Positive Safety and Efficacy data for Ibudilast (MN-166/AV411) Phase Ib/2a Study

Results for Opioid Withdrawal and Analgesia on December 13, 2010

Investment Highlights

*Anticipated completion dates based on current projections