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): July 17, 2013
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) |
(I.R.S. Employer Identification No.) | ||
| 4275 EXECUTIVE SQUARE, SUITE 650, LA JOLLA, CA |
92037 | |||
| (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 8.01 | Other Events. |
On July 17, 2013, MediciNova Inc. (the “Company”) updated the slide presentation to be used by the Company at investor meetings. A copy of the revised slide presentation is attached as Exhibit 99.1 and is incorporated herein by reference.
| Item 9.01 | Financial Statements and Exhibits. |
| (d) | Exhibits. |
| Exhibit No. |
Description | |
| 99.1 | Slide presentation of the Company. | |
SIGNATURE
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. | ||||||
| By: | /s/ Michael Gennaro | |||||
| Michael Gennaro | ||||||
| Chief Financial Officer | ||||||
Date: July 17, 2013
EXHIBIT INDEX
| Exhibit No. |
Description | |
| 99.1 | Slide presentation of the Company. | |
 Developing Novel Therapeutics for
the Treatment of Serious Diseases
with Unmet Medical Needs
Exhibit 99.1 |
 ©
MediciNova, Inc. 2013
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 of obtaining future partner or grant funding for development of MN-166 and
MN-221 and risks of raising sufficient capital when needed to fund MediciNova’s
operations and contribution to clinical development, risks and uncertainties
inherent in clinical trials, including the potential cost, expected timing and risks associated with clinical trials designed to
meet FDA guidance and the viability of further development considering these factors,
product development and commercialization risks, risks associated with the
reliance on third parties to sponsor and fund clinical trials, risks regarding intellectual property rights in product
candidates and the ability to defend and enforce such intellectual property rights, 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 regulatory authorities; 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 obtain third party funding for programs and 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, 2012 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 July
17, 2013. MediciNova disclaims any intent or obligation to revise or
update these forward-looking statements.
Forward-Looking Statements |
 ©
MediciNova, Inc. 2013
Two novel product candidates
in clinical development, both with encouraging
efficacy and safety data
MN-166 (ibudilast)
for the treatment of drug addiction & progressive MS
Licensed from Kyorin Pharmaceuticals
Two Phase 2 studies (methamphetamine and opioid addiction)
Two progressive MS trials (pending grant funding)
Newly-issued patents (addiction and Progressive MS)
MN-221
for the treatment of acute exacerbations of asthma
Licensed from Kissei Pharmaceutical Co., Ltd.
Had an End of Phase 2 meeting with FDA
Newly-issued patent
Well-capitalized
Experienced management team
3
MediciNova Highlights |
 ©
MediciNova, Inc. 2013
MediciNova: Active Programs in
Clinical Development
4 |
 MN-221
(bedoradrine): MN-221 (bedoradrine):
A Novel Intravenous Treatment for
A Novel Intravenous Treatment for
Acute Exacerbations of Asthma
Acute Exacerbations of Asthma
5 |
 ©
MediciNova, Inc. 2013
6
NCE (new chemical entity), small molecule, beta
2
-adrenergic receptor
agonist in iv form
In development for the treatment of Acute Exacerbations of Asthma (AEA)
adjunctive to standard of care
Licensed from Kissei Pharmaceutical Co., Ltd.
Completed four Phase 2 clinical trials in asthma or AEA and
two Phase 1b/2a clinical trials in COPD
New method-of-use patent may significantly extend market exclusivity
with patent protection until at least 2030 in U.S.
Had an End of Phase 2 meeting with FDA
MN-221 (bedoradrine) Overview |
 ©
MediciNova, Inc. 2013
7
MN-221 (bedoradrine) Overview
Acute Asthma Treatment Flow in Emergency Departments in the U.S.
Source: National Center for Health Statistics / CDC, National Hospital Discharge
Survey |
 ©
MediciNova, Inc. 2013
1.
API Manufacturing requirements of FDA
Kissei, our API supplier, is addressing requirements
Approximately 6-month duration
2. Clinical development work including:
Dose regimen optimization
Revision and validation of acute asthma exacerbation trial
•
Primary endpoint will include hospitalization, consistent with
FDA guidance
8
Next Steps for MN-221:
Based on End of Phase 2 meeting with FDA |
 ©
MediciNova, Inc. 2013
9
MN-221: Impact of Dose Timing
Note: Treatment Failure is hospitalization or return ER visit due to
asthma. Times are time difference between steroid dose and study drug.
Data is from Phase 2b trial of MN-221 in acute exacerbations of asthma.
Based on Phase 2b data, the ideal time to administer MN-221 is after the
patient has not responded to standard of care for more than 3-4 hours.
|
 MN-166
(ibudilast): MN-166 (ibudilast):
A Novel Oral Therapy for the
A Novel Oral Therapy for the
Treatment of Methamphetamine and
Treatment of Methamphetamine and
Opioid Addiction
Opioid Addiction
10 |
 ©
MediciNova, Inc. 2013
11
Non-addictive,
orally-administered
small
molecule
NCE in U.S. and Europe: NCE exclusivity / Data exclusivity
Large safety database with over 3.2M patient exposures in Japan
Primary use is in cerebrovascular disorders (post-stroke dizziness)
Pharmacokinetics
(PK)
enable
once
or
twice
daily
dosing
Unique mechanism of action
Encouraging Phase 1/2 data in targeted CNS indications with major
unmet medical needs
Received Fast Track
designation from U.S. FDA for the treatment of
methamphetamine addiction
U.S.
Patent
protection
until
at
least
2030
for
addiction
and
2029
for
progressive
multiple
sclerosis
(MS)
MN-166 (ibudilast) Overview |
 ©
MediciNova, Inc. 2013
MN-166 (ibudilast) Target Action -
Molecular
MIF
(macrophage migration
inhibitory factor)
PDE –
10,
PDE –
4
12
ibudilast
ibudilast
pro-inflammation via
CD74/CXCR2,4 receptors
degradation of cAMP
(& cGMP) |
 ©
MediciNova, Inc. 2013
MN-166 (ibudilast) Target Action -
Cellular
13
Withdrawal symptoms, drug-seeking and relapse associated with drug
addiction;
Neuropathology
in
drug
addiction
&
progressive
MS
ibudilast
ibudilast
An umbrella of cellular action covering the
disease indications…
PDE 4 , 10
MIF
Silence Activated Glia & interrupt glial-neuronal
viscous cycle
Glial cell activation is associated with key
features of drug addiction |
 ©
MediciNova, Inc. 2013
14
MN-166 (ibudilast)-Methamphetamine
(MA) Phase 1b Trial
Trial Design
n = 11
Non-treatment seeking MA dependent subjects
Double-blind, placebo-controlled
~1 month inpatient hospitalization
Dosing:
One week each of Placebo, 40 mg/day, 100 mg/day
Safety/Efficacy Measurements:
Cardiovascular response to 15, 30 mg IV MA
Cognitive & Subjective effects
Partners
Status: Completed
Data presented in June 2013 at
CPDD*
*College of Problems of Drug Dependence |
 ©
MediciNova, Inc. 2013
15
MN-166 (ibudilast)-Methamphetamine
Phase 1b Trial
Data presented at Annual CPDD Meeting in June 2013
Safety:
Phase 1b trial established safety of co-administration of
methamphetamine and MN-166 (ibudilast) in doses up to 100
mg/day Enables 100 mg/day dosing for Phase 2 outpatient trials
15 |
 16
MN-166 (ibudilast)-Methamphetamine
Phase 1b Trial
16
p=0.01
Efficacy:
Conner’s Continuous Performance Test-II (CPT-II) is a measure of sustained
attention MN-166 (ibudilast) significantly reduced perseverations and
variability in response times MN-166 (ibudilast) may have a protective effect
on sustained attention Note: Perseveration is a reaction time that is less than
100 ms; Variability is a measure of response speed consistency |
 ©
MediciNova, Inc. 2013
17
MN-166 (ibudilast) Phase 2 Trial for
Methamphetamine Addiction
Trial Design
n = 140
(seek to increase to 160)
Treatment-seeking volunteers
Randomized, double-blind, placebo-controlled
1:1 Randomization with placebo or 100 mg/day
of MN-166 (ibudilast)
12-week outpatient study
Primary endpoint
is methamphetamine
abstinence during final two weeks of treatment;
NIDA-
and FDA-preferred endpoint
Partners
Timing
Trial to commence 2H:2013 |
 ©
MediciNova, Inc. 2013
18
MN-166 (ibudilast) Phase 1b/2a
Trial: Opioid Withdrawal & Analgesia
Trial Design
n = 30
Heroin-dependent subjects; 3-week inpatient setting
Double-blind, placebo-controlled
Week One:
All subjects on morphine (30 mg/day) and Placebo
Week Two:
All subjects on morphine (30 mg/day) and either Placebo,
40 mg/day, or 80 mg/day of MN-166 (ibudilast)
Week Three:
Subjects continue on either Placebo, 40 mg/day, or 80
mg/day of MN-166 (ibudilast) with morphine removed
Objective:
Safety/tolerability/PK
and
preliminary
efficacy
for opiate withdrawal and analgesia
Partners
Status: Completed
Completed end 2010
Results were presented at
AAN* in March 2013
*American Academy of Neurology |
 ©
MediciNova, Inc. 2013
MN-166 (ibudilast) Phase 1b/2a Trial:
Ibudilast Effect on Primary Outcome -
Subjective Opioid Withdrawal Scale (SOWS)
19
Individual Measurements of SOWS
Composite
Primary Endpoint = Total SOWS score as a
function of ibudilast dose
Opioid-related pupil constriction
was greater in the 80 mg/day ibudilast group compared to
the placebo group (p
0.05) suggesting lessened tolerance development.
Note: One outlier subject in the 80 mg/day group was excluded from the Total SOWS score
analysis. |
 ©
MediciNova, Inc. 2013
20
MN-166 (ibudilast) Phase 2a Trial: Effects of MN-
166 (ibudilast) on Oxycodone Self-Administration
in Opioid Abusers
Trial Design
n = 24
Prescription opioid drug abusers (including OxyContin,
Vicodin, Percocet) or heroin
Randomized, placebo-controlled, double-blind
Inpatient study; two 20-day cross-over periods in-clinic
where patients detox & test self-administration when on
Placebo or 100 mg/day of MN-166 (ibudilast)
Objective:
Assess effect of MN-166 (ibudilast) on
craving and self-administration effects
Partners
Timing
Trial commenced at end of 2012
Trial completion expected 2H:2014 |
 ©
MediciNova, Inc. 2013
21
Addiction Competitive Landscape
No pharmaceutical treatment approved for methamphetamine addiction
Available therapeutics for treating opioid addiction have limited efficacy and
face increasing clinical-regulatory scrutiny
Buprenorphine & buprenorphine/naloxone combination (Subutex & Suboxone):
Potential for abuse, tolerance and addiction
Therapeutic effects reach a plateau at higher doses
Suboxone pills recently removed from shelves, highlighting the need for
safer alternatives
Naltrexone:
Precipitates withdrawal symptoms resulting in poor patient compliance
Source: Wall Street Equity Research, NIDA, Curr Drug Abuse Rev.
MAJOR UNMET NEED FOR NOVEL TARGETS AND DIFFERENTIATED THERAPEUTICS
|
 ©
MediciNova, Inc. 2013
22
US Methamphetamine Addiction Market
US Market Opportunity of Methamphetamine Addiction
(1)
(1)
Dr.
Phil
Skolnick,
Director,
Division
of
Pharmacotherapies
&
Medical
Consequences
of
Drug
Abuse,
NIDA;
2010
NSDUH
survey;
Neuropsychiatric R&D Conference, San Francisco, CA.
September 2012
~353,000 individuals used methamphetamine in the past month
~70,600 patients seek treatment (20%)
6-month, initial course of treatment is recommended at ~$1,000/month
353,000
x
0.20
x
$1000/month
x
6
months
>
$400
million
market |
 ©
MediciNova, Inc. 2013
23
US Opioid Addiction Market
US Market Opportunity for Opioid Addiction
(1) Reckitt Benckiser Annual Report, 2012; Assumes 1 £
= 1.55 USD
(2) Substance Abuse and Mental Health Services Administration's (SAMHSA) 2011 National
Survey on Drug Use and Health Current market for opioid addiction is
well-established with substitution therapeutic agents
such as Subutex/Suboxone
with worldwide sales of ~$1.3B
(1)
in 2012
Approximately 1.4 million people with nonmedical pain
reliever addiction and approximately 369,000 heroin addicts
in the U.S.
(2)
A non-addictive treatment would fill an unmet need in this
large market |
 MN-166
(ibudilast): MN-166 (ibudilast):
A Novel Oral
Therapy
A Novel Oral
Therapy
for the Treatment of
for the Treatment of
Progressive Multiple Sclerosis (MS)
Progressive Multiple Sclerosis (MS)
24 |
 25
MN-166 (ibudilast):
The Promise in Progressive MS
MN-166 (ibudilast) is a small molecule with established safety
297-patient, two-year Phase 2 clinical trial completed in MS
•
Significant dose-related improvements in disability progression and MRI
outcomes (whole brain atrophy, black-hole formation)
•
Results indicated that MN-166 (ibudilast) is best suited to treat Progressive
MS Glial-neuronal activation cycle leads to underlying progressive
neurodegeneration
MIF
knock-out
reduces
the
neuropathological
and
‘clinical’
disability
sequelae
in animal models
Phase 2b development of MN-166 (ibudilast) for the treatment of Progressive
MS via Academic Investigator/Government agency/MS society/MediciNova
consortium(s) and grant funding |
 ©
MediciNova, Inc. 2013
26
MN-166 (ibudilast) Phase 2
Multiple Sclerosis Trial |
 ©
MediciNova, Inc. 2013
27
Placebo
30 mg/day
Low Dose Group
60 mg/day
High Dose Group
Patient
Subset
% Brain Volume
Change
% Brain Volume
Change
Magnitude of
Effect
% Brain Volume
Change
Magnitude of
Effect
RRMS
-1.2
-1.1
8% less
-0.8
33% less**
SPMS
-1.0
-0.7
30% less
-0.44
56% less
MN-166 (ibudilast) Phase 2 Multiple
Sclerosis (MS) Trial
Mean change
**p=0.035
Whole Brain Atrophy Endpoint in
Secondary Progressive MS (SPMS) Patients
RRMS = Relapsing Remitting MS
SPMS = Secondary Progressive MS |
 ©
MediciNova, Inc. 2013
28
Placebo
30 mg/day
Low Dose Group
60 mg/day
High Dose Group
Patient
Subset
% Brain Volume
Change
% Brain Volume
Change
Magnitude of
Effect
% Brain Volume
Change
Magnitude of
Effect
RRMS
-1.2
-1.1
8% less
-0.8
33% less**
SPMS
-1.0
-0.7
30% less
-0.44
56% less
MediciNova is pursuing grant funding to support Phase 2b clinical trial(s)
treating Progressive MS with MN-166 (ibudilast)
MN-166 (ibudilast) Phase 2 Multiple
Sclerosis (MS) Trial
Mean change
**p=0.035
Whole Brain Atrophy Endpoint in
Secondary Progressive MS (SPMS) Patients
RRMS = Relapsing Remitting MS
SPMS = Secondary Progressive MS |
 ©
MediciNova, Inc. 2013
MN-166 (ibudilast) Clinical Trials
MN-166 (ibudilast) is advancing in multiple Phase 2 programs
29
GRANT-FUNDED CLINICAL DEVELOPMENT MODEL |
 ©
MediciNova, Inc. 2013
30
Key Milestones for 2013-2014
MAJOR NEAR TERM VALUE INFLECTION POINTS
2H:2013
2H:2013
2H:2013
2H:2014
Clinical Milestones
Timing
Results of Phase 1b UCLA methamphetamine trial
1H:2013
Commence Phase 2 UCLA methamphetamine trial
Announce grant funding for Phase 2b trial treating progressive MS with ibudilast
Results of Phase 2a MOH pain trial
Results of Phase 2a opioid dependence trial
Results of Phase 2 methamphetamine trial
2H:2014 |
 ©
MediciNova, Inc. 2013
31
MN-166 (ibudilast) Program Patents
* U.S. patent expiration does not include Waxman-Hatch patent term
restoration (industry average = 4.5 years) Patent
Exclusivity
Patent
Exclusivity
Method of Use
Composition of Matter
Addiction
US Exp.
2030
EU Exp. 2026
AV1013
US Exp.
2027
EU Pending
Progressive Multiple Sclerosis
US Exp.
2029
EU Exp. 2028
AV1013 Enantiomer
US Exp.
2030
EU Pending
Neuropathic Pain
US Exp.
2025
EU Pending
2
nd
Generation Analogs
Pending
Acute & Sub-Chronic Pain
US Pending
EU Exp. 2028
Anxiety-Traumatic Brain Injury / PTSD
Pending
Ibudilast + Immunomodulator for MS
Pending
MOH Pain
Pending |
          ©
MediciNova, Inc. 2013
32
Leadership
Years
Experience
Background
Yuichi Iwaki, MD, PhD
Yuichi Iwaki, MD, PhD
President & CEO, Founder
36
Professor at USC, formerly Professor at University
of Pittsburgh; Advisor to JAFCO, Tanabe
Michael Coffee
Michael Coffee
Chief Business Officer
28
Avigen, Amarin Corp., Elan Pharmaceuticals, N.A.,
Athena Neurosciences
Kirk Johnson, PhD
Kirk Johnson, PhD
Chief Scientific Officer
23
Avigen, Genesoft Pharmaceuticals, Chiron
Corporation (Novartis -
San Francisco)
Kazuko Matsuda, MD, PhD, MPH
Kazuko Matsuda, MD, PhD, MPH
Chief Medical Officer
22
Assistant Professor USC, Keck School of Medicine;
Children’s Hospital Los Angeles
Masatsune Okajima, CMA
Masatsune Okajima, CMA
VP, Head of Japanese Office
21
Daiwa Securities SMBC, Sumitomo Capital
Securities, Sumitomo Bank
Michael Gennaro, CPA, MBA
Michael Gennaro, CPA, MBA
Chief Financial Officer
38
Partner at FLG Partners, Sylantro Systems, Inverse
Network Technology, Novell, Piiceon, Verticom
Management Team with
Global Experience |