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): September 4, 2009
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:
| x | 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. |
Representatives of MediciNova, Inc. (the “Registrant”) will be attending the Rodman and Renshaw Annual Global Investment Conference commencing on September 9, 2009 and are scheduled to make a presentation at such conference on September 9, 2009 at 4:30 p.m. Eastern time. The information to be presented by the Registrant at this conference and investor meetings 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: September 4, 2009 | By: | /s/ Shintaro Asako | ||
| Shintaro Asako Vice President and Chief Financial Officer | ||||
EXHIBIT INDEX
| Exhibit |
Description | |
| 99.1 | Slide presentation of the Registrant |
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MediciNova, Inc. 2009 Accelerating the global development and commercialization of innovative pharmaceuticals Exhibit 99.1 |
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MediciNova, Inc. 2009 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 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,
anticipated benefits of the merger with Avigen, Inc., value and benefits to
stockholders from such transaction, 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 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; failure to complete the merger with Avigen, Inc. on a
timely basis or at all; 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, 2008 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 Forward-Looking Statements |
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MediciNova, Inc. 2009 This communication does not constitute an offer to sell or the solicitation of an offer to
buy any securities or a solicitation of any vote or approval. This material is
not a substitute for the registration statement/prospectus/proxy statement
MediciNova, Inc. and Avigen, Inc. will file with the SEC or any other
documents that the parties may file with the SEC and send to their respective shareholders in connection with the transaction. INVESTORS AND SECURITY HOLDERS OF
AVIGEN, INC. ARE URGED TO READ ANY SUCH DOCUMENTS FILED WITH THE SEC CAREFULLY IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE TRANSACTION. Investors and security holders will be
able to obtain free copies of any documents filed with the SEC by MediciNova, Inc.
and Avigen, Inc. through the website maintained by the SEC at http://www.sec.gov. |
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MediciNova, Inc. 2009 4 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: Intravenous (IV) acute asthma and COPD candidate • Potential $1 Billion+ combined market opportunity worldwide • MN-166: oral multiple sclerosis candidate • In 2008, over $8B in worldwide MS therapeutic sales* • A diversified portfolio consisting of six additional compounds Corporate Overview: Corporate Overview: MediciNova, Inc. MediciNova, Inc. *Source: Individual annual reports of leading MS companies, 2008 MNOV Headquarters: San Diego, CA Key Financials: • Signed Definitive Merger Agreement w/ Avigen, Inc. on 8/20/2009; anticipated closing 4Q09 • Dual listed company on NasdaqGM and Osaka Securities Exchange – Hercules • ~$40.7 million net Cash, Cash Equivalents and Marketable Securities as of
6/30/2009 • ~$85.5 million Market Cap (NasdaqGM) as of 8/19/09 |
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MediciNova, Inc. 2009 5 In-License: • Novel, small-molecule product candidates with significant clinical or preclinical data packages and attractive market opportunities Conduct Proof-of-Concept Clinical Trials: • Conduct Phase I and Phase II clinical trials to demonstrate
safety and efficacy of compound Two Pathways Towards ROI After Phase II: 1. Continue internal development of compound towards commercialization 2. Seek partnership for further development of compound Business Model:
Business
Model: Return On Investment Return On Investment MediciNova intends to pursue further development of MN-221 independently in the United
States; however, following our completion of the Phase II clinical trial of
MN-166 for the treatment of MS, we are not planning to pursue any further
significant clinical development of MN-166 until we secure a strategic
collaboration to further development. |
 Avigen Avigen Transaction Overview Transaction Overview 6 © MediciNova, Inc. 2009 Transaction • • • Rationale • • • • Signed Definitive Merger Agreement with Avigen, Inc. on 8/20/2009. Following the completion of the transaction, Avigen will become a wholly-owned
subsidiary of MediciNova. Anticipated closing will be 4Q, 2009. AV-411 (ibudilast) preclinical materials can be used as support for the development
pathway for MN-166 Anticipated cost savings of up to ~$7.0 million for
MediciNova to reproduce data. Clinical data with higher dose of ibudilast, an
open IND and obtaining control of the AV-411 use patent are expected
to enhance partnering potential and shorten the time to approval. Avigen’s
significant cash balance represents a potential financing opportunity with MediciNova potentially deriving proceeds of up to $37 million, assuming some or all of Avigen’s stockholders
elect to receive MediciNova convertible notes in the transaction and
subsequently convert those notes. |
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MediciNova, Inc. 2009 Avigen Avigen Transaction Overview Transaction Overview 7 Merger Consideration • Each Avigen stockholder will have the option of receiving their pro rata allocation of cash
or convertible notes aggregating approximately $37.0 million, subject to
potential upward and downward adjustments as set forth in the merger agreement:
• First payment consideration of approximately $35.5 million; and • Second payment consideration of approximately $1.5 million payable on June 30, 2010.
• This holdback amount is being held for any adjustments to certain Avigen defined expenses,
marketable security risk, sub-tenant risk, and other liabilities in excess
of amounts agreed by the parties. • Contingent Payment Rights • Provides for payment of certain assets to Avigen shareholders on a pro rata basis:
• $6.0 million milestone payment from Genzyme Corporation if such payment is received within
20 months of effective time of merger. • If the milestone payment has not occurred and the Parkinson’s product (as defined in
the Genzyme Agreement) is sold by MediciNova within 20 months of the effective
time of the merger, 50% of the net proceeds from such sale received within such
20-month period. • Certain amounts remaining in a plan trust created by Avigen upon satisfaction of certain
severance and benefits payments. |
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MediciNova, Inc. 2009 Avigen Avigen Transaction Overview Transaction Overview 8 Convertible Notes Consideration • 18-month maturity from the date of closing of merger (no early cash redemption).
• Principal from the notes will be held in a trust account with principal invested in certain
approved investment options. • The notes can be converted on a monthly basis into common shares of MediciNova at an initial
conversion price equal to $6.80. Approval Conditions • Requires affirmative vote of a majority of outstanding stock entitled to vote of:
• MediciNova for the approval of the issuance of the convertible notes; and • Avigen for the adoption of the Merger Agreement. Other Provisions • Customary conditions to closing and termination rights. • No break-up fees to either party; however, if Avigen board changes its recommendation
and the merger is not approved, MediciNova entitled to receive 50% of out of
pocket expenses up to $500,000. |
 (1) Assumes first payment consideration and second payment
consideration aggregate $37.0 million and are both paid at closing and that MediciNova issues no shares or options from August 20, 2009 through the first conversion date of the convertible notes.
(2) Assumes the convertible notes convert to MediciNova shares at $6.80. (3) Assumes all convertible notes are converted into MediciNova shares on the first monthly conversion
date. Sources of information: SEC Edgar Filings Pro Forma Stockholder Review Pro Forma Stockholder Review This pro forma ownership review is presented for illustrative purposes only and does not indicate actual ownership of MediciNova shares at any past, present, of future date. Actual ownership of MediciNova shares will depend on a variety of factors, including the actual amounts of the First Payment
Consideration and Second Payment Consideration and the rounding of fractional shares
set forth in the indenture governing the convertible notes. Summary Securities Ownership Review (Fully Diluted Basis) Pre -Transaction Pro Forma Shares Outstanding Post-Transaction (1) Consideration Shares All Cash 50% Cash 50% Conv. Notes (2) (3) 100% Conv. Notes (2) (3) Common Stock Equivalents MediciNova Stockholders 12,048,003 12,048,003 12,048,003 12,048,003 Avigen Stockholders - - 2,717,712 5,435,424 MediciNova Exercisable Options 1,711,350 1,711,350 1,711,350 1,711,350 13,759,353 13,759,353 16,477,065 19,194,777 Ownership % MediciNova Stockholders 87.6% 87.6% 73.1% 62.8% Avigen Stockholders 0.0% 0.0% 16.5% 28.3% MediciNova Exercisable Options 12.4% 12.4% 10.4% 8.9% 100.0% 100.0% 100.0% 100.0% |
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MediciNova, Inc. 2009 10 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 billion worldwide sales in 2008* Current Standard of Care: • Beta interferons (Rebif, Avonex, Betaserone), Copaxone ® , Tysabri ® • Administered either by intramuscular or subcutaneous injection or infusion MN-166 for Multiple Sclerosis: • Oral Administration • Anti-inflammatory and neuroprotective propreties Multiple Sclerosis Multiple Sclerosis *Source: Individual annual reports of leading MS companies, 2008
|
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MediciNova, Inc. 2009 Placebo-controlled, randomized, double-blind Phase II study: • Year 1 - 0, 10 mg three times a day (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 Expanded Disability Status Scale (EDSS) score of 5.5 or less at the screening
and baseline visits. Completed Clinical Study: Completed Clinical Study: MN-166-CL-001 MN-166-CL-001 11 |
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MediciNova, Inc. 2009 MN-166 Effects Outcomes Related to Disease Progression in RRMS Patients Clinical and MRI Outcomes: Indicative of Potential Neuroprotective Effect: 1. Reduced Brain Volume Loss 2. Reduced Conversion of Acute Lesions to Persistent Black Holes 3. 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
12 P-Value: 0.044 P-Value: 0.030 MN-166 Targets Primarily MN-166 Targets Primarily Chronic Aspects of MS Chronic Aspects of MS P-Value: 0.026 P-Value: 0.004 |
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MediciNova, Inc. 2009 N=71
1.59 Chronic Efficacy
Demonstrated: Chronic Efficacy Demonstrated: Effects on Brain Volume 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 13 |
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MediciNova, Inc. 2009 Parameter Treatment Groups Placebo 30 mg/day 60 mg/day Number Patients w. New Lesions at Month 2 72 64 56 Total Number New Lesions in all Patients 426 338 315 Total Number of Persistent Black Holes 98 58 47 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 Reduction of Persistent Black Hole (PBH) Formation (PBH) Formation 14 |
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MediciNova, Inc. 2009 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 Sustained Disability Progression P-Value: 0.026 15 |
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MediciNova, Inc. 2009 16 Acute Efficacy Demonstrated: Acute Efficacy Demonstrated: Time to First Relapse Time to First Relapse Median 401 days Median 244 days P-Value: 0.044 |
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MediciNova, Inc. 2009 17 AV-411 Package • Both AV-411 and MN-166 are derived from Ibudilast. • AV-411 preclinical data expected to support clinical package for MN-166. • Open IND for ibudilast. • AV-411 trial supports MN-166 dosing up to 100 milligrams (mg) versus the
maximum dosing of 60 mg in the Phase 2 trial for MN-166. • Expected time savings of six to twelve months. • Analog compounds behind ibudilast. • First-generation development candidate: AV1013. • Second-generation dual target leads. Additional Value from Avigen Additional Value from Avigen Deal Deal |
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MediciNova, Inc. 2009 18 MN-166: NEXT STEPS 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. |
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MediciNova, Inc. 2009 19 Definition: • Long-lasting and severe asthma episode that is not responsive to initial bronchodilator
or corticosteroid therapy Market Opportunity*: • Approximately 2 million annual emergency room visits and 500,000 annual hospitalizations in the US • Approximately 2.7 million annual emergency room visits and 560,000 annual hospitalizations
in UK/Spain/Germany/France/Italy • Potential $1 Billion+ combined market opportunity worldwide (Acute Asthma & COPD
exacerbations) Current Standard of Care (SOC): • Beta agonists - Inhaled • Anticholinergics (ipratropium bromide) - Inhaled • Corticosteroids (66-77% of patients) - IV or oral *Source: National Center for Health Statistics / CDC, WHO website, “Core Health
indicators” Acute Exacerbations of Asthma Acute Exacerbations of Asthma |
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MediciNova, Inc. 2009 20 MN-221: A novel, highly selective 2 - adrenergic receptor agonist; licensed from Kissei Pharmaceutical in 2004 Three Potential Advantages over current therapy 1. Improved Efficacy 2. Improved Safety 3. Reduced Health Care Expenses MN-221: A New Approach to Treating MN-221: A New Approach to Treating Acute Exacerbations of Asthma Acute Exacerbations of Asthma |
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MediciNova, Inc. 2009 21 • MN-221 may improve efficacy over current standard of care due to its route of administration. • Currently patients who are struggling to breathe are given beta agonists in an inhaled formulation. • MN-221’s intravenous formulation allows MN-221 to access the beta 2 receptors in the lungs without having to pass through the constricted airways. 1) Improved Efficacy 1) Improved Efficacy |
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MediciNova, Inc. 2009 22 • MN-221 has a higher selectivity for the beta 2 receptors than the beta 1 receptors as compared with other beta 2 agonists. • MN-221 is only a partial agonist for the beta 1 receptor. • This may result in fewer cardiovascular side effects which are common with the current standard of care. 2) Improved Safety 2) Improved Safety |
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MediciNova, Inc. 2009 23 • Approximately 25% of patients who present to the emergency department with an acute exacerbation of asthma have to be hospitalized. • Based on clinical data obtained in our first emergency department-based study, patients treated with MN-221 in the emergency department may lower the hospitalization rate. 3) Reduced 3) Reduced Health Care Health Care Expenses Expenses |
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MediciNova, Inc. 2009 24 Human Human -Adrenergic Receptor -Adrenergic Receptor Selectivity Selectivity Test Drug 1 IC 50 (M) 2 IC 50 (M) 2 -Adrenoceptor Selectivity (IC 50 for 1 / IC 50 for 2 ) 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 |
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MediciNova, Inc. 2009 Effect on Heart
rate: Effect on Heart
rate: Combination of MN-221 & Albuterol Combination of MN-221 & Albuterol in Dogs in Dogs 25 |
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MediciNova, Inc. 2009 MN-221 Phase II Study Designs MN-221 Phase II Study Designs 26 CL-004 CL-005 CL-006 CL-007 Type of Asthma Mild-to-moderate Moderate-to- Severe Acute Exacerbations Acute Exacerbations FEV 1 (Entry Criteria) FEV1 60% 75% FEV1 40% FEV1 55% FEV1 50% Number Patients 23 17 29 200 Number Sites 4 4 8 ~45 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 1200 µg over 1-hr |
 MN-221-CL-004:
MN-221-CL-004:
Mean Change in FEV Mean Change in FEV 1 1 (at 15 min.) (at 15 min.) Baseline: 77.83% 77.67% 76.78% 81.60% 74.78% 75.78% 78.07% 79.78% © MediciNova, Inc. 2009 27 |
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MediciNova, Inc. 2009 MN-221-CL-005:
MN-221-CL-005:
Mean Change in FEV Mean Change in FEV 1 1 (at end of infusion) (at end of infusion) 28 Baseline: 64.57% Baseline: 69.35% Mean: Mean: 82.04% 82.04% Mean: Mean: 81.47% 81.47% Baseline: 68.64% Baseline: 68.64% |
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MediciNova, Inc. 2009 MN-221-CL-006 MN-221-CL-006 Hospitalization Rate by Treatment Group Hospitalization Rate by Treatment Group 29 MN-221 reduced the hospitalization rate by 45% |
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MediciNova, Inc. 2009 Study Design • Randomized, placebo-controlled, double-blind, multi-center clinical trial
• 200 patients with severe, acute exacerbations of asthma (FEV 1 50% predicted) at ~45 Emergency Department sites in North America, Australia, and New Zealand • Dose: • 40 µg/min for 15 minutes;13.3 µg/min for 45 minutes (1,200 µg) • Patients will receive Standard of Care (SOC) treatment in addition to adjunctive treatment with MN-221 or placebo • Primary efficacy endpoint will be improvement in FEV 1 (% predicted) at 5 hours • The study is designed to have 80% power to detect a treatment difference
of 5 percentage points in FEV1 (% predicted) when comparing MN-221 + SOC to
Placebo + SOC at a two sided -level of 0.05. MN-221-CL-007 MN-221-CL-007 30 |
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MediciNova, Inc. 2009 31 Exacerbations of Chronic Obstructive Pulmonary Disease (COPD) are a sustained worsening of the patient's condition, from the stable state and beyond normal day-to-day variations, that is acute in onset. • An estimated 10 million adults with COPD in the US 1.5 million hospital emergency department visits 726,000 hospitalizations 119,000 deaths • The direct/indirect costs related to COPD amounted to approximately $42.6 billion in 2007. MN-221: Expanded Indication – MN-221: Expanded Indication – COPD Exacerbations COPD Exacerbations COPD patients are generally more ill than asthmatics with overall higher hospitalizations and mortality. Source: CDC, CDC COPD surveillance in U.S. 2000; US Census; American Lung Association
website COPD Discharged Hospitalized 72% 28% 1,900 Asthma 52% 48% 1,500 Hospitalization rates amongst Asthma and COPD patients Thousands 726 532 |
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MediciNova, Inc. 2009 32 MN-221 MN-221 Phase II Program 2007 2007 2008 2008 2009 2009 2010 2010 1H 1H 2H 2H 1H 1H 2H 2H 1H 1H 2H 2H 1H 1H 2H 2H Acute Asthma CL-004 Dose Escalation CL-005 Prolonged Infusion CL-006 Single-Blind CL-007 Double-Blind * COPD Exacerbations To be determined MN-221 Phase II Clinical MN-221 Phase II Clinical Development Timeline Development Timeline Note: Development plans / timelines for MN-221 are subject to change *Anticipated completion dates based on current projections |
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MediciNova, Inc. 2009 33 Commercially-Attractive Commercially-Attractive Diversified Portfolio Diversified Portfolio |
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MediciNova, Inc. 2009 34 Dual Listing: • MNOV (NasdaqGM) • 4875 (Osaka – Hercules) Net Cash, Cash Equivalents and Marketable Securities: ~$40.7 million as of 6/30/09 Market cap as of 8/19/09: ~$85.5 million Shares outstanding: ~12 million Key Financials Key Financials |
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MediciNova, Inc. 2009 35 Leadership Years Experience Background Yuichi Iwaki, MD, PhD Yuichi Iwaki, MD, PhD CEO & President 33 Professor at USC, formerly Professor at University of Pittsburgh; Advisor to JAFCO, Tanabe Shintaro Shintaro Asako, CPA Asako, CPA
, CPA Chief Financial Officer 11 KPMG USA (Audit), Arthur Andersen USA Masatsune Masatsune Okajima, CMA Okajima,
CMA , CMA VP, Head of Japanese Office 17 Daiwa Securities SMBC, Sumitomo Capital Securities, Sumitomo Bank Management Team with Management Team with Global Experience Global Experience Alan Dunton, MD, PhD Alan Dunton
, MD, PhD Dunton, MD,
PhD , MD, PhD Key Consultant & Board Director 20+ CEO of Panacos & Metaphore; President of the Janssen Research Foundation, a J&J company. |
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MediciNova, Inc. 2009 36 MN-221 (Exacerbations of Asthma/COPD Exacerbations): • Proven mechanism of action • Highly selective with improved safety profile vs. standard of care • Positive Phase II efficacy and safety data for Acute Exacerbations of Asthma • Phase II study ongoing for Acute Exacerbations of Asthma 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 • Enhanced value with anticipated addition of Avigen’s AV-411 data package Minimized Burn Rate: • Annual burn rate reduced compared to previous years as a result of focus
on MN-166 and
MN-221 development programs • ~$40.7 million net Cash, Cash Equivalents and Marketable Securities as of 6/30/09
Investment Highlights Investment Highlights |
 Addendum:
Addendum: Additional Information • Avigen Transaction • MN-221 Data • MN-166 Data |
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MediciNova, Inc. 2009 38 Other potential benefits that may accrue should Avigen’s shareholders elect to take convertible notes as merger consideration and subsequently convert these notes: • Increased liquidity in the U.S. markets: • Presuming that 100% of Avigen’s shareholders elect to receive convertible notes and convert such notes, MediciNova’s publicly held shares would increase by approximately 45%. Assuming that average daily volume of MediciNova’s shares traded increases commensurately, the range of potential investors would be expected to expand with the increased liquidity and market capitalization. • Using the conversion price of $6.80 and assuming 100% conversion into MediciNova shares, MediciNova’s post-transaction market capitalization would have been approximately $119 million as of 8/19/2009. • Effective share issuance at the market: • MediciNova effectively will have raised capital without payment of offering expenses and underwriting commissions, which are typically 15% in many small/micro-cap companies. • A conversion price of $6.80 and a 15% average discount yields savings of approximately $1.02 per MediciNova share. Once again, assuming 100% of Avigen’s shareholders elect to receive convertible notes and convert such notes, this could represent a savings of approximately $6.0 million from a marketed offering of MediciNova shares. Other Potential Value from Other Potential Value from Avigen Avigen Transaction Transaction |
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MediciNova, Inc. 2009 Study Design • Randomized, placebo-controlled, double-blind, dose escalation study • 23 subjects with mild-to-moderate stable asthma (FEV 1 60% predicted) at 4 sites • Patients are randomized to one of four different treatment groups (25% of patients on placebo for every dose level) • Each treatment sequence consist of placebo and escalating doses of MN-221 (0.35µg/min, 1.0 µg/min, 3.5µg/min, 10µg/min, 16µg/min,
30µg/min, 60µg/min) for 15 minutes • Primary endpoint - mean change in FEV 1 (forced expiratory volume in 1 second) from baseline at 15 minutes (the end of the infusion) • Outcome measures – inferential statistics – FEV 1 , pharmacokinetic (pk), safety and tolerability MN-221-CL-004 MN-221-CL-004 39 |
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MediciNova, Inc. 2009 Eligible subjects were randomly assigned in a 1:1:1:1 ratio to 1 of 4 dose escalation treatment sequences: MN-221-CL-004:
MN-221-CL-004:
Dose Treatment Groups
Dose Treatment Groups 40 Group A Group B Group C Group D Visit 2 Placebo 0.35 µg/min for 15 minutes 0.35 µg/min for 15 minutes 0.35 µg/min for 15 minutes Visit 3 1.0 µg/min for 15 minutes Placebo 1.0 µg/min for 15 minutes 1.0 µg/min for 15 minutes Visit 4 3.5 µg/min for 15 minutes 3.5 µg/min for 15 minutes Placebo 3.5 µg/min for 15 minutes Visit 5 10 µg/min for 15 minutes 10 µg/min for 15 minutes 10 µg/min for 15 minutes Placebo Visit 6 Placebo 16 µg/min for 15 minutes 16 µg/min for 15 minutes 16 µg/min for 15 minutes Visit 7 30 µg/min for 15 minutes Placebo 30 µg/min for 15 minutes 30 µg/min for 15 minutes Visit 8 60 µg/min for 15 minutes 60 µg/min for 15 minutes Placebo 60 µg/min for 15 minutes |
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MediciNova, Inc. 2009 Study Design • Randomized, placebo-controlled, single-blind, dose rate escalation study • 17 subjects with moderate-to-severe stable asthma (FEV 1 40%, but = 75% predicted) at 4 sites • Doses: • 16 µg/min for 15 minutes followed by 8 µg/min for 105
minutes (2-hour infusion with a total dose of 1,080
µg) or placebo • 30 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 • Outcome measures – descriptive statistics only – FEV 1 , pk, safety MN-221-CL-005 MN-221-CL-005 41 |
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MediciNova, Inc. 2009 Study Design • Randomized, placebo-controlled, modified single-blind, dose escalation study • 29 patients with acute exacerbations of asthma (FEV 1 = 55% predicted) at 8 Emergency Department sites • Doses: • 16 µg/min for 15 minutes (240 µg) • 30 µg/min for 15 minutes (450 µg) • 16 µg/min for 15 minutes; 8 µg/min for 105 minutes (1,080 µg) • Patients received Standard of Care (SOC) treatment in addition to adjunctive treatment with MN-221 or placebo • Outcome measures – descriptive statistics only – FEV 1 , pk, safety MN-221-CL-006 MN-221-CL-006 42 |
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MediciNova, Inc. 2009 MN-221 Safety Summary MN-221 Safety Summary Phase II Study Safety Findings: • No clinically significant cardiovascular, ECG, or vital sign changes, or other safety concerns, observed at doses up to 3840 micrograms in 4 hours. Safety Database: • MN-221 has been tested in almost 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 for a total of 3840 micrograms, and at lower doses for up to 24 hours 43 |
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MediciNova, Inc. 2009 Brain volume changes are linked to axonal loss 44 MN-166 - MN-166 - Chronic Efficacy Chronic Efficacy Demonstrated: Effects on Brain Volume Demonstrated: Effects on Brain Volume 1.20 |
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MediciNova, Inc. 2009 Reduction of Persistent Black Hole (PBH) Formation Parameter Treatment Groups Placebo 30 mg/day 60 mg/day # Patients w. New Lesions at Month 2 72 64 56 # 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 MN-166 - MN-166 - Reduction of Persistent Black Hole Reduction of Persistent Black Hole (PBH) Formation, a Sign of Axonal Loss (PBH) Formation, a Sign of Axonal Loss 45 |
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MediciNova, Inc. 2009 Approx. Sales 2008** Compound Sponsor Side Effects $2.3 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 $2.2 Billion Avonex® Biogen-Idec Depression and flu-like symptoms most common, also liver injury, severe allergic reactions, drop in red/white blood cell count $1.9 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 $1.6 Billion Betaseron® Bayer Lymphopenia, injection site reaction, asthenia, flu-like symptoms are most common, also necrosis at injection site $589 Million Tysabri® Biogen-Idec Infections, depression, pneumonia, acute hypersensitivity reactions, appendicitis most common, also liver damage, PML Multiple Sclerosis Market* Multiple Sclerosis Market* 46 *All these top selling drugs for MS are immunomodulators **Source: Company annual reports 2008 |
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MediciNova, Inc. 2009 47 •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 MN-166 Overview-Safety |
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MediciNova, Inc. 2009 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 GI disorders Liver enzymes Laquinimod Teva Phase III Liver enzymes Arthralgia Fibrinogen Hemoglobin MN-166 Safety Comparison MN-166 Safety Comparison with Other Oral Agents with Other Oral Agents 48 |