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): March 1, 2005
MEDICINOVA, INC.
(Exact name of registrant as specified in its charter)
| Delaware | 000-51133 | 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 8.01 Other Events.
On March 1, 2005, MediciNova, Inc. announced the start of a Phase II clinical trial with MN-305, a novel anti-anxiety agent.
Attached as Exhibit 99.1 hereto and incorporated herein by reference in its entirety is the press release issued by MediciNova, Inc. on March 1, 2005.
Item 9.01 Financial Statements and Exhibits.
| (c) | Exhibits. |
| Exhibit |
Description | |
| 99.1 | Press Release dated March 1, 2005. |
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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.
Dated: March 1, 2005.
| MEDICINOVA, INC. | ||||
| By: |
/s/ Takashi Kiyoizumi | |||
| Takashi Kiyoizumi, M.D., Ph.D. | ||||
| President and Chief Executive Officer | ||||
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EXHIBIT INDEX
| Exhibit No. |
Description | |
| 99.1 | Press Release dated March 1, 2005. |
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Exhibit 99.1
FOR IMMEDIATE RELEASE
MediciNova Announces the Start of a Phase II Clinical Trial with Novel Anti-Anxiety Agent
Specialty Pharmaceutical Company Embarks on Ambitious Clinical Program
SAN DIEGO, Calif. – March 1, 2005 — MediciNova, Inc., a specialty pharmaceutical company that is publicly traded on the Hercules Market of the Osaka Securities Exchange, today announced the enrollment of patients in a Phase II clinical study with MN-305, a novel anti-anxiety agent that was licensed in 2004 from Mitsubishi Pharma Corporation of Osaka, Japan. MN-305 is described as a serotonin type 1A receptor agonist, and based on preclinical and earlier clinical studies, appears to hold the potential for rapid onset of anti-anxiety effect combined with excellent tolerability.
Under the licensing agreement with Mitsubishi, MediciNova obtained exclusive worldwide rights, except for Japan, China, Taiwan, South Korea and other parts of Southeast Asia, to develop and commercialize MN-305. MediciNova has chosen to initiate the clinical development of MN-305 for generalized anxiety disorder, which, according to the National Institute of Mental Health, afflicts more than 4 million adult Americans.
“This study signals the beginning of a very ambitious clinical development undertaking for MediciNova during 2005,” commented Richard Gammans, Ph.D., Executive Vice President, Clinical Research at MediciNova. “We plan to enroll 400 patients at 15 sites in the U.S. in this study with MN-305, and before the end of this year we hope to initiate four additional Phase II clinical studies with other compounds in the Company’s portfolio, including potential new treatments for asthma, multiple sclerosis, interstitial cystitis, and premature labor.”
About MediciNova
MediciNova, Inc. is a publicly traded specialty pharmaceutical company focused on accelerating the global development and commercialization of innovative pharmaceutical products. MediciNova’s pipeline, which includes several compounds in clinical testing, targets a variety of prevalent medical conditions, including premature labor, cancer, asthma, multiple sclerosis and anxiety disorders. For more information on MediciNova Inc., please visit www.medicinova.com.
This press release may contain “forward looking statements” as defined by the Securities and Exchange Commission. All statements, other than statements of historical facts, included in this press release that address activities, events or developments that the Company expects, believes or anticipates will or may occur in the future are forward-looking statements. These statements are based on certain assumptions made by the Company based on management’s experience and perception of historical trends, current conditions, expected future developments and other factors it believes are appropriate in the circumstances. Such statements are subject to a number of assumptions, risks and uncertainties, many of which are beyond the control of the Company, which may cause the Company’s actual results to differ materially from those implied or expressed by the forward-looking statements. These risks include the risk factors detailed in MediciNova’s Securities and Exchange Commission filings.