Form 8-K

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 14, 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 14, 2005, MediciNova, Inc. announced the enrollment of patients in a Phase I clinical study with MN-221 in the United States, a novel agent for the management of preterm labor that was licensed in 2004 from Kissei Pharmaceutical Co. Ltd. of Nagano, Japan.

 

Attached as Exhibit 99.1 hereto and incorporated herein by reference in its entirety is the press release issued by MediciNova on March 14, 2005.

 

Item 9.01 Financial Statements and Exhibits.

 

(c) Exhibits.

 

Exhibit

 

Description


99.1   Press Release dated March 14, 2005.

 

2


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 14, 2005.

 

MEDICINOVA, INC.
By:  

/s/ Takashi Kiyoizumi


    Takashi Kiyoizumi, M.D., Ph.D.
    President and Chief Executive Officer

 

3


EXHIBIT INDEX

 

Exhibit No.

 

Description


99.1   Press Release dated March 14, 2005.

 

4

Press Release

Exhibit 99.1

 

LOGO  

CONTACT: Brian Anderson

MediciNova, Inc.

Phone: 858-622-9752

Email: banderson@medicinova.com

 

FOR IMMEDIATE RELEASE

 

MediciNova Initiates a Phase I Clinical Trial with MN-221 – a New Agent for

the Management of Preterm Labor

 

SAN DIEGO, Calif. – March 14, 2005 — MediciNova, Inc., (Code number: 4875, OSE Hercules Market) a specialty pharmaceutical company that is publicly traded on the Hercules Market of the Osaka Securities Exchange announced the enrollment of patients in a Phase I clinical study with MN-221 in the United States, a novel agent for the management of preterm labor that was licensed in 2004 from Kissei Pharmaceutical Co. Ltd. of Nagano, Japan. MN-221 is described as a selective beta-2 agonist, and based on preclinical and earlier clinical studies conducted by Kissei in Europe and Japan, MediciNova believes MN-221 has shown potential in preclinical and earlier clinical studies to delay premature delivery of infants due the early onset of labor in expectant mothers.

 

Under the licensing agreement with Kissei, MediciNova obtained exclusive worldwide rights, except for Japan, to develop and commercialize MN-221.

 

“According to the March of Dimes, one in eight infants in the United States is born before term. Premature babies are at a higher risk of needing hospitalization and having long-term health problems,” commented Richard Gammans, Ph.D., Executive Vice President, Clinical Research at MediciNova. “We are hopeful that the current Phase I clinical study will help to identify the appropriate dosing level and provide additional safety information for MN-221 before we proceed to the next stage of evaluation. It is worth noting that there are no FDA-approved drugs for the management of preterm labor and that there may be the opportunity with MN-221 to address a major unmet medical need.”


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.