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)

 

May 16, 2006

 


 

VIVUS, INC.

(Exact name of registrant as specified in its charter)

 

Delaware

 

000-23490

 

94-3136179

(State or other jurisdiction of

 

(Commission File Number)

 

(IRS Employer

incorporation)

 

 

 

Identification No.)

 

1172 CASTRO STREET

MOUNTAIN VIEW, CA 94040

(Address of principal executive offices, including zip code)

 

(650) 934-5200

(Registrant’s telephone number, including area code)

 

N/A

(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):

 

o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

o 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 May 16, 2006, VIVUS, Inc. issued a press release titled “VIVUS to Host Analyst Day Webcast on Thursday, May 18th”. A copy of the press release is attached hereto as Exhibit 99.1.

 

The information in this Form 8-K and the exhibit attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference into any of the Registrant’s filings under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in any such filing.

 

Item 9.01.  Financial Statements and Exhibits

 

(d)  Exhibits.

 

Exhibit No.

 

Description

 

 

 

99.1

 

Press Release dated May 16, 2006

 

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.

 

 

 
 
VIVUS, INC.

 

 

 

 

By:

/s/ Timothy E. Morris

 

 

 

Timothy E. Morris
Vice President and Chief Financial Officer

 

Date:  May 17, 2006

 

3



 

EXHIBIT INDEX

 

Exhibit No.

 

Description

 

 

 

99.1

 

Press Release dated May 16, 2006

 

 

4


Exhibit 99.1

 

 

CONTACT:

 

VIVUS, Inc.

Vida Communication

Timothy E. Morris

Stephanie Diaz & Tim Brons

Chief Financial Officer

415-675-7400

650-934-5200

 

 

 

FOR IMMEDIATE RELEASE

 

VIVUS to Host Analyst Day Webcast on Thursday, May 18th

 

MOUNTAIN VIEW, Calif., May 16, 2006 – VIVUS, Inc. (NASDAQ: VVUS), a pharmaceutical company dedicated to the development and commercialization of novel therapeutic products addressing obesity and sexual health, today announced that it will host a webcast of the company’s Analyst Day meeting on Thursday, May 18th from 12:00 p.m. to 2:30 p.m. (EDT).

 

During the Analyst Day program, VIVUS management and clinical investigators will provide a detailed update on all product programs including:

 

                  Qnexa – Presentation of positive Phase 2 data and discussion of the obesity market by Dr. Thomas Najarian, a leading obesity expert and inventor of Qnexa, as well as by VIVUS management

 

                  Evamist - Presentation of positive Phase 3 data by Dr. John Buster, Professor, Baylor College of Medicine, and principal investigator for Evamist trial

 

                  ALISTA - - Presentation of data from Phase 2B program for the treatment of Female Sexual Arousal Disorder (FSAD) by Dr. Marc C. Gittelman, Executive & Clinical Director, South Florida Medical Research, a leading expert in sexual health and investigator for ALISTA trial

 

                  Testosterone MDTS® - Presentation of data from completed Phase 2 program for the treatment of Hypoactive Sexual Desire Disorder (HSDD) also by Dr. John Buster

 

                  Avanafil - Presentation of data from completed Phase 2 program for the treatment of Erectile Dysfunction (ED) also by Dr. Marc Gittelman

 

 

VIVUS, Inc. 1172 Castro Street, Mountain View, CA 94040   Tel 650-934-5200   Fax 650-934-5389  www.vivus.com

 



 

Analyst Day Webcast:

 

A live webcast and 30-day archive of the Analyst Day event can be accessed at www.vivus.com.

 

About VIVUS

 

VIVUS Inc. is a pharmaceutical company dedicated to the development and commercialization of next-generation therapeutic products addressing obesity and sexual health. VIVUS has four products that are positioned to enter Phase 3 clinical trials, and one product that has completed Phase 3 evaluation, for which an NDA is anticipated to be submitted to the U.S. Food and Drug Administration (FDA) in late 2006. The pipeline includes: Qnexa™, for which a Phase 2 study has been completed for the treatment of obesity; ALISTA™, for which a Phase 2B program is ongoing for the treatment of Female Sexual Arousal Disorder (FSAD); Testosterone MDTS®, for which a Phase 2 program has been completed for the treatment of Hypoactive Sexual Desire Disorder (HSDD); Evamist™, for which a Phase 3 program has been completed for the treatment of menopausal symptoms; avanafil, for which a Phase 2 program has been completed for the treatment of erectile dysfunction (ED); and, MUSE®, which is approved and currently on the market for the treatment of ED. For more information on clinical trials and products, please visit the company’s web site at www.vivus.com.

 

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend,” among others. These forward-looking statements are based on VIVUS’ current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; uncertainties of patent protection and litigation; uncertainties of government or third party payer reimbursement; reliance on sole source suppliers; limited sales and marketing efforts and dependence upon third parties; risks related to the development of innovative products; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that future clinical studies discussed in this press release will be completed or successful or that any product will receive regulatory approval for any indication or prove to be commercially successful. VIVUS does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in VIVUS’ Form 10-K for the year ended December 31, 2005 and periodic reports filed with the Securities and Exchange Commission.

 

# # #