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)

 

November 16, 2007

 


 

VIVUS, INC.

(Exact name of registrant as specified in its charter)

 

Delaware

 

000-23490

 

94-3136179

(State or other jurisdiction of
incorporation)

 

(Commission File Number)

 

(IRS Employer
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 November 16, 2007, the Company issued a press release titled “VIVUS Initiates Second Qnexa Pivotal Phase 3 Trial in Obese Patients.” 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 November 16, 2007

 

 

 

 

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/ Lee B. Perry

 

 

 

Lee B. Perry

 

 

Vice President and Chief Accounting Officer

 

Date: November 20, 2007

 

3



 

EXHIBIT INDEX

 

Exhibit No.

 

Description

 

 

 

99.1

 

Press release dated November 16, 2007

 

 

 

 

4


Exhibit 99.1

 

 

CONTACT:

 

VIVUS, Inc.

 

Trout Group

Timothy E. Morris

 

Ian Clements (SF) 415-392-3385

Chief Financial Officer

 

Brian Korb (NYC) 646-378-2923

650-934-5200

 

 

 

 

FOR IMMEDIATE RELEASE

 

 

VIVUS INITIATES SECOND QNEXA PIVOTAL PHASE 3 TRIAL IN OBESE PATIENTS

 

CONQUER trial to study impact of Qnexa in overweight and obese patients with comorbidities

 

Mountain View, Calif, November 16, 2007— VIVUS, Inc. (NASDAQ: VVUS), a pharmaceutical company dedicated to the development and commercialization of novel therapeutic products, today announced that it has initiated the second of two pivotal phase 3 studies of its investigational drug, Qnexa, in overweight and obese patients with comorbidities including hypertension, dyslipidemia, or type 2 diabetes.  The CONQUER study (OB-303) will enroll patients with a Body Mass Index (“BMI”) ranging from 27 to 45, including patients with type 2 diabetes regardless of BMI.  The co-primary endpoints for these studies will evaluate the differences between treatments from baseline to the end of the treatment period, in mean percent weight loss and in the percentage of subjects achieving weight loss of 5% or more.

 

“The initiation of the second phase 3 study of Qnexa completes the requirements for the pivotal studies,” commented Leland Wilson, president and chief executive officer of VIVUS.  “Overweight and obese patients with hypertension, type 2 diabetes or dyslipidemia are at serious risk for increased cardiovascular disease.  This study will enroll obese patients that have serious metabolic comorbidities that cannot be controlled with diet and exercise alone.”

 

“Qnexa is a potentially important new treatment alternative for obese patients who are coping with serious weight-related medical conditions.  Current treatments for obesity do not cause sufficient weight loss to cause a clinically meaningful reduction in these comorbidities. In the phase 2 studies, patients treated with Qnexa were able to achieve the level of weight loss, and improvement in lipids, blood pressure and other risk factors that suggest a substantial potential for benefit in the CONQUER study,” said Dr. Arthur

 



 

Frank, chairman of the Qnexa scientific advisory board for VIVUS.   “Given the urgency of the need to treat the obesity epidemic, and the sensitivity of the FDA, the medical profession and the public for safe and effective medications, it will be critically important to demonstrate not only a significant reduction in weight, but also an associated improvement in these often life-threatening comorbidities.  VIVUS has done an excellent job in designing a study to meet these objectives,” said Dr. Frank.

 

About the CONQUER study

 

The CONQUER study will enroll approximately 2,500 subjects in up to 120 centers.  Patients will undergo a 4-week dose escalation period followed by 52 weeks of treatment.  The study is a randomized, double-blind, placebo-controlled prospective trial with subjects randomized to receive once-a-day treatment with mid-dose Qnexa (7.5 mg phentermine/46 mg topiramate) or full strength Qnexa (15 mg phentermine/92 mg topiramate) or placebo.  Randomization will be stratified by gender and diabetic status, and at least 20% of the subjects will be male. Approximately 2,500 subjects will be treated under the protocol, with 1,000 subjects randomized to placebo, 500 to mid-dose Qnexa and 1,000 to full strength Qnexa. At randomization, subjects will be instructed to follow a hypocaloric diet representing a 500-calorie/day deficit and advised to implement a lifestyle modification program throughout the study period.  VIVUS has completed the Special Protocol Assessment (“SPA”) process for this trial with the U.S. Food and Drug Administration (FDA).  Under the SPA process, the company and the FDA have reached agreement on study design features that will be employed throughout the entire phase 3 program, including the co-primary endpoints of the study, scope and size of the patient population, specific safety assessments, inclusion/exclusion criteria, duration of the trials and the statistical method for analyzing the co-primary study endpoints.  More information about the trial can be found at www.clinicaltrials.gov.

 

About a Special Protocol Assessment

 

A Special Protocol Assessment is a regulatory procedure by which the FDA can provide advice on the current thinking at the FDA regarding the evaluation of issues related to the adequacy (e.g., design, conduct, analysis) of certain proposed studies associated with the development of products in human drug applications as defined in section 735(1) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 379g(1)) (PDUFA products). The advice given by the FDA is not binding. For more information about the Agency’s Special Protocol Assessment process see http://www.fda.gov/cder/guidance/3764fnl.htm.

 

About VIVUS

 

VIVUS, Inc. is a pharmaceutical company dedicated to the development and commercialization of novel therapeutic products. The current portfolio includes investigational products addressing obesity and sexual health. The pipeline includes: Qnexa™, which is in phase 3 for the treatment of obesity; Testosterone MDTS®, for which a phase 2 study has been completed for the treatment of Hypoactive Sexual Desire Disorder (HSDD); and avanafil, for which a phase 2 study has been completed for the

 



 

treatment of erectile dysfunction (ED). MUSE® 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 http://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, 2006 and periodic reports filed with the Securities and Exchange Commission.