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)

January 9, 2008

 

 

VIVUS, INC.

(Exact name of registrant as specified in its charter)

 

 

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 January 9, 2008, VIVUS, Inc. issued a press release titled “VIVUS Initiates Extension Study with Qnexa for Diabetes.”  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 January 9, 2008

 

 

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:  January 10, 2008

 

 

3

 

EXHIBIT INDEX

 

Exhibit No.		Description
99.1		Press Release dated January 9, 2008

 

 

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 EXTENSION STUDY WITH QNEXA FOR DIABETES

 

Patients in Current Diabetes Study to Continue for an Additional 6 Months

 

Mountain View, Calif, January 9, 2008 — VIVUS, Inc (NASDAQ: VVUS) a pharmaceutical company dedicated to the development and commercialization of novel therapeutic products, today announced it has initiated a six-month extension study for patients currently enrolled in the OB-202 diabetes study.  The OB-202 study is a 28 week, randomized, double blind, placebo controlled, efficacy and safety study of Qnexa in the glycemic management of obese Type 2 diabetics.  The newly initiated study, DM-230, will allow subjects to continue, in a blinded fashion as randomized, in the study for an additional 28 weeks.

 

The primary endpoint of the studies will be improvement of glycemic control as measured by a reduction of glycosylated hemoglobin (HbA1c) levels.  The randomized, double-blind, parallel-designed study will also measure the effects of Qnexa on associated metabolic and cardiovascular risk factors as well as changes in total body weight, percent of baseline body weight lost, and a change in waist circumference.  The OB-202 study will measure endpoints at the end of 28 weeks.  The DM-230 study will measure endpoints after an additional 28 weeks (for a total time on treatment of one year).

 

Both studies are intended to assess both safety and efficacy of Qnexa in subjects with type 2 diabetes controlled with diet or oral medications.  Subjects have a Body Mass Index (BMI) between 27 to 42 kg/m2.  Patients on antidepressants such as SSRI’s or SNRI’s are allowed to participate in the study.  The trials involve 10 centers nationwide.  VIVUS has enrolled 210 subjects in the OB-202 study.   As subjects complete the first 28 weeks of treatment they will roll over into the DM-230 study.   Please see http://www.clinicaltrials.gov for more information.

 

 

 

“The results from a retrospective uncontrolled review of diabetic patients in private practice conducted by the inventor, revealed good improvement in glycemic control, as measured by reduction HbA1c.  Patients were also able to reduce the dose and the number of medications used in the treatment of their type 2 diabetes.  In June 2007, we initiated a phase 2 study in diabetes with Qnexa to confirm these results,” commented Peter Tam, senior vice president of product and corporate development.  “The extension study, DM-230, will allow us to see the impact of Qnexa for a full year of treatment on diabetes as a whole.  Patients with type 2 diabetes typically have numerous co-morbidities and are on several medications.  Treating these patients is complicated and requires constant monitoring.  We are hopeful Qnexa will help these patients improve glycemic control while losing weight and controlling their co-morbidities.”

 

Data from the OB-202 study is expected to be available in the second quarter of 2008.

 

About Type 2 Diabetes

 

Diabetes afflicts more than 18 million people in the United States. It is the main cause of kidney failure, limb amputations, and new onset blindness in adults and a major cause of heart disease and stroke. Type 2 diabetes accounts for up to 95 percent of all diabetes cases. Most common in adults over age 40, type 2 diabetes affects 8 percent of the U.S. population age 20 and older. It is strongly associated with obesity (more than 80 percent of people with type 2 diabetes are overweight), inactivity, family history of diabetes, and racial or ethnic background. The prevalence of type 2 diabetes has tripled in the last 30 years, and much of the increase is due to the dramatic upsurge in obesity. People with a BMI of 30 or greater have a five-fold greater risk of diabetes than people with a normal BMI of 25 or less.

 

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 and phase 2 for the treatment of type 2 diabetes; 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). For more information on clinical trials and products, please visit the company’s web site at http://www.vivus.com.

 

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