Additional Data from the Qnexa Phase 3 Studies Presented at The Obesity Society 27th Annual Scientific Meeting

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Thu Oct 29, 2009 5:40pm EDT

Additional Data from the Qnexa Phase 3 Studies Presented at The Obesity
Society 27th Annual Scientific Meeting
Results Support Qnexa's Overall Efficacy and Safety Profile; Company on Track
for NDA Filing By End of 2009

MOUNTAIN VIEW, Calif., Oct. 29 /PRNewswire-FirstCall/ -- VIVUS, Inc. (Nasdaq:
VVUS) today announced that additional data on Qnexa(TM), an investigational
drug candidate for obesity, was presented at the 27th annual scientific
meeting of The Obesity Society (TOS) in Washington D.C.  Wesley W. Day, PhD,
vice president of clinical development at VIVUS, presented the additional data
from the company's two year-long phase 3 obesity trials during the
Pharmacotherapy Update portion of the pre-conference on October 24, 2009.
Top-line results from the phase 3 studies were previously reported in
September 2009.  The presentation included data from the EQUIP (OB-302) and
CONQUER (OB-303) studies that further supports the safety and efficacy profile
of Qnexa.

The additional efficacy data from the EQUIP study that was presented included
weight loss by BMI category, on an intent-to-treat, last observation carried
forward (ITT-LOCF) basis for full dose Qnexa.


                     Percent Weight Loss (ITT-LOCF)
                     ------------------------------

    Baseline BMI                Placebo             Full Dose Qnexa
    ------------                -------             ---------------
    >35-40                        1.8%                    10.7%
    >40-45                        1.3%                    11.1%
    >45-50                        1.0%                    11.8%
    >50                           2.0%                    10.3%


"The EQUIP study was designed to look at the effect of Qnexa on morbidly obese
patients, that is, those patients with a baseline BMI of 35 or greater.  The
average baseline BMI in the EQUIP study was 42.1.  A review of results by
baseline BMI show a consistent effect across a broad range of patients based
on starting body weight," stated Wesley W. Day. "On an ITT-LOCF basis, the
overall percent weight loss in the EQUIP study was 11% for patients on full
dose Qnexa, as compared to 1.6% for the placebo group."

Also included in the presentation were discontinuation rates for cognitive
events.  Overall, these rates were low and the events were generally mild to
moderate and reversible with discontinuation of treatment.  There was one
severe event in the treatment arm and one in the placebo arm that led to
discontinuation. Specifically, the discontinuation rates for various
cognitive-related events were as follows:



    % of Patients             EQUIP (n=1,264)           CONQUER (n=2,485)
    -------------       ------------------------    -------------------------
    MedDRA Preferred               Qnexa   Qnexa               Qnexa    Qnexa
     Terms              Placebo     Low     Full    Placebo     Mid     Full
    ----------------    -------    -----   -----    -------    -----    -----
    Disturbance in
     Attention             0.4%     0.0%     1.4%      0.1%     0.0%     0.7%
    Memory Impairment      0.0%     0.0%     0.0%      0.1%     0.0%     0.5%
    Amnesia
     (forgetfulness)       0.2%     0.0%     0.6%      0.0%     0.2%     0.3%
    Aphasia (word
     finding
     difficulties)         0.0%     0.0%     0.2%      0.0%     0.0%     0.3%
    Cognitive Disorder     0.2%     0.0%     0.0%      0.0%     0.0%     0.2%
    Confusional State      0.0%     0.4%     0.2%      0.1%     0.2%     0.1%
    Bradyphrenia
     (slow thinking)       0.0%     0.0%     0.2%      0.0%     0.0%     0.0%
    Disorientation         0.0%     0.0%     0.0%      0.0%     0.0%     0.0%
    Mental Impairment      0.0%     0.0%     0.0%      0.0%     0.0%     0.0%

    Events are not additive as some patients have reported more than one event
    leading to study drug discontinuation.


Consistent with standard scientific and regulatory methodologies, these
infrequent events that lead to study drug discontinuation were pooled by dose
across all one-year studies in an effort to provide a more accurate estimation
of the incidence of each event.   This pooled analysis, presented in
September, which is a part of the Integrated Summary of Safety (ISS) in the
Qnexa NDA, demonstrates that the discontinuation rates for these various
cognitive-related events were low and all occurred at a frequency of less than
1%.  Specifically, the discontinuation rates from the ISS due to cognitive
events from the year-long Qnexa studies (OB-302, OB-303 and OB-202/DM-230)
were:



    MedDRA Preferred Terms             Qnexa    Qnexa    Qnexa    Qnexa All
                            Placebo     Low      Mid      Full     doses
                           (n=1,561)  (n=240)  (n=498) (n=1,580)  (n=2,318)
                            -------    -----    -----   -------    -------
    Disturbance in
     Attention               0.2%       0.0%     0.0%     0.9%       0.6%
    Memory Impairment        0.1%       0.0%     0.0%     0.3%       0.2%
    Amnesia (forgetfulness)  0.1%       0.0%     0.2%     0.4%       0.3%
    Aphasia (word finding
     difficulties)           0.0%       0.0%     0.0%     0.3%       0.2%
    Cognitive Disorder       0.1%       0.0%     0.0%     0.1%       0.1%
    Confusional State        0.1%       0.4%     0.2%     0.1%       0.2%
    Bradyphrenia (slow
     thinking)               0.0%       0.0%     0.0%     0.1%       0.0%
    Disorientation           0.0%       0.0%     0.0%     0.0%       0.0%
    Mental Impairment        0.0%       0.0%     0.0%     0.0%       0.0%

    Events are not additive as some patients have reported more than one
    event leading to study drug discontinuation


Of the events shown in the table above, the most frequent reason for patients
discontinuing Qnexa was disturbance in attention.  For the 1,580 patients
receiving full dose Qnexa, the discontinuation rate for this event was 0.9%. 
This rate is considerably lower than the similar event rates reported in the
Topamax® (topiramate) label.

The label for Topamax for the prevention of migraine includes a
discontinuation rate due to disturbance in attention of 3%.  In addition,
discontinuation rates for attention in a published study on topiramate
monotherapy were 3% to 4% for doses from 96 to 192 mg (Wilding, et. al.,
International Journal of Obesity).

The clinical relevance of the effect of Qnexa on cognitive function is low, as
demonstrated by the results from a prospective evaluation of cognitive
function using RBANS (Repeatable Battery for the Assessment of
Neuropsychological Status), a validated tool administered during previous
clinical studies of Qnexa (OB-301 and DM-202/DM-230).  Dr. Christopher
Randolph, clinical professor at Loyola University Medical School in Maywood,
Ill., the developer of the RBANS instrument and an expert in the assessment of
cognitive function, reviewed the results of the RBANS studies.  Dr. Randolph
commented, "My overall impression from the RBANS data is that Qnexa at the
doses tested does not appear to produce a clinically significant change in
cognitive function in this patient population."

"Qnexa is a proprietary formulation of controlled release topiramate and
phentermine.  As evidenced by the high retention and low dropout rates in the
pivotal trials, we believe the reduced Cmax of topiramate, in the presence of
phentermine, has a beneficial net effect on centrally mediated adverse events
such as attention, as compared to commercially available topiramate
formulations," stated Wesley Day, vice president of clinical development of
VIVUS.

"The integrated safety summary for the year-long studies showed that
discontinuation rates due to cognitive side effects were minimal as no MedDRA
preferred term associated with cognitive effects resulted in discontinuation
in more than 1% of subjects.   Previous studies of topiramate monotherapy have
discontinuation rates for disturbance in attention that were at least three
times greater than what was observed in our studies.  These results were
consistent with the expected profile and previous experience of Qnexa in our
studies," stated Leland Wilson, president and chief executive officer of
VIVUS.  "We believe this additional data further substantiates the safety
profile of Qnexa.  Taken in the context of the statistically significant
weight loss and improvement on co-morbidities, Qnexa has a positive
benefit/risk profile.  Completion rates for patients on Qnexa were
significantly better as compared to placebo in the phase 3 trials.  We believe
the overall efficacy and safety profile of Qnexa supports approvability."

The company anticipates filing the NDA for Qnexa by the end of 2009.

Previously reported highlights from the EQUIP and CONQUER studies were
included in the presentation:
    --  Average weight loss of 14.7% (37 lbs) was achieved by patients treated
        with Qnexa for 56 weeks in the EQUIP study;
    --  Significant improvements in cardiovascular, metabolic and inflammatory
        risk factors among patients treated with Qnexa;
    --  FDA efficacy benchmarks for weight loss agents were exceeded at all
        three doses of Qnexa tested in the clinical program; and
    --  Completion rates up to 69% were significantly higher than placebo at
all
        three doses of Qnexa, indicating favorable tolerability.
    --  Across both 56-week studies, the most commonly reported side effects
        were dry mouth, tingling, constipation, altered taste and insomnia.

    --  There were no serious adverse events reported for cognitive disorders.


EQUIP (OB-302) Study Overview

The EQUIP study included 1,267 morbidly obese patients (1,050 females and 217
males) across 93 centers in the United States. The average baseline BMI of the
study population was 42.1 kg/m(2) and baseline weight was 256 pounds. 
Patients had a 4-week dose titration period followed by 52 weeks of treatment.
The study was a randomized, double-blind, placebo-controlled, 3-arm,
prospective trial with patients randomized to receive once-a-day treatment
with low-dose Qnexa, full-dose Qnexa or placebo. Patients were asked to follow
a hypocaloric diet representing a 500-calorie/day deficit and advised to
implement a simple lifestyle modification program.

CONQUER (OB-303) Study Overview

The CONQUER study included 2,487 overweight and obese patients (1,737 females
and 750 males) with high blood pressure, high cholesterol or type 2 diabetes
across 93 centers in the United States. The average baseline BMI of the study
population was 36.6 kg/ m(2) and baseline weight was 227 pounds. Patients had
a 4-week dose titration period followed by 52 weeks of treatment. The study
was a randomized, double-blind, placebo-controlled, 3-arm, prospective trial
with patients randomized to receive once-a-day treatment with mid-dose Qnexa,
full-dose Qnexa or placebo. Patients were asked to follow a hypocaloric diet
representing a 500-calorie/day deficit and advised to implement a simple
lifestyle modification program.

About Qnexa 

Qnexa (Q-NEX-uh) is an investigational drug being developed to address weight
loss.  Qnexa is a once-a-day, proprietary, oral, controlled-release
formulation of low dose phentermine and topiramate, which is believed to
address both appetite and satiety - the two main mechanisms that impact eating
behavior - in one capsule. In phase 2 and 3 clinical data to date, Qnexa has
demonstrated significant weight loss, glycemic control, and improvement in
cardiovascular risk factors.

About VIVUS 

VIVUS is a biopharmaceutical company developing innovative, next-generation
therapies to address unmet needs in obesity, diabetes and sexual health. The
company's lead product in clinical development, Qnexa(TM), has recently
completed phase 3 clinical trials for the treatment of obesity. Qnexa is also
in phase 2 clinical development for the treatment of type 2 diabetes. In the
area of sexual health, VIVUS is in phase 3 development with avanafil, a
potentially best-in-class PDE5 inhibitor, and in phase 2 development of
Luramist(TM) for the treatment of hypoactive sexual desire disorder (HSDD) in
women. MUSE(R) (alprostadil), a first generation therapy for the treatment of
ED, is already on the market and generating revenue for VIVUS. For more
information about the company, please visit 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, 2008 and periodic reports filed with the Securities and Exchange
Commission.


CONTACT:   

    VIVUS, Inc.             Investor Relations:  The Trout Group
    Timothy E. Morris                            Brian Korb
    Chief Financial Officer                      646-378-2923
    650-934-5200
                            Media Relations:     Pure Communications, Inc.
                                                 Sheryl Seapy
                                                 949-608-0841






SOURCE  VIVUS, Inc.

VIVUS, Inc., Timothy E. Morris, Chief Financial Officer, +1-650-934-5200;
Investor Relations: The Trout Group, Brian Korb, +1-646-378-2923; or Media
Relations:  Pure Communications, Inc., Sheryl Seapy, +1-949-608-0841
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