Presentation at the Obesity Society Annual Scientific Meeting Shows
Weight Loss of 17 Pounds in 28 Weeks
VIVUS, Inc. (NASDAQ: VVUS), a pharmaceutical company dedicated to
the development and commercialization of novel therapeutic products,
today announced the weight loss effects of Qnexa in subjects with type 2
diabetes at The Obesity Society Annual Scientific Meeting in Phoenix,
Arizona. Dr. Barbara Troupin, Senior Director of Clinical Development,
announced the data in a poster presentation titled “The
Weight Loss Effects of VI-0521 in Type 2 Diabetes.”
On an intent-to-treat basis, subjects treated with Qnexa, an
investigational drug, for 28 weeks had a mean weight loss of
approximately 17 pounds or 8 percent of their starting body weight, as
compared to subjects treated with placebo who had weight loss of
approximately 2.9 pounds or 1.2 percent (p<0.0001).
In the study, 61 percent of the patients treated with Qnexa had weight
loss of 5 percent as compared to 14 percent of the patients in the
placebo group (p<0.0001).
VIVUS had previously reported the positive results of this study,
OB-202, at the American Diabetes Association Scientific Meeting in June
2008. Subjects treated with Qnexa had a mean reduction in HbA1c, a
common measure of glycemic control, of 1.2 percent, from 8.7 percent to
7.5 percent, as compared with a reduction of 0.6 percent, from 8.6
percent to 8.0 percent, in subjects in the placebo group (p<0.001).
Patients on placebo required a three-fold increase in the number and
dose of additional anti-diabetic medications during the study than those
receiving Qnexa. Fasting plasma glucose levels were reduced in the Qnexa
arm from 174.7 mg/dL to 141.9 mg/dL, and decreased from 174 mg/dL to
166.6 mg/dL in the placebo group (p<0.001).
The change in HbA1c was correlated with weight loss. Qnexa patients also
had significant improvement in cardiovascular risk factors including
blood pressure, triglycerides levels and waist circumference.
Specifically, patients in the Qnexa group reduced systolic blood
pressure from 122.8 mmHg to 118.9 mmHg, as compared to a neutral effect
in the placebo group from 124.4 mmHg to 124.5 mmHg (p<0.005).
Patients in the Qnexa group reduced diastolic blood pressure from 74.7
mmHg to 73.7 mmHg, as compared to a marginal increase in the placebo
group from 75.7 mmHg to 76.6 mmHg (p<0.018).
Patients in the Qnexa group also had a significant reduction in
triglycerides from 162 mg/dL to 143 mg/dL, as compared to subjects in
the placebo group that had a slight reduction from 172.2 mg/dL to 171.6
mg/dL (p<0.016). The trial randomized 206
subjects at 10 sites. The Qnexa treatment group had a study completion
rate of 85 percent, as compared to 72 percent in the placebo arm. Qnexa
subjects reported an overall improvement when evaluated for quality of
life, including physical function, self-esteem and distress.
"The weight loss of 17 pounds in 28 weeks is an outstanding result for
these diabetic patients. The reduction in blood sugar levels of 1.2%
coupled with improvement in the cardiovascular risk factors may make
Qnexa an ideal treatment for diabetics," commented Leland Wilson,
president and chief executive officer at VIVUS. "Thought leaders in the
diabetes community now recognize that treating diabetes through weight
loss should be the fundamental approach to managing glycemic and
cardiovascular risk. We are pleased with the results and look forward to
moving ahead with our plans for the phase 3 development of Qnexa in
diabetes.”
Subjects completing the OB-202 study were allowed to enroll in a
placebo-controlled extension study, DM-230. Subjects continued their
current treatment for an additional 28 weeks. Results from the DM-230
study are expected before the end of 2008.
About the OB-202 Study
In the OB-202 study, subjects underwent a 4-week dose escalation period
followed by 24 weeks of treatment. The study was a randomized,
double-blind, placebo-controlled prospective trial, with subjects
randomized to receive Qnexa (15 mg phentermine/100 mg topiramate) or
placebo. The study included 206 subjects (141 females, 65 males) with an
average age of 49 years. Baseline BMIs were greater than 35 in both
groups, and baseline body weight was 94.7 kg in the Qnexa group and 98.6
kg in the placebo group. At baseline, subjects had glycosylated
hemoglobin (HbA1c) of 8.7 percent. Most of the subjects had been
diagnosed with diabetes for more than 5 years (59 percent). Sixty
percent of subjects were on two or more oral diabetic medications.
Patients on antidepressant medications such as SSRIs and SNRIs were
allowed to participate in the study. Subjects were instructed to follow
a simple diet and lifestyle modification program throughout the study.
The primary endpoint was change in glycemic control as reflected by
measurements of HbA1c. Secondary endpoints included weight loss and
change in various cardiovascular risk factors. Investigators were
allowed to intervene and add/adjust anti-diabetic and anti-hypertensive
medications during the study based on predetermined rescue criteria and
nationally recognized standards of care. Subjects completing the study
were allowed to enroll in an extension study, DM-230. The extension
study will continue to monitor HbA1c levels, body weight, other
metabolic endpoints, and patient safety over an additional six months.
Despite a mean baseline HbA1c level of 8.7 percent, 41 percent of the
subjects treated with Qnexa were able to achieve the American Diabetes
Association (ADA) recommended goal of 7 percent or lower, versus 26
percent of the subjects in the placebo arm (p=0.008). The incidence of
hypoglycemia in the treatment and placebo arms were comparable (6
percent versus 5 percent, respectively). Qnexa was well-tolerated, with
no treatment-related serious adverse events (SAEs). The most common
treatment-related adverse events were nausea, paresthesias,
constipation, dry mouth and dizziness.
About Diabetes
Diabetes affects more than 24 million people in the United States and an
estimated 246 million adults worldwide. Common measures of blood sugar
include the percent of glycosylated hemoglobin (also referred to as
HbA1c) present in the blood and fasting plasma glucose (FPG), which is a
measure of blood sugar at a specific point in time. Diabetes is
diagnosed when FPG exceeds 125 mg/dL. According to the Centers for
Disease Control and Prevention's National Health and Nutrition
Examination Survey, approximately 60 percent of people with diabetes do
not achieve their target blood sugar levels with their current treatment
regimen.
About the Qnexa Phase 3 Obesity Program
Qnexa is currently under development for obesity. A phase 2 study in
obese patients with controlled co-morbidities (no type 2 diabetes)
previously reported weight loss of 10.7 percent over 24 weeks. The phase
3 Qnexa program includes two pivotal, double-blind, placebo-controlled,
multi-center studies that will compare the efficacy and safety of Qnexa
to placebo during a 56-week treatment period. The first study, known as
EQUIP (OB-302), has enrolled approximately 1,250 morbidly obese adult
subjects with a Body Mass Index (BMI) of 35 or greater with or without
controlled co-morbidities. The second trial, known as CONQUER (OB-303),
has enrolled overweight and obese adult subjects with BMIs from 27 to 45
and at least two co-morbid conditions, such as hypertension,
dyslipidemia and type 2 diabetes. The co-primary endpoints for these
studies are the mean percent weight loss and the percentage of subjects
achieving a weight loss of 5 percent or more.
The phase 3 program also includes a six-month confirmatory factorial
study, known as EQUATE (OB-301), in obese subjects with BMIs from 30 to
45. This trial is designed to evaluate two dose levels of Qnexa compared
to placebo and to the individual components in Qnexa. The primary
endpoints will be similar to those evaluated in the pivotal studies.
Safety and tolerability of Qnexa will be determined by reports of
adverse events, physical exam, clinical laboratory data,
electrocardiogram, cognitive function tests, psychological assessments,
and clinical assessment of clinical laboratory variables. The phase 3
program has enrolled a total of approximately 4,500 subjects.
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(TM), which is in phase 3 for obesity and
phase 2 for diabetes; avanafil, for which a phase 2 study has been
completed for the treatment of erectile dysfunction (ED) and
Testosterone MDTS(R), for which a phase 2 study has been completed for
the treatment of Hypoactive Sexual Desire Disorder (HSDD). MUSE(R) 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, 2007 and
periodic reports filed with the Securities and Exchange Commission.
VIVUS, Inc.
Timothy E. Morris
Chief Financial Officer
650-934-5200
or
The
Trout Group
Ian Clements (SF) 415-392-3385
Brian Korb
(NYC) 646-378-2923
