VIVUS Announces Express Scripts Adds Qsymia (Phentermine And Topiramate Extended-Release) Capsules CIV To Its Standard Benefits

   VIVUS Announces Express Scripts Adds Qsymia (Phentermine And Topiramate
       Extended-Release) Capsules CIV To Its Standard Benefits Program

PR Newswire

MOUNTAIN VIEW, Calif., Dec. 20, 2012

MOUNTAIN VIEW, Calif., Dec. 20, 2012 /PRNewswire/ --VIVUS, Inc. (NASDAQ:
VVUS) today announced that Express Scripts, among the country's largest
Pharmacy Benefit Managers (PBMs), has added Qsymia™ to its national pharmacy
formularies, allowing for coverage where available by benefit design of the
first new FDA-approved medication commercially available in the U.S. in over a
decade for the treatment of chronic weight management.

Express Scripts provides the formulary design, pharmaceutical contract
management and claims processing for some of the largest payers and employers
in the U.S.

Qsymia has been added as a standard benefit option to Express Scripts'
national formulary in a tier-3 position with a prior authorization. Under the
Express Scripts plan, participating patients will now pay an estimated $50.00
to $60.00 for their co-payment for a monthly prescription of Qsymia,
approximately one-third of the retail price.

"This is a major step forward in expanding access to an important new
medication for a population that needs effective pharmacological
interventions," said Peter Tam, President of VIVUS. "Obesity has a devastating
impact on our society and contributes significantly to comorbidities such as
high blood pressure, type 2 diabetes, or high cholesterol."

Qsymia is available only through mail order from the Qsymia Certified Home
Delivery Pharmacy Network, including CVS Pharmacy, Express Scripts, Walgreens
and Walmart, as part of the Qsymia Risk Evaluation and Mitigation Strategy
(REMS) program.Contact information for the certified pharmacies can be found
on and

Qsymia was made available September 17, 2012 and is the first FDA-approved
once daily combination therapy — and the first new medication available in 13
years — for the treatment of obesity.

About Qsymia

Qsymia is approved in the U.S. and is indicated as an adjunct to a
reduced-calorie diet and increased physical activity for chronic weight
management in adults with an initial body mass index (BMI) of 30 kg/m^2 or
greater (obese) or 27 kg/m^2 or greater (overweight) in the presence of at
least one weight-related medical condition such as high blood pressure, type 2
diabetes, or high cholesterol.

The effect of Qsymia on cardiovascular morbidity and mortality has not been
established. The safety and effectiveness of Qsymia in combination with other
products intended for weight loss, including prescription and over-the-counter
drugs, and herbal preparations, have not been established.

Important Safety Information

Qsymia (phentermine and topiramate extended-release) capsules CIV is
contraindicated in pregnancy; in patients with glaucoma; in hyperthyroidism;
in patients receiving treatment or within 14 days following treatment with
monoamine oxidase inhibitors (MAOIs); or in patients with hypersensitivity to
sympathomimetic amines, topiramate, or any of the inactive ingredients in

Qsymia can cause fetal harm. Females of reproductive potential should have a
negative pregnancy test before treatment and monthly thereafter and use
effective contraception consistently during Qsymia therapy. If a patient
becomes pregnant while taking Qsymia, treatment should be discontinued
immediately, and the patient should be informed of the potential hazard to the

The most commonly observed side effects in controlled clinical studies, 5% or
greater and at least 1.5 times placebo, include paraesthesia, dizziness,
dysgeusia, insomnia, constipation, and dry mouth.


VIVUS is a biopharmaceutical company commercializing and developing
innovative, next-generation therapies to address unmet needs in obesity, sleep
apnea, diabetes and sexual health for U.S., Europe and other world markets.
Qsymia is also in phase 2 clinical development for the treatment of type 2
diabetes and obstructive sleep apnea. For more information about the company,
please visit

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," "estimate," "expect," "intend," "likely,"
"may," "plan," "potential," "predict," "opportunity" and "should," among
others. 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, our limited commercial experience
with Qsymia in the U.S.; the timing of initiation and completion of the
clinical studies required as part of the approval of Qsymia by the United
States Food and Drug Administration, or FDA; the response from the FDA to the
data that VIVUS will submit relating to post-approval clinical studies; the
impact of the indicated uses and contraindications contained in the Qsymia
label and the REMS requirements; the impact of distribution of Qsymia through
a certified pharmacy network; whether or not the FDA approves our amendment to
the REMS for Qsymia, which, if approved, would allow dispensing through select
retail pharmacies to increase access while meeting all requirements of the
REMS; that we may be required to provide further analysis of previously
submitted clinical trial data; our appeal of the negative opinion of the
European Medicines Agency's, or EMA, Committee for Medicinal Products for
Human Use, or CHMP, for the Marketing Authorization Application, or MAA, for
Qsymia; our ability to successfully commercialize or establish a marketing
partnership for avanafil, which will be marketed in the U.S. under the name
STENDRA™, or our partner's ability to obtain and maintain regulatory approval
to manufacture and adequately supply avanafil to meet demand; our history of
losses and variable quarterly results; substantial competition; risks related
to the failure to protect our intellectual property and litigation in which we
may become involved; uncertainties of government or third party payer
reimbursement; our reliance on sole source suppliers; our limited sales and
marketing and manufacturing experience; our reliance on third parties and our
collaborative partners; our failure to continue to develop innovative
investigational drug candidates and drugs; risks related to the failure to
obtain FDA or foreign authority clearances or approvals and noncompliance with
FDA or foreign authority regulations; our ability to demonstrate through
clinical testing the safety and effectiveness of our investigational drug
candidates; the timing of initiation and completion of clinical trials and
submissions to foreign authorities; the volatility and liquidity of the
financial markets; our liquidity and capital resources; and our expected
future revenues, operations and expenditures. As with any pharmaceutical in
development, there are significant risks in the development, the regulatory
approval, and the commercialization of new products. There are no guarantees
that the product will receive regulatory approval outside the United States
for any indication or prove to be commercially successful. VIVUS does not
undertake an obligation to update or revise any forward-looking statements.
Investors should read the risk factors set forth in VIVUS's Form 10-K for the
year ending December 31, 2011, and periodic reports filed with the Securities
and Exchange Commission.


Contact: VIVUS, Inc., Timothy E. Morris, Chief Financial Officer,; or Investor Relations: The Trout Group, Brian Korb,, +1-646-378-2923; or Media Relations, GolinHarris, Ashley
Buford,, +1-917-653-5694; or Nadia Deba,, +1-646-671-1240
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