VIVUS Receives Formal Decision From CHMP
MOUNTAIN VIEW, Calif., Oct. 18, 2012 (GLOBE NEWSWIRE) -- VIVUS, Inc.
(Nasdaq:VVUS) today announced that is has received the formal opinion from the
European Medicines Agency's (EMA) Committee for Medicinal Products for Human
Use (CHMP) following their October 15-18 meeting. As expected, the CHMP
recommended against approval of the Marketing Authorization Application (MAA)
for Qsiva™ (phentermine/topiramate ER) for the treatment of obesity in the
European Union.The reasons for their decision were due to concerns over the
potential cardiovascular and central nervous system effects associated with
long-term use, teratogenic potential and use by patients for whom Qsiva is not
indicated. The company currently intends to appeal this opinion and request a
re-examination of the decision by the CHMP.
"The lack of effective pharmacologic treatments for obesity remains a high
medical need for many patients in Europe," stated Peter Tam, VIVUS' president.
"We are committed to getting Qsiva approved in Europe and will work closely
with the new rapporteur and co-rapporteur to make this happen."
Qsymia is approved in the US 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. There are certain limitations of use for
Qsymia.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, which the company intends to market outside of the U.S. under the name
Qsiva™, 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 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," "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 lack of 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; that we may be required to provide further
analysis of previously submitted clinical trial data; ourappeal 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 the ability of our partners to maintain
regulatory approvals to manufacture and adequately supply our products 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 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' 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
The Trout Group
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