VIVUS Receives Decision Regarding Qsiva Appeal
MOUNTAIN VIEW, Calif., Feb. 21, 2013 (GLOBE NEWSWIRE) -- VIVUS, Inc.
(Nasdaq:VVUS) announced today that the European Medicines Agency's (EMA)
Committee for Medicinal Products for Human Use (CHMP) confirmed its October
18, 2012 decision to decline the Marketing Authorization Application (MAA) for
Qsiva™ (phentermine/topiramate ER) for the treatment of obesity in the
VIVUS had requested a re-examination of the opinion. After considering the
grounds for this request, CHMP again declined the marketing authorization on
February 21, 2013.In its consideration of the Qsiva MAA, CHMP indicated that
a pre-approval cardiovascular outcomes trial would be necessary to establish
"We are disappointed with the CHMP decision regarding Qsiva and the position
the Committee adopted with respect to the need for a preapproval
cardiovascular outcomes trial," said Peter Y. Tam, president of VIVUS. "We
have worked diligently throughout Europe with key opinion leaders and
regulatory and risk management experts to highlight the favorable safety and
efficacy profile of Qsiva.Despite the positive recommendation of CHMP's own
Scientific Advisory Group (SAG) and the high unmet medical need in obese
patients, a majority of CHMP members have failed to recognize the importance
of making this treatment option available, particularly for patients whose
only effective intervention is surgery."
Qsiva was approved by the U.S. FDA in July 2012 and is sold under the trade
name Qsymia™. The pivotal Phase 3 clinical trial program included over 4,500
subjects studied up to two years, establishing Qsymia as a safe and effective
treatment for obesity.
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.
For more information, visit: www.qsymia.com.
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 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 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; 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™; the ability of our
partners to maintain regulatory approval 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 payor 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 results of post-marketing studies are not
favorable;compliance with post-marketing regulatory standards is not
maintained; 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
The Trout Group
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