VIVUS Announces Acceptance of Qsymia Decentralized Marketing Authorization Application in Europe
October 07 2019 - 7:30AM
VIVUS, Inc. (Nasdaq: VVUS) (the “Company”), a biopharmaceutical
company, announced today that European regulatory agencies in
Sweden, Denmark, Finland, Iceland, Norway, and Poland (the
“Concerned Member States”) have accepted the Marketing
Authorization Application (the “MAA”) for Qsymia (phentermine and
topiramate extended-release) on a decentralized basis, with Sweden
acting as the lead Concerned Member State, also known as the
Reference Member State, for purposes of assessing the MAA. Under
the decentralized MAA procedure, the regulatory authorities in each
of the Concerned Member States may simultaneously provide Marketing
Authorization for use of a product within those specific countries.
“With the growing body of real world evidence
supporting the safety and efficacy of Qsymia and its recent
approval in the Republic of Korea, we believe that there is growing
recognition of the benefit that this therapy can provide to
patients seeking to achieve and maintain a healthy body mass
index,” said John Amos, Chief Executive Officer of VIVUS. “As we
gain traction in capturing a growing share of the market for weight
management therapies in the United States, we continue to work with
international regulators and current or potential commercial
partners to expand Qsymia into additional countries. We believe
that Qsymia has an important role to play in addressing the growing
challenge of obesity in the United States, Europe, and other
markets.”
Based on the decentralized MAA procedure
timelines, the Company anticipates the completion of the MAA
assessment and, if approved, Marketing Authorizations to begin in
the second half of 2020.
About Qsymia
Qsymia is approved in the United States 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/m2 or greater (obese) or 27
kg/m2 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; or in patients with hypersensitivity to
sympathomimetic amines, topiramate, or any of the inactive
ingredients in Qsymia.
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
fetus.
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.
About VIVUS
VIVUS is a biopharmaceutical company
committed to the development and commercialization of innovative
therapies that focus on advancing treatments for patients with
serious unmet medical needs. For more information, please
visit www.vivus.com.
Forward-Looking Statements
Certain statements in this press release are
forward-looking within the meaning of the Private Securities
Litigation Reform Act of 1995 and are subject to risks,
uncertainties and other factors, including risks and uncertainties
related to our ability to execute on our business strategy to
enhance long-term stockholder value; risks and uncertainties
related to our expected future revenues, operations and
expenditures; risks and uncertainties related to our dialog with
certain concerned member states in Europe relating to the pending
decentralized Marketing Authorization Application, the timing and
scope of the assessment by such Concerned Member State health
authorities of our Marketing Authorization Application, and
ultimately the decision of such Concerned Member State health
authorities whether to grant Marketing Authorization for Qsymia in
such EU countries; risks and uncertainties related to our, or our
current or potential partners’, ability to successfully seek and
gain approval for Qsymia in territories outside the U.S.; risks and
uncertainties related to our, or our current or potential
partners’, ability to successfully commercialize Qsymia; and risks
and uncertainties related to our ability to sell through the Qsymia
retail pharmacy network and the Qsymia Advantage Program. These
risks and uncertainties could cause actual results to differ
materially from those referred to in these forward-looking
statements. The reader is cautioned not to rely on these
forward-looking statements. Investors should read the risk factors
set forth in VIVUS’ Form 10-K for the year ended December 31, 2018
as filed on February 26, 2019, and periodic reports filed with the
Securities and Exchange Commission. VIVUS does not undertake an
obligation to update or revise any forward-looking statements.
VIVUS, Inc.Mark Oki Chief
Financial Officeroki@vivus.com 650-934-5200 |
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Investor Relations: Lazar FINN
PartnersDavid CareySenior
Partnerdavid.carey@finnpartners.com 212-867-1768 |
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