VIVUS Announces Approval of Qsymia® in the Republic of Korea
August 05 2019 - 7:30AM
VIVUS, Inc. (Nasdaq:VVUS) (the “Company”), a biopharmaceutical
company, announced today that its Korean marketing partner,
Alvogen, has obtained marketing approval for Qsymia (phentermine
and topiramate extended-release) from the South Korea Ministry of
Food and Drug Safety (MFDS).
“VIVUS and our partner Alvogen are proud that the South Korean
MFDS has approved Qsymia as a safe and effective pharmaceutical to
help people in the quest for a healthier BMI,” said John Amos, CEO
of VIVUS. “The MFDS approval followed a robust review of existing
Qsymia clinical trial and safety surveillance data and does not
require additional safety-related post marketing clinical studies.
We are encouraged by the now global recognition of Qsymia as an
important solution to the growing challenge of obesity, and look
forward to building on our productive relationship with Alvogen as
we support their commercialization of Qsymia in South Korea.”
Under an agreement executed in September 2017, Alvogen, a
prominent leader in the Korean anti-obesity market, is solely
responsible for obtaining and maintaining regulatory approvals and
for all sales and marketing activities in Korea. In addition
to the upfront payment that VIVUS received at the time the
agreement was executed and the milestone payment related to MFDS
approval, the agreement also includes future milestone payments
contingent upon initiating the commercial launch and achieving
sales goals within the covered territory. VIVUS will also
receive royalties on Alvogen's net sales of Qsymia.
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 about VIVUS, 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, or our current or potential partners’, ability to
successfully commercialize Qsymia; and risks and uncertainties
related to the failure to obtain FDA or foreign authority
clearances or approvals and noncompliance with FDA or foreign
authority regulations. 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. |
Investor Relations: Lazar Partners |
Mark Oki |
David Carey |
Chief Financial Officer |
Managing Director |
oki@vivus.com |
dcarey@lazarpartners.com |
650-934-5200 |
212-867-1768 |
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