VIVUS Announces Commercial Launch of Qsymia® in the Republic of Korea Establishing New Royalty Revenue Stream
February 19 2020 - 7:30AM
VIVUS, Inc. (Nasdaq:VVUS) (the “Company”), a biopharmaceutical
company, announced today that its Korean marketing partner,
Alvogen, has launched Qsymia (phentermine and topiramate
extended-release) in the Republic of Korea.
“We believe that Qsymia has significant
unrealized clinical and commercial value, and the South Korean
launch of this important tool for helping patients achieve and
maintain a healthy body-mass index will advance our strategy for
unlocking this potential,” said John Amos, CEO of VIVUS.
“Alvogen is an established leader in the South Korean
anti-obesity market, and we believe that our agreement with Alvogen
exemplifies our strategy for maximizing the value of our
commercial-stage assets in an efficient and cost-effective manner.
We are confident in Alvogen’s ability to make Qsymia a significant
product in the South Korean market.”
Under an agreement executed in September 2017,
Alvogen, a leader in the South 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 received upon approval of Qsymia by the South
Korea Ministry of Food and Drug Safety (MFDS) in August 2019, VIVUS
will receive a $2 million payment tied to the commercial
launch of Qsymia. Under the agreement, VIVUS is also eligible
to receive royalties on Alvogen's net sales of Qsymia and future
milestone payments contingent upon achievement of net sales goals
within the covered territory.
About Qsymia
Qsymia is approved in the United States and
South Korea 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 ability to address our outstanding balance of the
convertible notes due in May 2020; risk and uncertainties related
to the timing, strategy, structure and success of our capital
raising efforts; risks and uncertainties related to our expected
future revenues, operations and expenditures; risks and
uncertainties related to the impact of the indicated uses and
contraindications contained in the Qsymia label and the Risk
Evaluation and Mitigation Strategy requirements; risks and
uncertainties related to the timing of initiation and completion of
the post-approval clinical studies required as part of the approval
of Qsymia by the U.S. Food and Drug Administration (“FDA”),
including the Phase 4 post-marketing study of Qsymia in obese
adolescents; risks and uncertainties related to the response from
FDA to any data and/or information relating to post-approval
clinical studies required for Qsymia; risks and uncertainties
related to the impact of any possible future requirement to provide
further analysis of previously submitted clinical trial data; risks
and uncertainties related to the design and outcome of any clinical
study required by FDA to expand the Qsymia label; risks and
uncertainties related to our, or our current or potential
partners’, ability to successfully commercialize Qsymia in their
respective territories, including our partner in South Korea; 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. |
Investor Relations: Lazar FINN Partners |
Mark Oki |
David Carey |
Chief Financial Officer |
Senior Partner |
oki@vivus.com |
david.carey@finnpartners.com |
650-934-5200 |
212-867-1768 |
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