VIVUS to Share Qsymia® Safety and Efficacy Data with a Global Audience at ICOMES & AOCO 2019
August 27 2019 - 7:30AM
VIVUS, Inc. (Nasdaq: VVUS; the “Company”) today announced that
Santosh T. Varghese, MD, Chief Medical Officer at VIVUS, will
present at the 2019 International Congress on Obesity and MEtabolic
Syndrome (ICOMES) & Asia-Oceania Conference on Obesity (AOCO),
in Seoul, Korea, which is taking place August 29-31, 2019.
Dr. Varghese will give two presentations summarizing
previously reported safety and efficacy data for Qsymia
(phentermine and topiramate extended-release) capsules CIV.
“The joint ICOMES and AOCO conference is an
excellent venue in which to introduce Qsymia to the international
community of physicians and researchers focused on advancing
treatments and improving outcomes for patients who are overweight
or obese,” said Dr. Varghese. “Qsymia is relevant to the
theme of this year’s meeting, ‘Sea of Obesity: Navigating the
Future,’ as we believe it has an important role in helping patients
achieve and maintain their healthy body mass index goals.
With Alvogen’s recent receipt of approval of Qsymia by the
South Korea Ministry of Food and Drug Safety, this an opportune
time for us to educate physicians in Korea and other global regions
about the robust body of data supporting the safety and efficacy of
Qsymia.”
Dr. Varghese will make the following
presentations:
- Optimizing clinical outcomes in obese and overweight patients
with combination phentermine plus topiramate extended release.
Thursday, August 29, 6:00 p.m. – 6:30 p.m. Korea Standard Time
(KST), Room 3.
- Addressing common challenges in obesity treatment and
optimizing long-term patient outcomes with combination phentermine
plus topiramate extended release. Saturday, August 31, 7:30 a.m. –
8:30 a.m. KST, Room 6.
“Our participation in ICOMES and AOCO is an
important step in our strategy for making Qsymia a global brand,
and we look forward to leveraging Dr. Varghese’s presence at the
event to build productive relationships with physicians in Korea
and other countries,” said John Amos, Chief Executive Officer at
VIVUS. “Other ongoing initiatives designed to expand the
Qsymia market include our planned re-filing of a new Qsymia
Marketing Authorization Application on a decentralized basis in
Europe, the launch of our U.S. telemedicine program and an improved
payor strategy. VIVUS is committed to realizing the full clinical
and commercial potential of Qsymia in the U.S. and in our
international markets.”
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 the Company, 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; risks and uncertainties related to our
ability to sell through the Qsymia retail pharmacy network and the
Qsymia Advantage Program; 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 the impact of the indicated uses and
contraindications contained in the Qsymia label and the Risk
Evaluation and Mitigation Strategy requirements; and risks and
uncertainties related to our dialog with the European Medicines
Agency (“EMA”) or certain member states on a decentralized basis
relating to the resubmission of an application for the grant of a
marketing authorization, the timing and scope of such resubmission,
the assessment by European health authorities of the application
for marketing authorization, and ultimately the decision of such
European health authorities whether to grant marketing
authorization for Qsymia in the EU. 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 OkiChief Financial
Officeroki@vivus.com650-934-5200
Investor Relations: Lazar PartnersDavid
CareyManaging Directordcarey@lazarpartners.com212-867-1768
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