VIVUS Announces it will Provide Telehealth to Patients through an Enhanced 'Engage' Program in Collaboration with UpScriptHealth

Collaboration will deliver a seamless telehealth experience, providing patients with immediate access to QSYMIA®, a chronic weight loss medication, enhancing their healthcare journey

CAMPBELL, Calif., April 22, 2024 (GLOBE NEWSWIRE) -- VIVUS LLC, a biopharmaceutical company committed to the development and commercialization of innovative therapies that focus on advancing treatments for patients with serious unmet medical needs, today announced it has entered into a strategic partnership with UpScriptHealth, a leading, nationwide, direct-to-consumer telemedicine company. The program, titled “VIVUS Engage,” will establish a robust online telemedicine platform for the distribution of QSYMIA® (phentermine and topiramate extended-release capsules CIV), the leading non-injectable branded weight loss medication in the U.S. for adults.

Under the terms of the agreement, UpScript LLC will make QSYMIA available to patients through its proprietary Telehealth Platform. QSYMIA is indicated as an FDA-approved adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in some adults and certain pediatric patients aged 12 years and older.

“With its growing popularity in recent years, telehealth presents a significant opportunity not only to enhance patient access, but also to improve the lives of patients throughout the entire treatment journey,” said John Amos, Chief Executive Officer at VIVUS LLC. “In collaboration with UpScript LLC, our goal is to offer eligible patients an ethical and trusted solution to access QSYMIA.”

Patients will be able to access high quality health care and directly communicate with a healthcare provider through the UpScript Platform. They may also select to have their medication mailed directly to them through a mail order pharmacy. This solution is designed to increase access to QSYMIA nationwide, offer patients a time-saving solution and help them manage the coverage administration process through UpScript’s benefit support capabilities.

With over 20 years of experience and more than one million patients served, UpScriptHealth specializes in creating effective web-based campaigns for pharmaceutical companies. Its comprehensive services include virtual prescribing, coverage and benefit support, as well as long-term adherence support. For patients actively seeking online support and solutions, UpScriptHealth offers a fast and convenient option.

“UpScriptHealth has provided direct-to-consumer solutions for pharma for more than a decade and is proud to add VIVUS LLC as a new partner in weight loss management, making their solution accessible and affordable,” said Peter Ax, CEO and founder of UpScriptHealth.

The projected global impact of obesity is staggering, with an estimated one billion people expected to be affected by 2030. This marks nearly a twofold increase from the 2020 prevalence of around 511 million. Significantly, obesity escalates the risk of type 2 diabetes, hypertension, and dyslipidemia. Consequently, this heightened risk contributes to an overall increased susceptibility to cardiovascular disease and mortality. Achieving and maintaining healthy weight goals can play a crucial role in mitigating this risk.

“We are dedicated to patients not only by introducing innovative therapies to the market but also ensuring these treatments are convenient and readily accessible,” said Santosh T. Varghese, MD, President VIVUS Global Pharmaceutical Development and Chief Medical Officer at VIVUS LLC.

QSYMIA was approved by the U.S. Food and Drug Administration in 2012 for chronic weight management. The once-daily pill is covered by the majority (81%) of commercial healthcare plans and is indicated for long-term use. QSYMIA is designed to help patients manage hunger and reduce cravings throughout the day. Combined with a healthy diet and exercise, it has been proven to help patients lose weight and maintain weight loss.

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 http://www.vivus.com.

About UpScriptHealth
UpScriptHealth provides a fully compliant direct-to-consumer Telemedicine platform for pharmaceutical companies and consumer products companies. This unique platform allows for convenient access to high quality health care including state of the art medicines. In 2002 UpScriptHealth was the first company in the US to be licensed to write prescriptions on the internet through an online physician consultation. Since then, we’ve treated more than a million patients in all fifty states. Learn more at www.UpScriptHealth.com. Check URL

About QSYMIA
QSYMIA is a combination of phentermine, a sympathomimetic amine anorectic, and topiramate, 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 comorbidity such as hypertension, type 2 diabetes mellitus, or dyslipidemia. QSYMIA may also be used in pediatric patients aged 12 years and older with BMI in the 95th percentile or greater standardized for age and sex.

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 on QSYMIA, please visit https://QSYMIA.com/

Important Safety Information for QSYMIA
Do not take QSYMIA if you are pregnant, planning to become pregnant, or become pregnant during QSYMIA treatment; have glaucoma; have thyroid problems (hyperthyroidism); are taking certain medicines called monoamine oxidase inhibitors (MAOIs) or have taken MAOIs in the past 14 days; are allergic to topiramate, sympathomimetic amines such as phentermine, or any of the ingredients in QSYMIA.

Common side effects of QSYMIA in adults include numbness or tingling in the hands, arms, feet, or face (paraesthesia), dizziness, changes in the way foods taste or loss of taste (dysgeusia), trouble sleeping (insomnia), constipation, and dry mouth. Common side effects of Qsymia in children aged 12 years and older include depression, dizziness, joint pain, fever, flu, and ankle sprain.

QSYMIA can cause serious side effects, including birth defects (cleft lip/cleft palate), increases in heart rate, visual field defects (independent of elevated intraocular pressure), suicidal thoughts or actions, serious eye problems, and severe rash with blisters and peeling skin. QSYMIA may slow the increase in height in children 12 years and older.

Forward-Looking Statements

Important Information and Cautionary Note Regarding Forward-Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, and/or covered by the “Bespeaks Caution” doctrine applied by the courts under the antifraud provisions of the federal securities laws, and other applicable provisions of the federal securities laws. Such forward-looking statements are based on current expectations, management’s beliefs and certain assumptions made by the Company’s management. These statements may be identified by the use of forward-looking words such as “will,” “shall,” “may,” “believe,” “expect,” “forecast,” “intend,” “anticipate,” “predict,” “should,” “plan,” “likely,” “opportunity,” “estimated,” and “potential,” and/or the negative use of these words or other similar words. All forward-looking statements included in this document are based on our current expectations, and the Company assumes no obligation to update any such forward-looking statements except to the extent otherwise required by law.

Forward-looking information about QSYMIA, including its potential benefits, approvals in potential markets outside the U.S. and anticipated product availability, involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied in this press release. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when drug applications may be filed in any other markets or approved, whether QSYMIA will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of QSYMIA; uncertainties regarding the impact of COVID-19 on our business, operations, and financial results; and competitive developments.

The above factors, risks and uncertainties are difficult to predict, contain uncertainties that may materially affect actual results and may be beyond the Company’s control. New factors, risks and uncertainties emerge from time to time, and it is not possible for management to predict all such factors, risks and uncertainties. Although the Company believes that the assumptions underlying the forward-looking statements contained herein are reasonable, any of the assumptions could be inaccurate, and therefore any of these statements may prove to be inaccurate. In light of the significant uncertainties inherent in the forward-looking statements included herein, the inclusion of such information should not be regarded as a representation or warranty by the Company or any other person that the Company’s objectives and plans will be achieved. These forward-looking statements speak only as of the date such statements were made or any earlier date indicated, and the Company does not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events, changes in underlying assumptions or otherwise, unless otherwise required by law.

Contacts

VIVUS LLC
T: +1 (650) 934-5200

Media – FINN Partners
Glenn Silver
glenn.silver@finnpartners.com
T: +1 973-818-8198


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