Carmustine

CAMPBELL, Calif., Jan. 12, 2026 (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 will provide updates to its pipeline and key program milestones during the 44th Annual J.P. Morgan Healthcare Conference 2026. “During the J.P. Morgan Healthcare Conference, VIVUS will share key highlights from 2025, demonstrating our commitment to advancing innovative clinical therapies across a variety of conditions,” said John Amos, Chief Executive Officer at VIVUS LLC. “The year was particularly transformative for QSYMIA, with new market approvals, expanded pharmacy partnerships, and more affordable pricing, broadening patient access to effective weight-management solutions. We also reached an important clinical milestone by enrolling over 20% of patients in our Phase 2 trial of VI-0609, an innovative ethanol-free formulation of carmustine, as part of high-dose conditioning chemotherapy for patients with refractory or relapsed Hodgkin or non-Hodgkin lymphoma undergoing autologous hematopoietic cell transplant. Looking ahead to 2026, we plan to initiate patient enrollment in our global pulmonary arterial hypertension, or PAH, clinical trial in Q1, involving 80 centers worldwide. Throughout all our efforts, we remain focused on disciplined execution and keeping patients at the center of every decision we make.” Key 2025 highlights include: Reduced QSYMIA price at Costco Pharmacies nationwide (October 7, 2025): The price of a 30-day supply of QSYMIA available via Costco Member Prescription Program at Costco Pharmacies nationwide was lowered to less than $99 for all doses.First patient enrolled in Phase 2 study assessing ethanol-free carmustine as a component of high-dose chemotherapy prior to transplant in patients with Hodgkin or non-Hodgkin lymphoma (April 14, 2025): VIVUS enrolled the first patient in a randomized, multicenter Phase 2 trial (NCT06915246) evaluating VI-0609 versus BiCNU as part of the BEAM high-dose conditioning regimen in patients with refractory or relapsed Hodgkin or non-Hodgkin lymphoma undergoing autologous hematopoietic cell transplant (AHCT), with the goal of improving safety and reducing infusion-related toxicities.Market approval of QSYMIA in the United Arab Emirates (March 10, 2025): QSYMIA is available to patients with overweight and obesity who could benefit from weight loss in the United Arab Emirates, the first country in the Middle East to approve and market QSYMIA(R).Continued progress toward expanding global availability of QSYMIA and QSIVA® (phentermine and topiramate modified-release): The Company is on track to launch its obesity management medication in additional European countries. “The past year represented an important period of execution for VIVUS, with meaningful progress across our commercial and clinical programs,” said Santosh T. Varghese, MD, President VIVUS Global Pharmaceutical Development and Chief Medical Officer at VIVUS LLC. “The Company advanced key milestones, including expanding access to QSYMIA and QSIVA internationally and initiating clinical development of our ethanol-free carmustine program, underscoring our commitment to improving patient outcomes through innovative formulations. As we look ahead to 2026, we are focused on disciplined clinical advancement, regulatory progress, and building on our momentum to deliver differentiated therapies for patients with serious unmet medical needs.” QSYMIA is the leading non-injectable branded weight loss medication in the U.S. for adults. QSYMIA is a combination of phentermine, a sympathomimetic amine anorectic, and topiramate, indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight in some adults and certain pediatric patients aged 12 years and older. In addition to QSYMIA, VIVUS has continued to advance PANCREAZE®, indicated for EPI, a condition where the pancreas does not make enough enzymes to digest food normally. PANCREAZE is a pancreatic enzyme replacement therapy (PERT) that replaces the digestive enzymes that patients need. The PERT helps the body digest food properly and absorb fat, protein and carbohydrates, which are needed for healthy growth, weight gain and improved nutritional health. About VIVUSVIVUS 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 PANCREAZEPANCREAZE is a prescription medicine used to treat people who cannot digest food normally because their pancreas does not make enough enzymes due to cystic fibrosis or other conditions. PANCREAZE may help your body use fats, proteins, and sugars from food. PANCREAZE contains a mixture of digestive enzymes including lipases, proteases, and amylases from pig pancreas. PANCREAZE is safe and effective in children when taken as prescribed by your doctor. Important Safety Information for PANCREAZEWhat is the most important information I should know about PANCREAZE? PANCREAZE may increase your chance of having a serious, rare bowel disorder called fibrosing colonopathy that may require surgery.The risk of having this condition may be reduced by following the dosing instructions that your healthcare provider gave you. Call your doctor right away if you have any unusual or severe stomach area (abdominal) pain, bloating, trouble passing stool (having bowel movements), nausea, vomiting, or diarrhea. Take PANCREAZE exactly as prescribed by your doctor. Do not take more or less PANCREAZE than directed by your doctor. What are the possible side effects of PANCREAZE? PANCREAZE may cause serious side effects, including: A rare bowel disorder called fibrosing colonopathy.Irritation of the inside of your mouth. This can happen if PANCREAZE is not swallowed completely.Increase in blood uric acid levels. This may cause worsening of swollen, painful joints (gout) caused by an increase in your blood uric acid levels.Allergic reactions including trouble with breathing, skin rashes, or swollen lips. Call your doctor right away if you have any of these symptoms. The most common side effects include pain in your stomach (abdominal pain) and gas. Other possible side effects: PANCREAZE and other pancreatic enzyme products are made from the pancreas of pigs, the same pigs people eat as pork. These pigs may carry viruses. Although it has never been reported, it may be possible for a person to get a viral infection from taking pancreatic enzyme products that come from pigs. These are not all the side effects of PANCREAZE. Talk to your doctor about any side effect that bothers you or does not go away. You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. What should I tell my doctor before taking PANCREAZE? Tell your doctor if you: are allergic to pork (pig) products.have a history of blockage of your intestines, or scarring or thickening of your bowel wall (fibrosing colonopathy).have gout, kidney disease, or high blood uric acid (hyperuricemia).have trouble swallowing capsules.have any other medical condition.are pregnant or plan to become pregnant.are breast-feeding or plan to breast-feed. Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. The Product Information and Medication Guide for PANCREAZE is available at www.pancreaze.com. About QSYMIAQSYMIA is indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults and pediatric patients aged 12 years and older with obesity, and in adults with overweight in the presence of at least one weight-related comorbid condition. 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 drugs, over-the-counter drugs, and herbal preparations, have not been established. For more information on QSYMIA, please visit https://QSYMIA.com/ About QSIVAQSIVA (the European brand name for QSYMIA) is approved in Sweden, Denmark, Finland, Iceland, Norway, and Poland. QSIVA 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 QSIVA on cardiovascular morbidity and mortality has not been established. The safety and effectiveness of QSIVA 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 QSIVA, please visit www.QSIVA.eu. Important Safety Information for QSYMIADo 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. QSYMIA can cause serious side effects, including birth defects (cleft lip/cleft palate), serious eye problems (secondary angle closure glaucoma), visual field defects (independent of elevated intraocular pressure), suicidal thoughts or actions, and severe rash with blisters and peeling skin. QSYMIA may slow the increase in height in children 12 years and older. 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. For more information, please read the QSYMIA Medication Guide, Full Prescribing Information, and Risk of Birth Defects with QSYMIA patient brochure. 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 the Company's products and product candidates, including QSYMIA, QSIVA, VI-0609, and PANCREAZE, as well as the Company's clinical development programs and international expansion plans, involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied in this press release. Risks related to QSYMIA and QSIVA include the potential benefits of QSYMIA, approvals in potential markets outside the U.S., anticipated product availability, pricing strategies and their impact on revenue, the success of expanded pharmacy partnerships, international regulatory approvals and commercial launches in additional European countries and other markets, competitive developments in the weight management market including injectable medications, and whether QSYMIA and QSIVA will continue to be commercially successful. Risks related to VI-0609 include uncertainties inherent in clinical development and research, including the ability to enroll patients at anticipated rates, maintain enrollment momentum, meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, 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 clinical studies, whether and when drug applications may be filed in any markets for VI-0609, whether VI-0609 will receive regulatory approval, decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of VI-0609, and competitive developments in the oncology and transplant conditioning space. Risks related to the planned PAH clinical trial include the ability to initiate patient enrollment as planned in Q1 2026, challenges in establishing and coordinating approximately 90 clinical trial centers globally, patient recruitment and retention difficulties, regulatory approval requirements across multiple countries, potential delays in trial commencement or completion, and the uncertainties inherent in developing treatments for pulmonary arterial hypertension. General risks include uncertainties regarding the impact of COVID-19 or other public health emergencies on the Company's business, operations, and financial results; the ability to successfully manage multiple clinical and commercial programs simultaneously; regulatory submission dates, regulatory approval dates and/or launch dates for any product candidates; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of the Company's products; supply chain challenges; and competitive developments across all therapeutic areas in which the Company operates. 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 LLCT: +1 (650) 934-5200 Media – FINN Partners Glenn Silver glenn.silver@finnpartners.com T: +1 973-818-8198