VIVUS
VIVUS is a biopharmaceutical company focused on development, regulatory approval, and commercialization of prescription therapies for obesity, exocrine pancreatic insufficiency, pulmonary arterial hypertension, and other conditions. The company operates global clinical development, CMC, regulatory, pharmacovigilance, and commercial functions. Recent communications describe international pricing changes for an oral weight-management therapy, clinical trial results combining an oral weight-management therapy with a digitally enhanced lifestyle intervention, and a patient copay assistance program for a pancreatic enzyme replacement therapy.
Industries
Nr. of Employees
medium (51-250)
Patents
Orally disintegrating dosage form for administration of avanafil, and associated methods of manufacture and use
US-10028916-B2
View Details
Orally disintegrating dosage form for administration of avanafil, and associated methods of manufacture and use
US-10028916-B2
View DetailsProducts
Pancrelipase delayed-release capsules (pancreatic enzyme replacement therapy)
Oral pancreatic enzyme replacement composed of porcine-derived lipases, proteases, and amylases for treatment of exocrine pancreatic insufficiency.
Phentermine/topiramate extended/modified-release oral capsules (weight-management therapy)
Oral combination therapy indicated as an adjunct to reduced-calorie diet and increased physical activity for chronic weight management in adults and selected pediatric patients.
Investigational pulmonary arterial hypertension compound (lead program)
Pipeline small-molecule candidate in development for pulmonary arterial hypertension (investigational).
Early-stage investigational compounds for transplant preparation and metabolic disease
Additional pipeline programs in early development for indications including bone marrow transplant preparation and diabetes.
PANCREAZE MT
PANCREAZE is a combination of porcine-derived lipases, proteases, and amylases indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions.
PANCREASEMT (pancrelipase) capsules
PANCREASE MT capsules are indicated for the treatment of pancreatic insufficiency attributed to cystic fibrosis, chronic pancreatitis, or any other medically defined pancreatic disease requiring pancreatic enzyme therapy.
Pancrelipase delayed-release capsules (pancreatic enzyme replacement therapy)
Oral pancreatic enzyme replacement composed of porcine-derived lipases, proteases, and amylases for treatment of exocrine pancreatic insufficiency.
Phentermine/topiramate extended/modified-release oral capsules (weight-management therapy)
Oral combination therapy indicated as an adjunct to reduced-calorie diet and increased physical activity for chronic weight management in adults and selected pediatric patients.
Investigational pulmonary arterial hypertension compound (lead program)
Pipeline small-molecule candidate in development for pulmonary arterial hypertension (investigational).
Early-stage investigational compounds for transplant preparation and metabolic disease
Additional pipeline programs in early development for indications including bone marrow transplant preparation and diabetes.
PANCREAZE MT
PANCREAZE is a combination of porcine-derived lipases, proteases, and amylases indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions.
PANCREASEMT (pancrelipase) capsules
PANCREASE MT capsules are indicated for the treatment of pancreatic insufficiency attributed to cystic fibrosis, chronic pancreatitis, or any other medically defined pancreatic disease requiring pancreatic enzyme therapy.
Services
Protocol design, patient enrollment, trial conduct and reporting across early and late-stage clinical programs, including studies that integrate digital devices and apps.
Regulatory strategy and submission support, post-marketing safety surveillance, REMS/risk-management program implementation, and corporate compliance program operation.
Market launches, pricing implementation across international markets, pharmacy partnerships, and patient access programs including copay assistance.
Protocol design, patient enrollment, trial conduct and reporting across early and late-stage clinical programs, including studies that integrate digital devices and apps.
Regulatory strategy and submission support, post-marketing safety surveillance, REMS/risk-management program implementation, and corporate compliance program operation.
Market launches, pricing implementation across international markets, pharmacy partnerships, and patient access programs including copay assistance.
Expertise Areas
- Clinical trial management
- Clinical trials with integrated digital endpoints
- Regulatory compliance and global submissions
- Chemistry, Manufacturing and Controls (CMC) and oral formulation development
Key Technologies
- Randomized controlled trial design
- Wearable and connected devices for clinical programs
- Digital health platforms and smartphone applications
- Modified-release and delayed-release oral formulation technologies
News & Updates
Announcement of updated pricing and market availability for an oral weight-management therapy across Sweden, Denmark, Finland, Iceland, and Poland; includes country-level pricing and notes on pharmacy partnerships.
Follow-up confirmation that the new pricing structure for the oral weight-management therapy is effective in approved European markets; includes risks and commercial considerations.
Press release summarizing clinical evidence supporting efficacy and safety of the oral weight-management therapy in chronic weight management.
Initial announcement describing the structure of the pricing reduction by country and the rationale for expanding access in European markets.
Launch of a patient copay assistance program providing reduced out-of-pocket costs for commercially insured patients, including program benefit limits and terms.
Results of a randomized, double-blinded trial showing greater weight loss and improvements in cardiovascular risk measures when an oral weight-management therapy was combined with a digitally enhanced lifestyle intervention versus digital intervention plus placebo.
Announcement of updated pricing and market availability for an oral weight-management therapy across Sweden, Denmark, Finland, Iceland, and Poland; includes country-level pricing and notes on pharmacy partnerships.
Follow-up confirmation that the new pricing structure for the oral weight-management therapy is effective in approved European markets; includes risks and commercial considerations.
Press release summarizing clinical evidence supporting efficacy and safety of the oral weight-management therapy in chronic weight management.
Initial announcement describing the structure of the pricing reduction by country and the rationale for expanding access in European markets.
Launch of a patient copay assistance program providing reduced out-of-pocket costs for commercially insured patients, including program benefit limits and terms.
Results of a randomized, double-blinded trial showing greater weight loss and improvements in cardiovascular risk measures when an oral weight-management therapy was combined with a digitally enhanced lifestyle intervention versus digital intervention plus placebo.