California-based biopharmaceutical company Vivus Inc. (VVUS:NASDAQ) today announced that "the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for an improved formulation of PANCREAZE® (pancrelipase) Delayed Release Capsules that extends the shelf life to 36 months across all PANCREAZE dosages."
The company reported that PANCREAZE is indicated for the treatment of exocrine pancreatic insufficiency (EPI) due to cystic fibrosis or other conditions. The firm advised that it worked closely with its PANCREAZE manufacturing partner Nordmark Arzneimittel GmbH & Co on obtaining the FDA approval and that the sNDA was based on the amended terms of the contract manufacturing agreement between the two firms which was first previously announced in June 2019.
The company's Chief Executive Officer John Amos commented, "The approval of this sNDA is an important milestone for VIVUS and for the patients with EPI we seek to treat...It highlights our ability to derive additional value from our marketed products and allows patients to store PANCREAZE for longer periods of time, which may help to reduce their out-of-pocket expenses. We also expect that the 36-month shelf life will limit the amount of returned product and, over time, will lower our overall supply chain costs. We look forward to working with Nordmark and our supply chain and commercial partners on the transition to the improved formulation."
The firm advised in the release that PANCREAZE, which was originally approved in 2010, is "a pancreatic enzyme preparation consisting of pancrelipase, an extract derived from porcine pancreatic glands, as well as other enzyme classes, including porcine-derived lipases, proteases and amylases." The company explained in further detail that the pancreatic enzymes in PANCREAZE act like digestive enzymes physiologically secreted by the pancreas.
The company noted that that PANCREAZE is for use in the treatment of people who cannot digest food normally because their pancreas does not make enough enzymes due to cystic fibrosis and other conditions. The firm claims that PANCREAZE, which contains a mixture of digestive enzymes from pig pancreas, may help the human body use fats, proteins and sugars from food.
VIVUS is headquartered in Campbell, Calif., and is a biopharmaceutical company focused on development and commercialization of innovative therapies for patients with serious unmet medical needs. The company's commercial products include Qsymia®, which is indicated for the treatment of obese and overweight patients and PANCREAZE®, used in treatment of exocrine pancreatic insufficiency (EPI). The firm stated that EPI affects many patient populations, including patients with cystic fibrosis, chronic pancreatitis, celiac disease, diabetes, both type 1 and type 2, inflammatory bowel disease and HIV infection.
Vivus has a market capitalization of around $24.5 million with approximately 10.64 million shares outstanding and a short interest of about 6.3%. VVUS shares opened greater than 30% higher today at $3.02 (+$0.72, +31.30%) over yesterday's $2.30 closing price. The stock has traded today between $2.82 and $3.97/share and is currently trading at $3.80 (+$1.50, +65.22%).[NLINSERT]
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