Healthcare Business

Why This FDA Approval Is a Big Win for Vivus

Vivus Inc. (NASDAQ: VVUS) shares jumped on Wednesday after the company announced a crucial approval by the U.S. Food and Drug Administration (FDA). Specifically, the FDA approved the company’s supplemental New Drug Application (sNDA) for an improved formulation of Pancreaze.

Pancreaze is indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions. The pancreatic enzymes in Pancreaze act like digestive enzymes physiologically secreted by the pancreas.

The improved formulation for the Pancreaze delayed-release capsules would extend the shelf life to 35 months across all Pancreaze dosages.

Vivus has worked with Nordmark Arzneimittel, its manufacturing partner for Pancreaze, on the FDA approval pursuant to the terms of the amended contract manufacturing agreement announced in June 2019.

John Amos, CEO at Vivus, commented:

The approval of this sNDA is an important milestone for VIVUS and for the patients with [exocrine pancreatic insufficiency] 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.

Shares of Vivus traded up about 34% to $3.09 early Wednesday, in a 52-week range of $2.10 to $5.78. The consensus price target is $10.00.