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Drug Names(s): pancrelipase, Ultrase MT, Ultrase Capsules, Enzepi
Description: ULTRASE (pancrelipase) Capsules are orally administered and contain 250 mg of enteric-coated microspheres of porcine pancreaticenzyme concentrate, predominantly pancreatic lipase, amylase, and protease. ULTRASE Capsules are designed to prevent inactivation by gastric acid thereby resulting in the delivery of high levels of biologically active enzymes into the duodenum. The enzymes catalyze the hydrolysis of fats into glycerol and fatty acids, starch into dextrins and sugars, and protein into proteoses and derived substances.
ULTRASE Capsules are indicated for patients with partial or complete exocrine pancreatic insufficiency caused by:
- Cystic fibrosis (CF)
- Chronic pancreatitis due to alcohol use or other causes
- Surgery (pancreatico-duodenectomy or Whipple's procedure, with or without Wirsung duct injection, total pancreatectomy)
- Obstruction (pancreatic and biliary duct lithiasis, pancreatic and duodenal neoplasms, ductal stenosis)
- Other pancreatic disease (hereditary, post traumatic and allograft pancreatitis, hemochromatosis, Shwachman's Syndrome,lipomatosis, hyperparathyroidism)
- Poor mixing (Billroth II gastrectomy, other types of gastric bypass surgery, gastrinoma)
Pancrelipase capsules are effective in controlling steatorrhea.
Aptalis no longer reports revenues for Ultresa as of Q4 2010.
Existing products to treat exocrine pancreatic insufficiency have been marketed in the U.S. since before the passage of the Federal Food, Drug, and Cosmetic Act, or FDCA, in 1938 and, consequently, there are currently marketed PEPs that have not been approved by the FDA. In 1995, the FDA issued a final rule requiring that these PEPs be marketed by prescription only, and, in April 2004, the FDA mandated that all manufacturers of exocrine pancreatic insufficiency drug products file an NDA and receive approval for their products by April 2008 or be subject to regulatory action.
Axcan (now Aptalis) and Eurand
ULTRASE is licensed from Eurand under an exclusive development license and supply agreement signed in 2000. It was for an original term of ten years with automatic renewals for subsequent periods of two years. The agreement was amended in 2007 and the term extended to the end of 2015. Axcan...See full deal structure in Biomedtracker
Pink Sheet March Full Approvals
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