Expecting FDA Approval for Eurand's Zenpep

| About: Eurand N.V. (EURX)
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Eurand Inc. (NASDAQ:EURX) is waiting for the FDA to decide upon its proprietary pancreatic enzyme product Zenpep for exocrine pancreatic insufficiency. The condition is associated with various diseases, including chronic pancreatitis, cystic fibrosis, pancreatic cancer, partial or total gastrectomy, pancreatic resection and other causes. The various causes of exocrine pancreatic insufficiency may be associated with changes in gastrointestinal intraluminal pH, bile acid metabolism, gastric emptying, and intestinal motility.

The resulting maldigestion can cause serious weight loss, nutritional deficiencies, and subjective complaints associated with inability to digest fat (steatorrhea) even after ingesting currently available pancreatic enzymes.

Why Zenpep?

While currently available enzyme replacement treatments are good at treating carbohydrate and protein malabsorption, they are not successful in treating fat malabsorption (steatorrhea). The reason for the failure is believed to be the destruction of these enzymes by acid denaturation and proteolytic digestion.

Eurand’s Zenpep was developed in response to the 2004 FDA initial guidance on pancreatic enzyme products, which outlined the need to reduce the variability in enzyme levels and stability of currently marketed enzyme therapies and regulate them under NDAs. Zenpep is being described as a highly stable formulation of a porcine pancreatic extract that is biologically similar to the endogenous human pancreatic secretions necessary for proper human digestion.

What are we expecting?

We personally expect Zenpep to be approved. The market is big, as indigestion is associated with many diseases.

The firm has a product pipeline that has five products in various phases of clinical trials. They target bpolar disorders, hypertension, inflammatory bowel syndrome and an antiemetic drug.

Disclosure: No positions