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EUR-1008: ZENPEP (pancrelipase) Delayed-Release Capsules

Gastroenterology

The first new pancreatic enzyme product (PEP) developed in 15 years, Zenpep® (pancrelipase) Delayed-Release Capsules is one of only three FDA approved PEPs in the U.S., and is the first PEP eligible for centralized EMEA review in the EU due to Technical Innovation.1


ZENPEP was the first FDA-approved PEP formulation studied in children as young as 1 year. It is available in a broad dosage range to fulfill the needs of all patient groups and provide easy titration according to disease severity. ZENPEP has a full data package with clinical studies in multiple age groups, with data in EPI due to both chronic pancreatitis and cystic fibrosis.

ZENPEP, an innovative new product, is Eurand’s first internally developed and commercialized product. ZENPEP is the lead product in Eurand’s portfolio of gastrointestinal and cystic fibrosis products.

Marketed by Eurand in the U.S., ZENPEP is a pancreatic enzyme product (PEP) indicated for the treatment of exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF) or other conditions such as chronic pancreatitis (CP), gastrointestinal surgery, and pancreatic cancer.2 ZENPEP has been shown to improve fat absorption (CFA), a key indicator of nutrient absorption, and reduce GI symptoms.2,3,4

Eurand seeks to license Zenpep® (pancrelipase) Delayed-Release Capsules (EUR-1008) to a partner with the capabilities and expertise to successfully market and sell the product in Europe and other world markets (excluding the United States).

Eurand was granted U.S. patent protection for Zenpep through 2028. Eurand’s patent portfolio includes more than 700 issued and pending U.S. and international patents.

Therapeutic Category

Gastrointestinal

Indication

Treatment of exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF) or other conditions such as chronic pancreatitis (CP), gastrointestinal surgery, and pancreatic cancer.2

Development Status

Marketed in the U.S. by Eurand; Licensing opportunities available

Available Dosage Strength(s)

Broad range of product strengths available

Product Description
  • ZENPEP (EUR-1008) is a pancreatic enzyme preparation consisting of pancrelipase. Pancrelipase contains multiple enzyme classes, including porcine-derived lipases, proteases, and amylases.
  • ZENPEP (EUR-1008) is available in capsules containing delayed-release enteric-coated beads. Capsules can be taken whole or opened and sprinkled on food (e.g. applesauce).

Eurand Technology
  • Enteric-coated bead technology

Qualified for centralized EMEA review due to Technological Innovation1

Licensing Opportunities

Eurand is seeking licensing partners in various ex-U.S. territories.

ZENPEP—For the treatment of exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF) or other conditions such as chronic pancreatitis (CP), gastrointestinal surgery, and pancreatic cancer.2


ZENPEP significantly improved fat (CFA) and protein (CNA) absorption, key indicators of nutrient absorption, in patients with EPI due to CF.5

  • ZENPEP reduced gastrointestinal (GI) pain associated with malabsorption, a common side effect of EPI.6,7
  • ZENPEP was effective regardless of age, sex, and disease severity.5
  • ZENPEP has been proven to be safe and effective in adults and children with CF.5
  • ZENPEP is efficacious for the treatment of EPI due to chronic pancreatitis (CP), achieving significant improvements in fat (CFA) absorption in patients.3

Latest News:


2/16/2010

Eurand Issued U.S. Patent for Zenpep®: Receives 5 Years Marketing Exclusivity, Protection Until 2028

11/30/2009

Eurand Launches Zenpep® in the U.S.

11/13/2009

Phase II/III Clinical Study Compares Safety and Efficacy of Two Doses of Zenpep® for Fat Absorption in Adult Chronic Pancreatitis Patients With Exocrine Pancreatic Insufficiency

Current Partners:
Eurand has partnered with Samil Pharm. Co., Ltd. to commercialize, license, and supply ZENPEP in South Korea.

Read the ZENPEP Full Prescribing Information

This information is provided solely for the purpose of the evaluation of business opportunities by potential collaboration partners. The information is based on currently existing data and marketing authorizations in a number of jurisdictions and should not be assumed to be approved by regulatory authorities in any individual country. Consumers should consult with their individual physician for product information and should not rely upon any information provided here.

For more information on this product, please contact Eurand.

1 Article 3(2)b, No.726/2004
2 Zenpep® (pancrelipase) delayed release capsules [package insert]. Eurand Pharmaceuticals, Inc., 2009
3 Press Release. Phase II/III Clinical Study Compares Safety and Efficacy of Two Doses of ZENPEP(TM) (Pancrelipase) Delayed-Release Capsules for Fat Absorption in Adult Chronic Pancreatitis Patients With Exocrine Pancreatic Insufficiency
4 Data on file MED-0127. Eurand SpA. Milan, Italy.
5 Wooldridge JL, et al. EUR-1008 pancreatic enzyme replacement is safe and effective in patients with cystic fibrosis and pancreatic insufficiency [published online ahead of print, Aug 14, 2009]. J Cyst Fibros.
6 Meier RF, Beglinger C. Nutrition in pancreatic diseases. Best Prac Res Clin Gastroenterol. 2006;20(3):507-529
7 Boat TF, Acton JD. Cystic fibrosis. In: Kleigman RM, Behrman RE, Jenson HR, Stanton BMD, eds. Nelson Textbook of Pediatrics.18th ed. Philadelphia, PA: Saunders; 2007.

ZENPEP is a registered trademark of Eurand Pharmaceuticals, Ltd.

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