Products

Ex-U.S. ONLY
ZENPEP™ (pancrelipase) Delayed-Release
Capsules (EUR-1008)

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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).

Patent applications have been filed by Eurand worldwide.


Therapeutic Category Gastrointestinal
Indication
  • Treatment of exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF) or other conditions1
  • Accepted as eligible for centralized review procedure in the European Union
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 beads
Data
  • Significantly improves key indicators of nutrient absorption and reduces GI symptoms3
  • Offers a proven safety profile, as demonstrated in adults and children as young as 1 year old2
  • Provides a clinical therapy for exocrine pancreatic insufficiency (EPI)
  • Marketed by Eurand in the U.S.

Click here to read the Ex-U.S. Brochure (PDF)

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 available ex-U.S. licensing opportunities for EUR-1008, please contact us at partners@eurand.com.

1Zenpep® (pancrelipase) delayed release capsules [package insert]. Eurand Pharmaceuticals, Inc., 2009
2Wooldridge 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.
3Article 3(2)b, No.726/2004
4EMEA Article 14(11) of Regulation (EC) No 726/2004:

ZENPEP is a registered trademark of Eurand Pharmaceuticals, Ltd.

More Information

For more information, contact Eurand at partners@eurand.com or +1-267-759-9340

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The information contained in this document is for Ex-U.S. use only.
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