For Immediate Release
Eurand Granted FDA Approval for ZENPEP™
First and Only FDA-Approved Pancreatic Enzyme Product
Clinically Tested in Patients under 12 Years Old
PHILADELPHIA, Pa. — Aug. 28, 2009 — Eurand N.V. (NASDAQ: EURX), a specialty pharmaceutical
company, today announced U.S. Food and Drug Administration (FDA) approval of its New Drug Application
(NDA) for ZENPEP™ (pancrelipase) Delayed-Release Capsules for the treatment of exocrine pancreatic
insufficiency (EPI) in patients with cystic fibrosis (CF) or other conditions.
ZENPEP is the only FDA-approved pancreatic enzyme product (PEP) that has been evaluated in clinical studies
in adults and children — including children from one to 12 years old — and will offer four dosage strengths to
meet the varied needs of infants, toddlers, adolescents and adults with EPI.
“The availability of clinical evidence in a pediatric population is particularly important for EPI patients with CF
and their caregivers, as early improvements in BMI (Body Mass Index) significantly affect long-term
survivability,” said Jamie Wooldridge, M.D., Assistant Professor, Department of Pediatrics, Division of
Pulmonary Medicine at Cincinnati Children’s Hospital Medical Center, Cincinnati, Ohio, and a principal
investigator in the ZENPEP pediatric trial. ZENPEP capsules were formulated to allow the contents to be
sprinkled on food where necessary, which is a key attribute to support the developmental needs of very young
children as well as older patients.
EPI is the inability to properly digest food due to a lack of digestive enzymes made by the pancreas. Loss of
digestive enzymes leads to maldigestion and malabsorption of nutrients. This is a common disorder for those
suffering from cystic fibrosis and other conditions compromising the exocrine function of the pancreas, such as
pancreatic cancer, gastrointestinal surgery and chronic pancreatitis. EPI results in malnutrition and, especially in
CF patients, impaired growth in children, compromi