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Eurand's Zentase Effective in Treating Exocrine Pancreatic,Insufficiency, Studies Show

ics on the worldwide incidence of EPI, but in the U.S., it is estimated that more than 200,000 people suffer from EPI.

"Nutritional status, lung function and life expectancy are tightly connected in cystic fibrosis patients. In general, enhancing CFA and CNA levels improves nutrition. Good nutrition improves lung function. And, better lung function improves life expectancy," said James E. Heubi, MD, Director, General Clinical Research Center, Professor of Pediatrics, Cincinnati Children's Hospital Medical Center. "These data suggest that Zentase could provide EPI patients with an effective treatment option that would normalize CFA which could protect lung function and increase life expectancy."

Zentase is a zero-overfill, highly-stable, porcine-derived PEP. If approved by the FDA, it is expected to be available in four dose strengths, including a low-dose formulation for children that can be sprinkled on food.

"As a company, our goal is to develop products that optimize efficacy and tolerability while meeting patient needs for convenience, which is why we developed Zentase specifically with patients in mind," said Gearoid Faherty, Chief Executive Officer, Eurand. "The data presented in Turkey are an indication that with Zentase, we are well on the way toward meeting that goal."

About the Studies

The two phase III studies were designed to test Zentase in EPI patients presenting with the full range of disease severity. The studies included patients from 1-24 years of age with disease severity including mild, moderate and severe malabsorption. Half of the patients enrolled in the pivotal study had a baseline CFA greater than 65 percent and half had a baseline CFA lower than 65 percent (median CFA levels were 65.8 percent). Patients enrolled in the pivotal study had a wide range of baseline CFA levels with one patient as low as 28.7 percent (very severe disease) and five patients with CFA levels above 80 percent.

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