Navigation Links
Eurand Announces Positive Phase III Clinical Study Results

Company's Pancreatic Enzyme Replacement Therapy Significantly Improved Absorption of Fat and Protein during Clinical Trials

MILAN, Italy and DAYTON, Ohio, April 04, 2007 /PRNewswire/ -- Eurand, a global specialty pharmaceutical company, today unveiled data from two phase III clinical trials on its lead product candidate, Zentase(TM), formerly EUR-1008, for the treatment of Exocrine Pancreatic Insufficiency (EPI). The US Food and Drug Administration (FDA) granted fast track status for Zentase for the treatment of EPI. The company intends to file for FDA approval during the second quarter of 2007 for this potentially first-in-class pancreatic enzyme replacement therapy.

Zentase is a zero-overfill, highly-stable, porcine-derived pancreatic enzyme replacement therapy used to treat EPI and was designed to meet FDA guidelines for pancreatic enzyme replacement products(1). According to the FDA, no currently marketed pancreatic enzyme product (PEP) has been shown to demonstrate consistent enzyme bioactivity that results in predictable safety and effectiveness(2). Many of the current enzyme products contain overfill to compensate for product instability during shelf life, which can lead to variability in dosing. As a highly-stable product, Zentase does not require overfill. Currently, there are no FDA approved PEPs for the treatment of EPI on the market in the US.

"We are excited to present the results of our phase III studies supporting Zentase for the full spectrum of cystic fibrosis patients suffering from EPI, including those needing limited supplementation to those with very aggressive enzyme deficiency," said Gearoid Faherty, Eurand Chairman and CEO.

Zentase met all primary and secondary endpoints in two phase III clinical trials. The studies were designed to determine whether the product candidate could alleviate serious malabsorption associated with EPI in both a pediatric (younger than 7 ye ars) and an older patient population.

Study results showed a clinically and statistically significant increase in the coefficient of fat absorption (CFA) in patients treated with Zentase. The mean percentage of CFA in patients receiving Zentase was 88.3 percent versus 62.8 percent in patients receiving placebo (p<0.001). Treatment guidelines suggest that the CFA should be at least 85 percent in cystic fibrosis (CF) patients(3).

"The protocols for these trials were reviewed by the FDA and developed in collaboration with the Cystic Fibrosis Foundation (CFF). We want to thank the CFF for their support," added Faherty.

Phase III Pivotal Study Results

This randomized, double-blind, placebo-controlled, cross-over study evaluated CF patients with EPI aged seven years and older. Patients treated with Zentase showed a statistically significant increase in the coefficient of fat absorption and coefficient of nitrogen absorption (CNA) as compared to those receiving a placebo. They also had fewer symptoms associated with impaired absorption such as bloating, flatulence, pain and evidence of fat in stools.

Moreover, in all study patients, regardless of starting levels while taking placebo, Zentase returned CFA and CNA absorption levels to ranges considered normal in healthy patients. We believe this suggests Zentase can provide the level of enzyme supplementation required by cystic fibrosis patients with different levels of EPI.

"I believe the results of this successful trial demonstrated the efficacy and safety of Zentase," said James E. Heubi, MD, Professor and Associate Chair for Clinical Research of Pediatrics at Children's Hospital Medical Center in Cincinnati, OH. "During the study, the level of fat absorption achieved with Zentase was very high and close to levels seen in healthy patients, even without the use of proton pump inhibitors (PPIs). This high fat absorption, without relying on PPIs could significantly reduce the number of pills patients take each day."

Phase III Pediatric Supportive Study Results

This open label study in CF patients under the age of seven involved a seven-day dose stabilization period followed by a seven-day treatment period. The study evaluated the percentage of "responders," or those patients without excess fat in stools and without signs and symptoms of malabsorption after one and two weeks of treatment. Secondary endpoints included weight change, nutritional status, stool frequency and consistency, incidences of bloating, pain and flatulence as well as physician and parent or guardian judgment of clinical symptoms improvement.

In the study, malabsorption symptoms were significantly lower at the end of treatment than at screening, consistent with control of malabsorption symptoms with Zentase in the pivotal phase III trial.

EPI and Cystic Fibrosis

EPI is a deficiency of digestive enzymes normally produced by the pancreas. The deficiency leads to malnutrition, impaired growth in children and shortened life expectancy. EPI is commonly associated with cystic fibrosis and chronic pancreatitis.

Cystic Fibrosis affects about 30,000 individuals in the US and 100,000 worldwide. Approximately 90 percent of these individuals suffer from EPI. Treatment with PEPs helps replace enzymes lost through this disease. Other than enzyme replacement, Eurand is not aware of any other alternative therapy for EPI.


Zentase is a zero-overfill, highly-stable, porcine-derived pancreatic enzyme replacement therapy designed to treat EPI, a deficiency of digestive enzymes normally produced by the pancreas.

Zentase closely mimics the enzyme profile of normal human pancreatic secretions. Formulated with eight key enzymes and other co-enzymes and cofactors required for proper digestion, Zentase is highly stable and requires no product overfill. The product is being developed in multiple strengths as well as a pediatric formu lation, which can be sprinkled on food for easier administration to young children.

The full results of the two phase III trials will be published in peer reviewed journals and presented at upcoming medical meetings in the United States and Europe.

About Eurand

Eurand is a specialty pharmaceutical company that develops enhanced pharmaceutical and biopharmaceutical products based on its proprietary drug formulation technologies. Eurand has had four products approved by the FDA since 2000 and has a pipeline of product candidates in development for itself and its partners. Eurand's technology platforms include bioavailability enhancement of poorly soluble drugs, customized release, taste-making/fast- dissolving formulations and drug conjugation.

Eurand is a global company with research, development and manufacturing facilities in Milan, Italy, Dayton, Ohio, USA, Trieste, Italy and Paris, France. For more information, visit Eurand's website at

This release, and oral statements made with respect to information contained in this release, constitutes forward-looking statements. Such forward-looking statements include those which express plan, anticipation, intent, contingency, goals, targets or future development and/or otherwise are not statements of historical fact. These statements are based upon management's current expectations and are subject to risks and uncertainties, known and unknown, which could cause actual results and developments to differ materially from those expressed or implied in such statements.

    (1) Guidance for Industry Exocrine Pancreatic Insufficiency Drug Products

        -Submitting NDAs

        U.S. Department of Health and Human Services, Food and Drug

        Administration (FDA), Center for Drug Evaluation and Research (CDER),

        April 2006

    (2) Federal Register/ Vol. 69 No. 82. April 28, 2004

    (3) Littlewood, 
James M., and Susan P. Wolfe. "Control of Malabsorption in

        Cystic Fibrosis." Paediatric Drugs (2000; 2 : 205-22)

CONTACT: Eurand, Marian Cutler, (US) +1-973-517-0519

Web site:

Terms and conditions of use apply
Copyright © 2007 PR Newswire Association LLC. All rights reserved.
A United Business Media Company


Related medicine technology :

1. Eurands Zentase Effective in Treating Exocrine Pancreatic Insufficiency, Studies Show
2. Eurand to Present Zentase Phase III Data
3. Antisoma Announces Further Data From ASA404 Ovarian Cancer Trial
4. Neose Announces Presentation of Positive Preclinical Data on GlycoPEGylated Factor VIIa at the XXI Congress of the International Society on Thrombosis and Haemostasis
5. Biofrontera AG Announces Clinical Study Confirms Excellent Efficacy of BF-200 ALA In Actinic Keratosis
6. YM BioSciences Announces Secondary Efficacy and Safety Findings in Randomized Phase IIB Aerolef Trial
7. BioSante Pharmaceuticals Announces New Findings for Potential Bird Flu Vaccine
8. Portola Pharmaceuticals Announces Positive Data from a Phase II Study of its Factor Xa Inhibitor at the XXI Congress of the International Society on Thrombosis and Haemostasis
9. Manhattan Pharmaceuticals Announces Results of Phase 2a Studies for Oral Oleoyl-estrone
10. AVI BioPharma Partner Cook Medical Announces Completion of Patient Enrollment for APPRAISAL Phase II Clinical Trial for Treatment of Cardiovascular Disease
11. Protox Announces Positive Clinical Data from Prostate Cancer Study
Post Your Comments:
(Date:4/18/2017)... , April 18, 2017  Cardinal Health (NYSE: ... 1 fiscal 2017 earnings per share (EPS) guidance ... 2019.  This is in conjunction with this morning,s announcement ... Vein Thrombosis and Nutritional Insufficiency businesses. Cardinal ... continuing operations will be at the bottom of its ...
(Date:4/18/2017)... April 18, 2017 Viverae ® , a ... the integration of IBM ® Watson Campaign Automation, ... targeted communications for a personalized experience. Through digital engagement, ... their health in real time. The enhanced experience drives ... to members, wherever they are in their journey to ...
(Date:4/18/2017)... DIEGO , April 18, 2017  Astute Medical, ... a case series to be presented at the 2017 ... which begins today and continues through April 22. Physicians ... IGFBP-7 , used to assess risk for acute kidney ... decompensated heart failure (ADHF). Elevated levels ...
Breaking Medicine Technology:
(Date:4/28/2017)... , ... April 28, 2017 , ... Getting enough sleep affects much more than energy ... going just 19 hours without sleep can compromise motor reaction time, which can increase the ... Amica Insurance is sharing the following tips from the NSF to help you sleep better ...
(Date:4/28/2017)... Fairfax, VA (PRWEB) , ... April 28, 2017 , ... ... elected volunteer board members and officers for 2017-2018. The annual board election process has ... serving on a volunteer basis. , Thomas C. Dickerson, Ed.D., FACHE, succeeds Jim Hamilton, ...
(Date:4/28/2017)... ... April 28, 2017 , ... From April ... of Urgent Care Medicine will host industry leaders for the annual spring Convention ... those in the industry adapt to the issues currently affecting urgent care and ...
(Date:4/28/2017)... ... ... Overseer at The House of Yahweh in Abilene, Texas, has published a new post that ... Yisrayl says with so many titles and names for the Creator, it’s hard for many ... Scripture, backed with a lot of research, the truth is undeniable. , “If you ...
(Date:4/28/2017)... York, New York (PRWEB) , ... April 28, ... ... high-quality anti-aging skincare and advanced nutraceutical supplements, through its Nova Skin ... cream provides the hydrating benefits of a moisturizer with the power of an ...
Breaking Medicine News(10 mins):