Healthcare Industry News: CoFactor
News Release - February 2, 2006
Eurand Initiates the First of Two Phase 3 Studies for EUR-1008M in Patients With Pancreatic InsufficiencyMILAN, Italy, Feb. 2 (HSMN NewsFeed) -- Eurand, a specialty pharmaceutical company, announced today the initiation of the first of two Phase 3 clinical trials required for registration of its pancreatic enzyme product (PEP), EUR- 1008M, in patients with exocrine pancreatic insufficiency (EPI). EPI is a deficiency of digestive enzymes normally produced by the pancreas, which leads to malnutrition, impaired growth and shortened life expectancy. EPI can result from a number of diseases and conditions, including cystic fibrosis (CF), chronic pancreatitis and pancreatic cancer.
The trial will involve approximately 20 clinical study sites in the United States. Patient enrollment has commenced and is expected to be complete by end of June 2006. Results of the study are expected in the fourth quarter of 2006. The trial is designed to determine the safety and tolerability of EUR-1008M and will compare the active drug to placebo in improving absorption of fat and other nutrients. The protocol for the trial has been prepared in collaboration with the Cystic Fibrosis Foundation Therapeutic Development Network Coordinating Center.
EUR-1008M is a new and proprietary PEP developed by Eurand. It has been developed as a delayed-release capsule intended to provide consistent product dosing over time, and EUR-1008M will be available in multiple dosage strengths to provide flexibility and convenience in dosing.
Gearoid Faherty, chief executive officer of Eurand commented: "The commencement of these trials is a major milestone in our development of a new PEP formulation for the treatment of pancreatic insufficiency. This new product builds on our 15 years of experience in developing and manufacturing pancreatic enzyme products and we believe that if these Phase 3 trials are successful, EUR-1008M could represent a significant advance in the treatment of pancreatic insufficiency."
An additional trial of EUR-1008M in a pediatric population is expected to commence in the second quarter of 2006.
Trial Design and Endpoints
The Phase 3 trial will be conducted in CF care centers in the United States. The study will be a multi-center, double-blind, placebo-controlled, cross-over trial in patients over seven years of age with pancreatic insufficiency and cystic fibrosis. The study will evaluate the safety and efficacy of EUR-1008M compared to placebo in improving coefficient of fat absorption, while assessing among other endpoints, improvements in protein and other nutrient absorption.
EUR-1008M is a new orally delivered pancreatic enzyme product consisting of approximately 14 enzymes, coenzymes and CoFactors. It is biologically similar to endogenous human pancreatic secretions and is intended to treat malabsorption of fats, proteins, carbohydrates and other essential nutrients in patients with pancreatic insufficiency. EUR-1008M is a highly stable formulation that has been developed to meet the U.S. Food and Drug Administration (FDA) draft guidelines(1) for pancreatic enzyme products. EUR- 1008M is being developed in a number of dosage forms and strengths that Eurand believes will provide consistent product dosing, stability, long-term shelf life and convenient dosing.
Current treatment of pancreatic insufficiency requires the use of pancreatic enzyme products. None of the currently marketed products in the United States have been approved by the US Food and Drug Administration (FDA). The FDA has issued regulations requiring all PEPs marketed after April 2008 to have an FDA approved registration. Eurand is conducting Phase 3 trials in support of registering EUR-1008M for the treatment of exocrine pancreatic insufficiency.
About Exocrine Pancreatic Insufficiency and Cystic Fibrosis
EPI is a deficiency of digestive enzymes normally produced by the pancreas, which leads to malabsorption of fats, proteins, carbohydrates and other essential nutrients. Impaired absorption can result in malnutrition and a host of secondary complications including, retarded growth and development, impaired immune response, infections and shortened life expectancy among others. EPI can result from a number of diseases and conditions, including cystic fibrosis, chronic pancreatitis and pancreatic cancer.
Cystic fibrosis is a genetic disease affecting approximately 30,000 children and adults in the United States. A defective gene causes the body to produce an abnormally thick, sticky mucus that clogs the lungs resulting in severe lung infections and obstructs the pancreas, preventing digestive enzymes from reaching the intestines and leading to pancreatic insufficiency. Approximately 90% of cystic fibrosis patients suffer from pancreatic insufficiency.
Eurand is a privately held specialty pharmaceutical company that develops enhanced pharmaceutical and biopharmaceutical products based on its proprietary drug delivery technologies. The Company specializes in four areas: bioavailability enhancement of poorly soluble drugs, customized release, taste masking/fast-dissolving formulations, and drug targeting. Eurand has had three products approved by the FDA since 2000 and is currently developing a pipeline of products based on its proprietary drug delivery technologies. The company also works with many of the world's leading pharmaceutical and biotechnology companies to develop enhanced forms of their existing products and development compounds.
Eurand is a global company with more than 500 employees and annual revenue of more than $100 million. Eurand is based in Milan, Italy, with research, development and manufacturing facilities throughout the world, including sites in Milan, Italy; Vandalia, Ohio (US) and Paris, France. For more information, visit Eurand's website at http://www.eurand.com.
CONTACT: Gearoid Faherty
Italy Phone: +39-02-954281
(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),
Issuer of this News Release is solely responsible for its
Please address inquiries directly to the issuing company.