BETHLEHEM, Pa., Oct. 27 Digestive Care, Inc. (DCI)announced today that it has completed the submission of the New DrugApplication ("NDA") for PANCRECARB(R) (pancrelipase), used in the treatment ofExocrine Pancreatic Insufficiency ("EPI"), to the U.S. Food and DrugAdministration ("FDA"). The FDA had previously granted the product Fast Trackdesignation and approved a rolling NDA submission schedule.
"Digestive Care has provided vital products used to improve thenutritional status of patients living with chronic diseases, such as cysticfibrosis, for over a decade. We are excited about the results of our ClinicalTrials submitted with the PANCRECARB(R) NDA, and are pleased to have completedthe NDA submission prior to the April 28, 2009 deadline set forth by the FDA,"said Dr. Tibor Sipos, President and Chief Scientific Officer. "PANCRECARB(R)is a unique bicarbonate buffered enteric-coated formulation of pancrelipasethat has been an essential component of the armamentarium for the treatment ofEPI associated with cystic fibrosis (CF) and other diseases affecting thepancreas. We are dedicated to continuing to provide PANCRECARB(R) to CFpatients and others suffering from EPI," added Dr. Sipos.
The results of the recently completed randomized, double-blind,placebo-controlled, multi-center, crossover study on PANCRECARB(R) MS-16 waspresented at the 2008 North American Cystic Fibrosis Conference, October 23-25in Orlando, Florida.
PANCRECARB(R) is a pancreatic enzyme replacement therapy for the treatmentof Exocrine Pancreatic Insufficiency. It is the only enteric coated,bicarbonate buffered pancreatic enzyme available on the market today, andseveral U.S. patents protect PANCRECARB(R). In April 2004, the FDA determinedthat prescription exocrine pancreatic insufficiency drug products aremedically necessary and, accordingly, allowed the drug manufacturers fouryears (April 2008) to obtain approved new drug applications. The FDA thenannounced the deadline extension for unapproved pancreatic enzyme drugproducts to April 28, 2010, but only if the manufacturers have investigationalnew drug applications on active status on or before April 28, 2008 and havesubmitted NDAs on or before April 28, 2009.
About Digestive Care, Inc.
DCI is a privately held fully integrated pharmaceutical company dedicatedto developing unique pharmaceutical products to alleviate complications andsymptoms of gastrointestinal disorders. DCI was founded in 1990. The companyholds 15 U.S. and foreign patents and has a national distribution network.The technology of DCI is based on the ability to commercially develop uniquedrug delivery systems for delivering bioactive molecules to their target site.The company has grown from an initial research based organization to a fullyintegrated pharmaceutical company encompassing Research, Product Development,Manufacturing, Packaging, Distribution, Marketing, and Sales. DCI's researchinto the controlled delivery of gastric acid resistant digestive enzymes andbuffered bile acids through micro encapsulation led to the development of thesuccessful drug product, PANCRECARB(R) (pancrelipase) which is manufactured inthe USA. For information, please visit us at www.digestivecare.com.
SOURCE Digestive Care, Inc.