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"Digestive Care has provided vital products used to treat EPI for over adecade and we are committed to filing the remaining modules for the NDA forPANCRECARB(R) to meet the April 28, 2009 requirements set forth by the FDA,"said Dr. Tibor Sipos, President and Chief Scientific Officer. "Digestive Careis committed to improving the quality of life for individuals suffering fromchronic illnesses such as Cystic Fibrosis," added Dr. Sipos.
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In addition, Digestive Care recently completed a randomized, double-blind,placebo-controlled, multi-center, crossover study on PANCRECARB(R) MS-16. Theclinical trial was conducted at 5 centers and included 21 subjects. Theresults will soon be published at upcoming scientific meetings.
About PANCRECARB(R)
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. PANCRECARB(R) is on track tofulfill these requirements.
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 Company's technology is based on the ability to commercially developunique drug delivery systems for delivering bioactive molecules to theirtarget site. The company has grown from an initial research basedorganization to a fully integrated pharmaceutical company encompassingResearch, Product Development, Manufacturing, Packaging, Distribution,Marketing, and Sales. DCI's research into the controlled delivery of gastricacid resistant digestive enzymes and buffered bile acids through microencapsulation led to the development of the successful drug product,PANCRECARB(R) (pancrelipase). For information, please visit us athttp://www.digestivecare.com.
SOURCE Digestive Care, Inc.
