EUR-1008
Collaboration Partner:
Not Applicable
Status:
NDA Filed and Currently Under FDA Review
Profile:
EUR-1008 is a new, zero-overfill, highly-stable, porcine-derived, pancreatic enzyme replacement product (PEP) being developed for the treatment of Exocrine Pancreatic Insufficiency (EPI). EPI results from various diseases such as cystic fibrosis (CF), chronic pancreatitis, pancreatic cancer, cytomegalovirus infection and HIV/AIDS. EPI can also result from surgical procedures, including open gastric bypass, extensive small bowel resection and pancreatectomy.
EPI is a deficiency of digestive enzymes normally produced and secreted by the pancreas into the digestive tract. These enzymes primarily consist of lipases for fat digestion, proteases for protein digestion and amylases for starch digestion. If the pancreas is not able to produce and secrete sufficient amounts of these enzymes, food cannot be digested and the appropriate levels of nutrients cannot be absorbed into the bloodstream. Maldigestion and malabsorption associated with pancreatic insufficiency causes malnutrition, which can lead to impaired growth, impaired immune response and shortened life expectancy.
A normally functioning human pancreas secretes eight key enzymes required for the effective and efficient digestion and absorption of food. Scientific evidence indicates that, in addition to these key digestive enzymes, several coenzymes and cofactors are also required for absorption of essential nutrients. Porcine-derived PEPs are practically identical in composition to human pancreatic secretions and contain all of the key enzymes, coenzymes and cofactors necessary for proper digestion.
EUR-1008 is designed as a replacement product for these missing enzymes and is designed to restore and maintain digestion, absorption and to promote normal growth in these patients.
Pancreatic enzyme replacement products are used to treat:
Cystic Fibrosis
Cystic fibrosis is a life-threatening genetic disease that, because of a defective gene, causes the body to produce a faulty protein that leads to abnormally thick, sticky mucus that clogs the lungs and obstructs the pancreas. When cystic fibrosis affects the pancreas, the body does not absorb sufficient nutrients to grow and thrive. Cystic fibrosis is one of the most prevalent genetic diseases among caucasians in the United States. The disease affects an estimated 30,000 adults and children in the United States and 100,000 patients worldwide, an estimated 90 percent of whom suffer from EPI.
Chronic Pancreatitis
Chronic pancreatitis is a slow, clinically silent disease that gradually destroys the pancreas and is most often caused by excessive alcohol consumption, but may also result from other conditions such as hyperlipidemia, hyperparathyroidism, injuries or obstructions. Because chronic pancreatitis is not necessarily characterized by inflammation or pain, it often goes undiagnosed and therefore its exact prevalence is unknown. Based on industry reports, it is estimated that chronic pancreatitis results in more than 500,000 physician visits per year in the United States.
Eurand has completed two phase III clinical trials on EUR-1008 and submitted an NDA for this product in December 2007. The NDA is currently under FDA review.
Patients with EPI are currently treated with enzyme supplement products. The PEPs available on the market today generated approximately $720 million in worldwide sales during 2005, according to IMS Health. None of the currently marketed PEPs have been approved by the FDA in the United States. The FDA is now requiring that all PEPs available on the market after April 2010 receive approval for a NDA.