Firm expands to meet demand for Pancrecarb

By Katrina Megget

- Last updated on GMT

Related tags Digestion

US company Digestive Care (DCI) is quadrupling its manufacturing,
research and development capacity following an increase in demand
for its drug Pancrecarb (pancrelipase).

Based in Bethlehem, Pennsylvania, DCI, which develops pharmaceutical products for gastrointestinal disorders, is investing around $12m in the new facility, which will grow from its current 14,000sq ft to 30,000sq ft. Pancrecarb is an exocrine pancreatic insufficiency drug, supplying pancreatic enzymes for people who have an insufficiency in producing their own, such as in cystic fibrosis, chronic pancreatitis due to alcohol use or other causes, post-pancreatectomy, and post-gastrointestinal bypass surgery. DCI president and founder Dr Tibor Sipos said the company had experienced a 35-40 per cent increase from year-to-year in the demand for Pancrecarb, which was released in 1995. He put this down to the unique formulation of the drug, which is the only enteric-coated and bicarbonate-buffered pancreatic enzyme which is protected by several US patents. "This expansion is essential to ensuring that there is ample supply ofPancrecarbfor patients whose lives are dependent on the availability of this medication,"​ he said. "This is an extensive expansion for us. We want to grow. We have the potential to double our current markets right away and triple our size in three to five years." ​ The expanded facility, which will be completed by the end of the year, will also enable DCI to research, develop and manufacture other therapeutic products, including those for managing digestive disorders associated with cystic fibrosis and cholestatic liver disease. The company has several drugs at the forefront of drug delivery developments in the pipeline with the hope of approval, and the new facilities would be needed to cope with their manufacture, Sipos said. Pancrecarb contains the pancreatic enzymes lipase, amylase and protease within microsperes. The microsperes are protected by a pH sensitive enteric coating to protect against stomach acid so that the enzymes can be delivered to the intestine where they are activated by the change in pH and aid in digestion. Pancreatic extract products have a long history of use, some preceding the US Federal Food, Drug, and Cosmetic Act of 1938. More than three dozen different products are currently marketed. In April 2004 the US Food and Drug Administration (FDA) announced that manufacturers of pancreatic insufficiency products needed to get the drugs approved by the FDA within four years in order to remain on the market. The FDA decided to require approval of new drug applications (NDAs) for all pancreatic extract drug products after data showed substantial variations in drug potency among marketed products thereby affecting the safety and effectiveness of the drugs. Pancrecarb is in the process of getting this approval and Sipos said the drug was on track to fulfil the requirements. Other pancreatic insufficiency drugs that contain pancrelipase are Cotazym from Organon, Creon from Solvay, Lipram from Global Pharmaceuticals, and Viokase from Scandiphrm. Generic pancrelipase tablets and capsules are not available.

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