Abbott Japan and Eisai Announce Launch of Pancreatic Digestive Enzyme Replacement Drug Lipacreon® (pancrelipase)

Abbott Japan Co., Ltd.
Eisai Co., Ltd.

Abbott Japan Co., Ltd. (Pharma Products Group Headquarters: Tokyo, President: Gary M. Winer) and Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito) announced today that they will launch the pancreatic digestive enzyme replacement drug Lipacreon® Capsules 150 mg and Lipacreon® Granules 300mg Sachets (pancrelipase) on August 30 in Japan.

Abbott Japan received approval to manufacture and market Lipacreon® in Japan as a pancreatic digestive enzyme replacement in patients with pancreatic exocrine insufficiency (PEI) on April 22 of this year, with the drug being registered on the National Health Insurance Drug Price List on July 19. Eisai will market the Lipacreon® and ensure the provision of information on its proper use.

Lipacreon® is the first pancreatic digestive enzyme replacement therapy to be approved in Japan for the treatment of PEI due to chronic pancreatitis, pancreatectomy, cystic fibrosis and other conditions. The drug contains high-titer pancreatic enzymes such as amylase, lipase and protease, which have been extracted and purified from porcine pancreas. In comparison with Japanese Pharmacopoeia-listed pancreatin, the titer per unit weight of Lipacreon® is approximately 8 times that of lipase, approximately 7 times that of protease and approximately 6 times that of amylase. It also has an enteric coating to prevent gastric juices from causing inactivity. Furthermore, because the drug has been designed with an optimal granule diameter to ensure that it passes into the duodenum, it is expected to effectively stimulate digestion and absorption in PEI patients, thereby improving their nutritional health.

The results of a placebo-controlled double-blind study carried out in Japan in patients with PEI due to chronic pancreatitis or pancreatectomy showed that Lipacreon® significantly improved fat absorption, an indicator used to measure nutritional status. In a long term study, the drug also demonstrated significant improvements in nutritional endpoints. While the most commonly reported adverse effects of Lipacreon® include constipation, diarrhea, fever, abdominal distension and hyperglycemia, it has been confirmed to have a favorable tolerability profile.

In Europe and North America, enzyme-replacement therapy using high-titer pancreatin is recognized as a fundamental treatment for PEI, with Lipacreon® being marketed in over 80 countries around the world including Germany, the United Kingdom and the United States under the brand names Creon® and Kreon®.

Both Abbott Japan and Eisai will make contributions to improving the quality of life of PEI patients by providing Lipacreon® as a new treatment for PEI.