Submission of a New Drug Application for Pancreatic Enzyme Replacement Therapy

A New Drug Application for the pancreatic enzyme replacement therapy agent for pancreatic exocrine insufficiency, SA-001 (API name: Pancrelipase) that Solvay Seiyaku K. K. co-developed with Eisai Co., Ltd. was submitted by Solvay Seiyaku on December 22, 2009 in Japan.

The agent is a high performance, acid resistant enteric-coated pancreatic enzyme obtained by formulating highly purified pancrelipase with a proprietary technology. It is marketed as Creon(R)/Kreon(R) in 75 countries outside Japan including the United States, the United Kingdom and Germany. Creon/Kreon is the global market leader in pancreatic enzyme replacement therapy for pancreatic exocrine insufficiency due to cystic fibrosis, chronic pancreatitis, and pancreatectomy and other conditions. After obtaining its manufacturing and marketing authorization for the agent, distribution in Japan will be conducted by Eisai. Solvay Seiyaku retains co-promotion rights with Eisai.

The agent significantly improved the difference of fat absorption ratio calculated from fat intake and discharged fat in stool before and after administration in its double blind placebo controlled clinical study in patients with pancreatic exocrine insufficiency due to chronic pancreatitis or pancreatectomy conducted in Japan. Furthermore, the agent showed significant improvements of the nutrition evaluation scale in its long term study. Also, the agent showed important improvements of fat absorption ratio and nutrition evaluation scale in a clinical study in patients with pancreatic exocrine insufficiency caused by cystic fibrosis.

Solvay Seiyaku is a Japanese entity of Solvay Pharmaceuticals, which is the pharmaceutical sector of the chemical and pharmaceutical global company, Solvay Group. It is a development-driven pharmaceutical company that seeks to fulfill carefully selected, unmet needs in the therapeutic areas of neuroscience, cardio-metabolic, and gastroenterology.

With the proton pump inhibitor Pariet(R) and gastritis/gastric-ulcer treatment Selbex(R) amongst its main products in Japan, Eisai considers gastroenterology as an area of therapeutic focus. It aims to enhance this area even further through the addition of SA-001 to its product portfolio.

Solvay Seiyaku and Eisai work in tandem to bring SA-001 as a new treatment option to contribute to the treatment of patients with pancreatic exocrine insufficiency and to improving their quality of life.

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