Sucampo Pharmaceuticals, Inc and Abbott announced that Sucampo Pharma Ltd, a wholly-owned subsidiary of Sucampo Pharmaceuticals, Inc, has submitted a marketing application to the Japanese Pharmaceuticals and Medical Devices Agency for approval to market Amitiza (lubiprostone) 24 mcg for the treatment of chronic idiopathic constipation (CIC).
The submission includes the results of a phase 3 efficacy trial. The efficacy trial, which enrolled 124 patients, met its primary endpoint with statistical significance (p<0.001) and demonstrated a safety profile consistent with previously reported lubiprostone clinical data. The submission will be amended in early 2011 with the complete results of the phase 3 long-term, open-label, multi-centre, confirmatory, safety trial in 209 Japanese CIC patients. Top-line interim results from this trial were disclosed in August 2010 and top-line final results from this safety trial continue to be expected during the fourth quarter of 2010.
"We are pleased to have submitted the Japanese regulatory application for Amitiza, a first in class therapeutic. We will work diligently to achieve licensure in order to bring this potentially important new therapeutic tool to Japanese patients," said Ryuji Ueno, Sucampo's chairman and chief executive officer.
"Amitiza represents a major breakthrough in improving the quality of life for CIC patients, and we are excited to be able to make the product available for Japanese patients suffering from this condition," said Gary M Winer, president, Abbott Japan, which holds commercialization rights to lubiprostone in Japan.
In February 2009, Sucampo entered into a license, commercialization and supply agreement for lubiprostone with Abbott Japan Co. Ltd. under which Abbott received exclusive rights to commercialize lubiprostone in Japan for the treatment of CIC. Sucampo led the development program and is leading the regulatory activity of lubiprostone in Japan. This regulatory submission triggers a US$ 5,000,000.00 milestone payment from Abbott Japan to Sucampo Pharmaceuticals, Inc. The submission also triggers a US$ 1,250,000 milestone payment from Sucampo Pharmaceuticals Inc. to Sucampo AG.
Lubiprostone (trade named Amitiza) is a local activator of type-2 chloride channels in cells lining the small intestine. Lubiprostone increases fluid secretion into the intestinal tract.
Sucampo Pharma is an international biopharmaceutical company based in Bethesda, Maryland, focuses on the development and commercialization of medicines based on prostones.