Firms project filing sNDA for lubiprostone during first half of 2012.
Partners Sucampo Pharmaceuticals and Takeda reported positive results from a second Phase III trial evaluating lubiprostone as a treatment for opioid-induced bowel dysfunction (OBD) in patients with chronic noncancer pain, excluding those taking methadone. The 12-week Phase III study in 439 patients showed that the overall spontaneous bowel movement (SBM) response rate among those treated twice daily using oral lubiprostone was 26.9% compared with 18.6% for the placebo cohort.
The firms say they anticipate filing an sNDA during the first half of 2012 and will discuss with FDA the potential for priority review. “These data confirm the results from a previous Phase III trial of lubiprostone in OBD patients and together with data from the associated long-term safety trial, complete what we believe are the data requirements to support the submission of a supplemental new drug application,” comments Ryuji Ueno, M.D., Sucampo chairman and CEO.
Trademarked Amitiza, lubiprostone is a chloride channel activator that is already approved in the U.S. for the treatment of adults with chronic idiopathic constipation and for constipation-predominant irritable bowel syndrome.
Sucampo and Takeda inked their collaboration and license agreement to codevelop and commercialize Amitiza for CIC and IBS-C and other gastrointestinal indications in the U.S. and Canada back in 2004. Takeda is primarily responsible for selling Amitiza in the U.S. and recorded net Amitiza (lubiprostone) sales of $57.6 million for the third quarter 2011, up 1.1% on the equivalent 2010 period.
However, there is little love lost between the firms, apparently. Sucampo believes its partner hasn’t been putting nearly enough effort into marketing Amitiza, which means sales and hence Sucampo’s royalties are well down on expected figures. The latter says this failure by Takeda to generate an appropriate level of U.S. sales of Amitiza is the result of a material breach of their agreements. As a result, Sucampo filed for arbitration back in 2010, and a decision is now pending.
Sucampo separately has a license, commercialization, and supply agreement with Abbott for lubiprostone in Japan. The deal, signed in 2009, gives Abbott exclusive rights to commercialize lubiprostone for the treatment of CIC in Japan and the right of first refusal to any additional indications for which lubiprostone is developed in that country. Sucampo is still responsible for the carrying out and funding development of the drug for the Japanese market. Regulatory review for the CIC indication is currently in progress, and approval could be granted during early 2012, Sucampo stated in a recent financial report.