The global specialty biopharmaceutical company, Shire plc, and Janssen Pharmaceutica N.V. have entered into an agreement under which Shire has acquired the US rights to develop and market Resolor (prucalopride) from Janssen Pharmacetica. Terms of the agreement have not been disclosed.
Resolor is a 5-HT4 receptor agonist. 5-HT4 receptors are mainly found in the gut wall and are involved in the stimulation of high-amplitude contractions and coordination of bowel motility.
Resolor, a prokinetic, is part of Shire’s gastrointestinal (GI) portfolio in Europe and is approved for use in 33 countries for the symptomatic treatment of chronic constipation in women in whom laxatives fail to provide adequate relief. Resolor is currently available in Germany, Ireland, Belgium, France, Greece and the United Kingdom, and will be commercially available in Italy in mid-January 2012. Additional launches throughout Europe are planned for 2012.
“We are excited about the opportunity to develop Resolor in the US and we look forward to working with the FDA and the GI physician community to define the path forward for registration of the medicine as a treatment for chronic constipation in the US,” said Roger Adsett, senior vice president of Shire’s global GI business.
Resolor was developed for the European market by the Belgian-based pharmaceutical company Movetis, which acquired the European rights to Resolor from Janssen Pharmaceutica N.V. Shire acquired Movetis in 2010.
Under the terms of the agreement, the US rights to the Resolor trademark will be transferred to Shire.
Resolor is indicated in the European Economic Area for symptomatic treatment of chronic constipation in women in whom laxatives fail to provide adequate relief. Resolor is not currently approved for use in the US.