Shire recently announced that it has entered into an agreement with Janssen Pharmaceutica N.V., a Johnson & Johnson company, to acquire the rights to develop and commercialize Resolor (”prucalopride”) in the US. The terms of the agreement were not disclosed.
Resolor is the first of a new generation of selective, high-affinity 5-HT4 receptor agonists. The product was approved in the EU by the European Medicines Agency (“EMA”) in October 2009 for the symptomatic treatment of chronic constipation in women in whom laxatives fail to provide adequate relief. The product is currently available in various European countries including Germany, Ireland, Belgium, France, Greece and the United Kingdom. The company is planning to launch Resolor in Italy in mid-January 2012 and several other European nations in 2012.
Resolor is currently not approved in the US. Shire plans to work with the US Food and Drug Administration (“FDA”) on determining the future development and regulatory path for Resolor for the chronic constipation indication.
Movetis N.V., a Belgium-based pharma company, had acquired the rights to develop and commercialize Resolor in Europe from Janssen. In October 2010, Shire acquired Movetis and obtained the European rights of Resolor.
Resolor’s revenues, till date, have been lackluster. Shire is currently engaged in various marketing efforts to drive Resolor revenues. Considering the disappointing performance in Europe, we remain cautious about the drug’s potential in the US.
We currently have a Neutral recommendation on Shire. The stock carries a Zacks #3 Rank (Hold rating) in the short run.