Shire Acquires US Rights to Resolor (prucalopride)

Agreement allows development for potential treatment of chronic constipation

PHILADELPHIA, January 10, 2012/PRNewswire-FirstCall/ --Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announced today that it has acquired the rights to develop and market Resolor(R) (prucalopride) in the United States (US) in an agreement with Janssen Pharmaceutica N.V. Terms of the agreement have not been disclosed.

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.

About Resolor (prucalopride)

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 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.

Important Safety Information

Healthcare professionals in the EU should consult the Resolor Prescribing Information before prescribing, particularly in relation to hypersensitivity to any of the constituents, renal impairment requiring dialysis, intestinal perforation or obstruction, obstructive ileus, severe inflammatory conditions of the intestinal tract, severe and clinically unstable concomitant diseases, in particular arrhythmias or ischaemic cardiovascular disease. Based on placebo-controlled clinical study data, very common side effects associated with Resolor are headache, nausea, diarrhoea, abdominal pain, occurring predominantly at the start of therapy and usually disappearing within a few days with continued treatment; common side effects are dizziness, vomiting, dyspepsia, rectal haemorrhage, flatulence, abnormal bowel sounds, pollakiuria, fatigue. The efficacy of prucalopride has been established in double-blind placebo-controlled studies for up to 3 months. Reassess periodically the benefit in case of prolonged treatment. In the EU, detailed information on this medicinal product is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu.

About chronic constipation

Chronic constipation is characterized by infrequent and difficult passage of stools over a prolonged period and a range of bothersome symptoms. Traditional treatment options for chronic constipation consist mainly of dietary and lifestyle changes in combination with laxatives.

SHIRE PLC

Shire's strategic goal is to become the leading specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on attention deficit hyperactivity disorder, human genetic therapies, gastrointestinal diseases and regenerative medicine as well as opportunities in other therapeutic areas to the extent they arise through acquisitions. Shire's in-licensing, merger and acquisition efforts are focused on products in specialist markets with strong intellectual property protection and global rights. Shire believes that a carefully selected and balanced portfolio of products with strategically aligned and relatively small-scale sales forces will deliver strong results.

For further information on Shire, please visit the Company's website: http://www.shire.com.

"SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

Statements included herein that are not historical facts are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, the Company's results could be materially adversely affected. The risks and uncertainties include, but are not limited to, risks associated with: the inherent uncertainty of research, development, approval, reimbursement, manufacturing and commercialization of the Company's Specialty Pharmaceuticals, Human Genetic Therapies and Regenerative Medicine products, as well as the ability to secure new products for commercialization and/or development; government regulation of the Company's products; the Company's ability to manufacture its products in sufficient quantities to meet demand; the impact of competitive therapies on the Company's products; the Company's ability to register, maintain and enforce patents and other intellectual property rights relating to its products; the Company's ability to obtain and maintain government and other third-party reimbursement for its products; and other risks and uncertainties detailed from time to time in the Company's filings with the Securities and Exchange Commission.

For further information please contact:

        Investor Relations     Eric Rojas                    erojas@shire.com     +1-781-482-0999     Sarah Elton-Farr              seltonfarr@shire.com +44-1256-894157     Media     Ingrid Jansen                 ijansen@shire.com    +32-14-404-360     Matthew Cabrey                mcabrey@shire.com    +1-484-595-8248

Source: Shire plc

Posted: January 2012


View comments

Hide
(web5)