Navigation Links
Shire Acquires US Rights to Resolor® (prucalopride)
Date:1/10/2012

PHILADELPHIA, January 10, 2012 /PRNewswire/ --

Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announced today that it has acquired the rights to develop and market Resolor® (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
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Shire Provides Update on ProAmatine® (midodrine HCl)
2. National Pharmaceutical Council Welcomes Shire as Its Newest Member
3. Shire plc: Board Changes
4. Shire plc: Lialda® (Mesalamine) Now Approved in U.S. for Maintenance of Remission of Ulcerative Colitis
5. Shire plc : Second Quarter 2011 Results Date Notification - July 28, 2011
6. Shire Files Lawsuits Against Sandoz and Amneal for Infringement of VYVANSE® (lisdexamfetamine dimesylate) Patents
7. United Lincolnshire Hospitals NHS Trust Selects Jayex QI Interactive Patient Survey and Information Management Kiosk
8. Shire Completes Acquisition of Advanced BioHealing, Inc.
9. European Authorities Approve New Manufacturing Facility for Shires REPLAGAL® (agalsidase alfa)
10. Prasco Announces Agreement with Shire for Future Exclusive Distribution and Supply of Authorized Generic for PENTASA®
11. Shire Recognized by ISPE Facility of the Year Awards Program
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... and SAN CLEMENTE, Calif. , June 24, 2016 ... mobile pulmonary function testing company, is now able to perform sophisticated ... by ndd Medical Technologies , Inc. Patients ... hospital-based labs.  Thanks to ndd,s EasyOne PRO ® , ARL patients ... get any needed testing done in the comfort of her own ...
(Date:6/24/2016)... June 24, 2016   Pulmatrix, Inc ., (NASDAQ: ... innovative inhaled drugs, announced today that it was added ... reconstituted its comprehensive set of U.S. and global ... is an important milestone for Pulmatrix," said Chief Executive ... awareness of our progress in developing drugs for crucial ...
(Date:6/23/2016)... , June 23, 2016  MedSource announced today ... its e-clinical software solution of choice.  This latest ... possible value to their clients by offering a ... preferred relationship establishes nowEDC as the EDC platform ... MedSource,s full-service clients.  "nowEDC has long been a ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... June 25, 2016 , ... Experts from the American ... Annual Research Meeting June 26-28, 2016, at the Hynes Convention Center in Boston. ... including advance care planning, healthcare costs and patient and family engagement. , AIR ...
(Date:6/25/2016)... ... June 25, 2016 , ... "With 30 hand-drawn hand gesture ... said Christina Austin - CEO of Pixel Film Studios. , ProHand Cartoon’s package ... Final Cut Pro X . Simply select a ProHand generator and drag it ...
(Date:6/25/2016)... City, Oklahoma (PRWEB) , ... June 25, 2016 ... ... helping both athletes and non-athletes recover from injury. Recently, he has implemented orthobiologic ... the Oklahoma City area —Johnson is one of the first doctors to perform ...
(Date:6/24/2016)... ... 24, 2016 , ... A recent article published June 14 on ... article goes on to state that individuals are now more comfortable seeking to undergo ... such as calf and cheek reduction. The Los Angeles area medical group, Beverly Hills ...
(Date:6/24/2016)... ... 24, 2016 , ... Marcy was in a crisis. Her son James, eight, was out of ... verbally and physically. , “When something upset him, he couldn’t control his emotions,” remembers Marcy. ... throw rocks at my other children and say he was going to kill them. ...
Breaking Medicine News(10 mins):