Shire Acquires US Rights to Resolor(R) (prucalopride)
PHILADELPHIA, January 10, 2012 /PRNewswire/ –
– Agreement allows development for potential treatment of chronic constipation
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
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
# # #
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:
“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.
SOURCE Shire plc