-Linaclotide is a first-in-class therapeutic option for the symptomatic
treatment of moderate to severe irritable bowel syndrome with
constipation (IBS-C) in adult patients-
-In two pivotal Phase III studies evaluating its efficacy and safety in
IBS-C in adults, linaclotide was found to significantly improve
abdominal pain/discomfort and relief of other IBS-C symptomsi,ii
-
-Almirall holds exclusive marketing rights for linaclotide in Europe-
BARCELONA, Spain & CAMBRIDGE, Mass.--(BUSINESS WIRE)--
Almirall,
S.A. (ALM:MC) and Ironwood
Pharmaceuticals, Inc. (NASDAQ: IRWD) announced today that the
European Committee for Medicinal Products for Human Use (CHMP) has
issued a positive opinion recommending the marketing approval for
Constella® (linaclotide 290 micrograms), for the symptomatic
treatment of moderate to severe irritable bowel syndrome with
constipation (IBS-C) in adults.
The CHMP positive opinion is a recommendation to the European Commission
(EC) and one of the final steps in the review of a marketing
authorization application. The EC usually follows the recommendations of
the CHMP. Once approved, it will be marketed under the brand name
Constella®.
"Patients with IBS-C suffer from several very uncomfortable
gastrointestinal symptoms for which there are currently very few
available therapies", said Bertil Lindmark, Chief Scientific Officer at
Almirall. "With linaclotide physicians will have one of the first
specifically designed therapies with proven efficacy and tolerability
over time. Therefore, we are very pleased at Almirall with this first
IBS-C treatment recommended for approval by CHMP and are confident in
linaclotide's benefits".
This positive recommendation is based on the efficacy and safety of
linaclotide evaluated in two double-blind, placebo-controlled Phase III
clinical studies. The clinical trials involved approximately 1,600 adult
patients, of which more than 800 were treated with linaclotide 290 mcg.
In both trials, treatment with linaclotide resulted in statistically
significant improvements in both abdominal pain/discomfort and degree of
relief of IBS-C symptoms (co-primary endpoints), as well as complete
spontaneous bowel movement frequency, stool consistency and severity of
straining and bloating (secondary endpoints). These improvements were
maintained over the entire treatment period (12 and 26 weeks). The
incidence of adverse events was similar in both studies, with diarrhoea
being the most common adverse event in linaclotide-treated patientsi,
ii.
"This positive opinion is a significant step toward helping these highly
symptomatic adult patients; many of whom are searching for new treatment
options," said Mark
Currie, PhD, Senior Vice President, R&D and Chief Scientific Officer
of Ironwood. "The discovery of linaclotide by Ironwood scientists and
the work we have done to reach patients in Europe with our partner,
Almirall, has been a collaborative effort with the goal of helping this
underserved patient population."
Almirall holds exclusive marketing rights for linaclotide in Europe.
About linaclotide (Constella®)
Linaclotide is a guanylate cyclase-C agonist (GCCA) that is provided as
an oral capsule intended for once-daily administration for the treatment
of irritable bowel syndrome with constipation.
It binds to guanylate cyclase C locally in the intestine, with no
measurable blood plasma concentrations, resulting in an increase in both
intracellular and extracellular concentrations of cyclic guanosine
monophosphate (cGMP). Elevations in intracellular cGMP are believed to
stimulate secretion of intestinal fluid and accelerate gastrointestinal
transit resulting in increased frequency of bowel movements. Elevations
in extracellular cGMP are believed to decrease activity of pain-sensing
nerves, which is thought to be responsible for a reduction in intestinal
pain, according to nonclinical models.
Constella® is a trademark owned by Ironwood Pharmaceuticals,
Inc. and its use in Europe is pending marketing approval from the
European Commission.
About Irritable Bowel Syndrome with Constipation (IBS-C)
IBS is defined as a functional bowel disorder in which abdominal pain or
discomfort is associated with defecation or a change in bowel habit and
with features of disordered defecation.iii IBS-C is one of
four clinically different subtypes of IBS. One-third of patients with
IBS are thought to have IBS-Civ and suffer chronically from
both abdominal pain and constipation.
The Rome III Diagnostic Criteria for Functional Gastrointestinal
Disorders includes criterion for the diagnosis of IBSiii as:
-
Recurrent abdominal pain or discomfort at least three days/month, in
the last three months with symptom onset at least 6 months prior to
diagnosis, associated with two or more of the following:
-
improvement with defecation
-
onset associated with a change of frequency of stool
-
onset associated with a change in form (or appearance) of stool
The estimated prevalence of IBS at 10-15% of the European population
puts it in line with conditions such as migraine (12%) and asthma (11%).v
IBS can have a negative impact on daily living with considerable
socio-economic and psychological consequences, and represents a major
proportion of gastrointestinal workload in both primary and secondary
care. Due to the complex, multimodal nature of the condition there is no
cure for IBS and minimal therapeutic options.vi
About Almirall
Almirall is an international pharmaceutical company based on innovation
and committed to health. Headquartered in Barcelona, it researches,
develops, manufactures and commercialises its own R&D and licensed drugs
with the aim of improving people's health and wellbeing. Almirall
focuses its research resources on respiratory, gastrointestinal,
dermatology and pain. Almirall's products are currently present in over
70 countries in the five continents. With the opening of the Canadian
affiliate, Almirall has now direct presence in Europe, Mexico and Canada
through 13 affiliates. For further information please visit: www.almirall.com
About Ironwood Pharmaceuticals
Ironwood Pharmaceuticals (NASDAQ: IRWD) is an entrepreneurial
pharmaceutical company dedicated to the art and science of great
drugmaking. Ironwood is located in Cambridge, Mass. To learn more, visit www.ironwoodpharma.com.
This press release contains forward looking statements. Investors are
cautioned not to place undue reliance on these forward‐looking
statements, including, but not limited to, the anticipated approval for
marketing authorization by the European Medicines Agency (EMA), the
potential indication and patient population for linaclotide and the
anticipated brand name for linaclotide. Each forward‐looking statement
is subject to risks and uncertainties that could cause actual results to
differ materially from those expressed or implied in such statement.
Applicable risks and uncertainties include the risks that the EMA does
not grant marketing authorization for linaclotide, the EMA does not
approve the brand name Constella®, serious adverse events arise in
patients that are deemed to be definitely or probably related to
linaclotide treatment, and the incidence or severity of diarrhea in
patients treated with linaclotide is higher than expected, as well as
risks related to the difficulty of predicting regulatory approvals.
Applicable risks also include those that are listed in Ironwood
Pharmaceuticals' Quarterly Report on Form 10‐Q for the quarter ended
June 30, 2012, in addition to the risk factors that are listed from time
to time in Ironwood Pharmaceuticals' Annual Reports on Form 10‐K,
Quarterly Reports on Form 10‐Q and any subsequent SEC filings. We
undertake no obligation to update these forward‐looking statements to
reflect events or circumstances occurring after this press release.
These forward‐looking statements speak only as of the date of this press
release. All forward‐looking statements are qualified in their entirety
by this cautionary statement.
References
iE.M. Quigley, A.J. Lembo, C. Diaz, et al. Significant
improvements in abdominal pain and bowel symptoms in a phase 3 trial of
linaclotide in patients with irritable bowel syndrome with constipation
(IBS-c): A european perspective. Gut 2011; 60 (Suppl 3) A80.
iiA.J. Lembo, J. Fortea, C. Diaz, et al. 26-Week Efficacy
and safety of once-daily oral linaclotide in patients with irritable
bowel syndrome with constipation: a european perspective. Gut 2011; 60
(Suppl 3) A41.
iii Longstreth GF, Thompson WG, Chey WD et al. - Functional
Bowel Disorders. Gastroenterology 2006; 130: 1480-1491
ivAmerican College of Gastroenterology Task Force on
Irritable Bowel Syndrome. An evidence-based position statement on the
management of irritable bowel syndrome. Am J Gastroenterol 2009;
104 Suppl 1:S1-35
v P. S. Hungin et al - The prevalence, patterns and impact of
irritable bowel syndrome: an international survey of 40,000 subjects -
Aliment Pharmacol Ther 2003; 17: 643—650.
vi Camilleri M, Chang L. - Challenges to the therapeutic
pipeline for irritable bowel syndrome: end points and regulatory
hurdles. Gastroenterology 2008;135:1877—1891
Almirall, S.A.
Media enquiries:
Bianca
Daneshfar-Nia , +44 20 7611 3510
bianca.daneshfar-nia@ketchumpleon.com
or
Jordi
Molina, +34 93 2913087
jordi.molina@almirall.com
or
Ironwood
Pharmaceuticals, Inc.
Media Relations:
Lisa
Buffington, 617-374-5103
lbuffington@ironwoodpharma.com
or
Investor
Relations:
Meredith Kaya, 617-374-5082
mkaya@ironwoodpharma.com
Source: Ironwood Pharmaceuticals
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