CAMBRIDGE, Mass. & SHANGHAI--(BUSINESS WIRE)--
Ironwood
Pharmaceuticals, Inc. (NASDAQ: IRWD) and AstraZeneca Pharmaceuticals
Co., Ltd. today announced the initiation in China of a Phase III
clinical trial of linaclotide for the treatment of adults with irritable
bowel syndrome with constipation (IBS-C). Linaclotide is currently
approved in the United States for adults with IBS-C or chronic
idiopathic constipation (CIC) and in the European Union for adults with
moderate to severe IBS-C.
"IBS-C is estimated to affect at least 13 million adults in China,
causing hallmark symptoms such as abdominal pain and constipation," said
David Snow, President of AstraZeneca China. "If approved in China,
linaclotide could be the first prescription treatment specifically for
IBS-C and could then help address an unmet need for millions of
suffering patients."
The double-blind, randomized, placebo-controlled Phase III clinical
trial is expected to enroll approximately 800 adults with IBS-C in
China, Australia and New Zealand. The design of the trial is similar to
the 12-week Phase III IBS-C trial that supported linaclotide regulatory
approval in the United States and European Union. Patients will be
randomized 1:1 to receive either 290mcg of linaclotide or placebo for 12
weeks. The co-primary endpoints of the trial are (i) Abdominal
Pain/Discomfort Responder at 12 weeks, which is defined in the study
protocol as a patient who has at least a 30 percent improvement in
his/her abdominal pain/discomfort level for at least half of the
treatment period, and (ii) IBS Degree of Relief Responder at 12 weeks,
which is defined in the study protocol as a patient who is considerably
or completely relieved of symptoms for at least half of the treatment
period.
Ironwood and AstraZeneca anticipate the availability of top-line data in
the first half of 2015 and, if approved by the China Food and DrugAdministration (CFDA), anticipate that linaclotide could be
commercialized in China in 2017.
"Linaclotide is approved in the U.S. and in the European Union, and the
initiation of this Phase III trial is a critical step along the
regulatory pathway to support approval in China. We continue to make
strides toward our goal of bringing linaclotide to appropriate adult
patients around the world, and we look forward to continuing to
collaborate with AstraZeneca to serve the unmet needs of patients in
China," said Mark Currie, Ph.D., senior vice president, chief scientific
officer, and president of research and development at Ironwood.
Based on a collaboration announced in October 2012, Ironwood and
AstraZeneca are jointly responsible for the development and
commercialization of linaclotide in China, with AstraZeneca primarily
responsible for local operational execution. Under the terms of the
collaboration, AstraZeneca made an upfront payment of $25 million to
Ironwood, and the two companies will share the net profits and losses
associated with linaclotide in China, with AstraZeneca carrying 55
percent of each until a certain specified milestone is achieved, moving
to a 50/50 split thereafter. Ironwood is also eligible for $125 million
in additional commercial milestone payments contingent on the
achievement of certain sales targets.
About linaclotide
Linaclotide is a guanylate cyclase-C (GC-C) agonist that is thought to
work in two ways based on nonclinical models. Linaclotide binds to
guanylate cyclase-C locally in the intestine, resulting in an increase
in both intracellular and extracellular concentrations of cyclic
guanosine monophosphate (cGMP). Elevation in intracellular cGMP is
believed to stimulate secretion of intestinal fluid and accelerate
gastrointestinal transit. Elevation in extracellular cGMP is believed to
decrease the activity of pain-sensing nerves, which is thought to be
responsible for a reduction in intestinal pain. The clinical relevance
of the effect on pain fibers in nonclinical models has not been
established.
About Ironwood Pharmaceuticals
Ironwood Pharmaceuticals (NASDAQ: IRWD) is committed to the art and
science of making medicines, from discovery through commercialization.
We're focused on three goals: transforming knowledge into medicines that
make a difference for patients, creating value that will inspire the
continued support of our fellow shareholders, and building a team that
passionately pursues excellence. Our first product, linaclotide, is
approved in the United States and Europe. Our pipeline priorities
include exploring further opportunities for linaclotide, leveraging our
deep expertise in functional gastrointestinal disorders, and advancing
programs in other areas such as allergic conditions, cardiovascular
disease, central nervous system disorders and other conditions defined
by patient symptoms. Ironwood was founded in 1998 and is headquartered
in Cambridge, Mass. Connect with us at www.ironwoodpharma.com
or on Twitter at www.twitter.com/ironwoodpharma
to learn more about Ironwood. Information that may be important to
investors will be routinely posted in both these locations.
About AstraZeneca Pharmaceuticals Co. Ltd.
AstraZeneca is a global, innovation-driven biopharmaceutical business
that focuses on the discovery, development and commercialisation of
prescription medicines, primarily for the treatment of cardiovascular,
metabolic, respiratory, inflammation, autoimmune, oncology, infection
and neuroscience diseases. AstraZeneca operates in over 100 countries
and its innovative medicines are used by millions of patients worldwide.
For more information please visit: www.astrazeneca.com
This press release contains forward looking statements. Investors are
cautioned not to place undue reliance on these forward‐looking
statements, which include, among other things, statements about the
development plans for linaclotide in China, including the Phase III
clinical trial and expectations regarding its protocol, patient
enrollment, and timeline, as well as the timing of the availability of
the data from such trial; the potential for, and timing of, approval of
linaclotide for marketing by the CFDA; the timing of the potential
commercialization of linaclotide in China and the availability of
competitive products; the estimated number of adults in China affected
by IBS-C; and the potential for Ironwood to receive commercial
milestones and other payments from AstraZeneca under the collaboration.
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 advancements in the linaclotide
development program in China do not proceed as expected, Ironwood and
AstraZeneca are unable to successfully enroll or complete the Phase III
clinical trial or to demonstrate the efficacy of linaclotide in patients
in China in order to obtain marketing authorization, serious adverse
events arise in patients that are deemed to be related to linaclotide
treatment, the incidence or severity of diarrhea in patients treated
with linaclotide is higher than expected, Ironwood and AstraZeneca are
unable to effectively commercialize linaclotide in China, Ironwood or
AstraZeneca terminates all or part of the collaboration arrangement, as
well as risks related to the difficulty of predicting regulatory
approvals and the acceptance of and demand for new pharmaceutical
products. Applicable risks also include those that are listed in
Ironwood's Quarterly Report on Form 10‐Q for the quarter ended June 30,
2013, in addition to the risk factors that are listed from time to time
in Ironwood's Annual Reports on Form 10‐K, Quarterly Reports on Form
10‐Q and any subsequent SEC filings. Ironwood undertakes 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.
Ironwood Pharmaceuticals, Inc.
Media Relations
Lisa
Buffington, 617-374-5103
Vice President, Corporate Communications
[email protected]
or
Investor
Relations
Meredith Kaya, 617-374-5082
Director, Investor
Relations
[email protected]
or
AstraZeneca
China
Media Relations
Chris Wang, 86-21-6070 1073
Senior
Manager, Public Relations, China
[email protected]
Source: Ironwood Pharmaceuticals, Inc.
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