Ironwood and AstraZeneca Initiate Linaclotide Phase III Trial in China for Adults with IBS-C

  Ironwood and AstraZeneca Initiate Linaclotide Phase III Trial in China for
  Adults with IBS-C

Business Wire

CAMBRIDGE, Mass. & SHANGHAI -- September 10, 2013

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 Drug Administration
(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.

Contact:

Ironwood Pharmaceuticals, Inc.
Media Relations
Lisa Buffington, 617-374-5103
Vice President, Corporate Communications
lbuffington@ironwoodpharma.com
or
Investor Relations
Meredith Kaya, 617-374-5082
Director, Investor Relations
mkaya@ironwoodpharma.com
or
AstraZeneca China
Media Relations
Chris Wang, 86-21-6070 1073
Senior Manager, Public Relations, China
chris.wang@astrazeneca.com
 
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