CAMBRIDGE, Mass. & LONDON--(BUSINESS WIRE)--
AstraZeneca and Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) announced
today an agreement to co-develop and co-commercialize Ironwood's
linaclotide in China. Linaclotide is the first and only guanylate
cyclase-C (GC-C) agonist approved by the US Food and Drug
Administration, in August.
In May, Ironwood filed a clinical trial application with the State Food
and Drug Administration in China for a Phase III clinical trial to
assess the efficacy and safety of linaclotide in adult patients
suffering from irritable bowel syndrome with constipation (IBS-C).
IBS-C, which is characterized by symptoms of abdominal pain and
constipation, is a chronic and prevalent functional gastrointestinal
disorder in China and there are currently few treatment options for this
condition.
"China is one of the fastest growing prescription medicines markets in
the world and linaclotide represents a valuable opportunity to meet the
needs of local patients by providing an innovative new treatment
option," said Mark Mallon, Regional Vice-President for Asia Pacific and
President, AstraZeneca China. "We are pleased to be partnering with
Ironwood for linaclotide in China, which capitalizes on our leadership
in the gastrointestinal sector in the emerging markets."
Peter Hecht, Ironwood's Chief Executive Officer, said: "As we continue
to advance our efforts to make linaclotide available to patients around
the world, we are excited about this opportunity to collaborate in China
with AstraZeneca, one of the world's most successful companies in
gastrointestinal medicine."
AstraZeneca and Ironwood are jointly responsible for strategic oversight
of the development and commercialization of linaclotide in China.
AstraZeneca will have primary responsibility for the local operational
execution.
Under the terms of the collaboration, AstraZeneca will make an upfront
payment of $25 million to Ironwood and 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 will also be eligible for
$125 million in additional commercial milestone payments contingent on
the achievement of certain sales targets.
In addition, the companies also announced today their agreement that
Ironwood's sales force of approximately 160 experienced clinical sales
specialists will promote AstraZeneca's NEXIUM® (esomeprazole
magnesium) in the US. This agreement will augment AstraZeneca's existing
interactions with gastroenterologists and primary care physicians on
behalf of NEXIUM and the patients who need it. It will also provide
Ironwood with an opportunity to increase its presence with the key
gastrointestinal physicians in the US.
"A large percentage of adult patients who have IBS-C or who have chronic
idiopathic constipation, may also suffer from gastroesophageal reflux
disease," said Thomas McCourt, Chief Commercial Officer, Senior Vice
President, Marketing and Sales, Ironwood Pharmaceuticals. "This
agreement provides our experienced clinical sales specialists with the
opportunity to bring two different and effective therapies to physicians
for managing their patients who have these prevalent and troublesome
gastrointestinal disorders."
About Linaclotide
Linaclotide is a guanylate cyclase-C (GC-C) agonist that is provided as
an oral capsule intended for once-daily administration.
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 non-clinical models.
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 development plans for
linaclotide in China, the potential for linaclotide to be approved for
marketing by the State Food and Drug Administration in China, the
commercialization opportunity for linaclotide in China, the potential
for Ironwood to receive sales-related milestones, and the opportunity
for Ironwood to promote NEXIUM in the United States. 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, the State Food and Drug Administration
in China does not agree with the Phase III clinical trial design,
Ironwood and AstraZeneca are unable to successfully 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 definitely or
probably related to linaclotide treatment, Ironwood and AstraZeneca are
unable to effectively commercialize linaclotide in China, Ironwood is
unable to successfully co-promote NEXIUM in the U.S., Ironwood or
AstraZeneca terminates all or part of the collaboration or co-promotion
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, 2012, in addition to the risk factors that are listed from time
to time in its 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.
About AstraZeneca
AstraZeneca is a global, innovation-driven biopharmaceutical business
with a primary focus on the discovery, development and commercialization
of prescription medicines for gastrointestinal, cardiovascular,
neuroscience, respiratory and inflammation, oncology and infectious
disease. 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.
Ironwood Pharmaceuticals, Inc.
Media Relations:
Lisa
Buffington, 617-374-5103
lbuffington@ironwoodpharma.com
or
Investor
Relations:
Meredith Kaya, 617-374-5082
mkaya@ironwoodpharma.com
or
AstraZeneca
Contacts
Media Enquiries UK
Esra Erkal-Paler, +44
20 7604 8030
Vanessa Rhodes, +44 20 7604 8037
or
Media
Enquiries Sweden
Ann-Leena Mikiver, +46 8 553 260 20
or
Investor
Enquiries
James Ward-Lilley, +44 20 7604 8122, mob: +44 7785
432613
Karl Hård, +44 20 7604 8123, mob: +44 7789 654364
Nicklas
Westerholm, +44 20 7604 8124, mob: +44 7585 404950
Ed Seage, +1 302
886 4065, mob: +1 302 373 1361
Source: Ironwood Pharmaceuticals, Inc. and AstraZeneca
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