-Filing Triggers $15 Million Milestone Payment to Ironwood from
Astellas-
CAMBRIDGE, Mass.--(BUSINESS WIRE)--
Ironwood
Pharmaceuticals, Inc. (NASDAQ: IRWD) today announced that a new drug
application (NDA) seeking approval of linaclotide for the treatment of
adults with irritable bowel syndrome with constipation (IBS-C) in Japan
was filed with the Japanese Ministry of Health, Labor and Welfare by
Astellas Pharma Inc., Ironwood's partner for linaclotide in Japan.
Linaclotide is a guanylate cyclase‐C (GC‐C) receptor agonist currently
approved, and is the branded prescription market leader, for the
treatment of adults with IBS-C or chronic idiopathic constipation (CIC)
in the United States, where more than 40 million patients are estimated
to suffer from these conditions. To date, more than 1 million unique
U.S. patients have filled a linaclotide prescription since its launch
in December 2012, according to IMS Health. Linaclotide is also approved
for adults with IBS-C or CIC in more than 30 other countries.
"Today's filing for regulatory approval in Japan by our partner
Astellas, and our recent filing for regulatory approval in China with
our partner AstraZeneca, are important achievements by Ironwood and our
global partners toward bringing linaclotide to appropriate patients
around the world," said Mark Currie, Ph.D., chief scientific officer and
president of research and development at Ironwood. "In Japan, 2.9
percent of adults are estimated to suffer from IBS-C, with no
prescription medicines currently approved for this disease. We hope to
help address this unmet need, and we continue to explore further
innovation with linaclotide across a broad spectrum of patient needs."
The NDA submission in Japan is based mainly on the results obtained from
the double-blind, placebo-controlled, parallel-group comparative Phase
III study conducted in Japan in adults with IBS-C, which demonstrated
linaclotide's clinical efficacy and safety profile, and which were
announced by the companies in November 2015.
Ironwood and Astellas entered into a licensing agreement in 2009 to
develop and commercialize linaclotide in Japan for the treatment of
IBS-C, chronic constipation and other gastrointestinal conditions. Per
the agreement, Astellas paid Ironwood a $30 million upfront licensing
fee and a $15 million development milestone payment upon enrollment of
the first patient in the Phase III IBS-C trial. These payments are in
addition to the $15 million milestone payment earned by Ironwood upon
the NDA submission announced today. The agreement also includes an
additional $15 million milestone payment for Ironwood upon receipt of
approval of linaclotide by the Japan regulatory authority. The agreement
also provides for Ironwood to receive royalties, which escalate based on
sales volume, if linaclotide is approved in Japan.
About Linaclotide
Linaclotide is a guanylate cyclase‐C (GC‐C) agonist that is thought to
work in two ways based on nonclinical studies. Linaclotide binds to the
GC-C receptor locally, within the intestinal epithelium. Activation of
GC-C results in increased intestinal fluid secretion and accelerated
transit and a decrease in the activity of pain-sensing nerves in the
intestine. The clinical relevance of the effect on pain fibers, which is
based on nonclinical studies, has not been established. Linaclotide is
marketed by Ironwood and Allergan plc in the United States as LINZESS® and
is indicated for the treatment of adults with irritable bowel syndrome
with constipation (IBS-C) or chronic idiopathic constipation (CIC), with
more than 1 million unique patients in the United States having filled
more than 4 million linaclotide prescriptions since launch, according
to IMS Health. Linaclotide is marketed by Allergan for the treatment of
adults with moderate to severe IBS-C in Europe under the brand name
CONSTELLA®. Ironwood also has partnered with Astellas for
development and commercialization of linaclotide in Japan and with
AstraZeneca for development and commercialization in China, Hong Kong
and Macau.
About Ironwood Pharmaceuticals
Ironwood Pharmaceuticals (NASDAQ: IRWD) is a commercial biotechnology
company focused on creating medicines that make a difference for
patients, building value for our fellow shareholders, and empowering our
passionate team. We are advancing an innovative pipeline of medicines in
multiple areas of significant unmet need, including irritable bowel
syndrome with constipation (IBS-C)/chronic idiopathic constipation
(CIC), vascular and fibrotic diseases, and refractory gastroesophageal
reflux disease, among others. We discovered, developed and are
commercializing linaclotide, the U.S. branded prescription market leader
in the IBS-C/CIC category, and we are applying our proven R&D and
commercial capabilities to advance multiple internally-developed and
externally-accessed product opportunities. Ironwood was founded in 1998
and is headquartered in Cambridge, Mass. For more information, please
visit ironwoodpharma.com or follow @ironwoodpharma on Twitter;
information that may be important to investors will be routinely posted
in both these locations.
LINZESS and CONSTELLA are trademarks owned by Ironwood Pharmaceuticals,
Inc. Any other trademarks referred to in this press release are the
property of their respective owners. All rights reserved.
This press release contains forward-looking statements. Investors are
cautioned not to place undue reliance on these forward-looking
statements, including statements about the achievement of milestones and
the payment of royalties under our license agreement with Astellas, and
the amount and timing thereof; the design and possible benefits of
linaclotide and its potential as a treatment for adult IBS-C patients
in Japan; the ability of Ironwood and its partners to bring linaclotide
to appropriate patients in Japan and around the world; IBS-C prevalence
and unmet need; and Astellas' plans with respect to the development of
linaclotide in Japan. 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 those related to the risk that Astellas is unable
to effectively execute on its linaclotide development plan in Japan,
including obtaining regulatory approval for linaclotide as a treatment
for adult IBS-C patients; those related to decisions made by regulatory
authorities; those related to competition in disease states and the
commercial potential of linaclotide in Japan; the risks related to
pricing and reimbursement, and their impact on potential royalty
revenues; those related to competition and challenges from and rights of
competitors or potential competitors; and the risks listed under the
heading "Risk Factors" and elsewhere in Ironwood's Annual Report on Form
10-K for the year ended December 31, 2015, and in our subsequent SEC
filings. These forward-looking statements (except as otherwise noted)
speak only as of the date of this press release, and Ironwood undertakes
no obligation to update these forward-looking statements.
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Ironwood Pharmaceuticals, Inc.
Media Relations:
Trista
Morrison, 617-374-5095
tmorrison@ironwoodpharma.com
or
Investor
Relations:
Meredith Kaya, 617-374-5082
mkaya@ironwoodpharma.com
Source: Ironwood Pharmaceuticals, Inc.
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