Ironwood
Pharmaceuticals, Inc. (NASDAQ: IRWD) announced today that it has
earned a $15 million development milestone payment from Astellas Pharma
Inc., its partner for linaclotide in Japan. This milestone was triggered
by Astellas’s enrollment of the first patient in a randomized,
double-blind, placebo-controlled Phase III clinical trial of linaclotide
in adult patients with irritable bowel syndrome with constipation
(IBS-C) in Japan. Astellas expects to complete the Phase III trial in
2016.
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. In addition to the $15 million development milestone payment upon
enrollment of the first patient in the Phase III trial, the agreement
also includes additional development milestone payments that could total
up to $30 million, consisting of $15 million upon filing for regulatory
approval in Japan and $15 million upon receipt of approval. The
agreement also provides for Ironwood to receive royalties which escalate
based on sales volume.
Astellas also plans to expand its development of linaclotide in Japan
and is entering into a Phase II clinical trial with linaclotide in
adults with chronic constipation. If approved, the same royalty terms
would apply.
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 Actavis 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).
Linaclotide is marketed by Almirall, S.A. for the treatment of adults
with moderate to severe IBS-C in Europe under the brand name CONSTELLA®.
Ironwood also has partnered with Astellas Pharma Inc. for development
and commercialization of linaclotide in Japan and with AstraZeneca for
development and commercialization in China.
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.
About Ironwood Pharmaceuticals
Ironwood Pharmaceuticals (NASDAQ: IRWD) is focused on creating medicines
that make a difference for patients, building value to earn the
continued support of our fellow shareholders, and empowering our team to
passionately pursue excellence. We discovered, developed and are
commercializing linaclotide, which is approved in the United States and
a number of other countries. Our pipeline priorities include exploring
further opportunities for linaclotide, as well as leveraging our
therapeutic expertise in gastrointestinal disorders and our
pharmacologic expertise in guanylate cyclases to address patient needs
across the upper and lower gastrointestinal tract. 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;
information that may be important to investors will be routinely posted
in both these locations.
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, statements about the
achievement of milestones and the payment of royalties under our license
agreement with Astellas, and the amount and timing thereof; the
completion of the Phase III clinical study in adult IBS-C patients for
Japan and the timing thereof; and Astellas’ plans with respect to the
development of linaclotide in Japan, and any expansion thereof,
including the Phase II clinical trial in adults with chronic
constipation. 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, but are not limited to, the risk that Astellas is
unable to enroll as many patients in its clinical studies or on the same
timeline as it currently anticipates or is otherwise unable to
effectively execute on its linaclotide clinical programs in IBS-C or
chronic constipation in Japan; the risk that clinical studies need to be
discontinued for any reason, including safety, efficacy, tolerability,
enrollment, manufacturing or economic reasons; those related to
decisions made by regulatory authorities; the risk that the data from
such clinical studies is not available when currently anticipated or
does not demonstrate efficacy; 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; and those risks related to competition and future
business decisions made by Ironwood or Astellas and their competitors or
potential competitors. Applicable risks also include those that are
listed under the heading "Risk Factors" and elsewhere in Ironwood's
Quarterly Report on Form 10-Q for the quarter ended September 30, 2014,
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 other subsequent SEC filings. Ironwood undertakes no obligation
to update these forward-looking statements to reflect events or
circumstances occurring after this press release. Except as otherwise
noted, 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.
Copyright Business Wire 2014