Full Press Release Details
Ironwood Pharmaceuticals and AstraZeneca
LINZESS (linaclotide) Collaboration in China
- Ironwood to receive up to $125
million, consisting of $35 million in non-contingent payments and up to $90 million in commercial milestones, in addition to tiered
royalties up to 20 percent -
- AstraZeneca obtains full responsibility
for the development, manufacturing
and commercialization of LINZESS in China -
Mass., September 18, 2019 - Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD), a GI healthcare company, announced
today that it has amended its collaboration agreement with AstraZeneca for the development and commercialization of LINZESS in
China. LINZESS was approved by the National Medical Products Administration for adults with IBS-C in China in January 2019. LINZESS
is expected to be launched in China in the second half of 2019.
Under the terms of the amended
agreement, AstraZeneca will obtain exclusive rights to develop, manufacture and commercialize linaclotide in China (including
Hong Kong and Macau) and will be responsible for all expenses associated with these activities. In return, Ironwood will
receive up to a total of $125 million, including non-contingent payments totaling $35 million paid in three installments
through 2024 and up to $90 million in commercial milestone payments contingent on the achievement of certain net sales
targets. Additionally, Ironwood will receive royalties beginning in the mid-single-digit percent and increasing up to 20
percent based on annual net sales of LINZESS in China. In connection with the amended agreement, Ironwood will no longer be
jointly funding the development and commercialization of linaclotide or sharing in the net profit from sales in China.
Mark Mallon, chief executive officer of
Ironwood, stated, "This amended collaboration - combined with our recent amendment to our Astellas agreement -
reflects our continued strategy to focus our efforts in the U.S., thereby streamlining our business while enabling strong partners
to bring linaclotide to patients worldwide. AstraZeneca has substantial experience and capabilities in developing and commercializing
medicines in China. There are approximately 14 million adults suffering from IBS-C in China, and we believe AstraZeneca is well-positioned
to bring LINZESS to these patients."
The original collaboration between Ironwood and AstraZeneca
for linaclotide was established in 2012. Linaclotide is available for the treatment of adults with IBS-C or chronic idiopathic
constipation (CIC) in the United States and more than 30 other countries.
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). Linaclotide is marketed by Allergan for the treatment of
adults with moderate to severe IBS-C in Europe under the brand name CONSTELLA . AstraZeneca has the exclusive rights to
develop and commercialize linaclotide in China (including Hong Kong and Macau). Astellas has the exclusive rights to develop
and commercialize linaclotide in Japan. Allergan has rights to develop and market in the rest of the world countries.
Important Safety Information
INDICATIONS AND USAGE
LINZESS (linaclotide) is indicated in adults for the treatment
of both irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC).
IMPORTANT SAFETY INFORMATION
Warnings and Precautions
Common Adverse Reactions (incidence 2% and greater
Please see full Prescribing Information including Boxed Warning:
About Ironwood Pharmaceuticals
Ironwood Pharmaceuticals (Nasdaq: IRWD) is a GI-focused healthcare
company dedicated to creating medicines that make a difference for patients living with GI diseases. We discovered, developed and
are commercializing linaclotide, the U.S. branded prescription market leader for adults with irritable bowel syndrome with constipation
(IBS-C) or chronic idiopathic constipation (CIC).
We are also advancing two late-stage, first-in-category GI product
candidates: IW-3718 is a gastric retentive formulation of a bile acid sequestrant being developed for the potential treatment of
persistent gastroesophageal reflux disease, and MD-7246 is a delayed-release formulation of linaclotide that is being evaluated
as an oral, intestinal, non-opioid, pain-relieving agent for patients suffering from abdominal pain associated with IBS with diarrhea.
Ironwood was founded in 1998 and is headquartered
in Cambridge, Mass. For more information, please visit our website at www.ironwoodpharma.com or www.twitter.com/ironwoodpharma;
information that may be important to investors will be routinely posted in both these locations.
Ironwood Forward Looking Statements
This press release contains
forward-looking statements. Investors are cautioned not to place undue reliance on these forward-looking statements including
statements about the anticipated benefits of the amended collaboration agreement with AstraZeneca including
AstraZeneca's ability to commercialize LINZESS in China; the potential non-contingent and commercial milestone payments
and royalties Ironwood may receive under the terms of such agreement; the development, launch, commercial availability and
commercial potential of LINZESS in China, including the timing of launch and the patient population in China;
Ironwood's relationships with partners and efforts to make linaclotide available to patients worldwide; and
Ironwood's business and development strategies. 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 effectiveness of commercialization efforts in China,
including the risk that certain sales targets, including annual net sales targets of LINZESS in China (including Hong Kong
and Macau) are not achieved; decisions by regulatory or other authorities in China; the risk that Ironwood's clinical
programs and studies may not progress or develop as anticipated, including that studies are delayed or discontinued for any
reason such as safety, tolerability, enrollment, manufacturing, economic or other reasons; the risks that findings from
Ironwood's completed studies may not be replicated in later studies; the efficacy, safety and tolerability of
linaclotide and Ironwood's other product candidates and the risks listed under the heading "Risk Factors"
and elsewhere in Ironwood's Quarterly Report on Form 10-Q for the quarter ended June 30, 2019, and in
Ironwood's subsequent SEC filings. These forward-looking statements speak only as of the date of this press release,
and Ironwood undertakes no obligation to update these forward-looking statements.
Investors and Media:
Meredith Kaya, 617-374-5082
Vice President, Investor Relations and Corporate Communications