8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d)

OF THE SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of earliest event reported)

October 26, 2015

IRONWOOD PHARMACEUTICALS, INC.

(Exact name of registrant as specified in charter)

Delaware	001-34620	04-3404176
(State or Other Jurisdiction of Incorporation)	(Commission File Number)	(I.R.S. Employer Identification No.)

301 Binney Street

Cambridge, Massachusetts 02142

(Address of Principal Executive Offices, including Zip Code)

(617) 621-7722

(Registrant’s telephone number, including area code)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

oWritten communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

oSoliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

oPre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

oPre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item 1.01 Entry into a Material Definitive Agreement

On October 26, 2015, Ironwood Pharmaceuticals, Inc. (“Ironwood”), Almirall S.A. (“Almirall”) and Allergan Pharmaceuticals International Ltd. (“Allergan”) entered into a Novation Agreement (the “Novation Agreement”) pursuant to which Almirall transferred to Allergan that certain License Agreement, dated as of April 30, 2009, by and between Ironwood and Almirall (as amended, the “License Agreement”), and certain other agreements pertaining to the European partnership for linaclotide.  The Novation Agreement was entered into in connection with a transaction between Allergan and Almirall pursuant to which (i) the license from Ironwood for the development and commercialization of linaclotide in Europe (the “License”) was transferred from Almirall to Allergan, (ii) the rights to commercialize linaclotide in Mexico that had previously been sublicensed to Almirall were returned to Allergan, and (iii) Almirall and Allergan entered into certain agreements for transitional services.  Pursuant to the terms of the Novation Agreement, (a) Almirall transferred to Allergan, and Allergan assumed from Almirall, the License, (b) Almirall transferred to Allergan, and Allergan assumed from Almirall, certain of Almirall’s liabilities, obligations, rights and benefits under the License Agreement and certain related agreements from and after the date of the Novation Agreement, and (c) Almirall and Ironwood will continue to be responsible for any liabilities and obligations that arose under the License Agreement and certain related agreements prior to the date of the Novation Agreement.

On October 26, 2015, Ironwood and Allergan separately entered into an amendment to the License Agreement, which became effective immediately following the execution of the Novation Agreement (the “Amendment”).  Pursuant to the terms of the Amendment, (i) the remaining sales-based milestones payable to Ironwood under the License Agreement were modified such that, when aggregated with the remaining commercial launch milestones, they could total up to $38.5 million, (ii) the royalties payable to Ironwood during the term of the License Agreement were modified such that the royalties based on sales volume in Europe begin in the mid-single digit percent effective immediately and escalate to the upper-teens percent by calendar year 2019, and (iii) Allergan assumed responsibility for the manufacturing of linaclotide active pharmaceutical ingredient (“API”) for Europe from Ironwood, as well as the associated costs.  With Ironwood no longer responsible for the manufacturing of linaclotide API for Europe, the royalties under the License Agreement will no longer be reduced by the transfer price paid for the API included in the product actually sold by Allergan in Europe in any given period.

The foregoing description of the Novation Agreement and the Amendment do not purport to be complete and are qualified in their entirety by reference to each of the Novation Agreement and the Amendment, which will be filed with the Securities and Exchange Commission as exhibits to Ironwood’s Annual Report on Form 10-K for the year ended December 31, 2015.

The full text of the press release issued in connection with the transfer of the License from Almirall to Allergan and the execution of the Novation Agreement and the Amendment is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

Item  9.01  Financial Statements and Exhibits

(d)              Exhibits

99.1   Ironwood and Allergan Press Release dated October 27, 2015.

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

IRONWOOD PHARMACEUTICALS, INC.
By:	/s/ Thomas Graney
Name:	Thomas Graney
Title:	Chief Financial Officer & Senior Vice President of Finance and Corporate Strategy

Date: October 27, 2015

EXHIBIT INDEX

Exhibit No.	Description
99.1	Ironwood and Allergan Press Release dated October 27, 2015.

EX-99.1

Exhibit 99.1

NEWS RELEASE
		CONTACTS:
		Allergan
		Investors:
		Lisa DeFrancesco
		(862) 261-7152
		Media:
		Mark Marmur (U.S.)
		(862) 261-7558
		Janet Kettels (Int’l)
		+447738506476
		Ironwood
		Investors:
		Meredith Kaya
		(617) 374-5082
		Media:
		Trista Morrison
		(617) 374-5095

ALLERGAN ACQUIRES RIGHTS TO IRONWOOD’S CONSTELLA® (LINACLOTIDE) FROM ALMIRALL IN MORE THAN 40 COUNTRIES

— Signals Allergan’s Commitment to Offering Innovative GI Therapies for Patients and Physicians Worldwide —

— Transaction includes the European Union, Switzerland, Turkey and the Commonwealth of Independent States—

— Agreement Also Returns to Allergan Rights to LINZESS® (linaclotide) in Mexico —

DUBLIN, IRELAND and CAMBRIDGE, MASS — October 27, 2015— Allergan plc (NYSE: AGN), a leading global pharmaceutical company, and Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) today announced that Allergan has acquired rights to CONSTELLA® (linaclotide) in the European Union, Switzerland, Turkey and the Commonwealth of Independent States from Almirall, S.A. and has also reacquired rights to LINZESS® (linaclotide) in Mexico from Almirall.

Under the terms of the agreement, Allergan acquired an exclusive license for CONSTELLA in these countries. The license agreement includes the development and commercialization of CONSTELLA for the treatment of irritable bowel syndrome with constipation (IBS-C), chronic idiopathic constipation (CIC) and other gastrointestinal (GI) conditions. CONSTELLA is currently approved by the European Commission for the symptomatic treatment of moderate-to-severe IBS-C in adults.

“The acquisition of rights for CONSTELLA in these international markets is the next step towards our goal of becoming an even stronger partner for physicians globally seeking innovative therapies for their patients suffering from gastrointestinal disorders,” said Paul Navarre, EVP and President of International Brands at Allergan. “This agreement allows us to add CONSTELLA to our existing GI portfolio in select countries internationally and paves the way for future GI treatments in our own pipeline.”

“CONSTELLA is the only prescription product approved for IBS-C patients in Europe, providing them with a treatment option that can improve symptoms such as abdominal pain, bloating and constipation which are associated with this disorder,” said Tom McCourt, Chief Commercial Officer of Ironwood. “With Allergan’s strong global commercial presence, including experience in Europe commercializing both specialty and primary care brands, we look forward to their efforts to bring CONSTELLA to adult IBS-C patients internationally.”

Linaclotide was approved in 2012 by the European Commission and, until assumed by Allergan under the announced transaction, was marketed in a number of European countries under the brand name CONSTELLA through a license agreement between Ironwood and Almirall. Linaclotide was approved in 2014 in Mexico as a treatment for adults suffering from IBS-C or CIC under the brand name LINZESS and was marketed by Almirall through a sublicense from Allergan. Allergan and Ironwood co-develop and co-commercialize linaclotide under the brand name LINZESS in the U.S. and Allergan is commercializing linaclotide in Canada under the brand name CONSTELLA.

Note to Editors: This transaction includes current and any future member states of the European Union (currently consisting of the following countries: Austria, Belgium, Bulgaria, Cyprus, Croatia, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, and the United Kingdom), Albania, Andorra, Lichtenstein, Iceland, San Marino, Switzerland, Turkey, Norway and Russia, as well

as other countries of the former Yugoslavia and those other countries forming the Commonwealth of Independent States.

About Linaclotide

Linaclotide is a guanylate cyclase-C receptor agonist (GCCA) with visceral analgesic and secretory activities. Linaclotide is a 14-amino acid synthetic peptide structurally related to the endogenous guanylin peptide family. Both linaclotide and its active metabolite bind to the guanylate cyclase-C receptor, on the luminal surface of the intestinal epithelium. Through its action at GC-C, linaclotide has been shown to reduce visceral pain and increase GI transit in animal models and increase colonic transit in humans. Activation of GC-C results in an increase in concentrations of cyclic guanosine monophosphate (cGMP), both extracellularly and intracellularly. Extracellular cGMP decreases pain-fiber activity, resulting in reduced visceral pain in animal models. Intracellular cGMP causes secretion of chloride and bicarbonate into the intestinal lumen, through activation of the cystic fibrosis transmembrane conductance regulator (CFTR), which results in increased intestinal fluid and accelerated transit. Linaclotide was discovered by scientists at Ironwood.

About IBS-C

Estimates indicate that 10 to 15 percent of the European population suffers from Irritable Bowel Syndrome. One-third of patients with IBS are thought to have IBS-C and suffer chronically from both abdominal pain and constipation. CONSTELLA is the only available prescription treatment option for IBS-C in Europe.

About Allergan

Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a unique, global pharmaceutical company and a leader in a new industry model — Growth Pharma.  Allergan is focused on developing, manufacturing and commercializing innovative branded pharmaceuticals, high-quality generic and over-the-counter medicines and biologic products for patients around the world.

Allergan markets a portfolio of best-in-class products that provide valuable treatments for the central nervous system, eye care, medical aesthetics, gastroenterology, women’s health, urology, cardiovascular and anti-infective therapeutic categories, and operates the world’s third-largest global generics business, providing patients around the globe with increased access to affordable, high-quality medicines. Allergan is an industry leader in research and development, with one of the broadest development pipelines in the pharmaceutical industry and a leading position in the submission of generic product applications globally.

With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives.

For more information, visit Allergan’s website at www.allergan.com.

About Ironwood

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.

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.

Forward-Looking Statement

Statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect the current perspective of Allergan or Ironwood on existing trends and information as of the date of this release. Except as expressly required by law, Allergan and Ironwood disclaim any intent or obligation to update these forward-looking statements. Actual results may differ materially from the current expectations of Allergan or Ironwood depending upon a number of factors affecting the business of each company. These factors include, among others, the risks associated with transactions and the transition of a marketed product between companies; the risk that linaclotide does not reach its commercial potential in Europe, Mexico or elsewhere throughout the world; the uncertainty associated with pricing and reimbursement of CONSTELLA in European countries; the impact of competitive products and pricing; market acceptance of and continued demand for linaclotide and competitive products; the efficacy, safety and tolerability of linaclotide; the difficulty of predicting

the timing or outcome of FDA and other regulatory approvals or actions, if any; difficulties or delays in manufacturing; and other risks and uncertainties detailed in the periodic public filings with the Securities and Exchange Commission by both Allergan and Ironwood, including but not limited to each company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2015 (for Allergan, such periodic public filings having been filed under the “Allergan plc” or “Actavis plc” names) and from time to time in each company’s other investor communications. Except as expressly required by law, Allergan and Ironwood disclaim any intent or obligation to update these forward-looking statements.