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Constella® (linaclotide) Approved In Europe For The Treatment Of Irritable Bowel Syndrome With Constipation (IBS-C) In Adults

Almirall, S.A. (ALM:MC) and Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) announced today that the European Commission has granted marketing authorization to Constella ® (linaclotide 290mcg) for the symptomatic treatment of moderate to severe Irritable Bowel Syndrome with Constipation (IBS-C) in adults. This approval follows the positive recommendation received from the European Committee for Medicinal Products for Human Use (CHMP) in September.

Constella ® is an oral, once-daily medication. Linaclotide, the active ingredient in Constella ®, is a guanylate cyclase-C agonist (GCCA) with visceral analgesic and secretory activities, as stated in the product label for European use. In non-clinical studies, linaclotide has been shown to reduce visceral pain by decreasing pain-fiber activity and to accelerate gastrointestinal transit by increasing intestinal fluid secretion. Linaclotide acts locally in the intestine with minimal systemic exposure.

“Despite affecting more than 10% of the population in the EU there are few effective treatment options for IBS. Approximately one third of IBS patients suffer from the IBS-C form of the disease and the approval of Constella ® provides physicians with an innovative medication, for improving the lives of patients whose quality of life is impaired,” said Professor Jan Tack, Head of Clinic in the Department of Gastroenterology, and Professor in Internal Medicine at the University Hospital Gasthuisberg of the University of Leuven, Belgium.

IBS is a functional gastrointestinal disorder impacting over 10% of the European population, and it is estimated that one-third of IBS patients suffer from IBS-C 1, which means that approximately 15 million adults across the European Union might be affected. Symptoms associated with IBS-C include abdominal pain and discomfort, bloating, and constipation resulting in a significant impact on affected individuals. There are few prescription treatment options for this condition approved in the European Union. Constella ® is the first and only prescription medicine approved by the European Commission for the symptomatic treatment of moderate to severe Irritable Bowel Syndrome with Constipation (IBS-C) in adults.

“Almirall is delighted with the approval of Constella ® , the first prescription medicine approved by the European Commission for the treatment of IBS-C in adults. This new medicine has the potential to improve some of the hallmark symptoms of IBS-C patients who up until now have had few treatment options. Furthermore the approval of Constella ® is an important growth opportunity for Almirall and will strengthen our gastrointestinal franchise,” said Eduardo Sanchiz, Chief Executive Officer at Almirall.

Almirall expects to begin launching Constella ® in Europe in the first half of 2013.

“Linaclotide was discovered by Ironwood scientists, and obtaining marketing authorization for Constella ® in Europe is important progress towards our goal of translating knowledge into medicines that make a difference for patients,” said Peter Hecht, Ironwood’s Chief Executive Officer. “ We look forward to continuing to work closely with our partner Almirall in their efforts to bring Constella ® to adult IBS-C patients in Europe, and we will continue collaborating with our global network of partners with the goal of bringing this medicine to appropriate patients worldwide.”

In April 2009, Almirall signed a license agreement with Ironwood, under which Almirall holds exclusive marketing rights for linaclotide in all European Union member states, plus Russia, the CIS (Commonwealth of Independent States of the former USSR), Switzerland, Norway and Turkey, as well as other countries in Europe, including the countries of former Yugoslavia. In September 2012, Almirall also signed an agreement by which Forest Laboratories sublicensed its commercialization rights for linaclotide in Mexico to Almirall.

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