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Ironwood Pharmaceuticals Provides Fourth Quarter 2012 Investor Update

Stocks in this article: IRWD

Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) today provided an update on its fourth quarter 2012 and recent business activities.

“The past several months have been a remarkable period of time for us at Ironwood – particularly with the commercial launch of LINZESS in the U.S. and the approval of Constella in the E.U.,” said Peter Hecht, Chief Executive Officer of Ironwood. “In December, the joint Ironwood and Forest team stocked LINZESS in over 44,000 pharmacies across the U.S. and began educating over 85,000 physicians. Looking ahead, we will continue to focus on the LINZESS launch, while also exploring development opportunities to strengthen the clinical profile of linaclotide and broaden the product label in other indications and geographies. We will also continue to progress our other pipeline programs, including potential linaclotide-based combination products, IW-9179 for functional dyspepsia and IW-2143 for anxiety, among others. Through these activities, we continue to work towards our overarching goals of delivering differentiated medicines to patients and value to our shareholders.”

Fourth Quarter 2012 and Recent Highlights

LINZESS (linaclotide)

  • LINZESS net product sales, as reported by Forest Laboratories, Inc., were $19.2 million in the fourth quarter of 2012.
  • In December 2012, Ironwood and Forest initiated promotional efforts for LINZESS in the United States, with more than 1,400 sales specialists now educating over 85,000 physicians. LINZESS is available in more than 44,000 pharmacies. The United States Food and Drug Administration (FDA) approved LINZESS in August 2012 as a once-daily treatment for adult men and women suffering from irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC). LINZESS can help to relieve abdominal pain and constipation associated with IBS-C, as well as constipation, infrequent bowel movements, incomplete evacuation and hard stools associated with CIC.
  • Ironwood and Forest are exploring development opportunities to strengthen the clinical profile of LINZESS within its indicated population and to expand the product label for broader patient populations and indications, as well as exploring the potential for linaclotide-based combination products. In July 2012, the companies initiated a Phase 3b clinical trial to further characterize the effect of LINZESS on abdominal symptoms in patients with CIC. Ironwood expects to report data from this trial in the second half of 2013.

Constella (linaclotide)

  • In November 2012, Ironwood and Almirall, S.A. announced that Almirall received marketing authorization from the European Commission for Constella ® (linaclotide 290mcg) for the symptomatic treatment of moderate to severe IBS-C in adults in the European Union. Initial launches in Europe are expected in the first half of 2013.

Linaclotide (Rest of World)

  • In October 2012, Ironwood and AstraZeneca formed a collaboration to co-develop and co-commercialize linaclotide in China. The two companies are jointly responsible for strategic oversight of the development and commercialization of linaclotide in China. AstraZeneca will have primary responsibility for local operational execution, including clinical development. In addition, as part of the arrangement, Ironwood’s sales force will promote AstraZeneca’s NEXIUM in the United States.
  • In October 2012, Astellas initiated a double-blind, placebo-controlled, dose-ranging Phase 2 clinical trial of linaclotide in more than 500 Japanese adult patients with IBS-C.

Research & Development

  • In addition to exploring further linaclotide development opportunities, Ironwood continues to advance its pipeline, which includes early development candidates and discovery research efforts focused on gastrointestinal disease, central nervous system disorders, allergy conditions and cardiovascular disease.
  • In October 2012, the company advanced its second GC-C agonist, IW-9179, into a Phase 2 clinical trial designed to evaluate its safety in approximately 80 patients with functional dyspepsia. Functional dyspepsia is a condition characterized by upper gastrointestinal pain, fullness, early satiety and bloating, and is estimated to affect more than 35 million people in the United States. There are a limited number of approved treatment options for functional dyspepsia.
  • In December 2012, Ironwood advanced its investigational anti-anxiety compound, IW-2143, into a Phase 1 clinical trial. IW-2143 was in-licensed from Bionomics Limited in January 2012.
  • In December 2012, Ironwood expanded its research collaboration with Protagonist Therapeutics, Inc. The collaboration, originally announced in January 2011, leverages Protagonist’s proprietary disulfide‐rich peptide (DRP) technology platform and is aimed at providing Ironwood with novel peptides against targets for potential development in therapeutic areas with significant unmet medical needs.

Corporate

  • Ironwood ended 2012 with approximately $168 million of cash, cash equivalents and available-for-sale securities. Ironwood used approximately $70 million of net cash for operations during the year ended December 31, 2012.
  • In January 2013, Ironwood completed a debt offering of $175 million bearing an 11% interest rate.

Conference Call Information

Ironwood will host a conference call and webcast at 8:30 a.m. Eastern Time, on Tuesday, January 15, to discuss its fourth quarter 2012 and recent business activities. Individuals interested in participating in the call should dial (877) 643-7155 (U.S. and Canada) or (914) 495-8552 (international) using conference ID number 83300312. To access the webcast, please visit the Investors section of Ironwood’s website at www.ironwoodpharma.com at least 15 minutes prior to the start of the call to ensure adequate time for any software downloads that may be required. The call will be available for replay via telephone starting today at approximately 11:30 a.m. Eastern Time, running through 11:59 p.m. Eastern Time on January 22, 2013. To listen to the replay, dial (855) 859-2056 (U.S. and Canada) or (404) 537-3406 (international) using conference ID number 83300312. The archived webcast will be available on Ironwood’s website for 14 days.

About LINZESS (linaclotide)

LINZESS is the first and only guanylate cyclase-C (GC-C) agonist approved by the FDA for the treatment of both irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) in adults. LINZESS is a once-daily capsule that helps relieve the abdominal pain and constipation associated with IBS-C, as well as the constipation, infrequent stools, hard stools and incomplete evacuation associated with CIC. The recommended dose is 290 mcg for IBS-C patients and 145 mcg for CIC patients. LINZESS should be taken at least 30 minutes before the first meal of the day.

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