Ironwood (IRWD) Updates on Q3 Activity; FDA Approves LINZESS, Linaclotide Gets Nod from CHMP

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

Third Quarter 2012 and Recent Highlights

Linaclotide

• The U.S. Food and Drug Administration (FDA) approved LINZESS 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, and constipation and hard stools associated with CIC. Ironwood and Forest Laboratories, Inc. expect LINZESS to be available to U.S. patients in December 2012.
  
• Ironwood and Almirall, S.A. received a positive opinion from the European Committee for Medicinal Products for Human Use (CHMP), recommending approval of linaclotide for the symptomatic treatment of moderate to severe IBS-C in adults in the E.U. A decision by the European Commission is expected in 2012. If approved, the product will be marketed under the brand name Constella®.
  
• Astellas, Ironwood’s linaclotide partner in Japan, initiated a double-blind, placebo-controlled, dose-ranging Phase 2 clinical trial of linaclotide in more than 500 Japanese adult patients with IBS-C.
  
• Results from the two Phase 3 trials of linaclotide for the treatment of IBS-C in adults were published in the October 2012 issue of the American Journal of Gastroenterology (AJG).
  
• Ironwood and Forest will present 10 abstracts at the American College of Gastroenterology (ACG) 2012 Annual Scientific Meeting being held in Las Vegas from October 19-24, 2012. Data being presented include analyses of abdominal and bowel symptoms from Phase 3 trials of linaclotide in IBS-C and CIC, as well as data about the economic burden of IBS-C and CIC and data on the use of patient-reported outcomes to assess the symptoms of these conditions.
  
  
• Ironwood and Almirall will present six abstracts and two oral presentations at the 20th United European Gastroenterology Week being held in Amsterdam from October 20-24, 2012. Data being presented include analyses of abdominal and bowel symptoms from Phase 3 trials of linaclotide in IBS-C.

Research & Development

• In addition to the company’s ongoing efforts to evaluate linaclotide’s pharmacological potential in a variety of patient populations, Ironwood continues to pioneer the guanylate cyclase-C (GC-C) agonist space through the advancement of a second GC-C agonist, IW-9179. IW-9179 is currently being investigated in a Phase 2a clinical trial designed to evaluate its safety in approximately 80 patients with functional dyspepsia.
  
  
• Ironwood continues to advance its broader pipeline, which includes early development candidates and discovery research efforts focused on gastrointestinal disease, central nervous system disorders, respiratory disease, and cardiovascular disease.

Corporate

• Ironwood received an $85 million milestone payment from Forest for FDA approval of LINZESS.
  
  
• Including the $85 million milestone payment, Ironwood ended the third quarter of 2012 with approximately $193 million of cash, cash equivalents, and available-for-sale securities and used approximately $47 million of net cash for operations during the nine months ended September 30, 2012.

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