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| Linaclotide is a GC-C agonist in development for the treatment of irritable bowel syndrome with constipation (IBS-C) and chronic constipation (CC). The clinical efficacy portion of the linaclotide development program is complete and two long-term safety studies are still ongoing. Across four Phase 3 efficacy trials in patients with IBS-C or CC, linaclotide met all primary and secondary endpoints encompassing abdominal and bowel symptoms. In these trials, diarrhea was the most commonly reported adverse event and the most commonly reported adverse event that led to study discontinuation. Most occurrences of diarrhea were reported as mild to moderate. More than 3,200 patients have enrolled in one of two ongoing 18-month open label safety studies. |
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| Linaclotide is a peptide designed to be orally delivered once a day. Linaclotide acts locally in the gut with no measurable systemic exposure at therapeutic doses. In preclinical models, linaclotide reduced visceral hypersensitivity, increased fluid secretion, and accelerated intestinal transit. The effects on secretion and transit are thought to be mediated through cyclic guanosine monophosphate (cGMP), which is also believed to modulate the activity of local nerves to reduce pain. |
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| Ironwood is committed to ensuring that linaclotide, if approved by the appropriate regulatory authorities, is made available to the millions of IBS-C and CC sufferers around the world. In the United States, Ironwood and its partner, Forest Laboratories, are co-developing linaclotide and, if it is approved, will co-promote linaclotide. Ironwood has licensed linaclotide to Almirall S.A. for development and commercialization in Europe, and to Astellas Pharma for development and commercialization in Japan, Indonesia, Korea, the Philippines, Taiwan, and Thailand. Ironwood retains all rights to linaclotide in all other territories. Issued composition of matter patents for linaclotide provide protection in the U.S. to 2025 and outside the U.S. to 2024–2025. |
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| In August 2011, Ironwood and Forest submitted a New Drug Application (NDA) with the Food and Drug Administration (FDA) seeking approval to market linaclotide to IBS-C and CC patients ages 18 and older in the U.S. |
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| In September 2011, our European partner, Almirall S.A. submitted a Market Authorization Application (MAA), with the European Medicines Agency (EMA), seeking approval to market linaclotide to IBS-C patients in the E.U. |
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| IBS-C and CC are chronic conditions characterized by frequent and bothersome abdominal and/or constipation symptoms. Patients with IBS-C experience frequent and recurrent abdominal pain and/or discomfort and constipation symptoms, such as infrequent bowel movements, hard/lumpy stools, and straining during defecation. CC is primarily characterized by constipation symptoms, but a majority of these patients report experiencing bloating and abdominal discomfort as among their most bothersome symptoms. |
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| We estimate that in 2010, approximately 40 million people in the U.S. suffered from symptoms of IBS-C or CC, of whom an estimated 18 million patients sought medical care. Patients are often treated with fiber and laxatives; however, according to market research, over 70 percent are not satisfied with current treatment options. This large, highly symptomatic, and dissatisfied patient population could benefit from new treatments. |
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