Almirall seeks European approval for linaclotide to treat irritable bowel syndrome with constipation

- Linaclotide has demonstrated statistically significant improvement in abdominal pain/discomfort and global relief of IBS-C symptoms in Phase III clinical trials

- IBS-C is a debilitating disease associated with reduced quality of life and considerable socio-economic and psychological consequences

Almirall, S.A. (ALM.MC) announced today that it has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for linaclotide, an investigational guanylate cyclase-C (GC-C) receptor agonist for the treatment of irritable bowel syndrome with constipation (IBS-C). Once approved, linaclotide will be marketed in Europe under the trademark Constella^®.

"IBS is associated with significant reduction in quality of life and intensive consumption of healthcare resources. In particular, people suffering from IBS-C currently have very limited treatment options available to them. Patients and physicians are frustrated because of this lack of specific therapy for IBS-C", said Bertil Lindmark, Chief Scientific Officer at Almirall. "The results of clinical trials are extremely encouraging and, with this regulatory submission of linaclotide in IBS-C, we look forward to bringing this novel first in class medicine to patients in Europe."

The submission includes efficacy and safety data from a Phase III program comprising two double-blind placebo-controlled trials and two open-label long term safety studies. A total of more than 1,600 subjects received an once-daily dose of either linaclotide or placebo across the two placebo-controlled studies in patients with IBS-C. Full results of these two studies will be presented at the European Gastroenterology Week (UEGW) congress in Stockholm in October 23^rd-26^th, 2011.

This MAA follows the submission of an NDA for linaclotide to the US Food and Drug Administration (FDA) in August 2011 by Ironwood Pharmaceuticals Inc. and its US partner, Forest Laboratories Inc.

Almirall licensed from Ironwood the rights to develop and commercialize linaclotide in Europe.

SOURCE Almirall, S.A.