(By Balaseshan) Ironwood Pharmaceuticals Inc. (NASDAQ: IRWD) and Almirall S.A. say Constella (linaclotide 290mcg) was approved in Europe to treat Irritable Bowel Syndrome with Constipation (IBS-C) in adults.
The European Commission has granted marketing authorization to Constella (linaclotide 290mcg). This approval follows the positive recommendation received from the European Committee for Medicinal Products for Human Use (CHMP) in September. 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, Chief Executive of Ironwood.
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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.
"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," said Peter Hecht.
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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.
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-C1, 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.
IRWD closed Tuesday's regular session down 2.04% at $10.79. The stock has been trading between $10.02 and $15.92 for the past 52 weeks.