Ironwood’s drug for irritable bowel syndrome with constipation gets regulatory approval in Europe

Ironwood Pharmaceuticals Inc. of Cambridge and its European partner Almirall S.A. said Wednesday that Ironwood’s drug for irritable bowel syndrome with constipation has been approved by European regulators.

That same drug is about to go onto the US market, following approval by the Food and Drug Administration earlier this year. According to a recent Globe story, irritable bowel syndrome, or IBS, afflicts 30 million to 40 million Americans. Given the number of people affected, the drug has the potential to be a blockbuster, ringing up annual sales of $1 billion or more.

The drug will be marketed under one brand name in the US, Linzess, and under another brand name --- Constella --- in Europe.

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The active ingredient in Linzess and Constella is linaclotide, and it has been approved for the treatment of moderate to severe irritable bowel syndrome with constipation in adults, Ironwood and Almirall said in a press release. (Irritable bowel syndrome with constipation is also known as IBS-C.)

In 2009, Almirall and Ironwood signed a license agreement that gives Almirall exclusive marketing rights for linaclotide in all European Union member states, plus Russia, Turkey, as well as several other countries in Europe.

Almirall expects to begin launching Constella in Europe in the first half of 2013.

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