The European Commission recently granted approval to Ironwood Pharmaceuticals Inc. (IRWD) and partner Almirall, S.A.’s Constella (linaclotide - 290 mcg). Constella is approved for the symptomatic treatment of adult patients suffering from moderate-to-severe irritable bowel syndrome with constipation (IBSC).
With the EU approval, Constella became the first and only approved medication for the symptomatic treatment of adults suffering from moderate-to-severe IBSC in the EU. Almirall expects European launch of Constella in the first half of 2013.
In September this year, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) had provided a positive opinion in favor of approving Constella.
As per the 2009 license agreement with Almirall, the latter has the exclusive marketing rights of Constella in the EU. We also note that in September this year, Almirall signed an agreement with Forest Laboratories, Inc. (FRX), under which the latter granted the commercialization rights for Constella in Mexico to Almirall.
We remind investors that in August 2012, Ironwood Pharmaceuticals and its US partner Forest Laboratoriesreceived approval from the US Food and Drug Administration (FDA) for Linzess (US trade name of Constella). Linzess is approved in the US for the once-daily treatment of adults suffering from IBS-C or chronic idiopathic constipation (CIC).
Ironwood Pharmaceuticals is currently working with its Japanese partner, Astellas Pharma Inc. for the development of Constella in Japan and other Asian countries.
We currently have a Neutral recommendation on Ironwood Pharmaceuticals, Inc. Ironwood Pharmaceuticals carries a Zacks #3 Rank (Hold rating) in the short run. We expect investor focus to remain on the successful commercialization of Constella. Ironwood Pharmaceuticals is totally dependent on its lead product, Constella, for growth.