The European Commission recently granted approval to
Ironwood Pharmaceuticals Inc.
) 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
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
Forest Laboratories, Inc.
), 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.
FOREST LABS A (FRX): Free Stock Analysis
IRONWOOD PHARMA (IRWD): Free Stock Analysis
To read this article on Zacks.com click here.