EU Approval for Ironwood's Constella - Analyst Blog
November 30 2012 - 8:30AM
Zacks
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.
Our Take
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 Report
IRONWOOD PHARMA (IRWD): Free Stock Analysis Report
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