The Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) recently provided a positive
opinion in favor of approving
Ironwood Pharmaceuticals, Inc.
) and partner Almirall, S.A.'s Constella (linaclotide - 290
The companies are looking to get Constella approved for the
symptomatic treatment of adult patients suffering from moderate to
severe irritable bowel syndrome with constipation (IBSC).
We note that in September 2011, Almirall had submitted a Market
Authorization Application (MAA) to the EMA for Constella. As per
the license agreement, Almirall has exclusive marketing rights to
Constella in the EU.
The CHMP's positive opinion was based on data from two
double-blind phase III studies. Results showed statistically
significant improvements in the relief of abdominal pain and other
IBS-C symptoms thereby meeting the primary as well as secondary
endpoints over the treatment periods of 12 and 26 weeks.
We remind investors that in August 2012, Ironwood
Pharmaceuticals and its US partner
Forest Laboratories, Inc.
) received approval from the US Food and Drug Administration (FDA)
for Linzess (linaclotide).
Linzess is approved in the US for the once-daily treatment of
adults suffering from IBS-C or chronic idiopathic constipation
However, the label carries a boxed warning stating that Linzess
is contraindicated in pediatric patients up to 6 years of age.
Moreover, Linzess' use in pediatric patients 6 through 17 years of
age should be avoided.
Ironwood Pharmaceuticals is currently working with its Japanese
partner, Astellas Pharma Inc. for the development of linaclotide 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 the lead product
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