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. (IRWD) and partner Almirall, S.A.’s Constella (linaclotide - 290 mcg).
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. (FRX) 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 (:CIC).
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 Linzess.Read the Full Research Report on IRWD
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