Ironwood Pharmaceuticals, Inc.'s
) third-quarter 2012 earnings of 42 cents per share compared
favorably with the year-ago loss of 21 cents per share and the
Zacks Consensus Estimate of 15 cents. Results were boosted by
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Total revenues in the reported quarter jumped to $96.4 million
from $12.2 million in the year-ago quarter. Revenues were above
the Zacks Consensus Estimate of $78 million. Revenues were
boosted by an $85 million milestone payment from
Forest Laboratories, Inc.
) on the US approval of Linzess (linaclotide).
We remind investors that in August 2012, Ironwood Pharma and its
US partner Forest Labs received approval from the US Food and
Drug Administration (FDA) for Linzess. Linzess is expected to be
launched in the US in December 2012 at an initial price of $7.10
Linzess is approved in the US for the once-daily treatment of
adults suffering from irritable bowel syndrome with constipation
(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 to 17 years of age
should be avoided.
In Europe, Ironwood has partnered with Almirall, S.A. for
linaclotide (proposed brand name Constella). In September 2012,
the Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) provided a positive opinion in
favor of approving Constella.
The companies are looking to get Constella approved in the EU for
the symptomatic treatment of adult patients suffering from
moderate to severe IBS-C.
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. Upon approval and launch of the drug in five
key European territories (Germany, the UK, Italy, Spain and
France), Ironwood Pharma would receive milestone payments up to
Ironwood Pharma is also working with its Japanese partner,
Astellas Pharma Inc. for the development of linaclotide in Japan
and other Asian countries. Currently, a phase II trial is ongoing
evaluating the use of linaclotide in patients with IBS-C.
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,