Ironwood Pharmaceuticals Inc.
) recently commenced a phase I study in the US with its
anti-anxiety candidate, IW-2143 (BNC210). The company informed
its licensing partner, Bionomics Limited, regarding the
IW-2143's safety and pharmacokinetics will be evaluated in the
study. Single and multiple doses of the candidate will be
Ironwood Pharma has a collaboration, research and license
agreement with Bionomics for IW-2143. Under the agreement signed
in Jan 2012, Ironwood Pharma is responsible for the global
development and commercialization of any resulting products. The
company made an upfront payment of $3 million and will fund
clinical studies. Besides this, Ironwood Pharma is liable to make
payments on the achievement of development and regulatory
milestones. Once IW-2143 is successfully commercialized, the
company will pay royalties on product sales.
With the phase I study in progress, Bionomics could receive a
$2 million milestone payment. The anxiety disorder market
represents significant potential with about 40 million Americans
suffering from anxiety every year. Although several treatments
are available, the market is characterized by a significant unmet
We are pleased to see Ironwood Pharma focusing on the
development of its early-stage candidates. However, the company
is better known for Linzess (linaclotide), its once-daily
treatment for adult men and women suffering from irritable bowel
syndrome with constipation (IBS-C) or chronic idiopathic
Linzess gained FDA approval in late Aug and was launched in
the US in Dec. Meanwhile, EU approval came in Nov under the trade
name Constella. While Ironwood Pharma's collaboration partner for
Linzess in the US is
), the company's EU partner is Almirall, SA.
) is collaborating with the company for the product in Japan and
a few other Asian countries.
We expect investor focus to remain on the successful
commercialization of Linzess. We currently have a Neutral
recommendation on Ironwood Pharma, which carries a Zacks #2 Rank
(Buy). Astellas carries a Zacks #1 Rank (Strong Buy).
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