Ironwood Anxiety Drug in Phase I - Analyst Blog
December 27 2012 - 12:37PM
Zacks
Ironwood Pharmaceuticals Inc. (IRWD) 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 development.
IW-2143’s safety and pharmacokinetics will be evaluated in the
study. Single and multiple doses of the candidate will be used.
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 need.
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 constipation
(CIC).
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 Forest Labs (FRX), the
company’s EU partner is Almirall, SA. Astellas
Pharma (ALPMY) 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).
(ALPMY): ETF Research Reports
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