Ironwood Pharmaceuticals, Inc.
) and partner
) recently announced that a phase III trial (n ~ 800) on
linaclotide for the treatment of adults with irritable bowel
syndrome with constipation (IBS-C) has been initiated in China.
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The double-blind, randomized, placebo-controlled study will
evaluate the safety and efficacy of linaclotide in patients
suffering from IBS-C. Top-line data from the study is expected in
the first half of 2015. Linaclotide is expected to reach the
market in 2017, subject to China Food and Drug Administration
In Oct 2012, Ironwood and AstraZeneca entered into an agreement
for the development and commercialization of linaclotide in
We note that the product is already available in the U.S. under
that trade name Linzess. Ironwood Pharma launched Linzess in Dec
2012 in collaboration with
Forest Laboratories, Inc.
) for patients suffering from IBS-C or chronic idiopathic
The companies are looking to broaden the Linzess label by
incorporating additional patient populations and indications. To
further analyze the effect of Linzess on abdominal symptoms in
patients suffering from CIC, Forest Labs and Ironwood Pharma have
initiated a phase IIIb clinical trial. Results from the trial are
expected shortly. Forest Labs and Ironwood plan to evaluate the
use of Linzess in the pediatric population and in opioid-induced
constipation patients in the first half of 2014.
Net sales of the drug, as reported by Forest Labs, came in at
$28.8 million in the second quarter of 2013 as compared to $4.5
million in the previous quarter. For 2013, Ironwood expects total
investment in sales and marketing for Linzess in the range of
$250 - $300 million.
In the EU, approval came in Nov 2012 under the trade name
Constella. Ironwood is collaborating with Almirall, S.A. in the
EU for the drug. The product is now available in Germany, the UK
and the Nordic countries and is expected to be launched across
Europe in 2013 and 2014.
Ironwood carries a Zacks Rank #3 (Hold). We expect investor focus
to remain on the market performance of Linzess. Stocks which
currently look attractive in the pharma space include
Questcor Pharmaceuticals, Inc.
), carrying a Zacks Rank #1 (Strong Buy).