Ironwood Pharmaceuticals, Inc.
) recently announced that it has launched Constella in
collaboration with Almirall, S.A. in Europe. The European
Commission approved the drug in Nov 2012 for the treatment of
moderate-to-severe irritable bowel syndrome with constipation
(IBS-C) in adults.
IRONWOOD PHARMA (IRWD): Free Stock Analysis
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The company noted that Constella is the only product approved for
the indication in Europe. The product is now available in
Germany, the UK and the Nordic countries and is expected to be
launched across Europe in 2013.
We note that the Scottish Medicines Consortium (SMC) recommended
the use of Constella in adults suffering from moderate-to-severe
IBS-C who have responded inadequately to other suitable
We note that the product is already available in the US 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
Net sales of Linzess, as reported by Forest Labs, came in at $4.5
million in the first quarter of 2013 as compared to $19.2 million
in the fourth quarter of 2012. We note that in the final quarter
of 2012 Linzess sales primarily consisted of initial trade
stocking. For 2013, Ironwood expects total investment in sales
and marketing for Linzess in the range of $250 - $300 million.
The companies are looking to expand Linzess' label into
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 are
conducting a phase IIIb clinical trial. Results from the trial
are expected in the second half of 2013. The companies plan to
conduct additional trials to evaluate Linzess for additional
Ironwood Pharma carries a Zacks Rank #3 (Hold). Though encouraged
by the company's efforts to develop and commercialize Linzess, we
are concerned about the company's over dependence on Linzess for
growth. It remains to be seen how the product performs in the
Currently, companies like
) look attractive with both sporting a Zacks Rank #1 (Strong