Ironwood Pharmaceuticals, Inc. (IRWD) 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.
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 therapies.
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. (FRX) for patients suffering from IBS-C or chronic idiopathic constipation (:CIC).
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 gastrointestinal disorders.
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 market.
Currently, companies like Santarus, Inc. (SNTS) and Jazz Pharmaceuticals (JAZZ) look attractive with both sporting a Zacks Rank #1 (Strong Buy).
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