Ironwood Pharmaceuticals, Inc. (IRWD) and partner AstraZeneca (AZN) 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.
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 approval.
In Oct 2012, Ironwood and AstraZeneca entered into an agreement for the development and commercialization of linaclotide in China.
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. (FRX) for patients suffering from IBS-C or chronic idiopathic constipation (:CIC).
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. (QCOR), carrying a Zacks Rank #1 (Strong Buy).