Ironwood/Astellas Report Positive Phase III Data on Linzess
Ironwood Pharmaceuticals, Inc. IRWD and partner Astellas Pharma, Inc. reported positive top-line data from a phase III study on Linzess (EU trade name – Constella) in adults with chronic constipation (CC).
A look at Ironwood’s share price movement over the past one year shows that the stock has outperformed the Zacks classified Medical - Drugs industry. Specifically, Ironwood gained 52.2% during this period, while the industry lost 10.1%.
Coming back to the latest news, the double-blinded, placebo-controlled study (n=186), which was conducted in Japan, achieved the primary endpoint. Results revealed that patients treated with Linzess (500 mcg) demonstrated a statistically significant improvement compared to placebo across the primary endpoint, change from baseline in mean spontaneous bowel movement frequency at week 1. Detailed results from the study are expected to be presented at a future scientific meeting.
The phase III study also includes an additional 52-week, open-label study period, which is currently ongoing. Based on the blinded efficacy data and open-label safety data, Astellas intends to file for regulatory approval in Japan in this indication. We note that Ironwood has a licensing agreement with Astellas for the development and commercialization of Linzess in Japan.
Moreover, Ironwood has partnered with Allergan plc AGN for the development and commercialization of Linzess in the U.S. and the EU, as well as with AstraZeneca plc AZN in China, Hong Kong and Macau.
Linzess is currently approved in the U.S. for the treatment of adults with irritable bowel syndrome with constipation (IBS-C; 290 mcg) and chronic idiopathic constipation (CIC; 145 mcg). Moreover, last week, the FDA approved a 72 mcg dose of Linzess for the treatment of adults with CIC. The new dose is expected to be available in the first quarter of 2017.
We are encouraged by the latest study results. As per IMS Health data, since its launch in Dec 2012, nearly 1.5 million patients have filled around 7 million prescriptions. Linzess has blockbuster potential, if approved for additional indications.
Ironwood Pharmaceuticals, Inc. Price and Consensus
Ironwood Pharmaceuticals, Inc. Price and Consensus | Ironwood Pharmaceuticals, Inc. Quote
Zacks Rank & Key Picks
Ironwood carries a Zacks Rank #3 (Hold). Sucampo Pharmaceuticals, Inc. SCMP is a better-ranked stock in the health care sector with a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Sucampo’s earnings estimates were stable at $1.22 for 2016 but have increased from $1.58 to $1.74 for 2017 over the last 60 days. The company posted a positive earnings surprise in all of the four trailing quarters with an average beat of 35.5%.
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