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Ironwood Begins New Phase III Study to Expand Linzess Label
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Ironwood Pharmaceuticals, Inc. (IRWD - Free Report) announced that it has initiated a phase IIIb study to expand the label of its drug, Linzess (linaclotide), for adding new bothersome symptoms associated with irritable bowel syndrome with constipation (IBS-C), which includes- bloating, discomfort and pain.
Linzess (linaclotide) is a guanylate cyclase-C (GC-C) agonist. The drug is approved in the IBS-C indication as a 290-mcg capsule to be taken once daily.
However, in the United States, most adult IBS-C patients complain of symptoms such as abdominal bloating and discomfort at least once a week. If approved, this new indication would expand the eligible patient population for the drug and drive its sales higher.
The double-blind placebo-controlled study (n=600) aims at enrolling adult IBS-C patients, who will take linaclotide 290 mcg once daily for 12 weeks, followed by a four-week withdrawal period. The primary efficacy endpoint is to measure the change in abdominal score based on daily patient assessments of abdominal bloating, discomfort and pain. Additional endpoints include change in spontaneous bowel movement frequency, complete spontaneous bowel movement frequency, stool consistency and straining.
Linzess (linaclotide) was launched in December 2012 in collaboration with Allergan Plc for patients suffering IBS-C (290 mcg) or chronic idiopathic constipation (145 mcg & 72 mcg).
Ironwood and Allergan are looking to extend Linzess’ label for including new indications, populations and formulations.
Ironwood and Allergan are also developing a delayed release formulation of Linzess — delayed release-2 or DR2 — to address new patient populations beyond IBS-C and chronic constipation. DR2 is being developed as a visceral non-opioid pain-relieving agent for patients afflicted with all IBS subtypes. Linzess is also being evaluated as a potential treatment of the GI dysfunction associated with opioid-induced constipation and in pediatric studies for the therapy of IBS-C patients.
Notably, Ironwood has partnered with Astellas Pharma for the development and commercialization of Linzess in Japan and with AstraZeneca plc (AZN - Free Report) in China, Hong Kong and Macau.
In the United States, Linzess generated net sales of $159.3 million in the first quarter of 2018, up 7.9% year over year. The drug’s uptake continues to grow in 2018 following a strong performance in 2017 and it remains a market leader among branded prescription drugs.
Linzess has potential to evolve as a blockbuster product. By the end of 2020, Ironwood expects Linzess’ annual sales to cross a $1-billion mark. It is well-protected by patents and is unlikely to face a generic competition before 2031. Ironwood and Allergan are working to strengthen the patent further.
Shares of Ironwood have surged 38.9% year to date, outperforming the industry’s increase of 3.2%.
Taro Pharmaceutical’s earnings estimates have been revised 13% upward for fiscal 2019 and 12.4% for fiscal 2020 over the past 60 days. The stock has gained 9.5% so far this year.
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It's hard to believe, even for us at Zacks. But while the market gained +21.9% in 2017, our top stock-picking screens have returned +115.0%, +109.3%, +104.9%, +98.6%, and +67.1%.
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Ironwood Begins New Phase III Study to Expand Linzess Label
Ironwood Pharmaceuticals, Inc. (IRWD - Free Report) announced that it has initiated a phase IIIb study to expand the label of its drug, Linzess (linaclotide), for adding new bothersome symptoms associated with irritable bowel syndrome with constipation (IBS-C), which includes- bloating, discomfort and pain.
Linzess (linaclotide) is a guanylate cyclase-C (GC-C) agonist. The drug is approved in the IBS-C indication as a 290-mcg capsule to be taken once daily.
However, in the United States, most adult IBS-C patients complain of symptoms such as abdominal bloating and discomfort at least once a week. If approved, this new indication would expand the eligible patient population for the drug and drive its sales higher.
The double-blind placebo-controlled study (n=600) aims at enrolling adult IBS-C patients, who will take linaclotide 290 mcg once daily for 12 weeks, followed by a four-week withdrawal period. The primary efficacy endpoint is to measure the change in abdominal score based on daily patient assessments of abdominal bloating, discomfort and pain. Additional endpoints include change in spontaneous bowel movement frequency, complete spontaneous bowel movement frequency, stool consistency and straining.
Linzess (linaclotide) was launched in December 2012 in collaboration with Allergan Plc for patients suffering IBS-C (290 mcg) or chronic idiopathic constipation (145 mcg & 72 mcg).
Ironwood and Allergan are looking to extend Linzess’ label for including new indications, populations and formulations.
Ironwood and Allergan are also developing a delayed release formulation of Linzess — delayed release-2 or DR2 — to address new patient populations beyond IBS-C and chronic constipation. DR2 is being developed as a visceral non-opioid pain-relieving agent for patients afflicted with all IBS subtypes. Linzess is also being evaluated as a potential treatment of the GI dysfunction associated with opioid-induced constipation and in pediatric studies for the therapy of IBS-C patients.
Notably, Ironwood has partnered with Astellas Pharma for the development and commercialization of Linzess in Japan and with AstraZeneca plc (AZN - Free Report) in China, Hong Kong and Macau.
In the United States, Linzess generated net sales of $159.3 million in the first quarter of 2018, up 7.9% year over year. The drug’s uptake continues to grow in 2018 following a strong performance in 2017 and it remains a market leader among branded prescription drugs.
Linzess has potential to evolve as a blockbuster product. By the end of 2020, Ironwood expects Linzess’ annual sales to cross a $1-billion mark. It is well-protected by patents and is unlikely to face a generic competition before 2031. Ironwood and Allergan are working to strengthen the patent further.
Shares of Ironwood have surged 38.9% year to date, outperforming the industry’s increase of 3.2%.
Ironwood currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the same sector is Taro Pharmaceutical Industries Ltd. (TARO - Free Report) , which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Taro Pharmaceutical’s earnings estimates have been revised 13% upward for fiscal 2019 and 12.4% for fiscal 2020 over the past 60 days. The stock has gained 9.5% so far this year.
Today's Stocks from Zacks' Hottest Strategies
It's hard to believe, even for us at Zacks. But while the market gained +21.9% in 2017, our top stock-picking screens have returned +115.0%, +109.3%, +104.9%, +98.6%, and +67.1%.
And this outperformance has not just been a recent phenomenon. Over the years it has been remarkably consistent. From 2000 - 2017, the composite yearly average gain for these strategies has beaten the market more than 19X over. Maybe even more remarkable is the fact that we're willing to share their latest stocks with you without cost or obligation.
See Them Free>>