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Ironwood's Linzess Gets Approval in Japan for New Indication
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Ironwood Pharmaceuticals, Inc. (IRWD - Free Report) and its Japanese partner Astellas Pharma announced that the label expansion application for its sole marketed drug, Linzess (linaclotide), to include chronic constipation has been approved in Japan. A dose of 0.25 mg in tablet formulation will be available in Japan.
The drug is already available in the country as a treatment for irritable bowel syndrome with constipation (IBS-C). Note that the drug is approved for treating IBS-C and chronic idiopathic constipation in the United States.
Shares of Ironwood have outperformed the industry so far this year. The stock has gained 22.6% during the period compared with an increase of 0.2% for the industry.
The approval was given based on data from the phase III study evaluating Linzess for change in weekly mean frequency of spontaneous bowel movement in patients with chronic constipation. Data, presented in past, from the study showed that Linzess achieved statistically significant improvement in patients at week 1 compared to placebo.
Per the press release, approximately 2.5% of men and 4.6% of women in Japan suffer from constipation, a situation where patients have inadequate or uncomfortable excretion of feces. This indicates significant demand for medications.
Ironwood has partnered with Astellas Pharma for the development and commercialization of Linzess in Japan, with Allergan in the United States and Europe, and with AstraZeneca plc (AZN - Free Report) in China, Hong Kong and Macau.
We reminds investors that in July, Ironwood and Allergan advanced Linzess to phase III development for the treatment of additional bothersome symptoms associated with irritable bowel syndrome with constipation (IBS-C), which includes bloating, discomfort and pain. The companies are also developing a delayed-release formulation of the drug to address patients beyond IBS-C and chronic constipation, and also evaluating the drug in pediatric patients.
Successful completion of these studies will expand the patient population of the drug, which, in turn will boost the prospects of the drug.
Linzess has blockbuster potential and it is anticipated to cross $1 billion in annual sales by the end of 2020. Moreover, the patents provide the drug with exclusivity till 2031 and will keep generic competition at bay.
BioSpecifics’ earnings per share estimates increased from $20.9 to $2.28 for 2018 and from $2.13 to $2.38 for 2019 over the last 30 days. The company delivered a positive earnings surprise in three of the trailing four quarters, with an average beat of 11.37%. The company’s shares have increased 22.1% so far this year.
More Stock News: This Is Bigger than the iPhone!
It could become the mother of all technological revolutions. Apple sold a mere 1 billion iPhones in 10 years but a new breakthrough is expected to generate more than 27 billion devices in just 3 years, creating a $1.7 trillion market.
Zacks has just released a Special Report that spotlights this fast-emerging phenomenon and 6 tickers for taking advantage of it. If you don't buy now, you may kick yourself in 2020.
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Ironwood's Linzess Gets Approval in Japan for New Indication
Ironwood Pharmaceuticals, Inc. (IRWD - Free Report) and its Japanese partner Astellas Pharma announced that the label expansion application for its sole marketed drug, Linzess (linaclotide), to include chronic constipation has been approved in Japan. A dose of 0.25 mg in tablet formulation will be available in Japan.
The drug is already available in the country as a treatment for irritable bowel syndrome with constipation (IBS-C). Note that the drug is approved for treating IBS-C and chronic idiopathic constipation in the United States.
Shares of Ironwood have outperformed the industry so far this year. The stock has gained 22.6% during the period compared with an increase of 0.2% for the industry.
The approval was given based on data from the phase III study evaluating Linzess for change in weekly mean frequency of spontaneous bowel movement in patients with chronic constipation. Data, presented in past, from the study showed that Linzess achieved statistically significant improvement in patients at week 1 compared to placebo.
Per the press release, approximately 2.5% of men and 4.6% of women in Japan suffer from constipation, a situation where patients have inadequate or uncomfortable excretion of feces. This indicates significant demand for medications.
Ironwood has partnered with Astellas Pharma for the development and commercialization of Linzess in Japan, with Allergan in the United States and Europe, and with AstraZeneca plc (AZN - Free Report) in China, Hong Kong and Macau.
We reminds investors that in July, Ironwood and Allergan advanced Linzess to phase III development for the treatment of additional bothersome symptoms associated with irritable bowel syndrome with constipation (IBS-C), which includes bloating, discomfort and pain. The companies are also developing a delayed-release formulation of the drug to address patients beyond IBS-C and chronic constipation, and also evaluating the drug in pediatric patients.
Successful completion of these studies will expand the patient population of the drug, which, in turn will boost the prospects of the drug.
Linzess has blockbuster potential and it is anticipated to cross $1 billion in annual sales by the end of 2020. Moreover, the patents provide the drug with exclusivity till 2031 and will keep generic competition at bay.
Ironwood Pharmaceuticals, Inc. Price
Ironwood Pharmaceuticals, Inc. Price | Ironwood Pharmaceuticals, Inc. Quote
Zacks Rank & Stock to Consider
Ironwood currently carries a Zacks Rank #3 (Hold).
BioSpecifics Technologies Corp is a better-ranked stock from the pharma space, sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
BioSpecifics’ earnings per share estimates increased from $20.9 to $2.28 for 2018 and from $2.13 to $2.38 for 2019 over the last 30 days. The company delivered a positive earnings surprise in three of the trailing four quarters, with an average beat of 11.37%. The company’s shares have increased 22.1% so far this year.
More Stock News: This Is Bigger than the iPhone!
It could become the mother of all technological revolutions. Apple sold a mere 1 billion iPhones in 10 years but a new breakthrough is expected to generate more than 27 billion devices in just 3 years, creating a $1.7 trillion market.
Zacks has just released a Special Report that spotlights this fast-emerging phenomenon and 6 tickers for taking advantage of it. If you don't buy now, you may kick yourself in 2020.
Click here for the 6 trades >>