– Trial did not achieve statistically significant improvement in heartburn severity (primary endpoint) –
– Ironwood plans to implement organizational restructuring, resulting in expected headcount reduction of approximately 100 full-time employees, or nearly 35% of current workforce –
– Expects total cost savings of greater than $95 million, excluding anticipated one-time costs –
BOSTON, MA, USA I September 29, 2020 I Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD), a GI-focused healthcare company, today announced that data from IW-3718-302, one of Ironwood’s two identical Phase III trials evaluating IW-3718 in refractory gastroesophageal reflux disease (GERD), did not meet the pre-specified criteria associated with a planned early efficacy assessment. Following the assessment from an independent data monitoring committee, Ironwood unblinded the data and confirmed that IW-3718-302 did not meet the criteria, including the study’s primary endpoint of achieving a statistically significant improvement in heartburn severity. IW-3718 was generally well-tolerated in study IW-3718-302.
Based on these findings, Ironwood plans to discontinue development of IW-3718, including stopping enrollment in IW-3718-301, the second Phase III trial.
“The outcome of this assessment is deeply disappointing for Ironwood and for patients, given the large unmet need among patients with refractory GERD for an alternative to standard treatment options,” said Mark Mallon, chief executive officer of Ironwood. “IW-3718-302 was a robust and well-conducted Phase III trial, and while we plan to conduct a complete analysis of the data set, we believe these findings are definitive. We extend our gratitude to the patients, investigators and their staff and the entire Ironwood team who played a critical role in advancing IW-3718.”
Ironwood plans to implement an organizational restructuring, reducing headcount by approximately 100 full-time employees, or nearly 35% of the current workforce. This is expected to affect both field-based and home-office employees, including the relevant general & administrative support functions. Following the changes, Ironwood expects to have approximately 210 full-time employees. The planned workforce reduction is anticipated to be substantially completed in the first quarter of 2021.
Ironwood expects these changes to result in total cost savings of greater than $95 million, comprised of at least $45 million in annualized cost savings related to the planned workforce reduction and an additional approximately $50 million related to external spend for IW-3718 previously expected through 2021. Ironwood expects to incur one-time costs of approximately $10 million to $12 million in connection with discontinuing development of IW-3718, primarily associated with the planned reduction in workforce. Such costs are expected to be incurred primarily in the fourth quarter of 2020.
As part of this workforce reduction and in light of recent changes in market dynamics related to the COVID-19 pandemic, Ironwood plans to restructure its commercial organization. Ironwood remains committed to seeking to maximize LINZESS, and commercial efforts are being designed to focus primarily on gastroenterologists where Ironwood has strong, established relationships and a demonstrated ability to educate and impact treatment decisions.
Mark Mallon continued, “We have made the difficult decision to re-align our resources and capital with our business moving forward. With a streamlined organization that we believe will be positioned well to deliver in this current environment, we aim to continue our efforts to maximize LINZESS and to drive further growth and profitability. There are approximately 70 million people today living with GI diseases in the U.S., and we remain steadfast in our mission to advance GI medicines and redefine the standard of care for these patients.”
Conference Call Information
Ironwood will host a conference call and webcast at 8:30 a.m. Eastern Time on Tuesday, September 29, 2020 to discuss the IW-3718 program. Individuals interested in participating in the call should dial (866) 324-3683 (U.S. and Canada) or (509) 844-0959 (international) using conference ID number 3895614. To access the webcast, please visit the Investors section of Ironwood’s website at www.ironwoodpharma.com at least 15 minutes prior to the start of the call to ensure adequate time for any software downloads that may be required. The call will be available for replay via telephone starting at approximately 11:30 a.m. Eastern Time on September 29, 2020 running through 11:59 p.m. Eastern Time on October 13, 2020. To listen to the replay, dial (855) 859-2056 (U.S. and Canada) or (404) 537-3406 (international) using conference ID number 3895614. The archived webcast will be available on Ironwood’s website for 14 days beginning approximately one hour after the call has completed.
About IW-3718
IW-3718 is a gastric-retentive investigational formulation of colesevelam. IW-3718 was designed to maintain the bile-acid sequestrant in the stomach over an extended period of time where it was positioned to intercept bile before it reaches the esophagus. Data from non-clinical and clinical studies collectively supported the extended release and gastric-retentive profile of IW-3718.
About Ironwood Pharmaceuticals
Ironwood Pharmaceuticals (Nasdaq: IRWD) is a GI-focused healthcare company dedicated to creating medicines that make a difference for patients living with GI diseases. We discovered, developed and are commercializing linaclotide, the U.S. branded prescription market leader for adults with irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC).
Ironwood was founded in 1998 and is headquartered in Boston, Mass. For more information, please visit our website at www.ironwoodpharma.com or www.twitter.com/ironwoodpharma; information that may be important to investors will be routinely posted in both these locations.
About LINZESS (linaclotide)
LINZESS® is the #1 prescribed brand for the treatment of adult patients with irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC), based on IQVIA data.
LINZESS is a once-daily capsule that helps relieve the abdominal pain and constipation associated with IBS-C, as well as the constipation, infrequent stools, hard stools, straining, and incomplete evacuation associated with CIC. The recommended dose is 290 mcg for IBS-C patients and 145 mcg for CIC patients, with a 72-mcg dose approved for use in CIC depending on individual patient presentation or tolerability. LINZESS should be taken at least 30 minutes before the first meal of the day.
LINZESS is contraindicated in pediatric patients less than 6 years of age. The safety and effectiveness of LINZESS in pediatric patients less than 18 years of age have not been established. In neonatal mice, linaclotide increased fluid secretion as a consequence of GC-C agonism resulting in mortality within the first 24 hours due to dehydration. Due to increased intestinal expression of GC-C, patients less than 6 years of age may be more likely than patients 6 years of age and older to develop severe diarrhea and its potentially serious consequences. In adults with IBS-C or CIC treated with LINZESS, the most commonly reported adverse event was diarrhea.
LINZESS is not a laxative; it is the first medicine approved by the FDA in a class called guanylate cyclase-C (GC-C) agonists. LINZESS contains a peptide called linaclotide that activates the GC-C receptor in the intestine. Activation of GC-C is thought to result in increased intestinal fluid secretion and accelerated transit and a decrease in the activity of pain-sensing nerves in the intestine. The clinical relevance of the effect on pain fibers, which is based on nonclinical studies, has not been established.
In the United States, Ironwood and AbbVie co-develop and co-commercialize LINZESS for the treatment of adults with IBS-C or CIC. In Europe, AbbVie markets linaclotide under the brand name CONSTELLA® for the treatment of adults with moderate to severe IBS-C. In Japan, Ironwood’s partner Astellas markets linaclotide under the brand name LINZESS for the treatment of adults with IBS-C or CIC. Ironwood also has partnered with AstraZeneca for development and commercialization of LINZESS in China, and with AbbVie for development and commercialization of linaclotide in all other territories worldwide.
LINZESS Important Safety Information
INDICATIONS AND USAGE
LINZESS (linaclotide) is indicated in adults for the treatment of both irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC).
SOURCE: Ironwood Pharmaceuticals
Post Views: 41
– Trial did not achieve statistically significant improvement in heartburn severity (primary endpoint) –
– Ironwood plans to implement organizational restructuring, resulting in expected headcount reduction of approximately 100 full-time employees, or nearly 35% of current workforce –
– Expects total cost savings of greater than $95 million, excluding anticipated one-time costs –
BOSTON, MA, USA I September 29, 2020 I Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD), a GI-focused healthcare company, today announced that data from IW-3718-302, one of Ironwood’s two identical Phase III trials evaluating IW-3718 in refractory gastroesophageal reflux disease (GERD), did not meet the pre-specified criteria associated with a planned early efficacy assessment. Following the assessment from an independent data monitoring committee, Ironwood unblinded the data and confirmed that IW-3718-302 did not meet the criteria, including the study’s primary endpoint of achieving a statistically significant improvement in heartburn severity. IW-3718 was generally well-tolerated in study IW-3718-302.
Based on these findings, Ironwood plans to discontinue development of IW-3718, including stopping enrollment in IW-3718-301, the second Phase III trial.
“The outcome of this assessment is deeply disappointing for Ironwood and for patients, given the large unmet need among patients with refractory GERD for an alternative to standard treatment options,” said Mark Mallon, chief executive officer of Ironwood. “IW-3718-302 was a robust and well-conducted Phase III trial, and while we plan to conduct a complete analysis of the data set, we believe these findings are definitive. We extend our gratitude to the patients, investigators and their staff and the entire Ironwood team who played a critical role in advancing IW-3718.”
Ironwood plans to implement an organizational restructuring, reducing headcount by approximately 100 full-time employees, or nearly 35% of the current workforce. This is expected to affect both field-based and home-office employees, including the relevant general & administrative support functions. Following the changes, Ironwood expects to have approximately 210 full-time employees. The planned workforce reduction is anticipated to be substantially completed in the first quarter of 2021.
Ironwood expects these changes to result in total cost savings of greater than $95 million, comprised of at least $45 million in annualized cost savings related to the planned workforce reduction and an additional approximately $50 million related to external spend for IW-3718 previously expected through 2021. Ironwood expects to incur one-time costs of approximately $10 million to $12 million in connection with discontinuing development of IW-3718, primarily associated with the planned reduction in workforce. Such costs are expected to be incurred primarily in the fourth quarter of 2020.
As part of this workforce reduction and in light of recent changes in market dynamics related to the COVID-19 pandemic, Ironwood plans to restructure its commercial organization. Ironwood remains committed to seeking to maximize LINZESS, and commercial efforts are being designed to focus primarily on gastroenterologists where Ironwood has strong, established relationships and a demonstrated ability to educate and impact treatment decisions.
Mark Mallon continued, “We have made the difficult decision to re-align our resources and capital with our business moving forward. With a streamlined organization that we believe will be positioned well to deliver in this current environment, we aim to continue our efforts to maximize LINZESS and to drive further growth and profitability. There are approximately 70 million people today living with GI diseases in the U.S., and we remain steadfast in our mission to advance GI medicines and redefine the standard of care for these patients.”
Conference Call Information
Ironwood will host a conference call and webcast at 8:30 a.m. Eastern Time on Tuesday, September 29, 2020 to discuss the IW-3718 program. Individuals interested in participating in the call should dial (866) 324-3683 (U.S. and Canada) or (509) 844-0959 (international) using conference ID number 3895614. To access the webcast, please visit the Investors section of Ironwood’s website at www.ironwoodpharma.com at least 15 minutes prior to the start of the call to ensure adequate time for any software downloads that may be required. The call will be available for replay via telephone starting at approximately 11:30 a.m. Eastern Time on September 29, 2020 running through 11:59 p.m. Eastern Time on October 13, 2020. To listen to the replay, dial (855) 859-2056 (U.S. and Canada) or (404) 537-3406 (international) using conference ID number 3895614. The archived webcast will be available on Ironwood’s website for 14 days beginning approximately one hour after the call has completed.
About IW-3718
IW-3718 is a gastric-retentive investigational formulation of colesevelam. IW-3718 was designed to maintain the bile-acid sequestrant in the stomach over an extended period of time where it was positioned to intercept bile before it reaches the esophagus. Data from non-clinical and clinical studies collectively supported the extended release and gastric-retentive profile of IW-3718.
About Ironwood Pharmaceuticals
Ironwood Pharmaceuticals (Nasdaq: IRWD) is a GI-focused healthcare company dedicated to creating medicines that make a difference for patients living with GI diseases. We discovered, developed and are commercializing linaclotide, the U.S. branded prescription market leader for adults with irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC).
Ironwood was founded in 1998 and is headquartered in Boston, Mass. For more information, please visit our website at www.ironwoodpharma.com or www.twitter.com/ironwoodpharma; information that may be important to investors will be routinely posted in both these locations.
About LINZESS (linaclotide)
LINZESS® is the #1 prescribed brand for the treatment of adult patients with irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC), based on IQVIA data.
LINZESS is a once-daily capsule that helps relieve the abdominal pain and constipation associated with IBS-C, as well as the constipation, infrequent stools, hard stools, straining, and incomplete evacuation associated with CIC. The recommended dose is 290 mcg for IBS-C patients and 145 mcg for CIC patients, with a 72-mcg dose approved for use in CIC depending on individual patient presentation or tolerability. LINZESS should be taken at least 30 minutes before the first meal of the day.
LINZESS is contraindicated in pediatric patients less than 6 years of age. The safety and effectiveness of LINZESS in pediatric patients less than 18 years of age have not been established. In neonatal mice, linaclotide increased fluid secretion as a consequence of GC-C agonism resulting in mortality within the first 24 hours due to dehydration. Due to increased intestinal expression of GC-C, patients less than 6 years of age may be more likely than patients 6 years of age and older to develop severe diarrhea and its potentially serious consequences. In adults with IBS-C or CIC treated with LINZESS, the most commonly reported adverse event was diarrhea.
LINZESS is not a laxative; it is the first medicine approved by the FDA in a class called guanylate cyclase-C (GC-C) agonists. LINZESS contains a peptide called linaclotide that activates the GC-C receptor in the intestine. Activation of GC-C is thought to result in increased intestinal fluid secretion and accelerated transit and a decrease in the activity of pain-sensing nerves in the intestine. The clinical relevance of the effect on pain fibers, which is based on nonclinical studies, has not been established.
In the United States, Ironwood and AbbVie co-develop and co-commercialize LINZESS for the treatment of adults with IBS-C or CIC. In Europe, AbbVie markets linaclotide under the brand name CONSTELLA® for the treatment of adults with moderate to severe IBS-C. In Japan, Ironwood’s partner Astellas markets linaclotide under the brand name LINZESS for the treatment of adults with IBS-C or CIC. Ironwood also has partnered with AstraZeneca for development and commercialization of LINZESS in China, and with AbbVie for development and commercialization of linaclotide in all other territories worldwide.
LINZESS Important Safety Information
INDICATIONS AND USAGE
LINZESS (linaclotide) is indicated in adults for the treatment of both irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC).
SOURCE: Ironwood Pharmaceuticals
Post Views: 41
