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, Ironwood Pharmaceuticals announced that it was in the process of restructuring its organizational structure, including cutting up to 100 full-time employees and suspending the development of its refroutable gastroesoesus reflow drug, IW-3718. Ironwood had previously reviewed non-blind data from phase III clinical trial IW-3718-302 of the company's GERD drug, which failed to reduce heartburn in patients.I
W-3718 reached its main endpoint in a previous Phase IIb clinical trial. The results showed that the combined PPI of IW-3718, which was 1500 mg orally twice a day, significantly reduced the degree of heartburn and the frequency of heart reflow in GERD patients compared to the use of proton pump inhibitors (PPI) alone. Of the patients treated, 52.9 percent were defined as heartburn remission patients, and only 37.1 percent of patients used PPI alone. The average rate of reflow decreased by 55.4% in patients receiving treatment, compared with 37.9% in patients who used PPI alone.IW-3718 is a new type of bile acid chelating agent formula that relieves symptoms in GERD patients by slowly releasing and staying in the stomach for a period of time, combining with bile to block bile from entering the esophageal esophageal. Mark Mallon, Ironwood's chief executive, said in a statement, "Ironwood and patients are deeply disappointed by the results of this Phase III trial data, given that the need for alternatives to current standard treatment options for patients with resuscable GERD is not being met."plans to cut nearly 35 percent of its workforce, which is expected to be completed in the first quarter of 2021, a move the company said would save about $95 million in total costs. Ironwood will have about 210 full-time employees left after the layoffs. Ironwood said the job cuts were expected to result in a one-time charge of about $10 million to $12 million. In addition to the layoffs, Ironwood will suspend the development of IW-3718 and suspend patient recruitment for Phase III trial IW-3718-301. Ironwood's shares fell 18 per cent to $7.80 in pre-market trading after the news broke.During this transition, Ironwood will shift its focus to enhancing the commercial marketing of LINZESS (Linalope), a drug sold in the U.S. by Ironwood and Eljian to treat constipation irritable bowel syndrome. Ironwood announced in early August that demand for prescriptions for the drug in the U.S. had increased 9 percent year-on-year, and the company hopes to use that demand to drive further sales growth.Mr Mallon said Ironwood had made the difficult decision to reallocate Ironwood's resources and capital as the business progressed. Ironwood's goal is to continue to maximize LINZESS and drive further growth and profitability by streamlining the organization to better position itself in the current environment. (
Sina Pharmaceutical News
): Ironwood Pharma to Halt Development of GERD Drug, Cut 100 Employees