Ironwood seeks FDA OK for drug
Treatment would be 1st in firm’s history
Ironwood Pharmaceuticals Inc. yesterday said it submitted the first application for a new drug in the Cambridge company’s 13-year history, seeking Food and Drug Administration approval for linaclotide, a treatment for irritable bowel syndrome and chronic constipation.
The application culminates years of development and clinical trials of the Ironwood drug, a synthetic peptide that could treat conditions affecting an estimated 40 million people worldwide. Some analysts have projected linaclotide, which began human testing in 2004, could become a blockbuster drug, meaning it would have annual sales of more than $1 billion.
“We’ve seen very clear evidence that the drug reduces the symptoms of abdominal pain, bloating, and abdominal discomfort,’’ said Mark Currie, chief scientific officer and senior vice president of research and development at Ironwood.
FDA officials typically accept new drug applications within 60 days, at which time the agency gives petitioning companies a date when it is likely to decide whether to approve a treatment. In the case of linaclotide, submitted by Ironwood and its partner, Forest Laboratories Inc. of New York, an FDA ruling is not expected until next year.
Linaclotide is among a new generation of promising Massachusetts-developed drugs expected to come on the market in the coming year. FDA officials in May approved a hepatitis C treatment from Vertex Pharmaceuticals Inc. of Cambridge. Applications are being readied for two cancer-fighting drugs developed by another Cambridge biotechnology company, Ariad Pharmaceuticals Inc., to treat sarcomas and chronic myeloid leukemia.
Ironwood, formerly known as Microbia Inc., also plans to apply for approval to sell linaclotide in Europe, where it is working with a different partner, Almirall SA of Spain. The drug will compete in the United States with Amitiza, marketed by Takeda Pharmaceuticals America Inc. and Sucampo Pharmaceuticals Inc.
Currie said clinical trials have shown linaclotide is more effective in treating abdominal pain and other symptoms common to those suffering from irritable bowel syndrome and chronic constipation. “We obviously think it has a very large potential,’’ he said. “We think there’s a very large patient population waiting for a therapy that will work for this.’’
Ironwood has about 250 employees. Shares of the company, which went public 18 months ago in an initial public offering, climbed 3.5 percent yesterday to close at $12.64, a gain of 43 cents on the Nasdaq stock market.
Robert Weisman can be reached at email@example.com.