Allergan/Ironwood’s enhanced linaclotide CR1 could double Linzess franchise from $1B in U.S. net sales by 2020

Ironwood Pharmaceuticals and Allergan have been testing an irritable bowel syndrome with constipation (IBS-C) drug, a formulation of linaclotide colonic release. On Thursady, the companies said that the study showed greater abdominal pain improvement with CR1 300 mcg compared to placebo and to the 290 mcg immediate release (IR) formulation of linaclotide.

The companies are now planning phase III study, and will soon approach the U.S. Food and Drug Administration (FDA) with trials in adults with IBS-C expected to begin in the second half of 2017.

Linaclotide IR (Linzess) is currently FDA-approved and available for the treatment of adults with IBS-C or chronic idiopathic constipation (CIC).

Ironwood and Allergan also announced results from the same Phase IIb trial with a second formulation, linaclotide colonic release-2 (CR2), in a separate press release issued today.

“Abdominal pain is usually the most difficult symptom to treat in patients with IBS-C. When that pain is not treated sufficiently, then that drives the patient back into my office again and again,” said Philip Schoenfeld, M.D., chief, gastroenterology section. “I’m encouraged by these initial data. This new formulation of linaclotide may produce additional relief of abdominal pain in patients with IBS-C.”

Tom McCourt, chief commercial officer of Ironwood, said:  “We believe the potentially enhanced clinical profile of linaclotide CR1 could support further growth of the Linzess franchise from $1 billion in U.S. net sales by 2020 to potentially greater than $2 billion in peak U.S. net sales.”

Bill Meury, chief commercial officer of Allergan. “Linzess is the market-leading U.S. branded prescription medicine for adults with IBS-C or CIC and has been utilized by more than 1 million patients to date. The CR1 formulation could provide an innovative brand to treat millions of additional suffering patients, extending the success of LINZESS and demonstrating our continued commitment to improving GI care.”