[Updated 3:23 pm ET] Ironwood Pharmaceuticals CEO Peter Hecht is fond of saying he wants to build the next great pharmaceutical company, and now he’ll have a chance to prove it. The company was cleared today by the FDA to start selling its first drug in the U.S.
Cambridge, MA-based Ironwood (NASDAQ: [[ticker:IRWD]]) was given the go-ahead to begin marketing linaclotide (Linzess) as a treatment for chronic constipation and irritable bowel syndrome with constipation (IBS-C) in adults, according to a statement on the FDA’s website. The drug’s prescribing information includes a warning that says it shouldn’t be used by children, and details about diarrhea being the product’s most common side effect. Ironwood and Forest said today in a statement that the drug will be available for sale during the fourth quarter.
Ironwood was founded back in 1998, and has burned through more than $508 million of investment cash to get to the point of selling its first product in the U.S., according to filings with the Securities & Exchange Commission. But the market opportunity it faces in the U.S., along with partner Forest Laboratories (NYSE: [[ticker:FRX]]) is more than big enough to recoup that investment. More than 60 million people in the U.S. are thought to have chronic constipation that doesn’t respond to existing treatment, and 15 million are thought to have irritable bowel syndrome, according to the FDA.
“It’s a great news day for us, for Forest, and mostly for these patients,” Hecht said by phone this afternoon. “There are millions of patients who have been suffering a long time and we’re happy to bring forward a new product for them.”
Ironwood’s strategy in going after this condition required some tricky science, in making a peptide drug that could be given in a once-daily capsule. Most peptides are injected, but Ironwood scientists figured out how to make an oral peptide that can withstand stomach acids, work its way into the intestines, and do its thing there, without being absorbed into the bloodstream, where it can cause side effects. The drug is thought to act in a novel way by stimulating secretions of fluids into the intestines, which softens stool and helps people have easier bowel movements.
The company’s application to the FDA hinged on four final-stage clinical trials that enrolled more than 2,800 patients altogether. The new drug showed in those tests it was better than a placebo for patients with chronic constipation or irritable bowel syndrome with constipation. See the links to previous coverage of the chronic constipation trials and the IBS-C trials.
[Updated with comments from Hecht]
The FDA-approved prescribing information includes a warning that the drug is not allowed for use in patients six or younger, and shouldn’t be used in patients six to 17. But the label does grant Ironwood and Forest much of the marketing latitude they sought, in that it’s cleared in adult men and women, the label includes language that says the drug helped with chronic abdominal pain, and there’s no restriction on duration of use, Hecht says.
“The manner in which the pain issue is documented in label is terrific news for us, and it will enable us to educate physicians and patients. The really big driver in the marketplace is chronic intestinal pain,” Hecht says, adding that patients and physicians tend to talk about other symptoms because little can currently be done about the pain.
Ironwood and Forest have a 50/50 partnership in the U.S. where each invests in the drug, makes joint decisions, and splits the profits equally. Ironwood has already hired its sales leadership to get ready for the market rollout, and plans to build a sales force of 150-200 reps who will call on gastroenterologists and other physicians who treat a lot of chronic constipation and IBS-C, Hecht says. Forest will use its larger sales force to call on the broader array of primary care physicians.
Investors will surely focus in now on how big the actual market is for a drug like linaclotide. Hecht says he’s a bit leery of some of the prevalence statistics that are regularly cited, but he focuses on data that says 10 million adults in the U.S. suffer from chronic abdominal pain and constipation and are actively seeking better care. That means that they see a doctor at least three times a year. If you add in the people who are frustrated by the lack of options and don’t bother seeking treatment, the pediatric population, and people outside the U.S., the numbers get much larger, Hecht says.
As part of the FDA approval in the adult U.S. population, Ironwood has committed to conduct a clinical trial assessing the safety and effectiveness of its product in children, Hecht says. While many companies don’t follow through with such commitments after a drug is on the market, and there’s legal liability in any study involving children, Hecht says he’s serious about moving forward with that plan. “We and FDA share a desire to appropriately and safely study linaclotide in the pediatric population. We always intended to do so, and we will,” Hecht says.
One of the big remaining questions about the drug is its price. Hecht wouldn’t disclose it in today’s interview, saying “that’s a topic for another day.”
Ironwood is planning to hold a conference call with investors at 4 pm Eastern time today.
