Rain, shine or blizzard, Tom McCourt always made a point to walk home through the streets of Cambridge, Mass., alongside his coworker at Ironwood Pharmaceuticals, then chief scientific officer, Mark Currie, during his early years as chief commercial officer. McCourt, who previously worked in both drug development and marketing at Merck & Co., AstraZeneca and Novartis, says the goal of the walks was to help integrate Ironwood’s development and commercialization efforts.
“When I first joined as the chief commercial officer at Ironwood, we were in two buildings in Kendall Square. We had Peter Hecht, the CEO, and a group of execs in one building, and Mark Currie and the discovery and development group in the other,” McCourt remembers. “[Hecht] wanted me to sit by him, but I said, ‘I'd rather sit next to [Currie] because if we don't understand each other, this ain't going anywhere.’”
Twelve years later, McCourt, now the CEO of Ironwood, is still taking that approach while steering the gastrointestinal (GI) focused pharma company past its first blockbuster drug success with Linzess. The drug, developed in partnership with AbbVie, is used to treat irritable bowel syndrome with constipation (IBS-C). It reached $1 billion in annual sales in 2021, earning it blockbuster status after nearly a decade on the market.
The company hopes to capitalize on that success in the coming year with plans to expand Linzess’ market into pediatric patients and build out its pipeline of GI medications. Those include the company’s wholly owned guanylate cyclase-C agonist IW-3300 candidate to treat visceral pain conditions and its option for U.S. rights to Cour Pharmaceutical’s CNP-104 candidate for the treatment of primary biliary cholangitis, a rare autoimmune liver disease.
“We believe we are in a strong position to realize our vision of becoming the leading U.S. GI healthcare company,” McCourt said during the company’s first quarter 2022 earnings call.
Here, McCourt talks further about his integrated approach to drug development and commercialization, next steps for Linzess and his strategy for achieving Ironwood’s goal of leading the U.S. GI pharma market.
This interview has been edited for length and clarity.
PharmaVoice: How do you blend drug development with commercialization efforts and how does patient centricity fall into the equation? How do you approach patient centricity at Ironwood?
Tom McCourt: I’m an insight advocate. For me, insight is about unearthing the ‘why’ that drives human behavior. I think it starts with understanding the problem you must solve. The first question is whether there is an unmet medical need. The answer in our category was absolutely. Then the question becomes, what is the patient’s primary complaint? We felt that for us to reach the right patients, we needed to position Linzess as a pain drug that also improves constipation because we knew that doctors would likely prescribe the medication for IBS-C patients because they have nothing for these patients.
One of the key problems we had to solve was the communication between doctors and patients because the patient would communicate their condition as constipation. But constipation for that patient is not just ‘I can’t go,’ it’s also ‘I hurt, I'm uncomfortable.’ How do you get the patient to better communicate their real problem? Then, how do you also get the doctor to ask the right next question? If the patient calls it constipation, can I get the doctor to ask the patient what other symptoms they have? We knew that once the doctor understood that a patient had a pain and bloating problem with constipation, the probability of them picking Linzess would go up exponentially. That was really the premise around our whole direct-to-consumer campaign. To me, that's patient centricity.
What insights have you gained while working on Linzess and bringing it to blockbuster status? What are the next steps for Linzess?
There are a couple of things that we've been able to do to get here. Part of it is the lifecycle management piece, meaning how do we broaden the clinical utility of drugs and strengthen the clinical profile.
We didn't get the product label we wanted initially because the FDA was originally uncomfortable giving us discomfort and bloating claims and additional abdominal pain, but we knew they were important. We worked with the FDA to redesign another trial to get those, and it expanded the physician's view of who the appropriate patient was.
We also launched with a box warning against use with pediatric patients. We've now convinced the FDA that the drug is safe in [some pediatric patients] and we had the box dramatically adjusted so it warns against use in children under age two as opposed to all kids under 18.
I think as we move forward, we still have a lot left to do. We've treated 4 million patients but there are still another 30 million patients out there needlessly suffering. We need to continue to bring them into the market. We’re working on the pediatric indication. [If approved], this will be the first drug ever approved for pediatric constipation, which is the No. 2 reason why a parent takes a child to see a doctor. So, this could be a very sizable opportunity for Linzess. We'll see data in the older children — aged 6 to 17 years old — later this year, which is probably somewhere around 6 to 8 million kids.
We still have another seven years of patent life to continue to grow and nurture Linzess and, of course, I think the last move here is the opportunity to take this over the counter at some point as we get towards the end of the patent.
In your Q1 earnings call, you mentioned a goal of strengthening Ironwood’s pipeline through the in-license or acquisition of innovative GI assets. Could you expand on that?
Absolutely. We have a wholly owned asset called IW-3300. What we're learning is through all these preclinical models, if we can stimulate [certain] receptors in the colon, it reduces pelvic pain, bladder pain and pain related to endometriosis. And there are no drugs out there that treat this. We'll see data on that later this year or early next year.
The second drug that we just licensed is from a company called COUR, and it is CNP-104. This is an exciting drug that works for primary biliary cholangitis, which is a rare liver disease. What happens in the liver is there's an antigen that the T-cells recognize that causes them to attack and destroy the bile ducts in the liver, which creates the symptoms of colon giantess. We have the rights to a technology that can desensitize the T-cells, so the T-cells don't attack the bile duct. We think we could actually cure the disease [but it is still in clinical trials].
We're in a situation right now where we're sitting on a fair bit of cash, Linzess continues to grow and we see other opportunities in the GI space that we're going to continue to evaluate. I'd love to see three to four more assets in development in our pipeline that would be in either GI or liver disease.
How do you plan to reach your vision of making Ironwood the leading U.S. GI healthcare company?
What we're trying to do is expand our presence in GI where we can leverage the expertise we have in development. We also have a very tenured, experienced, skilled sales force in GI that if I give them more products, I know they can be successful. We have a very experienced marketing team that knows GI very well. So, being able to harness that level of expertise across our organization, I think positions us pretty uniquely in the marketplace.