As the current CEO of Kala Pharmaceuticals and a former top exec at Sunovion, Sepracor, and Novartis, Mark Iwicki knows a person or two in the business. And yet even he was awed the first time he took a stroll — or, more accurately, attempted to take a stroll — through a crowded conference hall at a GI conference with his friend and peer Tom McCourt.
“There were something like 10,000 to 15,000 people at this thing and we couldn’t walk more than 15 feet at a time without a world-famous thought leader or scientist stopping and trying to talk with Tom,” Iwicki recalls. “Typically, it’s the other way around — the pharma person tries to get the attention of the thought-leader person — but Tom is kind of a rock star in this world. The volume and depth of his relationships are amazing to behold.”
McCourt, currently chief commercial officer and SVP, marketing and sales at Ironwood Pharmaceuticals, is quick to dismiss any such talk about his professional status, even as he presides over the commercialization of what might be Ironwood’s first bona fide blockbuster, IBS drug Linzess. He acknowledges, though, that during his evolution from “a science guy trying to be a marketer” to “a marketing guy who hopefully understands a little about drug development,” he has found allies and kindred souls in unexpected places.
Early in his career, while working at Astra Merck, McCourt — then on the drug-development side of the biz — was charged with setting up the then-nascent company’s medical-affairs group. Rather than merely connect with the usual suspects, McCourt forged alliances with R&D people, marketing and sales execs, and community groups.
“Without hearing out a lot of different people,” McCourt says, “I didn’t think we could do a really good job of translating great science into meaningful and patient-benefiting brands. Back then the idea that you’d somehow fit patient data and real-life experiences together was considered a little unorthodox.”
Dr. Brennan Spiegel, director of health services research at Cedars-Sinai Health System and director of the Center for Outcomes Research and Education at UCLA’s David Geffen School of Medicine, who has worked alongside McCourt on the patient–doctor engagement app My GI Health, acknowledges that such thinking and relationship building is par for the course with McCourt. “Tom is quite different from the other pharma leaders I’ve come across because he’s very much connected on the ground floor to every community, particularly the community of investigators,” he says. “He’s really creative in bringing people and partners together. He sees through the BS and gets right to the vision they have for improving human health.”
McCourt’s collaborative instincts and data-mindedness proved dead-on during one of the next assignments that came his way, on a little-heartburn-drug-that-could that went by the name of Prilosec. It’s easy to forget now that billions of dollars of sales are in the books, but at launch Prilosec contended with its share of issues. It was viewed as perhaps too potent, was burdened with a black-box warning, and faced estimable competition in the form of Zantac and Tagamet.
McCourt’s solution? Delve deep into the data around the dialogue between physicians and patients, particularly as it pertained to elimination of heartburn versus reduction of heartburn.
“What we saw was that when a patient visited his doctor and started taking about heartburn, he was prescribed Zantac. The next time he went in, the doctor asked, ‘Is your heartburn better?’ The patient would be like, ‘Yeah, it’s better,’ and that would be the end of it,” McCourt recalls. “We needed to change the question to, ‘Do you still have heartburn?’ The goal had to be no heartburn.” Once that subtle shift was effected, Prilosec surged.
When McCourt followed Iwicki and fellow mentor and friend Kurt Graves (now chairman, president, and CEO of Intarcia Therapeutics) over to Novartis, he applied a similar approach to the launch of IBS-C drug Zelnorm. Once again, it was all about “chasing down that one insight that changes the game,” he says.
And again McCourt found salvation in the semantics of the patient–physician dialogue. “A patient comes in with constipation and the doctor thinks, ‘If I make him go, I’ve solved the problem,’” he explains. “But what about the pain that comes with it? Why wasn’t anyone talking about that?”
The Zelnorm team’s solution? Alert physicians and patients alike to “the ABCs of IBS.” In this instance, the ABC acronym was meant to focus attention on “abdominal pain,” “bloating,” and “constipation” — as coincidence would have it, precisely the trio of symptoms the breakthrough Zelnorm therapy was designed to treat.
SUCCESS OF LINZESS
Again, McCourt’s role was both subtle and crucial. He worked alongside the Novartis development team to “make sure we had an indication for bloating. That’s what we needed to break the market open.”
Following a two-year stint in Amgen’s bone health business arm — “Working for a smaller, incredibly innovative company was such a different feel … well, they were smaller at the time, anyway” — McCourt earned the opportunity to build Ironwood’s commercial operation from scratch. It was a natural fit, given McCourt’s experience within the IBS space. But even with Linzess on the horizon, he went into his meeting with Mark Currie, Ironwood’s SVP, chief scientific officer, and president of R&D, feeling the slightest bit skeptical.
That skepticism lasted about 22 seconds. “I started by asking him, ‘What do you think we have here?’” Currie responded along the lines of “a great drug for IBS,” then shared the mechanism of action and the clinical data from Phase 3 trials. McCourt recalls pausing for a second to think, then asking, “Is this a constipation drug that improves abdominal symptoms, or is this an abdominal pain drug that improves constipation?”
The answer set Linzess on its path toward blockbusterdom. “If it was the former, well, then we’ve basically got a laxative. But if it was the latter — and it was — then I knew we’d have a clear space for us to plant the drug and grow it,” McCourt says. Ironwood announced in January that Linzess generated approximately $450 million in net sales in the U.S. during 2015 and expects that sum to soon increase into the billions.
McCourt credits its U.S. co-promote partner on Linzess, Forest Laboratories (since subsumed into Actavis and then Allergan), for its work in reaching primary care physicians and the payer community; he says that more than 170,000 physicians have prescribed the drug and that 75% of insured patients have unrestricted access to it. But McCourt can’t help but focus on what’s next.
“As good as it’s going, we only just recently passed the one million mark of patients treated. So I’m thinking about the 30 or 40 million patients we still have to go out and get,” he adds. Nonetheless, he believes that Linzess is well on its way and that Ironwood’s future in the GI space is bright. Taking care not to overshare pipeline specifics, McCourt points to fibrotic and inflammatory disorders, GERD, and heartburn as conditions that the company has in its crosshairs.
“We see ourselves bringing multiple blockbusters to market,” he says. “We are myopically focused on that.”