GSK execs change their tune as AZ, Sanofi heap pressure on respiratory hopeful Nucala

A lot has changed in the severe asthma market lately—including the way GlaxoSmithKline is talking about its contender, Nucala.

On the company’s third-quarter conference call last week, the British drugmaker’s pharma chief, Luke Miels, told investors the company had "very much held" AstraZeneca newcomer Fasenra "in place in Japan and Europe."

"I’m very encouraged by that," he said, adding, "we can compete."

That’s quite a tone-down from last year, when Cheryl MacDiarmid, GSK’s senior vice president of primary care, told FiercePharma the company was "ready to fiercely compete" to retain the market lead it built up during a two-year head start.

"It’s a challenge having someone new come to the market, but it’s also an exciting moment because it makes sure that we’re on our 'A' game," she said at the time.

To hear Miels tell it, though, the company wasn’t on its A-game when Fasenra launched at all. "The fact remains we're not getting enough with these patients in the U.S., and I put that down to more execution rather than data," he said.

The way he sees it, "if you go back 12 months ago, I think we were very much behind on several parameters in terms of the perception of Nucala versus Fasenra," he said on the call. Doctors were more interested in the AZ drug’s speed of onset and mechanism of action than GSK figured they would be, forcing Glaxo to go back and double down on its messaging.

There’s one Fasenra advantage that can’t be "neutralized," though, as Miels put it. Nucala is dosed every four weeks, while Fasenra only needs to be taken once every eight. And that’s why Glaxo is pinning its hopes on an autoinjector for at-home use that’ll improve Nucala’s convenience, on track to roll out next year.

Until then, though, "we’re expecting growth for the next few quarters to be a bit more challenging," CFO Simon Dingemans said on the call.

Glaxo isn’t taking the new rivalry lying down, of course. "We have changed some key members of the Nucala team in the U.S." and "increased the resources behind that product," and there’s more to come, too. "We'll be engaging in a more focused way with doctors, driving our message of long-lasting protection from exacerbations," Miels said.

Following its recent about-face on paid speaking engagement for docs, Glaxo also wrapped an external speaker event at the American College of Chest Physicians’ CHEST annual meeting.

The thing is, it’s not just Fasenra that’ll be giving Nucala trouble down the line—and GSK knows it. In October, Sanofi’s Dupixent picked up a severe asthma nod of its own, and analysts predict it’ll add $2.5 billion to peak sales.

"This is very much a three-dog fight between us and Fasenra and Dupixent," Miels said, adding, "I think if we keep working on these things and we can neutralize the dosing frequency, then in the second half of 2019, I'm more optimistic. But we have to be realistic in the short term."