With Amgen’s competing bone drug now sidelined, Radius has a big opportunity ahead with its Tymlos launch. And the company is staffing up accordingly.
Monday, the Massachusetts biotech said it had brought on Jesper Høiland, former president of Novo Nordisk’s U.S. business, as its new CEO. He’ll replace Bob Ward, who guided the company though its IPO and Tymlos’ journey to approval, which concluded with an FDA nod in late April.
Radius’ board “thought long and hard about making sure we have the right leader at the company with the right experience to maximize” the opportunities in front of the company, chairman Kurt Graves said in an interview, and it wanted someone with “true global experience” and multiple launches under his or her belt.
And Høiland—who departed in a shakeup last fall brought on by new insulin competition and stepped-up squeezing from payers—had both on his résumé. “I’ve worked globally my entire career,” he said in an interview, and in the U.S., where Radius is especially focused, he’s launched four products in the last four years into the specialty and diabetes spaces.
Analysts have written of the “significant commercial challenges” facing Tymlos, an osteoporosis treatment for postmenopausal women. But regulators Sunday diminished the threat from one key competitor—Amgen’s romosozumab, also known as Evenity—at least, for now.
The FDA handed the California biotech a complete response letter, asking that that Amgen and partner UCB resubmit their application for the candidate after integrating more data—including newly released results from a phase 3 study comparing romosozumab with Merck’s Fosamax. It’s a request that Amgen R&D chief Sean Harper said in a statement that the company both agrees with and anticipated.
But that romosozumab-Fosamax study, dubbed Arch, didn’t exactly inspire confidence among analysts or investors when data were unveiled in May. During the study, an imbalance in “serious cardiovascular adverse events” cropped up, with 2.5% of romosozumab patients suffering a CV issue versus just 1.9% in the Fosamax group.
Evercore ISI analyst Umer Raffat at the time called the news “clearly negative, and very surprising,” while Leerink Partners’ Geoffrey Porges set the probability of an eventual approval at 50-50.
That’s not to say that Høiland, along with Radius’ 230 reps and 22 medical science liaisons, won’t still have plenty on their plates, though. They’ll have to deal with Eli Lilly incumbent Forteo, as well lower-cost copycats, which could come along in 2019, Jefferies’ Eun Yang has predicted.
“The challenge is always to get known in the marketplace, to get to see your customers, to get them comfortable with you in the first place. When you’re selling products, it’s not so much about the product first, it’s about the people you have out there,” Høiland said.
Right now, he’s not envisioning any changes in Radius’ launch strategy, he said. But “competing with a new compound, that will take some time,” he noted, adding, “to support that whole movement, I’m here to help.”
By Carly Helfand
Source: Fierce Pharma
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