Massachusetts-based Radius Health scored an early approval Friday for Tymlos, an osteoporosis treatment for postmenopausal women. But to succeed with the drug, it’ll have to beat down a couple of Big Pharma rivals, and some analysts are skeptical.
Tymlos, which will have 230 reps and 22 medical science liaisons backing its launch, is set to face “significant commercial challenges”—including Eli Lilly’s Forteo, an established med that’s been on the market since 2002, Jefferies’ Eun Yang wrote in a note to clients last week.
Radius, though, is hoping it can get a leg up with Tymlos' price, which the Waltham company set at $19,500 per year. Especially considering that trials looked at 18 months of Tymlos use, followed by maintenance therapy with a bisphosphonate—a category that includes generic options—the company believes that for payers, "this is a very attractive value proposition," CEO Bob Ward said in an interview.
But while Tymlos' sticker is "lower than other products have been priced," Radius could soon have to deal with Forteo copycats, which could come its way in 2019. And “wide use” of Amgen bone drug Prolia has left fewer patients for the whole anabolic agent field, as it’s delayed their use, Yang noted.
Prolia won’t be the only Amgen thorn in Radius’ side, either. The California biotech and partner UCB are expecting an FDA decision on candidate romosozumab by mid-July. And while the speedy FDA OK, which came two months ahead of schedule, hands Radius a head start, Amgen’s treatment has a dosing-schedule edge; it’s administered only once a month, compared with once a day for Tymlos.
That fact doesn't necessarily hand romosozumab a convenience win, though, Ward pointed out. Like Forteo, Tymlos is administered at home, and "some patients prefer to be in control of their own healthcare," he said. He pointed to the rheumatoid arthritis field, in which "certainly ... there are some patients who prefer" Johnson & Johnson's Remicade "because it's administered by a physician." On the other hand, though, fellow blockbusters Humira from AbbVie and Enbrel from Amgen are both self-administered, and as two of the world's best-sellers, they're not exactly lacking for users.
Still, barring a buyout, Yang, for one, sees “limited upside” from the newcomer med and forecasts just $22 million in sales this year—despite potential for an EU approval later this year. Peak sales will reach about $450 million in 2028, Yang forecasts.
Editor's note: This story has been updated with comments from Radius CEO Bob Ward.