New Products

With Amgen hot on its heels, Radius races to get a jump on osteoporosis drug rivalry

This week, Radius Health $RDUS will open a brand new chapter in its history, armed with an FDA approval for its osteoporosis drug Tymlos (abaloparatide).

Bob Ward, Radius Health

Radius is launching its very first drug onto the market, about to set the price on their therapy (that arrives early Monday) and mapping out a commercial strategy that will have to take into account Eli Lilly’s aging Forteo with the rival romosozumab from Amgen and UCB being steered into a July 19 PDUFA date.

Leerink’s Geoffrey Porges thinks that Radius and Amgen might focus their commercial strategies on different markets, with Radius following its data suggesting greater efficacy for reducing the risk of non-vertebrae fractures for postmenopausal women vs Amgen’s focus on vertebrae fractures, which could potentially boost sales for Amgen to $868 million in 2023.

Radius’ drug sliced the risk of vertebrae fractures 86% and non-vertebrae fractures 43% compared with placebo. The absolute risk reductions were 3.6% and 2.0%, respectively. The label includes a warning for women who are at risk of bone sarcomas.

Amgen, meanwhile, tracked a 73 percent reduction in the relative risk of a new vertebrae (spine) fracture through 12 months but missed statistical significant on non-vertabrae fractures.

“While FDA approval is positive, we continue to see significant commercial hurdles as likely given competition (Forteo on market; romosozumab PDUFA date of 7/19/17; potential generic Forteo entry in 2019),” noted Eun Yang at Jefferies. “In addition, wide use of Amgen’s (AMGN, Hold) Prolia has been delaying use of anabolic agents (e.g., Forteo, Tymlos).”

The way Radius CEO Bob Ward looks at this, it’s not about watching the market fragment by vertebrae and non-vertebrae fracture risk. Radius is going after the entire market, including a move into frontline use for physicians and patients who want to get a jump on bone building. As for dosing regimens, he’s happy with his chances of a self-administered drug versus one you get at the doctor’s office (which is romo, Forteo is self-administered like Tymlos).

“I don’t think the market really segments on site of fracture,” he tells me. “It will on patients that want to self-administer.”

And where analysts see the competitive landscape shifting dramatically over the year as Amgen and UCB line up romo, Ward sees a low competitive environment, particularly after Merck and Lilly both scrapped potential rivals, with a likely 10-year run at capitalizing on the approval as the biotech brings along other drugs in the pipeline.

As for peak sales projections, Ward is quick to note that this is a big market, and every drug approved for it has gone on to blockbuster status. He’s recruited a sales force of more than 200 to tackle the US market, and he’s in the process of striking a European partnership to handle that launch, expected later in the year.

Analysts don’t necessarily agree. EvaluatePharma’s sell-side consensus on Tymlos estimated 2022 revenue at $467 million. And some analysts have been pointing to the radically different dosing schedules — Amgen at once a month, Radius daily — as likely to have an impact on the race in Amgen’s favor.

As The New York Times reported recently, patients are generally started on bisphosphonates like Fosamax, which are old and cheap. But they’re also limited, unable to build bone the way Forteo and these new drugs are designed to do.

Lilly, meanwhile, has been rapidly jacking up the price of Forteo ahead of its loss of patent protection. The Times reports that the wholesale price has soared to $3,100 a month, more than three times its price in 2010. Lilly has been increasing the price twice a year, for six years. And they’ve had plenty of time to evaluate how best to counter new entries with the arrival of drugs from Radius and Amgen this year.


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RAPS Regulatory Convergence 2017