Radius Health $RDUS has taken another big leap down the final stretch of its Phase III race with Amgen $AMGN, posting Phase III results that show abaloparatide’s clear clinical benefit over a placebo in treating osteoporosis. But while the data provide a fresh argument in favor of its near-term approval at the FDA and EMA, there’s still a big question left unanswered: Just how competitive will this drug be against Amgen’s Phase III rival, as well as Eli Lilly’s aging Forteo? And meanwhile, the roll up to the FDA is also lighting a fresh fire under the heated debate over the cost of drugs, both old and new.
First, the numbers, published in the Journal of the American Medical Association. In a large Phase III trial, just four of 824 patients taking Radius’s abaloparatide suffered a spinal fracture after 18 months. In a placebo arm, that potentially devastating event was experienced by 30 patients—giving the experimental drug a clear advantage. But in the Forteo arm with 818 patients, there were 6 spinal fractures. That’s slightly worse, but the study wasn’t large enough to show a clear difference between the standard of care and the new drug.
Patients on the Radius Health drug also experienced improvements in bone mineral density. Investigators in the study concentrated on older women with a history of fractures, the at-risk population that the drug is primarily aimed at, though it is being studied in other populations as well.
Not included in this matchup is Amgen’s romosozumab, it’s own bone-building drug that was filed for an approval on July 21. Amgen is partnered with UCB on the drug. Back in February, investigators noted that their Phase III study came out with a 73% reduction in the risk of fractures, which paled a bit in relation to Radius’s 86% risk reduction. That sparked a debate among analysts whether Amgen’s drug could distinguish itself with a much easier dosing regimen — once monthly versus once daily.
Analysts’ peak sales projections have been all over the map. Deutsche Bank last year pegged abalo’s peak at $1.1 billion, though they believed that romo would come out on top as the better drug with a bigger market share, depending on how the generics shake out.
While both Amgen and Radius stand a good chance of winning an approval, commercial success is a completely different issue. As The New York Times reports, patients are generally started on bisphosphanates like Fosamax, which are old and cheap. But they’re also limited, unable to build bone the way Forteo and the two 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 6 years.
Now the question is whether the new drugs will cost as much or more than Forteo, which is generally limited to two years of therapy due to fears about potential cancer risks. And insurers – who are likely to restrict access to these drugs to patients with the highest risk factors – have grown leery about covering the Lilly drug, often requiring big co-pays from patients.
Dr. Dolores Shoback, a professor of medicine at the University of California, San Francisco, told the Times:
“The cost in the private sector is getting prohibitive. You have to hunt for a reason, find a very strong reason that is ironclad,” to get an insurer to approve Forteo, she added. “We find it can be extremely difficult to get it covered.”
Radius may have just highlighted a clear path to an approval. But positioning this drug to win the four-way commercial poker match ahead is far more problematic.
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