- Radius Health last week won U.S. approval of its osteoporosis drug Tymlos (abaloparatide), securing a green light from the Food and Drug Administration one month after the regulator had unexpectedly extended its review.
- Tymlos, which is the first bone-building drug okayed for treatment of post-menopausal women with osteoporosis in over a decade, will challenge Eli Lilly's Forteo (teriparatide) and Amgen's Prolia (denosumab) for share of the relatively underserved market.
- Radius plans to price Tymlos at an annualized wholesale acquisition cost of $19,500, or $1,625 per each injectable pen (containing 30 daily doses), a price which company chief commercial officer David Snow said Monday would help support earlier use of anabolic agents in treating osteoporosis.
Tymlos is Radius' first commercial product and the Waltham, MA-based biotech has prepared a sales force of 230 reps to quickly build uptake, initially targeting physicians who prescribe injectables for osteoporosis.
Radius believes Tymlos can capture market share from Eli Lilly's once-daily Forteo and Amgen's twice-yearly Prolia, which each pulled in more than $1 billion in sales last year.
Forteo, as a similar anabolic osteoporosis treatment, will be Tymlos' principal competition out of the gate.
In a Phase 3 study, treatment with Tymlos led to an 86% reduction in relative risk of new vertebral fractures (3.6% lowering of absolute risk), a performance the equity research firm Maxim describes as an "incremental improvement" over Forteo.
Clinical trials also showed Tymlos helped reduce the risk of nonvertebral fractures and increase bone mineral density, an important market in detecting osteoporosis.
Both Tymlos and Forteo come with warnings against the risk of osteosarcoma, a type of bone cancer, and are not recommended for use beyond two years of treatment. Despite the boxed warning, the FDA will not require Radius to have a Risk Evaluation and Mitigation Strategy (REMS) program for the drug.
On a call with analysts Monday morning, Radius' David Snow noted how Forteo's price has steadily risen over the past several years as total prescription volume has declined.
At a list price of $2,727.84 per injectable pen of Forteo (containing 28 doses), Lilly's treatment now checks in at an annualized cost of roughly $35,500.
In that context, Radius hopes its pricing strategy will help secure payer coverage of the drug and eventually support wider first-line use of anabolic treatments like Tymlos. Currently many patients are treated first with older, cheaper drugs like Fosamax (alendronate).
"We have a weighted average wholesale cost of $19,500 a year, which is intended to place the product in the category where, for patients who have substantial co-pays, it is affordable and makes sense to them," said Radius CEO Robert Ward.
Initially, however, Radius expects prior authorization requirements during the drug's launch, but the company hopes that will lessen over time.
"We think as managed care learns more about who is the high risk patients, they will support having first line access to those patients when they recognize the risk level," Ward said.
While Radius sees Tymlos as a future blockbuster, the drug could face competition from lower-cost copies of Forteo in the near future. Lilly's patent on Forteo's formulation expires in December 2018 and a separate patent covering methods of use lapses in August 2019. Israeli generics giant Teva has already filed an Abbreviated New Drug Application, although Lilly filed a patent infringement lawsuit in March 2016.
Payers might see future generic versions of Forteo as a cheaper, yet similarly effective, treatment for some patients. And Amgen, along with partner UCB, has submitted the monoclonal antibody romosuzumab to the Food and Drug Administration for approval in postmenopausal women with osteoporosis. A decision on that drug is expected by mid-July.
While romosuzumab would be competing in the same indication as Forteo and Tymlos, Radius' Ward thinks approval of new drugs will help build interest in treating high-risk patients earlier, thereby expanding the entire market.
Note: This article has been updated to include comments from Radius Health CEO Robert Ward.