The company primarily focuses on the development of endocrine therapeutics in the areas of osteoporosis and oncology.
Radius Health got a significant boost with the FDA approval of Tymlos (abaloparatide -SC) injection for the treatment of postmenopausal women with high risk osteoporosis for fracture – defined as history of osteoporotic fracture – multiple risk factors for fracture, or patients, who have failed or are intolerant to other available osteoporosis therapies.
The drug was approved in 2017 and continued to gain traction in 2018. In October 2018, the FDA approved a labeling supplement for Tymlos to include additional information from the ACTIVExtend study. The labeling now reflects that after 24 months of open-label alendronate therapy, the vertebral fracture risk reduction achieved with Tymlos therapy was maintained.
The drug captured, on average, 20% of the U.S. anabolic osteoporosis market (based on Patient Months on Therapy, TRx PMOT) in 2018. In the first six weeks of 2019, the drug captured a 29% share of the U.S. anabolic osteoporosis market and more than 40% of new anabolic patient starts.
The company is also developing an abaloparatide transdermal patch (abaloparatide-patch) for the treatment of postmenopausal women with osteoporosis.
Apart from Tymlos, Radius Health is working on the development of elacestrant. The company initiated the phase III EMERALD study on elacestrant in November 2018. This is the first phase III study to evaluate treatment benefit for second- and third-line breast cancer patients following CDK 4/6 inhibitor therapy and compare outcomes in patients whose tumors harbor estrogen receptor 1 gene (ESR1) mutations. The study is open to enrollment, with a planned recruitment period of 18-21 months and potential data read-out in 2021.
While the market for postmenopausal osteoporosis provides significant commercial potential, it is pretty crowded given the presence of products like Amgen’s AMGN Prolia and Lilly’s LLY Forteo, among others. The recent approval of Amgen’s Evenity will further intensify competition for Tymlos. Novartis’ NVS Reclast is also approved for osteoporosis. Hence, it remains to be seen what the growth trajectory will be for Tymlos in 2019. Moreover, the drug has been refused approval in Europe.
Zacks Rank & Stock to Consider
Radius Health currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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