Radius Health (RDUS) Provides Abaloparatide Business Update

February 12, 2021 12:34 PM EST

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Radius Health, Inc. (“Radius” or the “Company”) (Nasdaq: RDUS) provided a business update on the abaloparatide global business. Progress was made, and continues to be made, across the following areas.

New Patient Growth: TYMLOS in the U.S. market

“Our focus on postmenopausal osteoporotic-related fracture patients continues to gain traction,” commented Sal Grausso, Chief Commercial Officer for the Company. Grausso added that “We are making progress adjusting our sales and marketing efforts to focus on these fragility fracture patients. We expect continued new patient growth with our U.S. TYMLOS business.”

Radius added 1,692 new patients in the month of January. This represents a 17% increase from the previous four-month trailing average. New patients are defined as those patients who have been prescribed TYMLOS and subsequently filled their first prescription.

Abaloparatide Publications: adding to the underlying data of the molecule

“Recently published data continues to reinforce the depth, breadth and overall quality of the abaloparatide molecule,” commented Bruce Mitlak, MD, the Company’s Chief Medical Officer, focusing on continued progress of the abaloparatide molecule and other bone and endocrine areas of interest. Two publications warrant being highlighted:

  • “Early Effects of Abaloparatide on Bone Formation and Resorption Indices in Postmenopausal Women with Osteoporosis”Dempster et al, JBMR January 2021In an open-label, single-arm study conducted over 90 days in 23 postmenopausal women with osteoporosis:
  • Abaloparatide demonstrated increases in bone formation across all four bone envelopes (cancellous, endocortical, intracortical, and periosteal envelopes) in iliac bone biopsies
  • Increases in the bone formation were associated with stimulation of both modeling-based and remodeling-based formation
  • Histomorphometric changes are correlated with the serum biomarker response to abaloparatide, which is associated with increases in bone mass at cortical and trabecular sites
  • “Cardiovascular Safety of Abaloparatide in Postmenopausal Women with Osteoporosis: Analysis From the ACTIVE Phase 3 Trial”Cosman et al, JCEM November 2020In a post-hoc analysis:
  • Treatment with abaloparatide and teriparatide resulted in a transient increase in heart rate and a small decrease in one-hour post dose blood pressure, however, these changes were not associated with an increase in serious cardiac adverse events evaluated in ACTIVE, major adverse cardiac events (MACE), or heart failure (HF)
  • Time to first incidence of MACE + HF was longer with abaloparatide and teriparatide vs. placebo

Expanding Abaloparatide

“We continue to make progress on expanding, strengthening and broadening the abaloparatide molecule,” commented Chhaya Shah, the Company’s Chief Business Officer and head of clinical, regulatory and supply chain for the asset.

Shah added that, “There is currently ongoing regulatory activity in the U.S., Japan, Canada and the E.U. Simultaneously, we are focused on completing both the ATOM study for male osteoporotic patients at high risk of fracture plus the wearABLe study.”

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