Radius Health Announces Positive Data On Lead Drug Tymlos

Radius Health, Inc. (NASDAQ:RDUS) announced positive results from the phase III study, ACTIVExtend, at ENDO 2018, the Endocrine Society's 100th Annual Meeting and Expo in Chicago.

The phase III study, ACTIVE (Abaloparatide Comparator Trial In Vertebral Endpoints) trial was a randomized, double-blind, placebo-controlled, comparative, multicenter, 18-month international study in 2,463 postmenopausal women with osteoporosis. The study evaluated the efficacy and safety of abaloparatide-SC 80 mcg to reduce the risk of vertebral and nonvertebral fractures. ACTIVExtend is an extension of the ACTIVE trial. The trial enrolled patients who completed 18 months of abaloparatide-SC or placebo in ACTIVE to receive up to 24 additional months of open-label alendronate.

Patients who completed 18 months of Tymlos injection or placebo in the ACTIVE trial were transitioned to receive 24 additional months of open-label alendronate, a bisphosphonate.

Bone Mineral Density (“BMD”) was measured at the lumbar spine, total hip, and femoral neck from the beginning of ACTIVE to the end of ACTIVExtend. Results showed that BMD response rates increased in both the abaloparatide followed by alendronate group and the placebo followed by alendronate group from ACTIVE baseline through the 43 months of ACTIVExtend. Additionally, greater BMD response rates of more than 0%, 3% and 6% were noted in the abaloparatide followed by alendronate group versus the placebo followed by alendronate group at all three sites combined at 43 months. At each anatomic site, BMD increases of more than 3% and 6% were noted respectively at each visit and at 43 months.

60.7% of abaloparatide followed by alendronate patients experienced BMD increases of more than 3 % at all three sites as compared with 24% of patients who received placebo followed by alendronate. The results from the ACTIVExtend Responder Analysis are consistent with the significant BMD response with Tymlos versus placebo observed in ACTIVE trial.

We remind investors that in April 2017, the FDA approved Tymlos (abaloparatide -SC) 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 therapy.

Radius Health’s shares have moved up 3.9% in the last six months compared with the industry’s gain of 6.8%.

Tymlos continues to gain traction with approximately 259 million covered lives and 93% coverage in commercial plans. Tymlos market share reached approximately 32% of new patients starting anabolic therapy (NBRx) and 13% of total prescriptions in the anabolic market.

Although the osteoporosis market in the United Sates has great potential as approximately 1.4 million postmenopausal women experience an osteoporotic fractur each year, Tymlos is expected to face significant competition from Eli Lilly & Co's (NYSE:LLY) Forteo and Amgen's (NASDAQ:AMGN) Prolia. The company also suffered a setback when the CHMP issued a third Day-180 List of Outstanding Issues.

Zacks Rank & Key Pick

Radius Health currently carries a Zacks Rank #3 (Hold).

A better-ranked stock in the health care sector is Regeneron Pharmaceuticals (NASDAQ:REGN) which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Regeneron’s earnings per share estimates have moved up to $18.68 from $18.65 in the last 30 days. The company pulled off a positive earnings surprise in three of the last four quarters with an average beat of 9.15%.

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