Radius Health, Inc. Provides Business Update

Dienstag, 15. Dezember 2020 15:00
  • Continued growth in net new patients for the month of November 2020
  • Company is on-track for record quarter in net revenue for TYMLOS-SC
  • Research Agreement reached with MGH in October 2020
  • Hired Head of Clinical Development for the abaloparatide molecule

WALTHAM, Mass., Dec. 15, 2020 (GLOBE NEWSWIRE) -- Radius Health, Inc. (“Radius” or the “Company”) (Nasdaq: RDUS) provided a general business update on progress made since October 2020. The key areas of activity and progress are outlined below.

Commercial Progress

The Company’s focus on postmenopausal osteoporotic fracture patients continues to gain traction. In the month of November, a truncated sales month due to the Thanksgiving holiday, Radius added 1,326 net new patients. Net new patients are defined as those patients who have been prescribed TYMLOS-SC and subsequently received their first dose. This represents an 8.0% increase from the previous four-month trailing average.

The Company adjusted this comparative metric from a three-month trailing average to a four-month trailing average to incorporate any seasonal factors more broadly, such as holidays, as well as COVID-19.

The current fourth quarter 2020 forecast for TYMLOS-SC net revenue projects a record quarter for the product since its launch. The previous quarterly net revenue high of $56,700,000 was reported in fourth quarter 2019.

Research Progress

Radius has entered into a discovery research collaboration with Massachusetts General Hospital (MGH). The Radius team of scientists will work with Marc Wein, MD, PhD, an Assistant Professor of Medicine at Harvard Medical School and an endocrinologist with a clinical focus on osteoporosis and metabolic bone diseases.

The core of the collaboration is to evaluate efficacy, safety, and specificity of small molecules as potential oral anabolic treatment for a broad array of musculoskeletal diseases. The area of focus includes salt inducible kinases and SIK inhibitors.

Radius has an exclusive option to license the IP as the collaboration progresses.

Talent Progress

Peter Butler, MD, FACE has been hired as Executive Director and Head of Clinical Development for the abaloparatide program. Dr. Butler is board certified in both Internal Medicine as well as Endocrinology and had a fellowship in Endocrinology, Diabetes and Metabolism at the National Institute of Health (NIH) in Bethesda, Maryland.

He is a graduate of Cambridge University in the UK. Prior to joining Radius, Peter was a Clinical Research Medical Director in bone therapeutics at Amgen and was acting Global Development Lead for denosumab. Peter will report to Chhaya Shah – Head of the abaloparatide product from a clinical, regulatory and supply chain point of view.

The Company will continue to provide business and progress updates as appropriate.

About TYMLOS (abaloparatide) injection
TYMLOS® (abaloparatide) injection was approved by the U.S. Food and Drug Administration for the treatment of postmenopausal women with osteoporosis at high risk for fracture defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy.

IMPORTANT SAFETY INFORMATION

WARNING: RISK OF OSTEOSARCOMA

  • Abaloparatide caused a dose-dependent increase in the incidence of osteosarcoma (a malignant bone tumor) in male and female rats. The effect was observed at systemic exposures to abaloparatide ranging from 4 to 28 times the exposure in humans receiving the 80-mcg dose. It is unknown if TYMLOS will cause osteosarcoma in humans.
  • The use of TYMLOS is not recommended in patients at increased risk of osteosarcoma including those with Paget's disease of bone or unexplained elevations of alkaline phosphatase, open epiphyses, bone metastases or skeletal malignancies, hereditary disorders predisposing to osteosarcoma, or prior external beam or implant radiation therapy involving the skeleton.
  • Cumulative use of TYMLOS and parathyroid hormone analogs (e.g., teriparatide) for more than 2 years during a patient's lifetime is not recommended.

Orthostatic Hypotension: Orthostatic hypotension may occur with TYMLOS, typically within 4 hours of injection. Associated symptoms may include dizziness, palpitations, tachycardia or nausea, and may resolve by having the patient lie down. For the first several doses, TYMLOS should be administered where the patient can sit or lie down if necessary.

Hypercalcemia: TYMLOS may cause hypercalcemia. TYMLOS is not recommended in patients with pre-existing hypercalcemia or in patients who have an underlying hypercalcemic disorder, such as primary hyperparathyroidism, because of the possibility of exacerbating hypercalcemia.

Hypercalciuria and Urolithiasis: TYMLOS may cause hypercalciuria. It is unknown whether TYMLOS may exacerbate urolithiasis in patients with active or a history of urolithiasis. If active urolithiasis or pre-existing hypercalciuria is suspected, measurement of urinary calcium excretion should be considered.

Adverse Reactions: The most common adverse reactions (incidence ≥2%) are hypercalciuria, dizziness, nausea, headache, palpitations, fatigue, upper abdominal pain and vertigo.

INDICATIONS AND USAGE

TYMLOS is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, TYMLOS reduces the risk of vertebral fractures and nonvertebral fractures.

Limitations of Use

Because of the unknown relevance of the rodent osteosarcoma findings to humans, cumulative use of TYMLOS and parathyroid hormone analogs (e.g., teriparatide) for more than 2 years during a patient's lifetime is not recommended.

For the TYMLOS prescribing information, including Boxed Warning, please visit www.tymlospi.com

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact, including those related to our revenue projections or forecasts, should be considered forward-looking statements. These forward-looking statements are based on management's current expectations. These statements involve known and unknown risks and uncertainties that may cause our actual results, performance or achievements to be materially different from any expressed or implied by the forward-looking statements. These risks include, but are not limited to, the following: uncertainty regarding the results of regulatory submissions and oversight; success of our commercial operations; success of our clinical trials and preclinical studies; risks related to manufacturing, supply and distribution; success of any collaboration, partnership, license or similar agreements; achievement of milestones; receipt of royalties or other future contingent payments; ability to implement pricing increases. These and other important risks and uncertainties discussed in our filings with the Securities and Exchange Commission, or SEC, including under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ending December 31, 2019 and subsequent filings with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

Investor & Media Relations Contact:
Peter Schwartzman
Email: pschwartzman@radiuspharm.com


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