“I am very pleased with the continued strong growth trajectory of TYMLOS which reached an exit 40% share in new patients in its first full-year in the U.S. market. 2019 will be a pivotal year for us as we move closer to our goal of U.S. anabolic market leadership and expect to advance our late-stage clinical pipeline of two innovative Phase 3 products, elacestrant and abaloparatide-patch, both with blockbuster potential,” said Jesper Hoeiland, President and Chief Executive Officer of Radius.
Elacestrant’s Phase 3 EMERALD study was initiated in
In 2018, TYMLOS captured on average 20% of the U.S. anabolic osteoporosis market and exited the year with a 27% total U.S. anabolic market share and 40% share of new anabolic patient starts in December. TYMLOS is currently the only promoted anabolic drug in the U.S. market and is consistently increasing its prescriber base.
A 5.9% price increase for TYMLOS took effect on
Radius maintains its financial guidance for 2019 and expects full-year TYMLOS U.S. net sales to be between
The Company will present further details at the 37th Annual
Radius is a science-driven fully integrated biopharmaceutical company that is committed to developing and commercializing innovative endocrine therapeutics in the areas of osteoporosis and oncology. Radius’ lead product, TYMLOS (abaloparatide) injection, was approved by the
About TYMLOS (abaloparatide) injection
TYMLOS (abaloparatide) injection was approved by the
About Elacestrant and EMERALD Phase 3 Study
Elacestrant is an investigational oral selective estrogen receptor degrader (SERD). In a Phase 1 study with a heavily pre-treated population (n=40), elacestrant was well-tolerated with the most commonly reported adverse events being low grade nausea and dyspepsia and demonstrated a single agent activity with a 27.3% objective response rate (ORR) and 5.4 months progression-free survival (PFS) as of the study cut-off date (
The EMERALD Phase 3 trial is a randomized, open label, active-controlled study evaluating elacestrant as second- or third-line monotherapy in advanced/metastatic ER-positive (ER+)/HER2-negative (HER2-) breast cancer patients. The study will enroll approximately 460 patients who have received prior treatment with one or two lines of endocrine therapy, including a cyclin-dependent kinase (CDK) 4/6 inhibitor. Patients in the study will be randomized to receive either elacestrant or the investigator’s choice of an approved hormonal agent. The primary endpoint of the study will be progression-free survival (PFS) in the overall patient population and in patients with estrogen receptor 1 gene (ESR1) mutations. Secondary endpoints will include evaluation of overall survival (OS), objective response rate (ORR), and duration of response (DOR).
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 should be considered forward-looking statements, including without limitation statements regarding our financial guidance, including expectations for full-year TYMLOS net sales and our year-end cash, cash equivalents and investments balance; our expectations regarding commercialization of TYMLOS in the U.S., including expectations for capturing a share of the U.S. anabolic osteoporosis market and growth of the anabolic market; our expectation that elacestrant and abaloparatide-patch each have blockbuster potential; our expectations regarding our clinical trials, including the design and timing thereof; the progress in the development of our product candidates, including abaloparatide-patch, elacestrant (RAD1901) and RAD140; and the potential clinical uses and therapeutic and other benefits of our product candidates, including abaloparatide-patch, elacestrant and RAD140.
These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: we expect to need to raise additional funding, which may not be available; risks related to raising additional capital; our limited operating history; quarterly fluctuation in our financial results; our dependence on the success of TYMLOS, and our inability to ensure that TYMLOS will obtain regulatory approval outside the U.S. or be successfully commercialized in any market in which it is approved, including as a result of risk related to coverage, pricing and reimbursement; risks related to competitive products and any collaboration agreements failing to be successful; risks related to clinical trials, including our reliance on third parties to conduct key portions of our clinical trials and uncertainty that results will support our product candidate claims; the risk that adverse side effects will be identified during the development of our product candidates or during commercialization, if approved; risks related to manufacturing, supply and distribution; and the risk of litigation or other challenges regarding our intellectual property rights. These and other important risks and uncertainties discussed in our filings with the
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Source: Radius Health Inc.