- TYMLOS® patent extended to 2031, adding approximately 3½ years to the TYMLOS-SC patent life
- Enrollment completed for ATOM Phase 3 study assessing the efficacy and safety of abaloparatide-SC in males with osteoporosis
Radius recently requested the extension under 35 U.S.C 156, which compensated for the term loss during the regulatory review process.
“We are pleased that the US Patent Office has extended the term of US patent 7,803,770, which protects TYMLOS by an additional three and a half years,” stated
Abaloparatide-SC Phase 3 Study
Patient enrollment in the Phase 3 ATOM study of TYMLOS (abaloparatide-SC) assessing the efficacy and safety of abaloparatide-SC in men with osteoporosis at high risk for fracture, is now complete. The study enrolled a total of 228 patients in four countries.
“We are excited to have completed patient enrollment in the first of our three ongoing Phase 3 clinical trials,” said Dr.
Kelly Martin, Chief Executive Officer, commented on the Company’s overall recent advancements summarizing that, “In the last eight weeks, we have made a number of internal organizational adjustments, completed the elacestrant transaction with the
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 history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy.
About ATOM Phase 3 Study
The ATOM Phase 3 study is a randomized, double-blind, placebo-controlled study to assess efficacy and safety of abaloparatide-SC in approximately 225 men with osteoporosis. The primary endpoint is change in lumbar spine BMD at 12 months compared with placebo, and if successful, will form the basis of a supplemental NDA seeking to expand the use of TYMLOS to treat men with osteoporosis at high risk for fracture.
Radius is a science-driven fully integrated biopharmaceutical company that is committed to developing and commercializing innovative endocrine therapeutics. For more information, please visit www.radiuspharm.com
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.
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: the adverse impact the COVID-19 pandemic may have on our business; availability of additional capital; 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; the risk of litigation or other challenges regarding our intellectual property rights; success of any collaboration or partnership agreements. These and other important risks and uncertainties discussed in our filings with the
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Source: Radius Health Inc.