- Company ascertained regulatory clarity for possible forward progression of abalo-TDS
- Additional and successful clinical trial would be required to advance towards an NDA filing
- New timeline for earliest possible abalo-TDS launch: 2H 2025
- Based on regulatory clarity, timeline, and costs, Radius will cease all work on the program
- Eliminates prospective program costs: $100+ million over 3+ years: CMC, clinical, and launch
- Company continues to dynamically manage capital and its allocation, risk, and overall timelines
BOSTON, June 01, 2022 (GLOBE NEWSWIRE) -- Radius Health, Inc. (“Radius” or the “Company”) (NASDAQ: RDUS) provided an update on the abaloparatide transdermal system (abalo-TDS) development program.
As previously reported on December 8, 2021, the Phase 3 results for abalo-TDS did not meet its primary endpoint of non-inferiority to abaloparatide subcutaneous injection (TYMLOS). The data for spine BMD vs. baseline showed abalo-TDS had a 7.1% increase vs. TYMLOS +10.9%, both considered clinically meaningful. Despite missing the non-inferiority margin, the transdermal system demonstrated a bone building benefit to patients.
Following the reported Phase 3 trial results, the Company outlined three requirements needed to move the abalo-TDS program forward. Those were regulatory clarity, a re-constructed supply chain and CMC agreement/economics and lastly, external funding.
Since December we have completed both our internal analysis and sought regulatory feedback on possible paths forward for abalo-TDS. We committed to providing clarity to the market by June of 2022.
Regulatory feedback from the U.S. Food and Drug Administration (FDA) on abalo-TDS indicated an additional pivotal trial would be required to move forward with any regulatory filings. If successful, we would then incorporate the newly generated data in a filing for future consideration by the FDA with the earliest possible launch timeline of 2H 2025.
Given the clarity on the regulatory pathway, delayed commercial timelines, and $100+ million of additional capital required over the next 3+ years, Radius will cease all work on abalo-TDS.
We remain open to third party interest in the abalo-TDS product opportunity which could fit well with both traditional as well as non-traditional counterparties whose business is focused on the primary care market.
About Radius
Radius is a global biopharmaceutical company focused on addressing unmet medical needs in the areas of bone health, neuroscience orphan diseases, and oncology. Radius’ lead product, 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. The Radius clinical pipeline includes investigational abaloparatide injection for potential use in the treatment of men with osteoporosis; an investigational abaloparatide transdermal system for potential use in the treatment of postmenopausal women with osteoporosis; the investigational drug, elacestrant (RAD1901), for potential use in the treatment of hormone-receptor positive breast cancer out-licensed to Menarini Group; and the investigational drug RAD011, a synthetic cannabidiol oral solution with potential utilization in multiple neuro-endocrine, neurodevelopmental, or neuropsychiatric disease areas, initially targeting Prader-Willi syndrome, Angelman syndrome, and infantile spasms.
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 the Abaloparatide Transdermal System and wearABLe Phase 3 Study
The abaloparatide transdermal system was developed in a collaboration between Radius and Kindeva Drug Delivery (“Kindeva”), as successor to 3M Company and 3M innovative Properties Company with the application of Kindeva’s innovative microstructured transdermal system technology. The Phase 3 wearABLe study was the first pivotal study to evaluate treatment using a novel non-injectable delivery of an anabolic therapy. The wearABLe study was a pivotal, randomized, open label, active-controlled, bone mineral density non-inferiority bridging study that evaluated the efficacy and safety of abaloparatide transdermal system versus TYMLOS (abaloparatide) injection in approximately 500 patients with postmenopausal osteoporosis at high risk for fracture. The primary endpoint of the study was the percentage change in lumbar spine BMD at 12 months.
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 should be considered forward-looking statements.
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: the adverse impact the ongoing COVID-19 pandemic is having and is expected to continue to have on our business, financial condition and results of operations, including our commercial operations and sales, clinical trials, preclinical studies, and employees; 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; risks related to our ability to successfully enter into collaboration, partnership, license or similar agreements; risks related to clinical trials, including our reliance on third parties to conduct key portions of our clinical trials and uncertainty that the results of those trials 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 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, 2021 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. Any such forward-looking statements represent management's estimates as of the date of 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:
Ethan Holdaway
Email: investor-relations@radiuspharm.com
Phone: (617) 583-2017
