Radius Health Update on Abaloparatide Transdermal System

 

• 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

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.

https://ir.radiuspharm.com/news-releases/news-release-details/radius-health-update-abaloparatide-transdermal-system