Benzinga | Jun 2, 2021 08:16AM EDT

Radius Health Provides Business Update; Says TYMLOS Saw 'Modest Growth'

Radius Health, Inc. ("Radius" or the "Company") (NASDAQ:RDUS), provided a business update covering continued progress for the Company. Additional business updates will be provided as progress is achieved.

ABALOPARATIDE ASSET

U.S. TYMLOS Commercial Performance:

* TYMLOS added ~1,650 new patients in April; 1% growth vs. trailing 4-month average

* New patients: defined as those who have been prescribed TYMLOS and received their first dose

* ~67% of new patients in April were initiated by a fracture focused bone health account

* Added 45 new fracture / bone health focused prescribers during the month of April

Life Cycle:

* ATOM (Male) Phase 3 pivotal study on schedule for readout: 2H, 2021

* wearABLe (Transdermal System) Phase 3 pivotal study on schedule for readout: 2H, 2021

* Anticipate abaloparatide depot formulation technical development work to commence 2H, 2021

Geographic Footprint:

* Europe: re-submission expected for abaloparatide SC to EMA in 2H, 2021

* Canada: abaloparatide SC submission -- by our partner -- expected in January, 2022

* Japan: 'planning discussions' with PMDA, a precursor to potential abaloparatide-TD agreement with Teijin

* Rest of world: multiple discussions ongoing with variety of counterparties

Intellectual Property Portfolio Advancement:

* Three U.S. patents are presently listed in the Orange Book for TYMLOS: U.S. Patent No. 7,803,770 which expires on April 28, 2031 and U.S. Patent Nos. 8,148,333 and 8,748,382 which each expire on October 30, 2027

* A fourth U.S. patent, U.S. Patent No. 10,996,208 directed to certain methods of analyzing abaloparatide to detect and quantify presence of beta Asp10, was issued on May 4, 2021 and will be added to the Orange book listing shortly; this patent expires on April 30, 2038

* A new Japanese patent covering the abaloparatide transdermal system and its use in treating osteoporosis was granted in April, 2021 and will expire October 8, 2036

FDA Guidance on Synthetic Peptides:

On May 19, 2021 the FDA published updated guidance and requirements for synthetic peptides and what would be required in any generic filings and advancement. Radius views this new guidance as meaningful in assessing the probability of a generic synthetic peptide being filed and gaining market entry.

In sum, the Company views these newly communicated FDA requirements as making it significantly more challenging to advance and develop a generic version of abaloparatide.

The key components of the new FDA guidelines include:

* Recombinantly sourced peptides cannot be approved in an ANDA and must be submitted in a 505(b)(2) NDA

* Explicit references to the potential for significant consequences if anti-drug antibodies cross-react against endogenous peptides

* New impurities must be within the FDA's threshold; if greater, must be submitted as a 505(b)(2)

* Explicit expectation: ANDA with new impurity must evaluate immunogenicity risks prior to filing

RAD011 ASSET

* FDA Type C meeting for PWS will take place the week of June 14

* Written minutes from the FDA meeting expected by the end of July

* Post FDA discussion, expectation is to initiate a pivotal PWS trial before year end

* Additional orphan indications being assessed in parallel -- decisions and clarity in 2H, 2021

* Multiple Advisory Board meetings completed: U.S., UK, EU for PWS plus a Psychiatry meeting

* Internal team formed: clinical, pharm. science, regulatory, bio-stats, CMC, global franchise

* External team established: manufacturing & supply chain, development, regulatory, advocacy