Benzinga | Mar 24, 2021 08:08AM EDT

Radius Health Says Teijin Pharma's Ostabaro Approved For Treatment Of Male And Female OP Patients At High Risk Of Fracture In Japan

Radius Health Provides Update on Abaloparatide

* Regulatory success achieved in Japan by partner Teijin Pharma Limited

* Ostabaro(r) approved for treatment of male & female OP patients at high risk of fracture

* Japan is currently the largest anabolic market in the world

* $10 million milestone to be generated from Japan approval

* EU: intend to re-file abaloparatide by Q4 2021 -- letter has been submitted to EMA

* Q1 2021 new patients on TYMLOS(r) expected to exceed Q4 2020

BOSTON, March 24, 2021 (GLOBE NEWSWIRE) -- Radius Health, Inc. ("Radius" or the "Company") (NASDAQ:RDUS) provided an update on the abaloparatide asset including regulatory progress as well as U.S. commercial activity.

The Company will continue to provide business updates when appropriate in a timely and transparent manner.

Japan Regulatory Approval for Female & Male Osteoporotic Patients

Teijin Pharma Limited, the core company of the Teijin Group's healthcare business, received approval for Ostabaro(r) abaloparatide acetate in Japan for the treatment of osteoporosis and for promotion of bone formation in both female and male patients with high risk of fractures.

Teijin Pharma Limited is developing an additional dosage for Ostabaro(r) in order to respond to Japan's 14-day prescription limit. The date when Teijin Pharma Limited starts exclusive sales of Ostabaro(r) in Japan is undecided.

The approval in Japan fundamentally advances the abaloparatide molecule opportunity for Radius. We congratulate our partner -- Teijin Pharma Limited -- on this significant accomplishment and look forward to supporting their future efforts in every way.

The two companies have initiated discussions on broadening the partnership to include abaloparatide-TD in Japan.

European Regulatory Re-Filing

Radius has nearly completed a multi-month scientific consultation with a number of EU member states. Based on general and specific feedback, the Company will re-file abaloparatide in the EU and has notified the European Medicines Agency (EMA) of its intentions. This notification was delivered by submitting a "Letter of Intent" to the agency.

As part of the re-filing process, Radius will explore positioning abaloparatide as a therapeutic for either patients 'with high risk of fracture' or patients 'with or who have suffered a fracture'.

U.S. TYMLOS(r) Commercial: New Patient Growth

Following a record quarter in Q4 2020, below are key metrics for our Q1 2021 results to date:

* New patients on TYMLOS(r) are estimated to be 4,742 in Q1 2021

* New patients on TYMLOS(r) were 4,495 in Q4 2020

* February new patients were 1,429 and March is estimated to be 1,634

* February impacted by fewer selling days coupled with weather related disruption in the Midwest

* Gross to net estimates for Q1 2021 reflect normal seasonal pressures and are higher than Q4 2020

* Distribution channel inventory is lower in Q1 2021 vs. Q4 2020 Despite seasonality of Q1 2021, Radius reiterates 2021 net revenue target of at least $250 millionR