Radius Health (RDUS) Provides Update on Abaloparatide
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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® 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® in order to respond to Japan’s 14-day prescription limit. The date when Teijin Pharma Limited starts exclusive sales of Ostabaro® 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® 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® are estimated to be 4,742 in Q1 2021
- New patients on TYMLOS® 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 million
Radius is a science-driven fully integrated biopharmaceutical company that is committed to developing and commercializing innovative endocrine and other therapeutics. 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 endocrine and metabolic orphan diseases, initially targeting Prader-Willi syndrome.
About the Teijin Group
Teijin (TSE: 3401) is a technology-driven global group offering advanced solutions in the fields of environmental value; safety, security and disaster mitigation; and demographic change and increased health consciousness. Originally established as Japan's first rayon manufacturer in 1918, Teijin has evolved into a unique enterprise encompassing three core business domains: high-performance materials including aramid, carbon fibers and composites, and also resin and plastic processing, films, polyester fibers and products converting; healthcare including pharmaceuticals and home healthcare equipment for bone/joint, respiratory and cardiovascular/metabolic diseases, nursing care and pre-symptomatic healthcare; and IT including B2B solutions for medical, corporate and public systems as well as packaged software and B2C online services for digital entertainment. Deeply committed to its stakeholders, as expressed in the brand statement “Human Chemistry, Human Solutions”, Teijin aims to be a company that supports the society of the future. The group comprises more than 170 companies and employs some 20,000 people across 20 countries worldwide. Teijin posted consolidated sales of JPY 853.7 billion (USD 8.0 billion) and total assets of JPY 1,004.2 billion (USD 9.4 billion) in the fiscal year that ended on March 31, 2020.
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