Radius Health Provides Update on Abaloparatide
- Regulatory success achieved in Japan by partner Teijin Pharma Limited
- Ostabaro® 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® 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® 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.
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, including without limitation statements regarding our EU regulatory submissions, expected net new patient numbers and net revenue targets. These forward-looking statements are based on management's current expectations and are neither promises nor guarantees. These statements 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 them, including, but not limited to, periodic fluctuations in our financial results and patient numbers and our inability to ensure that abaloparatide will obtain regulatory approval outside the U.S. or be successfully commercialized in any market in which it is approved. 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, 2020 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:
Peter A. Schwartzman
Phone: (617) 583-2017
Source: Radius Health Inc.