Pivotal Phase III trial of abaloparatide-SC in Japanese women and men with osteoporosis achieves primary endpoint
- Category: Proteins and Peptides
- Published on Thursday, 28 May 2020 11:25
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Radius partner Teijin Pharma has submitted a New Drug Application for abaloparatide-SC for treatment of osteoporosis in Japan
WALTHAM, MA, USA I May 27, 2020 I Radius Health, Inc. (“Radius” or the “Company”) (Nasdaq: RDUS), today announced that its partner, Teijin Pharma Limited, has submitted a New Drug Application for abaloparatide-SC in Japan for the treatment of osteoporosis in patients who are at high risk for fractures.
The application is based on the positive results of the Phase III clinical study of abaloparatide-SC in Japan which included osteoporosis patients at high risk for fracture. The study achieved its efficacy endpoint with a significant increase in lumbar spine bone mineral density at 18 months and showed an acceptable safety profile. Detailed results of this trial are planned to be presented at a global medical conference in the second half of this year.
“We are pleased that our partner Teijin has achieved this significant milestone toward the potential introduction of abaloparatide as a new treatment option for osteoporosis patients,” stated Kelly Martin, CEO of Radius. “Japan represents the largest anabolic market in the world. This is a critically important step in expanding our osteoporosis business globally.”
“Under the Teijin Group’s current medium-term management plan, we are contributing to sustainability by developing solutions for a demographic change and increased health consciousness,” said Ichiro Watanabe, president of Teijin Pharma Limited. “Launching abaloparatide will be a key factor in our implementation of this plan, so we hope to obtain approval and begin marketing to improve patients’ quality of life (QOL) as soon as possible.”
It is estimated that there are 13 million patients1 with osteoporosis in Japan. Fractures associated with osteoporosis can restrict patients’ activities of daily living and reduce their quality of life dramatically. Therapies – such as abaloparatide-SC, that increase bone mass and decrease risk for subsequent fractures, will provide a meaningful treatment option for physicians and their patients.
The market for osteoporosis drugs in Japan reached USD 3 billion in 2019. Under its license and development agreement with Teijin, Radius is entitled to receive milestone payments upon achievement of certain regulatory and sales milestones and a fixed double-digit royalty based on net sales of abaloparatide-SC in Japan during the royalty term.
Radius is a science-driven fully integrated biopharmaceutical company that is committed to developing and commercializing innovative endocrine 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 the investigational use of abaloparatide injection for the treatment of men with osteoporosis, an investigational abaloparatide-patch for potential use in osteoporosis; the investigational drug elacestrant (RAD1901) for potential use in hormone-receptor positive breast cancer; and the investigational drug RAD140, a non-steroidal, selective androgen receptor modulator (SARM) under investigation for potential use in hormone-receptor positive breast cancer. For more information, please visit www.radiuspharm.com.
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. Please visit www.teijin.com.
SOURCE: Radius Health