Tokyo, Japan --- Teijin Pharma Limited, the core company of the Teijin Groups healthcare business, announced today that it has applied for approval in Japan to manufacture and sell abaloparatide acetate, a therapeutic drug known generically as ITM-058, as an indication for osteoporosis to promote bone formation in patients with high risk of bone fractures.
Abaloparatide acetate, a derivative of the human parathyroid hormone-related peptide (hPTHrP), selectively stimulates the G protein-coupled parathyroid hormone type 1 receptor. In a phase III clinical trial conducted in Japan for osteoporosis patients with a high risk of bone fractures, a significant effect on lumbar spine bone mineral density was observed as the trials efficacy endpoint. The Japan trial produced no major difference compared to other global studies in terms of drug safety and no new side effect was observed in Japanese patients.
Under the Teijin Groups 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 ITM-058 will be a key factor in our implementation of this plan, so we hope to obtain approval and begin marketing ITM-058 to improve patients quality of life (QOL) as soon as possible.
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.
In April 2017, Radius Health, Inc. received manufacturing and sales approval in the United States for ITM-058 as a medication for treating postmenopausal osteoporosis in patients with a high risk of bone fractures.
Japan is estimated to have about 13 million patients with osteoporosis (*1), many of whom are at risk of suffering bone fractures that could greatly reduce their activities of daily living (ADL) and QOL. Osteoporosis is particularly troublesome for people who have low bone density, bone fragility or a high frequency of fractures due to aging. There is a strong demand in Japan for therapeutic drugs capable of increasing bone mass quickly to help patients avoid debilitating bone fractures.
(*1) Guidelines for Prevention AND Treatment of OSTEOPOROSIS 2015 Teijin Pharma contributes to improved QOL of patients through solutions related to bones and joints, including its osteoporosis drugs Onealfa and Bonalon (*2) and sonic accelerated fracture healing system SAFHS.
(*2) Bonalon is the registered trademark of Merck Sharp & Dohme Corp., Whitehouse Station, NJ, USA.
About Radius
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
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TEIJIN LIMITED 
