Teijin to Commence Manufacture and Sale in Japan of Abaloparatide Acetate as Treatment for Osteoporosis[Teijin Pharma]

NEWS RELEASE Teijin to Commence Manufacture and Sale in Japan of Abaloparatide Acetate as Treatment for Osteoporosis Tokyo, Japan, March 23, 2021 --- Teijin Pharma Limited, the core company of the Teijin Group’s healthcare business, announced today that on March 23 it will commence the manufacture and sale of its OSTABALO® abaloparatide acetate treatment in Japan. The new solution has been approved for the treatment of osteoporosis and will help promote bone formation in patients with high risk of bone fractures. Now Teijin Pharma is developing an additional dosage for OSTABALO® in order to respond to Japan’s 14 -day prescription limit. The date when Teijin Pharma starts exclusive sales of OSTABALO® in Japan is undecided. Product name OSTABALO ® Subcutaneous Injection Cart General name Abaloparatide acetate Dosage form Aqueous injection (cartridge) Efficacy and effect Osteoporosis where there is a high risk of bone fractures Usage and dose For adults, subcutaneous injection of 80μg as an abaloparatide once a day. Administration limited to 18 months. Under its current medium-term management plan , the Teijin Group is contributing to sustainability by developing solutions that make allowance for demographic change and address increased health consciousness. The launch of new drugs will be a key factor in the implementation of this plan . The Teijin Group will continue to enhance patients’ quality of life by providing new treatment options for diseases with high unmet needs. The active ingredient in OSTABALO® Subcutaneous Injection Cart is abaloparatide acetate, a polypeptide containing a modification of one part of the 34 amino acid sequences from the N-terminus of human parathyroid hormone-related peptide (PTHrP). Abaloparatide selectively stimulates parathyroid hormone type 1 receptors involved in bone metabolism, and when administere d subcutaneously once a day, promotes bone formation through an increase in osteoblasts; it may also increase bone mass. The efficacy and safety of OSTABALO® Subcutaneous Injection Cart have been confirmed in clinical trials in Japan and worldwide involving osteoporosis patients with a high risk of bone fractures. In May 2020, Teijin Pharma accordingly applied for approval in Japan to manufacture and sell OSTABALO® Subcutaneous Injection Cart as a new treatment option. In April 2017, Radius Health, Inc. received Food and Drug Administration (FDA) approval in the United States for Tymlos® (abaloparatide-SC) for the treatment for postmenopausal women with osteoporosis at high risk for fracture. Japan is estimated to have about 13 million patients with osteoporosis (*1), many of whom are at risk of bone fractures that could greatly reduce their scope for everyday activity and their quality of life . Osteoporosis is particularly troublesome for those with low bone density, bone fragility or a high frequency of fractures due to aging. There is 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 is helping to improve patients’ quality of life through solutions that address problems with bones and joints; these include 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 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 materia ls 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/met abolic 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. Press Contact Corporate Communications Teijin Limited [email protected]

The release as fetched from its publisher. teijin.com ↗