ATOX to Supply Bayer with Galli EoTM for Prostate Cancer Study.
On 17th May 2023, ATOX entered into an agreement with Bayer Yakuhin Co., Ltd. (hereafter “Bayer Yakuhin”) to supply IRE ELiT’s 68Ge/68Ga generator “Galli EoTM”.
Bayer initiated a global Phase III clinical trial “ARASTEP” *1for darolutamide, an oral androgen receptor inhibitor (ARi). The new Phase III clinical study will investigate the efficacy of darolutamide plus androgen deprivation therapy (ADT) versus ADT alone in hormone-sensitive prostate cancer, in patients with high-risk biochemical recurrence (BCR) who have no evidence of metastatic disease by conventional imaging and a positive PSMA PET/CT at baseline.
In part of this global clinical trial, IRE ELiT’s 68Ge/68Ga generator “Galli EoTM” will be used in Japan to elute 68Ga, which is needed to produce the diagnostics agent 68Ga-PSMA-11 for PET scans to assess the course of the disease prior to and during years of treatment with the therapeutic agent.
For this supply of Galli EoTM to Bayer Pharma Japan, ATOX’s president Toshikazu Yaguchi stated “We are committed to providing maximum support for this clinical trial in cooperation with IRE ELiT in order to help prostate cancer patients in Japan as soon as possible.”
*1"Bayer expands global clinical program for darolutamide in prostate cancer." Bayer Yakuhin Co., Ltd. April 4, 2023.
About Bayer
Bayer is a global company whose core businesses are in the health care and food-related life science fields. Through our products and services, we contribute to people's lives and the prosperity of our planet by supporting efforts to overcome the critical challenges posed by a growing and aging global population. Bayer is committed to promoting sustainable development and creating a positive impact through our business. At the same time, we aim to increase profitability and create corporate value through technological innovation and growth. The Bayer brand is a symbol of trust, reliability and quality around the world. The group has sales of 50.7 billion euros and approximately 101,000 employees (2022). Research and development expenses before special items amounted to 6.2 billion euros. For more information, please visit https://www.bayer.com/en/.
About Bayer Yakuhin Co., Ltd.
Through our pharmaceutical and consumer health businesses, we are promoting sustainable initiatives that transform treatment for patients in Japan. In the medical pharmaceutical division, we deliver appropriate nutrition to babies in their “first 1000 days of life.” In the medical pharmaceutical division, we deliver appropriate nutrition to the cardiovascular and nephrology fields, oncology field, ophthalmology field, gynecology field, hematology field, and diagnostic imaging field. Therefore, we are focusing on supplements that support women's pregnancy preparation and pregnancy period. For more information, please visit https://www.pharma.bayer.jp, Facebook, and YouTube.
About IRE ELiT
IRE ELiT, a Belgium-based company, develops and manufactures radiopharmaceutical-related products. The company supplies the products to Europe, North and South America, the Middle East and Asia. IRE ELiT’s 68Ge/68Ga generator is approved by both authorities in Europe and North America. (For more information, please visit https://www.ire.eu/en/.)
ATOX signed an exclusive distribution agreement in Japan with IRE ELiT for its 68Ge/68Ga generator “Galli EoTM” in 2018 and has been supplying the product to domestic research institutes. This Galli EoTM is used to prepare 68Ga-PSMA-11 injection solution. The prostate cancer lesion can be detected by the highly sensitive scanned data acquired by 68Ga-PSMA-11 injection which would not be detected by the conventional diagnostic imaging such as CT (Computed Tomography), MRI (Magnetic Resonance Imaging) and bone scintigraphy.