On February 3, 2020 Nippon Kayaku Co., Ltd. (Headquarters: Tokyo, President: Atsuhiro Wakumoto, hereafter, "Nippon Kayaku") and Bayer Yakuhin, Ltd. (Headquarters: Osaka, President: Heike Prinz, hereafter, "Bayer Yakuhin") reported that it signed an agreement on the co-promotion in Japan with regard to Nubeqa (generic name: darolutamide), for which Bayer received regulatory approval from the Ministry of Health, Labor and Welfare (MHLW) for the treatment of patients with non-metastatic castrationresistant prostate cancer (nmCRPC) (Press release, Nippon Kayaku, FEB 3, 2020, View Source [SID1234553749]).
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Based on this agreement, the medical representatives (MRs) of the two companies will collaborate to provide medical information on Nubeqa. The product will be marketed by Bayer and co-promoted with Nippon Kayaku.
Bayer will expand its prostate cancer portfolio with Nubeqa in addition to Xofigo Injection (generic name: radium-223 dichloride), which was launched in June 2016 as a treatment for CRPC with bone metastases. With the co-promotion agreement with Nippon Kayaku, a leading company in the area of prostate cancer, Bayer will provide appropriate information on Nubeqa to a broad range of healthcare professionals.
Nippon Kayaku has provided products for the treatment of urologic tumors and its respective information since the launch of BleoTM in 1969. Through this joint effort with Bayer Yakuhin to provide healthcare professionals with information on the proper use of Nubeqa, Nippon Kayaku would like to expand treatment options for patients and further contribute to the improvement of healthcare.
Bayer and Nippon Kayaku will promote proper use of Nubeqa and provide information on this product, aiming at further contributing to the treatment of patients with prostate cancer. Nippon Kayaku and Bayer sign agreement for the co-promotion of Nubeqa-2/4-
About Nubeqa
Nubeqa is an androgen receptor inhibitor (ARi) with a distinct chemical structure that binds to the receptor with high affinity and exhibits strong antagonistic activity, thereby inhibiting the receptor function and the growth of prostate cancer cells. The compound is also being investigated in a Phase III study in metastatic hormone-sensitive prostate cancer (ARASENS). Information about these trials can be found at View Source
Nubeqa, which is jointly developed by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company, has been approved in the U.S., Brazil and Japan under the brand name Nubeqa. Filings in the European Union and other regions are underway or planned.
About castration-resistant prostate cancer (CRPC)
Prostate cancer is the second most commonly diagnosed malignancy in men worldwide.1 In 2018, an estimated 1.2 million men were diagnosed with prostate cancer, and about 358,000 died from the disease worldwide.1 Prostate cancer is the fifth leading cause of death from cancer in men.1 Prostate cancer results from the abnormal proliferation of cells within the prostate gland, which is part of a man’s reproductive system.2 It mainly affects men over the age of 50, and the risk increases with age.3
Treatment options range from surgery to radiation treatment to therapy using hormonereceptor antagonists, i.e., substances that stop the formation of testosterone or prevent its effect at the target location.4 However, in nearly all cases, the cancer eventually becomes resistant to conventional hormone therapy.5
CRPC is an advanced form of the disease where the cancer keeps progressing despite androgen deprivation therapy (ADT) treatment, even when the amount of testosterone is reduced to very low levels in the body.6,7 In men with progressive nmCRPC, a rapid prostate specific antigen (PSA) doubling time has been consistently associated with reduced time to first metastasis and death.6-3/4-
About Oncology at Bayer
Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The oncology franchise at Bayer now expands to six marketed products and several other assets in various stages of clinical development. Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that cancer is treated.