Bayer and Orion Expand Clinical Development Program for BAY-1841788 (ODM-201) in Prostate Cancer

WHIPPANY, N.J., June 3, 2016 /PRNewswire/ -- Bayer and Orion Corporation today announced the expansion of the global clinical development program for the investigational androgen receptor (AR) antagonist BAY-1841788 (ODM-201) in the area of prostate cancer. The Phase III study ARASENS will evaluate the compound in combination with standard androgen deprivation therapy (ADT) and the chemotherapy docetaxel in men with newly diagnosed metastatic hormone-sensitive prostate cancer (mHSPC), who are starting first line hormone therapy. The compound, BAY-1841788 (ODM-201), is an investigational oral AR-antagonist currently in Phase III development for high-risk non-metastatic castration-resistant prostate cancer (nmCRPC). The ARASENS clinical trial is expected to start enrolling patients towards the end of 2016.

"Although the treatment options for patients with advanced prostate cancer who are castration-resistant have evolved considerably in recent years, there were only few advances in the earlier, hormone-sensitive stage of metastatic disease. Continued research of investigational agents is needed to give patients more options," said Dr. Joerg Moeller, member of the Executive Committee of Bayer AG's Pharmaceutical Division and Head of Development. "Bayer's commitment to prostate cancer research runs deep, and the initiation of ARASENS is the latest in a long line of studies designed to evaluate investigational compounds for prostate cancer."

Bayer and Orion have recently expanded the 2014 agreement to include the joint development of BAY-1841788 (ODM-201) for mHSPC. Under that agreement, Bayer will commercialize the product globally; Orion has the option to co-promote BAY-1841788 in Europe, and is responsible for the manufacturing of the product.

"We believe that the profile of ODM-201 makes it an excellent candidate for further investigation in patients with metastatic hormone-sensitive prostate cancer. This is another example of how Orion's oncology research is committed to investigating compounds in prostate cancer. We are also happy to see Bayer's continuous commitment to ODM-201," said Dr. Reijo Salonen, Senior Vice President of R&D at Orion.

About ARASENS
ARASENS (A Randomized, double-blind, placebo-controlled Phase III study of ODM-201 versus placebo in addition to standard Androgen deprivation therapy and docetaxel in patients with metastatic castration SENSitive prostate cancer) is planned to be initiated towards the end of 2016. Approximately 1,300 patients will be randomized (1:1 ratio) to receive either BAY-1841788 (ODM-201) or placebo in combination with an ADT of investigator's choice (LHRH agonist/antagonists or orchiectomy), started ≤12 weeks before randomization. Six cycles of docetaxel will be administered after randomization. The primary endpoint of the study is overall survival, and secondary endpoints include time to castration-resistant prostate cancer, time to initiation of subsequent antineoplastic therapy, symptomatic skeletal event free survival (SSE-FS), time to first symptomatic skeletal event (SSE), time to initiation of opioid use, time to pain progression, time to worsening of physical symptoms of disease and safety.

ARASENS adds to the ongoing clinical development program for BAY-1841788, which includes ARAMIS (NCT02200614), a randomized, Phase III, multicenter, double-blind, placebo-controlled trial evaluating patients with non-metastatic CRPC who are at high risk for developing metastatic disease. ARAMIS is currently enrolling patients.  

About Metastatic Hormone-Sensitive Prostate Cancer
Prostate cancer is the second most common cancer and the second leading cause of cancer-related death among American men. More than 180,000 new cases of prostate cancer are estimated to be diagnosed and approximately 26,000 American men will die from the disease in 2016.¹

At the time of diagnosis, most men have localized prostate cancer, meaning their cancer is confined to the prostate gland. For most men, active surveillance following early diagnosis means their cancer can be controlled; however, for some men, the disease will metastasize, or spread, before they are treated with hormone therapy. Additionally, approximately five percent of men will present with prostate cancer with distant metastases when first diagnosed.² Men with newly diagnosed metastatic hormone-sensitive prostate cancer (HSPC) may begin treatment with hormone therapy, such as androgen-deprivation therapy (ADT) or a combination of chemotherapy and ADT. Despite this first line treatment, most men with metastatic HSPC will eventually progress to castration-resistant prostate cancer (CRPC), which can impact survival.³

About BAY-1841788 (ODM-201)
BAY-1841788 (ODM-201) is an investigational oral androgen receptor (AR) antagonist. In preclinical studies, BAY-1841788 and its main circulating metabolite showed to be active also in known AR mutants (ex W742L, F877L).

BAY-1841788 (ODM-201) is not approved by the U.S. Food and Drug Administration, the European Medicines Agency or any other health authority.

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 includes three oncology products and several other compounds 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.

Bayer: Science For A Better Life
Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At the same time, the Group aims to create value through innovation, growth and high earning power. Bayer is committed to the principles of sustainable development and to its social and ethical responsibilities as a corporate citizen. In fiscal 2015, the Group employed around 117,000 people and had sales of EUR 46.3 billion. Capital expenditures amounted to EUR 2.6 billion, R&D expenses to EUR 4.3 billion. These figures include those for the high-tech polymers business, which was floated on the stock market as an independent company named Covestro on October 6, 2015. For more information, go to www.bayer.us.

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Forward-Looking Statement
This news release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. 

1.     American Cancer Society. Cancer facts & figures 2016. Available at: http://www.cancer.org/acs/groups/content/@research/documents/document/acspc-047079.pdf.

2.     University of Maryland Medical Center. Prostate Cancer. Available at: http://umm.edu/health/medical/reports/articles/prostate-cancer.

3.     National Cancer Institute. Hormone Therapy for Prostate Cancer. Available at: http://www.cancer.gov/types/prostate/prostate-hormone-therapy-fact-sheet.

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