Orion Corporation (Nasdaq Helsinki: ORNAV and ORNBV) and Bayer have agreed to start in 2016 a new Phase III study with oral androgen receptor antagonist ODM-201 (BAY-1841788). The new Phase III study ARASENS will evaluate the safety and efficacy of 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.
In 2014, Orion and Bayer entered into a global partnership for the development and commercialization of ODM-201 (BAY-1841788). The companies have expanded the 2014 agreement to include the joint development of ODM-201 (BAY-1841788) for mHSPC. The compound is currently in Phase III study ARAMIS for high-risk non-metastatic castration-resistant prostate cancer (nmCRPC). The new trial ARASENS is expected to start the enrolment of patients towards the end of 2016.
As disclosed in a stock exchange release of 2 June 2014, Orion is eligible to receive milestone payments from Bayer upon achievement of certain ODM-201 related development, tech transfer and commercialization milestones, as well as substantial royalties on future sales. In addition, Orion will be responsible for manufacturing of the product. Orion and Bayer will jointly develop ODM-201 with Bayer contributing a major share of the costs of the development. Bayer will commercialize the product globally and Orion has the option to co-promote it in Europe.
In this individual case Orion deviates from one main rule of its disclosure policy, according to which Orion publishes information on its R&D projects mainly in its interim reports and/or press releases, but, as a main rule, provides information on the results of clinical Phase III trials in separate stock exchange releases.
About Metastatic Hormone-Sensitive Prostate Cancer
Prostate cancer (PC) is the second most common form of cancer worldwide and the fifth leading cause of cancer-related death in men. More than 1.1 million men worldwide were diagnosed with the disease in 2012. (Source: GLOBOCAN 2012: Estimated Cancer Incidence, Mortality and Prevalence Worldwide in 2012.)
At the time of diagnosis, most men have localized prostate cancer, meaning their cancer is confined to the prostate gland and can be treated with curative surgery or radiotherapy. Upon relapse when the disease will metastasize or spread, androgen deprivation therapy (ADT) is the cornerstone of treatment for this hormone-sensitive disease. Approximately five percent of men will already suffer from prostate cancer with distant metastases when first diagnosed. (Source: University of Maryland Medical Center. Prostate Cancer. Available at: http://umm.edu/health/medical/reports/articles/prostate-cancer.)
Men with newly diagnosed metastatic hormone-sensitive prostate cancer (mHSPC) will start their treatment with hormone therapy, such as ADT or a combination of the chemotherapy docetaxel 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 and quality of life. (Source: National Cancer Institute. Hormone Therapy for Prostate Cancer. Available at: http://www.cancer.gov/types/prostate/prostate-hormone-therapy-fact-sheet.)
About ODM-201 (BAY-1841788)
ODM-201 (BAY-1841788) is an investigational oral androgen receptor (AR) antagonist that has a unique chemical structure designed to block the growth of cancer cells through binding to the AR with high affinity and inhibiting the receptor function. In preclinical studies, ODM-201 and its main circulating metabolite are active also in known AR mutants (ex W742L, F877L), and have been found to have negligible blood-brain barrier penetration.
| Timo Lappalainen |
President and CEO
| Olli Huotari |
SVP, Corporate Functions
Tuukka Hirvonen, Communications Manager, Financial Communications and Investor Relations
tel. +358 10 426 2721
Reijo Salonen, SVP, Pharmaceutical Research and Development, Chief Medical Officer
tel. +358 50 966 3647, available from 14.30 EEST (6.30 a.m. CDT) onwards.
Orionintie 1A, FI-02101 Espoo, Finland
Orion is a globally operating Finnish company developing pharmaceuticals and diagnostic tests - a builder of well-being. Orion develops, manufactures and markets human and veterinary pharmaceuticals, active pharmaceutical ingredients and diagnostic tests. The company is continuously developing new drugs and treatment methods. The core therapy areas of Orion's pharmaceutical R&D are central nervous system (CNS) disorders, oncology and respiratory for which Orion developes inhaled Easyhaler® pulmonary drugs.
Orion's net sales in 2015 amounted to EUR 1,016 million and the Company had about 3,400 employees. Orion's A and B shares are listed on Nasdaq Helsinki.