Orion Corporation                                                        Press Release 5 February 2019 at 3.00 p.m. EET

Orion and Bayer jointly present new data in prostate cancer from the Darolutamide ARAMIS -study

First presentation of data from the pivotal Phase III ARAMIS trial with the investigational compound darolutamide in patients with advanced prostate cancer that has not yet metastasized will be presented at 2019 ASCO GU Cancers Symposium.  

Orion Corporation and Bayer announced today that research on their jointly developed investigational compound darolutamide will be presented at the 2019 American Society of Clinical Oncology Genitourinary (ASCO GU) Cancers Symposium taking place February 14-16 in San Francisco.

Among the data presented will be the first results on the investigational cancer treatment darolutamide from the pivotal Phase III ARAMIS trial, a randomized, double-blind, placebo-controlled study to assess the safety and efficacy of darolutamide in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) being treated with androgen deprivation therapy (ADT) and at high risk for developing metastatic disease. Darolutamide is being developed jointly by Orion Corporation and Bayer. Bayer plans to discuss data from the ARAMIS trial with health authorities regarding the submission of a new drug application. Darolutamide has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) in patients with nmCRPC.

Notable darolutamide studies to be presented at the 2019 ASCO GU Cancers Symposium include:

ARAMIS : Efficacy and safety of darolutamide in non-metastatic castration-resistant prostate cancer (nmCRPC)

  • Abstract: 140, Board A4, Poster Session A: Prostate Cancer and Trials in Progress, Oral Abstract Session A: Prostate Cancer
  • Date: Thursday, February 14: 11:30 AM-1:00 PM PST and 5:30-6:30 PM PST (poster presentation), 1:45-1:55 PM PST (oral presentation)

Higher blood-brain barrier penetration of [14C]apalutamide and [14C]enzalutamide compared to [14C]darolutamide in rats using whole-body autoradiography

  • Abstract : 156, Board F21, Poster Session A: Prostate Cancer and Trials in Progress
  • Date: Thursday, February 14: 11:30 AM-1:00 PM PST and 5:30-6:30 PM PST

ODENZA: A study of patient preference between ODM-201 (darolutamide) and enzalutamide in men with metastatic castrate-resistant prostate cancer (mCRPC)

  • Abstract : TPS334, Board N10, Poster Session A: Prostate Cancer and Trials in Progress
  • Date: Thursday, February 14: 11:30 AM-1:00 PM PST and 5:30-6:30 PM PST

Drug-drug interaction (DDI) of darolutamide with cytochrome P450 (CYP) and P-glycoprotein (P-gp) substrates: Results from clinical and in vitro studies

  • Abstract : 297, Board D5, Poster Session B: Prostate Cancer, Urothelial Carcinoma, and Penile, Urethral, Testicular, and Adrenal Cancers
  • Date: Friday, February 15: 12:15-1:45 PM PST and 5:15-6:15 PM PST

About Darolutamide

Darolutamide is a non-steroidal androgen receptor antagonist 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. Darolutamide has shown promising activity in Phase I/II studies in patients with mCRPC. A Phase III study in metastatic hormone-sensitive prostate cancer (ARASENS) is ongoing. Information about these trials can be found at www.clinicaltrials.gov. Darolutamide is not approved by the U.S. FDA, the European Medicines Agency or any other health authority.

About Orion

Orion is a globally operating Finnish pharmaceutical company - a builder of well-being. Orion develops, manufactures and markets human and veterinary pharmaceuticals and active pharmaceutical ingredients. 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 diseases for which Orion develops inhaled Easyhaler® pulmonary drugs. Orion's net sales in 2017 amounted to EUR 1,034 million and the company had about 3,200 employees. Orion's A and B shares are listed on Nasdaq Helsinki.

About Bayer

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 2017, the Group employed around 99,800 people and had sales of EUR 35.0 billion. Capital expenditures amounted to EUR 2.4 billion, R&D expenses to EUR 4.5 billion. For more information, go to www.bayer.com .

Contact person and media requests:   Terhi Ormio Vice President, Communications, Orion Corporation Tel. +358 (0)50 966 4646 terhi.ormio@orion.fi

Publisher: Orion Corporation Communications Orionintie 1A, FI-02200 Espoo, Finland

Orion is a globally operating Finnish pharmaceutical company - a builder of well-being. Orion develops, manufactures and markets human and veterinary pharmaceuticals and active pharmaceutical ingredients. 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 diseases for which Orion develops inhaled Easyhaler® pulmonary drugs. Orion's net sales in 2017 amounted to EUR 1,034 million and the company had about 3,200 employees. Orion's A and B shares are listed on Nasdaq Helsinki.