23:14:09 Europe / Stockholm

Kurs & Likviditet

Kursutveckling och likviditet under dagen för detta pressmeddelande

Beskrivning

LandFinland
ListaLarge Cap Helsinki
SektorHälsovård
IndustriLäkemedel & Handel
Orion är en koncern med verksamhet inom läkemedelsindustrin. Bolaget bedriver forskning och utveckling av humana – och veterinära läkemedel, där störst fokus innehas inom sjukdomar som drabbar nervsystemet, samt onkologi och luftvägssjukdomar. Idag återfinns bolagets produkter på global nivå, med störst närvaro inom Norden och övriga Europa. Bolagets huvudkontor ligger i Esbo.

Kalender

2023-10-26 Kvartalsrapport 2023-Q3
2023-07-17 Kvartalsrapport 2023-Q2
2023-04-27 Kvartalsrapport 2023-Q1
2023-03-22 Årsstämma 2023
2023-02-09 Bokslutskommuniké 2022
2022-10-20 Kvartalsrapport 2022-Q3
2022-07-15 Kvartalsrapport 2022-Q2
2022-04-28 Kvartalsrapport 2022-Q1
2022-03-24 Ordinarie utdelning ORNBV 1.50 EUR
2022-03-24 Ordinarie utdelning ORNAV 1.50 EUR
2022-03-23 Årsstämma 2022
2022-02-10 Bokslutskommuniké 2021
2021-10-20 Kvartalsrapport 2021-Q3
2021-07-19 Kvartalsrapport 2021-Q2
2021-04-27 Kvartalsrapport 2021-Q1
2021-03-26 Ordinarie utdelning ORNBV 1.50 EUR
2021-03-26 Ordinarie utdelning ORNAV 1.50 EUR
2021-03-25 Årsstämma 2021
2021-02-09 Bokslutskommuniké 2020
2020-10-21 Kvartalsrapport 2020-Q3
2020-07-17 Kvartalsrapport 2020-Q2
2020-05-07 Ordinarie utdelning ORNBV 1.50 EUR
2020-05-07 Ordinarie utdelning ORNAV 1.50 EUR
2020-05-06 Årsstämma 2020
2020-04-28 Kvartalsrapport 2020-Q1
2020-03-26 Ordinarie utdelning ORNBV 1.50 EUR
2020-02-05 Bokslutskommuniké 2019
2019-10-23 Kvartalsrapport 2019-Q3
2019-07-17 Kvartalsrapport 2019-Q2
2019-04-25 Kvartalsrapport 2019-Q1
2019-03-27 Ordinarie utdelning ORNBV 1.50 EUR
2019-03-27 Ordinarie utdelning ORNAV 1.50 EUR
2019-03-26 Årsstämma 2019
2019-02-06 Bokslutskommuniké 2018
2018-10-24 Kvartalsrapport 2018-Q3
2018-07-18 Kvartalsrapport 2018-Q2
2018-04-24 Kvartalsrapport 2018-Q1
2018-03-21 Ordinarie utdelning ORNAV 1.45 EUR
2018-03-21 Ordinarie utdelning ORNBV 1.45 EUR
2018-03-20 Årsstämma 2018
2018-02-07 Bokslutskommuniké 2017
2017-10-26 Kvartalsrapport 2017-Q3
2017-07-19 Kvartalsrapport 2017-Q2
2017-05-18 Kapitalmarknadsdag 2017
2017-04-26 Kvartalsrapport 2017-Q1
2017-03-23 Bonusutdelning ORNBV 0.2
2017-03-23 Ordinarie utdelning ORNBV 1.35 EUR
2017-03-23 Ordinarie utdelning ORNAV 1.35 EUR
2017-03-23 Bonusutdelning ORNAV 0.2
2017-03-22 Årsstämma 2017
2017-02-08 Bokslutskommuniké 2016
2016-10-25 Kvartalsrapport 2016-Q3
2016-07-19 Kvartalsrapport 2016-Q2
2016-04-27 Kvartalsrapport 2016-Q1
2016-03-23 Ordinarie utdelning ORNBV 1.30 EUR
2016-03-23 Ordinarie utdelning ORNAV 1.30 EUR
2016-03-22 Årsstämma 2016
2016-02-02 Bokslutskommuniké 2015
2015-10-27 Kvartalsrapport 2015-Q3
2015-07-28 Kvartalsrapport 2015-Q2
2015-05-26 Kapitalmarknadsdag 2015
2015-04-29 Kvartalsrapport 2015-Q1
2015-03-25 Ordinarie utdelning ORNAV 1.30 EUR
2015-03-25 Ordinarie utdelning ORNBV 1.30 EUR
2015-03-24 Årsstämma 2015
2015-02-04 Bokslutskommuniké 2014
2014-10-21 Kvartalsrapport 2014-Q3
2014-07-29 Kvartalsrapport 2014-Q2
2014-04-29 Kvartalsrapport 2014-Q1
2014-03-26 Ordinarie utdelning ORNAV 1.25 EUR
2014-03-26 Ordinarie utdelning ORNBV 1.25 EUR
2014-03-25 Årsstämma 2014
2014-02-04 Bokslutskommuniké 2013
2013-10-22 Kvartalsrapport 2013-Q3
2013-07-30 Kvartalsrapport 2013-Q2
2013-04-23 Kvartalsrapport 2013-Q1
2013-03-20 Ordinarie utdelning ORNAV 1.30 EUR
2013-03-20 Ordinarie utdelning ORNBV 1.30 EUR
2013-03-19 Årsstämma 2013
2013-02-05 Bokslutskommuniké 2012
2012-10-23 Kvartalsrapport 2012-Q3
2012-07-31 Kvartalsrapport 2012-Q2
2012-05-24 Kapitalmarknadsdag 2012
2012-04-24 Kvartalsrapport 2012-Q1
2012-03-21 Bonusutdelning ORNBV 0.12
2012-03-21 Ordinarie utdelning ORNAV 1.30 EUR
2012-03-21 Ordinarie utdelning ORNBV 1.30 EUR
2012-03-21 Bonusutdelning ORNAV 0.12
2012-03-20 Årsstämma 2012
2012-02-07 Bokslutskommuniké 2011
2011-10-25 Kvartalsrapport 2011-Q3
2011-08-02 Kvartalsrapport 2011-Q2
2011-04-01 Ordinarie utdelning ORNAV 1.20 EUR
2011-04-01 Bonusutdelning ORNAV 0.06
2011-04-01 Ordinarie utdelning ORNBV 1.20 EUR
2011-04-01 Bonusutdelning ORNBV 0.06
2010-03-25 Ordinarie utdelning
2010-03-25 Ordinarie utdelning ORNBV 1.00 EUR
2010-03-25 Bonusutdelning ORNBV 0.1
2010-03-25 Bonusutdelning
2009-03-24 Ordinarie utdelning
2009-03-24 Ordinarie utdelning ORNBV 0.95 EUR
2008-03-26 Ordinarie utdelning ORNBV 1.00 EUR
2007-04-03 Ordinarie utdelning
2007-04-03 Ordinarie utdelning ORNBV 1.00 EUR
2006-03-22 Ordinarie utdelning ORNBV 0.85 EUR
2005-03-22 Ordinarie utdelning ORNBV 0.55 EUR
2005-03-22 Ordinarie utdelning
2004-09-15 Bonusutdelning ORNBV 2.14
2004-09-15 Bonusutdelning
2004-03-23 Ordinarie utdelning
2004-03-23 Ordinarie utdelning ORNBV 1.60 EUR
2003-12-12 Bonusutdelning
2003-12-12 Bonusutdelning ORNBV 1.5
2003-03-23 Ordinarie utdelning ORNBV 0.93 EUR
2003-03-23 Ordinarie utdelning
2002-04-16 Ordinarie utdelning ORNBV 1.10 EUR
2002-04-16 Ordinarie utdelning
2001-03-30 Ordinarie utdelning
2001-03-30 Ordinarie utdelning ORNBV 1.20 EUR
2000-03-31 Ordinarie utdelning ORNBV 1.18 EUR
2000-03-31 Ordinarie utdelning
1999-07-28 Bonusutdelning
1999-07-28 Bonusutdelning
1999-04-09 Ordinarie utdelning
1999-04-09 Ordinarie utdelning
1998-04-21 Ordinarie utdelning
1998-04-21 Ordinarie utdelning
1997-04-22 Ordinarie utdelning
1997-04-22 Ordinarie utdelning
1996-04-23 Ordinarie utdelning
1996-04-23 Ordinarie utdelning
2022-04-22 10:30:00

ORION CORPORATION
PRESS RELEASE
22 April 2022 at 11.30 EEST

Orion’s collaboration partner Bayer submits application for additional indication of darolutamide in China

  • Submission to the Center of Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for an additional indication in patients with metastatic hormone-sensitive prostate cancer (mHSPC)
  • Submission based on data from the pivotal Phase III ARASENS trial, showing that the use of darolutamide plus androgen deprivation therapy (ADT) and docetaxel led to a statistically significant improvement in overall survival (OS) compared to ADT plus docetaxel, as well as consistent benefits in key secondary endpoints in patients with mHSPC, with similar overall rates of adverse events (AEs) between study arms
  • Darolutamide is approved under the brand name Nubeqa® in non-metastatic castration-resistant prostate cancer (nmCRPC), in more than 60 markets around the world; additional submissions in mHSPC are planned globally by Bayer
  • Broad development programme underway with additional ongoing or planned large clinical studies for darolutamide across various stages of prostate cancer

Orion’s collaboration partner Bayer today announced the submission of a regulatory application to the Center of Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA), for the oral androgen receptor inhibitor (ARi) darolutamide. Bayer is seeking approval for the use of darolutamide for the treatment of adult patients with metastatic hormone sensitive prostate cancer (mHSPC) in combination with docetaxel. The compound is already approved under the brand name Nubeqa® for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease, in more than 60 markets around the world, including the U.S., the European Union (EU), Japan and China.

The CDE submission is supported by positive results from the Phase III ARASENS trial, showing a statistically significant improvement in overall survival (OS) for darolutamide plus androgen deprivation therapy (ADT) and docetaxel in men with mHSPC. These results were presented in February at the 2022 ASCO GU Cancers Symposium and simultaneously published in The New England Journal of Medicine.

Darolutamide is developed jointly by Orion and Bayer. Additional submissions in mHSPC are planned by Bayer globally. The compound is also being investigated in further studies across various stages of prostate cancer, including another Phase III trial in mHSPC (ARANOTE) as well as an ANZUP-led international co-operative group Phase III trial, evaluating darolutamide as an adjuvant treatment for localized prostate cancer with very high risk of recurrence (DASL-HiCaP, ANZUP1801).

About the ARASENS Trial

The ARASENS trial is a randomized, Phase III, multi-center, double-blind, placebo-controlled trial which was prospectively designed to investigate the efficacy and safety of oral darolutamide, an androgen receptor inhibitor (ARi), plus androgen deprivation therapy (ADT) and the chemotherapy docetaxel in patients with metastatic hormone-sensitive prostate cancer (mHSPC). A total of 1,306 newly diagnosed patients were randomized in a 1:1 ratio to receive 600 mg of darolutamide twice a day or matching placebo, plus ADT and docetaxel.

The primary endpoint of this trial was overall survival (OS). Secondary endpoints included time to castration-resistant prostate cancer (CRPC), time to pain progression, time to first symptomatic skeletal event (SSE), time to initiation of subsequent anticancer therapy, all measured at 12‐week intervals, as well as adverse events (AEs) as a measure of safety and tolerability.

About Metastatic Hormone-Sensitive Prostate Cancer

Prostate cancer is the second most commonly diagnosed malignancy in men worldwide. In 2020, an estimated 1.4 million men were diagnosed with prostate cancer, and about 375,000 died from the disease worldwide.1

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 5% of men will already suffer from prostate cancer with distant metastases when first diagnosed. Current treatment options for men with metastatic hormone-sensitive prostate cancer (mHSPC) include hormone therapy, such as ADT, androgen receptor pathway inhibitors plus ADT or a combination of the chemotherapy docetaxel and ADT. Despite these treatments, a large proportion of men with mHSPC will eventually progress to metastatic castration-resistant prostate cancer (mCRPC), a condition with limited survival.

About darolutamide

Darolutamide is an oral 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 low potential for blood-brain barrier penetration for darolutamide is supported by preclinical models and neuroimaging data in healthy humans. A low blood-brain barrier penetration would explain the overall low incidence of central nervous system (CNS)-related adverse events (AEs) compared to placebo as seen in the ARAMIS Phase III trial and the improved verbal learning and memory observed in the darolutamide arm of the Phase II ODENZA trial.

The product is approved under the brand name Nubeqa® in more than 60 markets around the world, including the U.S., EU, Japan, China, for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease. The compound is also being investigated in further studies across various stages of prostate cancer, including another Phase III trial in mHSPC (ARANOTE) as well as an ANZUP-led international co-operative group Phase III trial, evaluating darolutamide as an adjuvant treatment for localized prostate cancer with very high risk of recurrence (DASL-HiCaP, ANZUP1801). Information about these trials can be found at www.clinicaltrials.gov.

                                                
Contact person:
Tuukka Hirvonen, Investor Relations, Orion Corporation
tel. +358 10 426 2721

Reference

  1. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA: A Cancer Journal for Clinicians. https://acsjournals.onlinelibrary.wiley.com/doi/epdf/10.3322/caac.21660. Accessed March 2022.

Publisher:
Orion Corporation
Communications
Orionintie 1A, FI-02200 Espoo, Finland
www.orion.fi

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 currently are neurological disorders, oncology and respiratory diseases for which Orion develops inhaled pulmonary medication. Orion's net sales in 2021 amounted to EUR 1,041 million and the company had about 3,350 employees at the end of the year. Orion's A and B shares are listed on Nasdaq Helsinki.