Orion's R&D Pipeline

Pipeline presents Orion's key clinical pharmaceutical development projects.

Project Indication Clinical phase / registration

Darolutamide

Prostate cancer (mHSPC)

I II III  

About darolutamide

Orion and Bayer's ongoing Phase III clinical trial (ARASENS)  evaluates the efficacy and safety of darolutamide  in the treatment of patients with newly diagnosed metastatic hormone-sensitive prostate cancer (mHSPC) who are starting hormone therapy. The treatment is darolutamide in combination with hormonal therapy (androgen deprivation therapy) and docetaxel, a chemotherapy drug. The trial, which commenced at the end of 2016, is on track, and patient recruitment was finalized in the review period. The trial is estimated to be completed in 2021.

Darolutamide 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, darolutamide 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.

 

 

About prostate cancer

Prostate cancer is the second most commonly diagnosed malignancy in men worldwide.

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.)

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

More information

Scientific publications

Darolutamide

Prostate cancer (mHSPC)

I II  III  

About darolutamide

Orion and Bayer's ongoing Phase III clinical trial (ARANOTE)  evaluates the efficacy and safety of darolutamide  in the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC). The treatment is darolutamide in combination with hormonal therapy (androgen deprivation therapy). The trial commenced in the beginning of 2021 and is estimated to be completed in 2024.

Darolutamide 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, darolutamide 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.

About prostate cancer

Prostate cancer is the second most commonly diagnosed malignancy in men worldwide.

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.)

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

 

More information


ARANOTE study at ClinicalTrials.gov

 

Scientific publications

 ODM-208 (CYP11A1 inhibitor)

 Prostate cancer (CRPC)

 I   II    

About ODM-208

Steroid hormones stimulate the growth of hormonally regulated cancers, such as most prostate and breast cancers. Hormonal treatments are highly effective, but drug resistance will often eventually emerge and cancer will start growing again.

In the first quarter of 2018, Orion commenced a Phase I clinical trial for the development of a novel selective hormone synthesis inhibitor (CYP11A1 inhibitor) for castration-resistant prostate cancer. In preclinical studies, the molecule (ODM-208) has shown antitumor activity. It has potential efficacy also for those cancers that have become resistant to the standard hormonal treatments. The steroid hormones that are needed and do not promote cancer growth are replaced with additional medication. Orion is the first pharmaceutical company to develop a drug with this mechanism. The trial will investigate the safety and tolerability of the drug candidate in prostate cancer patients, but Orion also plans to study the potential of the molecule for breast cancer treatment.

 

 

About prostate cancer

Prostate cancer is the second most commonly diagnosed malignancy in men worldwide.Hormonal deprivation therapy allows long-lasting and effective control of cancer-related symptoms in advanced stages. Despite effective treatment strategies, in some patients with prostate cancer the disease will progress and become castration-resistant. CRPC is characterized by persistent, high level AR function and resistance to conventional anti-androgens such as bicalutamide. Effective treatment options for castrate-resistant patients are still limited, with the field evolving rapidly.

More information

The study at ClinicalTrials.gov

Scientific publications

 ODM-209 (CYP11A1 inhibitor)

 Prostate cancer (CRPC), breast cancer

 I       

About ODM-209

 

 

 

About prostate cancer

Prostate cancer is the second most commonly diagnosed malignancy in men worldwide.Hormonal deprivation therapy allows long-lasting and effective control of cancer-related symptoms in advanced stages. Despite effective treatment strategies, in some patients with prostate cancer the disease will progress and become castration-resistant. CRPC is characterized by persistent, high level AR function and resistance to conventional anti-androgens such as bicalutamide. Effective treatment options for castrate-resistant patients are still limited, with the field evolving rapidly.

More information

The study at ClinicalTrials.gov

Scientific publications

Easyhaler® tiotropium

 

COPD


Bioequivalence study ongoing

About Easyhaler tiotropium

An inhaled Easyhaler® tiotropium product is indicated for chronic obstructive pulmonary disease (COPD). Tiotropium is a long-acting anticholinergic bronchodilator used in the management of chronic obstructive pulmonary disease (COPD). Orion's Easyhaler® is an in-house developed dry-powder inhaler.

Orion has developed Easyhaler-adapted dry powder formulations of several well-known generic active substances (salbutamol, beclometasone, budesonide, formoterol and budesonide-formoterol combination) used in the treatment of asthma and COPD.

Orion announced in its Financial Statement Release 2017 on 7 February 2018 that it is developing a tiotropium formulation for European markets, and a bioequivalence study with the formulation is ongoing.

About COPD

Chronic Obstructive Pulmonary Disease is most often related to smoking that causes airway inflammation and airway obstruction that is mostly not reversible. Symptoms include cough, mucus production and breathlessness. Frequent exacerbations during respiratory infections are also common. Asthma and COPD are mostly treated with inhaled medication.

 

New dry-powder inhaler / indacaterol-glycopyrronium

COPD

Bioequivalence study ongoing

Glycopyrronium and indacaterol are long-acting bronchodilators.

About COPD

Chronic Obstructive Pulmonary Disease is most often related to smoking that causes airway inflammation and airway obstruction that is mostly not reversible. Symptoms include cough, mucus production and breathlessness. Frequent exacerbations during respiratory infections are also common. Asthma and COPD are mostly treated with inhaled medication.


 

 

 

= phase ongoing

 

 

= phase completed

See also:

 Scienfic publications and posters