Orion's R&D Pipeline

Pipeline presents Orion's key clinical pharmaceutical development projects.

Project Indication Clinical phase / registration

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.

  More information

 

Darolutamide

 Prostate cancer (nmCRPC)

I
II III  

About darolutamide

Orion and Bayer announced on 24 October 2018 that they have completed the phase III clinical trial (ARAMIS) of darolutamide, the novel oral androgen receptor antagonist for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC). The primary endpoint of the trial was met: Darolutamide significantly extended metastasis-free survival compared to placebo.The safety profile and the tolerability of darolutamide observed in the ARAMIS trial were consistent with previously published data on darolutamide.

The full data will be presented at an upcoming scientific meeting. Bayer plans to discuss the data from the ARAMIS trial with health authorities regarding the submission for marketing authorization application. As a rule, Orion will provide information on the progress of the marketing authorization application process in a press release or in its financial reports. Darolutamide has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment in men with nmCRPC.
 

Commenced in 2014, the ARAMIS trial evaluated the efficacy and safety of darolutamide in patients with non-metastatic castration-resistant prostate cancer who are currently being treated with androgen deprivation therapy (ADT) as standard of care and are at risk of developing metastatic disease. In the double-blind, placebo-controlled trial, more than 1,500 patients were randomized to receive 600 mg of darolutamide or matching placebo twice a day. The primary endpoint was metastasis-free survival, defined as time between randomization and evidence of metastasis or death from any cause.

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

 

 

ARAMIS study at ClinicalTrials.gov

 

Scientific publications

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 2022.

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

ODM-109 (oral levosimendan)

 ALS

I II III  

About ODM-109

In July 2018, Orion recruited the first patients in the Phase III clinical trial (REFALS) in which orally administered levosimendan (ODM-109) is being evaluated for the treatment of symptoms of amyotrophic lateral sclerosis (ALS). The purpose of the trial is to demonstrate that orally administered levosimendan, by enhancing respiratory muscle function, can help maintain breathing capacity and so benefit overall functioning of patients with ALS. Levosimendan does not cure ALS, but it is hoped to maintain the patient’s breathing capacity for longer and thus improve the quality of life by delaying the need for ventilation support. Orion is conducting the trial on its own and investing around EUR 60 million in the study over approximately three years. If the results of the trial are positive, Orion aims is to file for marketing authorisation in the United States and Europe. Orally administered levosimendan has been granted an Orphan Drug Designation both in the United States and in the European Union. Levosimendan is a molecule developed by Orion and launched already in 2000 for the treatment of acute decompensated heart failure.

About ALS

 
ALS (Amyotrophic lateral sclerosis) is a rare, rapidly progressive neurological disease characterised by degeneration of upper and lower motor neurons with subsequent muscle atrophy, weakness and loss of voluntary movements and respiratory function. The latter is due to the weakness and loss of the diaphragm muscle function. Respiratory failure is the most common cause of death in ALS.

More information


REFALS study at ClinicalTrials.gov

Access Policy for ALS

Scientific publications

ODM-104

(more effective COMT inhibitor)

 Parkinson's disease

I
II    

About ODM-104

ODM-104 is a new molecule that enhance the therapeutic effects of levodopa used to treat Parkinson’s disease by blocking the COMT enzyme. The pre-clinical study results indicated that ODM-104 is more effective than the COMT inhibitor entacapone, which is already in the markets.

Orion announced in its Half-Year Financial Report on 18 July 2018 that it has completed the Phase II trial. The primary endpoint was reached. The results are being analysed, and Orion is evaluating moving on to Phase III.  Orion is looking for a possible partner for the trial.

About Parkinson's disease

Parkinson’s disease is a progressive neurological disorder. Symptoms typical of Parkinson's disease, such as slowness of movements, stiffness and tremor, are caused by the brain's inability to produce enough dopamine, a neurotransmitter important for the body's motor functions. Levodopa is the natural precursor of dopamine and thus the standard drug used in the treatment of Parkinson's symptoms. When used alone, most of levodopa is metabolised in the body before it reaches the brain. Enzyme inhibitors such as entacapone have thus been developed to enhance the effect of levodopa. An unmet medical need has however been identified for novel and even more effective levodopa treatments.

 

 More information

NOCIFIM study at ClinicalTrials.gov

ODM-203

(targeted FGFR+VEGFR inhibitor)

 Solid tumours

I II    

About ODM-203

ODM-203 is an investigational targeted Fibroblast Growth Factor Receptor (FGFR) + Vascular Endothelial Growth Factor Receptor (VEGFR) inhibitor that is designed to block growth of FGFR signaling dependent tumours. ODM-203 is unique as it is a selective and equally potent inhibitor against both the FGFR and VEGFR family kinases. In accordance ODM-203 shows strong antitumour activity in both FGFR and VEGFR dependent nonclinical tumour models.

About solid tumors with genomic alterations in FGFR

Dysregulation of the FGFR signaling pathway has been associated with several types of solid tumors. Furthermore, both FGFRs and VEGFR signaling are known drivers of angiogenesis in solid tumors. Such tumors are for example bladder cancer, breast cancer and lung cancer. Many different molecules targeting FGFR are currently in preclinical and clinical development by various pharmaceutical companies.

 

More information


KIDES study at ClinicalTrials.gov

 

Scientific publications

ODM-207 (BET protein inhibitor)

 Cancer

  I
     
 

About ODM-207

ODM-207 is an investigational small molecule that has a unique chemical structure designed to block the growth of cancer cells through potent and selective inhibition of BET family proteins. In preclinical studies, ODM-207 has shown antiproliferative effects in several haematological and solid tumour cell lines.

 

More information

The study at ClinicalTrials.gov

 

Scientific publications

 ODM-208 (CYP11A1 inhibitor)

 Prostate cancer (CRPC)

 I       

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

 

 

= phase ongoing

 

 

= Phase completed

 

 

 

See also:

 Scienfic publications and posters