Clinigen launches managed access program for relugolix in Europe for treatment of advanced hormone-sensitive prostate cancer | Popgen Tech




December 20, 2022

Klinigen beginss a managed Access Program for relugulix in Europe for the treatment of advanced hormone sensitive prostate cancer

Clinigen Limited (‘Clinigen’), the global pharmaceutical and services company, has entered into an agreement with Accord Healthcare (‘Accord’) to initiate a Managed Access program in Europe for relugolix (ORGOVYX®).

Relugolix was approved by the European Medicines Agency (EMA) in April 2022 for the treatment of adult patients with advanced hormone-sensitive prostate cancer. The approval applies in specific European countries and is the first oral treatment for androgen deprivation available.

Prostate cancer is the most common cancer in men accounting for 23% of new cases in Europe in 2020 and the third most common cause of cancer-related death in men, after lung and colorectal cancer.1,2

The Managed Access program is designed to allow access to relugolix for selected candidates who are not eligible or able to participate in a clinical trial or in a country where reimbursement has yet to be approved by the respective healthcare authorities. Clinigen’s unlicensed medicines business will supply relugolix to patients in specific European countries until the medicine is available through normal commercial channels.

Suzanne Aitken, SVP Managed Access, Clinigen Group said:
Clinician is proud to extend our long-standing existence partnership with Accord to ensure this eligible patients with advanced hormone-sensitive prostate cancer will now be able to access this new and important medicine.”

Health workers can obtain details about the relugolix Managed Access program by calling the Clinigen Medicines Access Team on +44 1283 494 340 or emailing

– End –

Contact details

Klinigen Group Ltd.

+44 (0) 20 3907 0830

Michelle Shearly, Director of Communications

Consilium Strategic Communications
Mary-Jane Elliott / Matthew Cole / Jessica Hodgson

Tel: +44 (0) 20 3709 5700

Notes to editors

About Clinigen
Clinigen is a global specialist pharmaceutical services company focused on providing ethical access to medicines. His mission is to deliver the right medicine to the right patient at the right time. The Group operates from sites in North America, Europe, Africa and the Asia Pacific. Clinigen has more than 1,000 employees across five continents in 15 countries, with supply and distribution centers and operations centers of excellence in key long-term growth regions. The Group works with 32 of the top 50 pharmaceutical companies providing access across more than 120 countries.
For more information about Clinigen, please visit

Over Accord Healthcare
Accord Healthcare is one of the fastest growing pharmaceutical companies in Europe. Accord has one of the largest market footprints of any European generic and biosimilar company, selling generic medicines in more than 80 countries around the world.

Since Accord’s arrival in Europe in 2008, as the international arm of Intas Pharmaceuticals Ltd, their primary focus has been to ensure that patients have access to high quality medicines at the point of need. Accord has dynamically evolved from its heritage in generics and biosimilars to become experts in specialty and value-added medicine with four cornerstone franchises: Oncology & Hematology, Autoimmune, CNS and Critical Care.

Afight relugulix (ORGOVYX®)
ORGOVYX® (relugolix, 120 mg) is indicated in Europe for the treatment of adult patients with advanced hormone-sensitive prostate cancer. As a gonadotropin-releasing hormone (GnRH) receptor antagonist, ORGOVYX® blocks the GnRH receptor and reduces the production of testicular testosterone, a hormone known to stimulate the growth of prostate cancer.

Over Prostate cancer
In 2020, the total number of men in Europe with prostate cancer was approximately 1.4 million according to the World Health Organization.3

Prostate cancer is considered advanced when it has spread beyond the prostate, is localized to the prostate and is unlikely to be cured by surgery or radiation, or has returned after initial treatment and cannot be treated with salvage surgery. Front-line medical therapy for advanced prostate cancer typically involves androgen deprivation therapy, which lowers testosterone to very low levels, commonly referred to as castrate levels (< 50 ng/dL). Luteinizing hormone-releasing hormone (LHRH) receptor agonists, such as leuprolide acetate, are depot injections and the current standard of care for androgen deprivation therapy. LHRH agonists are associated with an initial increase in testosterone levels that may worsen clinical symptoms in some patients and delayed testosterone recovery after drug discontinuation due to their depot injection formulation.


¹,² Health at a Glance: Europe 2020: State of Health in the EU Cycle, OECD Publishing, Paris

Orgovyx® is a registered trademark of Accord Healthcare


Source link