Clinigen initiates a Managed Access Program for relugolix in Europe for the treatment of advanced hormone-sensitive prostate cancer

20 December 2022

Clinigen initiates aManaged Access Program forrelugolix 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 granted approval by the European Medicines Agency (EMA) in April 2022 for the treatment of adult patients with advanced hormone-sensitive prostate cancer. The approval is applicable in specific European countries and is the first oral androgen deprivation treatment 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 cancers.^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 is yet to be approved by respective healthcare authorities. Clinigen’s Unlicensed Medicines business will provide relugolix to patients in specific European countries until the medicine is available through normal commercial channels.

Suzanne Aitken, SVP Managed Access, Clinigen Group said:
“Clinigenis proud to expand our longstanding partnership with Accord to ensure that eligible patients with advanced hormone-sensitive prostate cancer will now be able to gain access to this new and important medicine.”

Healthcare professionals can obtain details about the relugolix Managed Access Program by calling the Clinigen medicine access team at +44 1283 494 340 or emailing medicineaccess@clinigengroup.com.

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Contact details

Clinigen Group Ltd.		+44 (0) 20 3907 0830
Michelle Shearly, Director of Communications		michelle.shearly@clinigengroup.com
Consilium Strategic Communications Mary-Jane Elliott / Matthew Cole / Jessica Hodgson		Tel: +44 (0) 20 3709 5700Clinigen@consilium-comms.com

Notes to Editors

About Clinigen
Clinigen is a global, specialist pharmaceutical services company focused on providing ethical access to medicines. Its 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 hubs and operational centres 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 on Clinigen, please visit http://www.clinigengroup.com

About 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 biosimilars companies, selling generic medicines in over 80 countries around the world.

Since Accord’s arrival into 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 have dynamically evolved from their heritage in generics and biosimilars to become experts in speciality and value-added medicines with four cornerstone franchises: Oncology & Haematology, Autoimmune, CNS and Critical Care.

About relugolix (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 production of testicular testosterone, a hormone known to stimulate the growth of prostate cancer.

About 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 unlikely to be cured by surgery or radiation or has comeback after initial treatment and cannot be treated with salvage surgery. Front-line medical therapy for advanced prostate cancer typically involves androgen deprivation therapy, which reduces 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 surge in testosterone levels that may exacerbate clinical symptoms in some patients and delayed testosterone recovery after the drug is discontinued due to their depot injection formulation.

References

¹,² Health at a Glance: Europe 2020: State of Health in the EU Cycle, OECD Publishing, Paris, https://doi.org/10.1787/429ff2a5-en
³ https://gco.iarc.fr/today/data/factsheets/cancers/27-Prostate-fact-sheet.pdf

Orgovyx® is a registered trademark of Accord Healthcare

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