NMIBC treatment update: medac plans stable production of BCG-medac in the medium term


Wedel, Germany (2023-03-10) Over the course of 2023 and 2024, medac GmbH plans to be in a position to successively supply all markets with an existing BCG-medac marketing authorisation and currently inactive marketing status with the immunotherapy product for the treatment of non-muscle invasive bladder cancer (NMIBC). This step has been made possible through the stable expansion of production capacities, which will also cover a future rise in demand for BCG-medac.

During the 38th annual congress of the European Association of Urology (EAU) in Milan, medac GmbH announced that the company will continue to make all efforts so that in the medium term, each prescription of BCG-medac for the treatment of NMIBC will also be fulfilled in markets with currently inactive marketing status. Based on the demand and indication growth (according to the WHO), this means that in the future each patient can be treated with BCG in line with the EAU guidelines[1]. Jørgen Bjerggaard Jensen, clinical professor and chair of urology at Aarhus University, Denmark, and member of the European Association of Urology guideline panels emphasised the relevance of BCG as gold standard in the treatment of high-risk NMIBC: “The perspective that NIMBC will soon once again be treated reliably with BCG is of huge significance in clinical practice – in particular for high-risk patients.”

The small number of manufacturers, together with a rising global demand for BCG made it difficult in the past to guarantee a reliable supply of the immunotherapy product.

BCG-medac: Simple and safe thanks to closed instillation system
BCG-medac is available in a closed instillation system which allows healthcare personnel to reconstitute the immunotherapy product directly at the patient’s hospital bed immediately before use. The fixed adapter connection with a metal spike between the transparent vial containing freeze-dried BCG-medac and the handy PVC bag with the solvent as well as the seal in the catheter connector of the instillation system minimise the risk of leakage and contamination – and thereby increase safety for both users and patients.

About BCG-medac
BCG-medac is authorised for the treatment of non-muscle invasive bladder cancer (NMIBC).[2] This includes the curative treatment of carcinoma in situ as well as the prophylactic treatment of recurrence of urothelial carcinoma limited to mucosa, Ta G1-G2 if multifocal and/or recurrent tumour, Ta G3, urothelial carcinoma in lamina propria but not the muscular layer of the bladder (T1), and carcinoma in situ.

About medac
As a global pharmaceutical company based in Germany, medac GmbH has been specialising for more than fifty years in the diagnosis and treatment of oncological, urological and autoimmune diseases. The company can look back on a long tradition of high-quality instillation therapies for bladder cancer. For instance, to increase the personal safety of users, medac GmbH developed the first closed instillation system which today is equipped as standard with the bladder cancer drugs Mitomycin medac or BCG-medac. Thereby, medac GmbH has a dual first-line treatment concept for the adjuvant therapy of non-muscle invasive bladder cancer (NMIBC). The objective of medac GmbH is to improve the quality of life of patients by providing high-quality therapies. Consequently, the company is working hard to guarantee the reliable supply of BCG-medac in the long term. Find out more at www.bladdercare.com.

medac Communications
Tel: 076 – 110 95 27
epost: info@medac.se
Hyllie Boulevard 34, 215 32 Malmö, Sverige

medac Gesellschaft für klinische Spezialpräparate mbH
medac is a privately-owned German pharmaceutical company with sites in Wedel and Tornesch. medac’s medicinal products are used worldwide to help doctors and patients manage acute and chronic diseases in the fields of oncology and haematology, urology, and autoimmune diseases. medac also develops and distributes specialist diagnostic systems. Since 1970, medac has been committed to its approach of uniting therapeutic and diagnostic products under one roof.

Further information on the company and its products can be found online at www.medac.se and www.medac.de.

[1] EAU Guidelines Edn. presented at the EAU Annual Congress Amsterdam 2022. ISBN 978-94-92671-16-5.
[2] BCG-medac Summary of Product Characteristics, May 2022