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

Nordic grant for research or projects focusing on stem cell transplantation

medac announces a Nordic grant for research or projects focusing on stem cell transplantation to support Nordic resident physicians and specialists within hematology.

Clinical projects within allogenic or autologous stem cell transplantation are eligible. Research/projects involving one or more of the Nordic countries will be prioritized.

Applications should be submitted before September 1st, 2023, to be considered for the Grant. The grant is 12.000 €, and one or two projects will be awarded by the end of 2023.

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medac GmbH create one Nordic organisation

1.3.2022 medac GmbH has decided to consolidate and strengthen its operations in the Nordic countries by creating one Nordic organisation.

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15.2.2022 Nordic medac Urology Grant -apuraha oli haettavana ensimmäistä kertaa vuonna 2021. Pohjoismaisen 10 000 euron apurahan on saanut suomalainen lääketieteen tohtori Liina Salminen post doc -tutkimustyönsä tueksi. Salmisen tutkimusprojektissa selvitetään uusia tapoja virtsarakon syövän diagnosoimiseen ja hoidon tehon seurantaan.

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Press release – Medac at DGRh 2017

Enhancing the potential of methotrexate.

Optimise rheumatism treatment with Metoject® and ensure long-term success of therapy

Stuttgart / Wedel (September 11, 2017). There is room for improvement in drug treatment of rheumatoid arthritis (RA) with the gold standard methotrexate (MTX). Current analyses of the CAPEA cohort suggest that German rheumatology exploits the potential of methotrexate as initial treatment and follows the treatment guidelines closely: “After 3 months, 82 % of patients with a diagnosis of RA were given first line treatment with methotrexate. […] In 78 % of the patients treated with methotrexate, the starting dose was 15 mg weekly”. Long-term data from the core documentation also confirm at 61 % the great importance of MTX in the treatment  of RA. Current data from  a German health insurance, however, paint  a dramatically different picture nationwide. Given that csDMARDS account for 35 % of drug treatment, Germany is some way from appropriate therapeutic treatment of patients with rheumatoid arthritis.

The symposium on methotrexate sponsored by Medac at the DGRh congress in Stuttgart addressed this issue. As well as a new research project on the actual medical treatment situation, various options for improving the first line therapy with MTX were revealed.

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