Discover Our Group:

Berlin-Chemie has been developing, manufacturing and distributing pharmaceutical products for over 130 years and has been a wholly owned subsidiary of the Menarini Group, the leading Italian pharmaceutical company, since 1992. 

Responsibility is a top priority at Berlin-Chemie. We not only make an important contribution to healthcare, but also put our values into practice through various social initiatives.

Discover More about Global Responsibility

From school kits to free meals and medicines, to caring for the environment around the world. In Menarini, being responsible means translating our values into concrete actions that are good for others and good for the planet

Berlin-Chemie – a strong partner. Our many years of experience and the success of joint projects make us the partner of choice. 

Discover More about Global Partnering

Menarini has in-depth know-how in many important therapeutic areas, thanks to many years of excellent market introduction, marketing and sales capabilities as well as expertise in regulatory aspects and market access. Collaboration is the key to great success, and at Menarini, partnership is part of the DNA.

Our holistic and professional health management offers doctors individual counselling, training or workshops, events and lectures on many topics, depending on their needs.

Our Medical Hub acts as a central point of contact for doctors and healthcare professionals. Here you will find all the information about our medications, additional service and training opportunities.

Welcome to the News & More section. Here you will find general information in the form of press releases, news and the latest graphical material. 

Menarini Blog

Follow Us

We employ professionals with a wide variety of career backgrounds and are employers who care about their staff. Together, we stand for innovation and reliability.

Our Job Portal

Find out about our current vacancies at Berlin-Chemie directly on our career portal.

Menarini Group News

2022 - 12 - 14

Circulating Tumor Cell detection by Menarini Group’s CELLSEARCH® System leading to genomic profiling of myeloma cells shows potential for non-invasive management of Multiple Myeloma patients at early

stages of disease

 

Researchers at Dana-Farber Cancer Institute showed that enumeration of circulating tumor cells (CTCs) with Menarini Silicon Biosystems’ CELLSEARCH® System and the CELLSERCH® Circulating Multiple Myeloma Cell (CMMC) Test* can be used to monitor and manage patients with Multiple Myeloma (MM) even at asymptomatic precursor stages

 

BOLOGNA, Italy and HUNTINGDON VALLEY, Pa., 14 December 2022 – Menarini Silicon Biosystems, a pioneer of liquid biopsy and single cell technologies, announced today the results of a study in which enumeration and genomic characterization of CTCs at varying stages of MM represents an invaluable tool to predict disease aggressiveness and pathology. This study was conducted in collaboration with Dana-Farber Cancer Institute researchers and published on December 7, 2022 in Cancer Discovery1.

According to Irene Ghobrial, MD, Director of the Clinical Investigator Research Program at Dana-Farber Cancer Institute, Boston, and senior author of the study “this new data represents another great milestone, both for our understanding of MM and abilities to prevent disease progression”. Dr Ghobrial was recently awarded the William Dameshek Prize, an award that is given annually by the American Society of Hematology (ASH) for outstanding contributions in hematology.

MM accounts for 10% of hematological malignancies and has a current worldwide incidence level of 160,0002. This type of blood cancer forms in plasma cells (PCs) located in the bone marrow (BM). Asymptomatic precursor stages such as monoclonal gammopathy of undetermined significance (MGUS) or smoldering multiple myeloma (SMM) can be highly heterogeneous in terms of their risk of progression and the lack of tools to monitor this population represents a critical unmet medical need. Current standard of care involves invasive BM biopsies to understand disease pathology and decide on treatment strategies. The CELLSEARCH® platform’s ability to enrich, capture and isolate MM CTCs within a 4ml blood sample, enables clinicians to leverage a minimally invasive diagnostic procedure for regular monitoring of patients.

Findings from this novel and robust proof-of-concept study were based on CTCs from 261 patients (84 MGUS, 155 SMM and 22 MM). The majority of precursor patients analyzed in the study showed evidence of CTCs, with one or more CTCs detected in 82% of the overall enrolled population-. In addition, the data showed an increase in the number of CTCs from MGUS to SMM, confirming the correlation between a higher disease burden and greater trafficking of CTCs. The Kaplan Meier analysis over a median follow-up time of 27 months, showed that SMM patients with CTCs (≥ 1 per 4mL of blood) had a higher probability of progression to MM (P=0.03). These data underline the value of CTC enumeration using the CELLSEARCH® platform and the CMMC test to stratify risk.

The study also demonstrated that a comprehensive genomic characterization of CTCs based on the Minimally Invasive Multiple Myeloma sequencing (MinimuMM-seq)** process enabled the detection of translocations and copy number abnormalities through whole-genome sequencing of highly pure CTCs. These analyses showed that the myeloma cells captured in the blood compartment showed an identical genomic architecture to those located in the BM, thus enabling disease monitoring over time without having to extract serial bone aspirates. The CELLSEARCH® System coupled with the CELLSEARCH® CMMC test* provides a simple approach to capturing myeloma cells, enumerate them and apply MinimuMM-seq to extract the maximum genetic information from each cell**.

“We reached yet another milestone on our quest to provide an alternative method to invasive and painful BM biopsies for MM which can have a transformative effect on how patients even with asymptomatic forms of disease can be managed moving forward” said Elcin Barker Ergun, CEO of Menarini Group.

 “We are thrilled to offer the CELLSEARCH® CMMC test* as a laboratory developed test (LDT) in the US and help professionals in the field of hematology, by providing a tool to potentially monitor disease progression in real time,” said Fabio Piazzalunga, President and CEO of Menarini Silicon Biosystems.  “This minimally invasive approach to capturing myeloma cells in blood, is not only important to identify patients at higher risk of progression but could potentially reduce the need for bone marrow biopsies.”

Menarini Silicon Biosystems CELLSEARCH® CMMC test* is available as a laboratory developed test (LDT) in MSB’s CLIA/CAP/ ISO 15189 accredited laboratory in Huntingdon Valley, Pa.

 

About Menarini Silicon Biosystems (MSB)

MSB offers unique rare cell technologies and solutions that provide clinical researchers with access to unparalleled resolution in the study of cells and their molecular characterization.

Menarini Silicon Biosystems, based in Bologna, Italy, and Huntingdon Valley, Pa., U.S., is a wholly owned subsidiary of the Menarini Group, a multinational pharmaceutical, biotechnology and diagnostics company headquartered in Florence, Italy, with more than 17,000 employees in 140 countries.

References

1 Dutta A, Alberge J-B, et al, MinimuMM-seq: Genome sequencing of circulating tumor cells for minimally invasive molecular characterization of multiple myeloma pathology, Cancer Discov CD-22-0482.

2 Ludwig H, Novis Durie S, Meckl A, Hinke A, Durie B. Multiple Myeloma Incidence and Mortality Around the Globe; Interrelations Between Health Access and Quality, Economic Resources, and Patient Empowerment. Oncologist. 2020 Sep;25(9): e1406-e1413. doi: 10.1634/theoncologist.2020-0141. Epub 2020 May 7. PMID: 32335971; PMCID: PMC7485361.

 

* The Circulating Multiple Myeloma Cell (CMMC) test is a CLIA-accredited laboratory developed test from Menarini Silicon Biosystems in USA. The performance characteristics and safety and effectiveness have not been established and are not cleared or approved by the FDA.

**For Research use only. Not to be used in diagnostic procedures. The performance characteristics and safety and effectiveness have not been established and are not cleared or approved by the FDA.