DELBERT Laboratories Are Proud to Announce the Acquisition From Noventia Pharma Srl of the European Marketing Authorisation of CEPLENE® 0.5mg/0.5ml
18.11.2022 17:29:00 EET | Business Wire | Press release
DELBERT Laboratories are proud to announce the acquisition from Noventia Pharma Srl of the European MA of CEPLENE® 0.5mg/0.5ml, solution for injection (histamine dihydrochloride) on September 12, 2022, and strengthens its commitment in hematology-oncology in Europe.
Ceplene® demonstrated a clinical interest in maintenance treatment of acute myeloid leukemia (AML) in patients below 60 years of age in first "complete remission" (symptom-free period of disease after initial treatment) in a clinical study published in Blood in 2006 and received orphan drug designation in 2005 1,2,3.
Acute myeloid leukemias are rare genetic diseases. In Europe, the incidence is estimated at 3.7/100,000 new cases per year. The prognosis for AML is unfavourable with a 5-year relative survival rate of 19%4.
DELBERT Laboratories (https://laboratoires-delbert.fr/) is a French pharmaceutical company specialized in the "renewal of essential medicines" frequently affected by marketing termination, stock shortages, particularly in times of crisis.
"We are focused on keeping essential medicines available to patients in 3 therapeutic areas (Antiinfectives, CNS and Oncology), with the mission of maintaining the therapeutic arsenal of doctors and preventing well-balanced patients from changing treatments.The acquisition of Ceplene's® MA in Europe is part of this strategy to maintain essential medicines and make available medicines with clinical benefit in rare diseases," said Eric Fidelin (Head of Strategy & Global Development).
With this acquisition, DELBERT Laboratories strengthens its presence in hematological oncology.
About DELBERT Laboratories
The mission of DELBERT Laboratories is to maintain access to Drugs of Major Therapeutic Interest for patients. Every year, Delbert Laboratories acquires new drugs whose future is compromised.
DELBERT Laboratories focuses its efforts on finding production sites in Europe. With their collaborators and the support of clinicians, galenicians, engineers and chemists, DELBERT Laboratories are reviving these drugs in order to guarantee their availability to the medical profession and patients.
DELBERT Laboratories will reach more than €30m in turnover in 2022 with double-digit growth each year and already markets 14 products (including 13 originators) with hospital or specialists reserved prescriptions.
DELBERT Laboratories financed this acquisition thanks to trusting relationships with their financial partners who strongly support these values focused on patient access to Drugs of Major Therapeutic Interest.
http://www.laboratoires-delbert.fr/
References:
1. Brune et al., Improved leukemia-free survival after postconsolidation immunotherapy with histamine dihydrochloride and interleukin-2 in acute myeloid leukemia: results of a randomized phase 3 trial Blood, 1 july 2006 volume 108, number 1, 88-96
2. Nilsson, Malin S., et al. Complete remission after the first cycle of induction chemotherapy determines the clinical efficacy of relapse‐preventive immunotherapy in acute myeloid leukaemia. British Journal of Haematology 188.4 (2020): e49
3. Ceplene® Epar, 2008 - EMEA/H/C/000796
4. Visser et al. Incidence, survival and prevalence of myeloid malignancies in Europe. Eur J Cancer 2012 Nov;48(17):3257-66.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20221116005760/en/
Contact information
Press Contact : G-Cliquet Consultant – contact@cliquet-consultant.com
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Focused Support Launches Cavok STRIKE to Expand Link-16 Participation Across the Joint Force14.9.2026 08:00:00 EEST | Press release
Focused Support LLC today announced the launch of Cavok STRIKE, an integrated software capability that expands the Link-16 tactical battlespace picture by enabling additional operational platforms to participate in the Link-16 network. Modern battlefields have increasing numbers of unmanned systems, sensors, and supporting platforms operating throughout the joint battlespace. The rapid proliferation of Group 1, 2, and 3 UAS, including both expendable and recoverable systems, has created a growing need to integrate these assets into the broader tactical network. Many of these platforms provide operationally relevant information but have historically remained outside the Link-16 network due to limitations in size, weight, power, platform integration complexity, or acquisition cost. Cavok STRIKE addresses this gap by enabling platforms to participate in the Link-16 network as non-command-and-control participants. This allows those platforms to interoperate with traditional Link-16 platfor
Fujirebio Expands Access to Blood-based Neurology Testing in Brazil with ANVISA Market Authorization for Lumipulse® G NfL Blood and Lumipulse G pTau 217 Plasma14.9.2026 08:00:00 EEST | Press release
H.U. Group Holdings Inc. and its wholly owned subsidiary Fujirebio today announced that the Brazilian Health Regulatory Agency (ANVISA) has granted market authorization for the Lumipulse G NfL Blood and Lumipulse G pTau 217 Plasma assays for use on the fully automated LUMIPULSE® G immunoassay platform in Brazil. “ANVISA authorization of the Lumipulse G NfL Blood and Lumipulse G pTau 217 Plasma assays marks another important step in our mission to expand access to reliable, clinically meaningful blood-based biomarkers for clinicians and patients worldwide,” said Christiaan De Wilde, CEO of Fujirebio Europe N.V. “By making both neurological biomarker assays available to laboratories on a single, fully automated platform, we are helping support more informed clinical decision-making across a broad range of neurological conditions and throughout the diagnostic pathway.” The Brazilian ANVISA authorizations are based on the already CE marked in vitro diagnostics (IVD) approvals of these two
MEX Exchange, Part of MultiBank Group, Expands Executive Team as International Growth Accelerates14.9.2026 08:00:00 EEST | Press release
MEX Exchange, the institutional electronic trading platform of MultiBank Group, has announced the appointment of Brian Liedberg as Chief Revenue Officer and Global Head of Sales, strengthening its commercial leadership as the company continues to develop its institutional trading business and expand its presence across international markets. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260913319267/en/ Brian Liedberg joins MEX Exchange, bringing more than 30 years of experience across global capital markets, electronic trading and FinTech Liedberg brings more than 30 years of experience across global capital markets, electronic trading and financial technology, with a career spanning institutional sales, business development, commercial strategy and revenue growth. Prior to joining MEX Exchange, Liedberg served as Head of Global Sales and Chief Revenue Officer at TradAir, where he led the company’s global commercial growth
Signaloid Announces Appointment of Quantitative Finance and Cloud Veterans to Advisory Board and Senior Commercialization Roles14.9.2026 06:00:00 EEST | Press release
British technology company Signaloid today announced the appointment of three distinguished industry veterans to its advisory board and senior leadership roles, to strengthen the commercialization momentum behind its technology: Dr. Han Lee, former Global Head of Quantitative Strategies and Automated Trading for the Fixed Income Division at Morgan Stanley, Dr. Nachiketh Potlapally, former Architect at Oracle Cloud Infrastructure, and Christian Roth, former Senior Director Enterprise Sales, Intel. Bringing deep expertise in quantitative finance and cloud infrastructure, the appointments build on Signaloid’s commercial traction momentum in Europe, Japan, and the United States. Dr. Lee, prior to his executive role at Morgan Stanley, served as Global Head of Quantitative Analytics at RBS and holds a Ph.D. in Theoretical Physics from the University of Cambridge. He is a co-founder of RLxPartners Ltd, and serves as an advisor to the Head of the Department of Physics at the University of Oxfo
SES’s Final Three O3b mPOWER Satellites Successfully Launched13.9.2026 23:22:00 EEST | Press release
SES today announced the successful launch of its eleventh, twelfth and thirteenth O3b mPOWER satellites, further expanding its second-generation medium Earth orbit (MEO) system designed to offer high-performance connectivity services around the world. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260913914517/en/ SES’s Final Three O3b mPOWER Satellites Successfully Launched The three satellites launched at 2:49 pm local time aboard a SpaceX Falcon 9 rocket from Space Launch Complex 40 (SLC-40) at Cape Canaveral Space Force Station. “This launch marks a defining milestone for SES as we complete the O3b mPOWER constellation and further strengthen our MEO capabilities,” said Adel Al-Saleh, CEO of SES. “More importantly, it reinforces our ability to deliver resilient, secure and scalable connectivity for customers around the world, helping governments, enterprises, cloud providers and mobility customers meet their most critical
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom