DELBERT-LABORATORIES
18.11.2022 15:30:37 CET | 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/
About Business Wire
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
Manna Air Delivery Raises $50Million Series B as It Announces Plans to Expand in the United States1.4.2026 18:00:00 CEST | Press release
ARK Invest, backer of OpenAI, Anthropic, Tesla and SpaceX, the Ireland Strategic Investment Fund and Schooner Capital back new round bringing total funding to $110M Plans to scale to 40 bases in the United States, supported by seven years of operational orchestration experience, and recently expanded its global partnerships with Uber, joining Deliveroo, Just Eat and DoorDash in delivering everyday items by air. Manna Air Delivery, a global leader in consumer drone delivery, has announced a $50 million funding round to scale its proven operations further in the United States and Europe. The round brings Manna’s total funding to $110million. Manna now operates one of the most active consumer drone delivery networks in the world, with more than 250,000 regulated commercial UAV flights completed. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260310714366/en/ Manna Air Delivery raises $50m Series B Investors in the round include
Bureau Veritas Launches an Independent AI Assessment Offering for European Enterprises, Developed in Partnership with Amazon Web Services (AWS)1.4.2026 17:45:00 CEST | Press release
Bureau Veritas, a global leader in Testing, Inspection, and Certification services (TIC), announces the launch of an AI systems audit to help European enterprises assess and demonstrate their compliance with the European Union's "AI Act" regulatory requirements. This offering combines on-site audits, document analysis, and direct testing to deliver an independent maturity report. Since the EU's AI regulation came into force in 2024, companies have faced major implementation challenges. According to a recent report*, 68% of them struggle to interpret the provisions of the text, while 60% have yet to put in place the governance needed to comply. Non-compliance can cost them up to 7% of annual revenue. Bureau Veritas has developed this new audit offering to help companies identify their compliance gaps and remedy them. Bureau Veritas's new audit offering comprises a pre-audit, document review, on-site audit, and direct testing, resulting in an independent report on the client's AI maturit
Greenland Resources Signs Eight Year Off-take Agreement With SSAB to Supply High Quality Molybdenum1.4.2026 16:29:00 CEST | Press release
Greenland Resources Inc. (TSX:MOLY, FSE:M0LY) (“Greenland Resources” or the “Company”) is pleased to announce the Company has signed a binding off-take agreement with SSAB, a Nordic and US-based steel producer headquartered in Sweden. The company is a leading producer on the global market for advanced high-strength steels providing solutions to the defence, automotive, infrastructure and energy industries. A stock exchange press release from SSAB can be found on their website at www.ssab.com This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260401270749/en/ The off-take agreement provides an established price floor and price ceiling and will allow SSAB to secure high quality low carbon emission ferromolybdenum extracted in Greenland and refined in Belgium. SSAB will be able to ensure a stable and responsibly sourced long term secured primary molybdenum supply with high sustainability standards and low scope 1&2 emissions from a
VDYNE Receives FDA Approval to Initiate the TRIVITA1 IDE Pivotal Trial of Transcatheter Tricuspid Valve Replacement System1.4.2026 15:30:00 CEST | Press release
VDYNE, Inc. (“VDYNE” or “the Company”), a privately held medical device company developing next generation transcatheter valve replacement technologies, today announced that the U.S. Food & Drug Administration (FDA) has approved an investigational device exemption (IDE) for the company’s pivotal clinical trial evaluating its Transcatheter Tricuspid Valve Replacement (TTVR) system. The IDE approval enables initiation of a U.S. pivotal study at leading clinical centers to evaluate the safety and effectiveness of the VDYNE system in patients with severe tricuspid regurgitation (TR). “This is a defining milestone for VDYNE and an important step toward bringing a much-needed therapy to patients with severe tricuspid regurgitation,” said Mike Buck, Chief Executive Officer. “Our focus now is on disciplined clinical execution and partnering with leading investigators to generate high-quality data that advances the field and improves patient care.” Significant unmet clinical needs exist in the
NetJets Introduces State-of-the-Art, Exclusive-Use Terminal in Augusta, Georgia1.4.2026 15:05:00 CEST | Press release
New facility set to elevate the experience for customers during golf’s most celebrated event—and beyond NetJets, the global leader in private aviation, is well underway on its development of a new exclusive-use terminal at Augusta Regional Airport (AGS). This state-of-the-art facility represents a significant investment in the region and reinforces NetJets’ commitment to delivering unparalleled experiences for its customers. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260330125414/en/ NetJets to open a new, exclusive-use terminal at Augusta Regional Airport (AGS). Guests arriving this April for golf’s most iconic championship will witness the construction in progress, including the finished ramp and foundational walls of what will soon become a full-service terminal. The private ramp, offering 432,000 square feet of space for aircraft parking, will be completed in time for the 2026 golf tournament. “Augusta is a key desti
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