DELBERT Laboratories Are Proud to Announce the Acquisition From Noventia Pharma Srl of the European Marketing Authorisation of CEPLENE® 0.5mg/0.5ml
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
CORRECTING and REPLACING PHOTO Decode the Future of AI and Customer Experience at Elevate'25 Digital Innovation Summit18.9.2025 21:23:00 EEST | Press release
Please replace the photo with the accompanying corrected photo. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250918928987/en/ Gain insight and advice from firms at the frontier of AI-powered, mobile-first customer experiences. The release reads: DECODE THE FUTURE OF AI AND CUSTOMER EXPERIENCE AT ELEVATE'25 DIGITAL INNOVATION SUMMIT With keynotes from Google Cloud and an independent research firm, Elevate’25 will provide actionable strategies to harness the power of AI and create exceptional experiences for today's mobile-first consumer As unprecedented advancements in AI reshape consumer behavior, digital innovation summit Elevate'25 opened for general registration today. Sponsored by Airship, the exclusive, one-day event is designed to equip business leaders with proven strategies to harness artificial intelligence and mobile-first technology for a decisive competitive advantage. Taking place on October 15, 2025, at the i
Sai Life Sciences Opens Dedicated Facility for Veterinary APIs in Bidar, India18.9.2025 19:22:00 EEST | Press release
Sai Life Sciences (BSE: 544306 | NSE: SAILIFE), an innovator-focused Contract Research, Development, and Manufacturing Organization (CRDMO), today announced the opening of Unit VI, a dedicated facility for Veterinary Active Pharmaceutical Ingredient (API) production, in Bidar, India. Located alongside Unit IV, the company’s flagship API manufacturing site, Unit VI has been established exclusively for veterinary APIs. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250918612071/en/ Sai Life Sciences’ Veterinary APIs Unit in Bidar, India. The new facility is designed to meet the highest standards of safety, sustainability, and regulatory compliance, ensuring the production of high-quality APIs for veterinary applications. With this expansion, Sai Life Sciences aims to provide efficient and scalable manufacturing solutions to leading global animal health companies. Making the announcement, Krishna Kanumuri, CEO & Managing Direct
Celltrion Announces Commercial Availability of Omlyclo™ Across Europe at EADV 202518.9.2025 18:45:00 EEST | Press release
Celltrion, Inc. today showcased its longstanding commitment to expanding its biosimilar portfolio in the field of immuno-dermatology by attending the 2025 European Academy of Dermatology and Venereology (EADV) Congress, held 17-20 September in Paris, France. Following the European Commission (EC) approval of Omlyclo™, the first and only omalizumab biosimilar in Europe in May 2024, Omlyclo™ will be commercially available starting in Norway, with subsequent rollouts in European countries. As part of Celltrion’s mission to advance knowledge and understanding in dermatology, especially in chronic spontaneous urticaria (CSU), the company hosted satellite symposium presenting the results of the global Phase III clinical trial of Omlyclo™. The global Phase III clinical trial involved 619 patients with CSU, following them up to week 40. Patients were randomized to receive 300 mg or 150 mg of Omlyclo™, or reference product, every 4 weeks. Starting from week 12, patients who received Omlyclo™ we
Setting the Standard: AMRA Medical Recognized as one of TIME Magazine’s ‘World’s Top HealthTech Companies’18.9.2025 17:40:00 EEST | Press release
AMRA Medical is proud to share its inclusion in the World’s Top HealthTech Companies list, published today by TIME in collaboration with Statista. This recognition positions AMRA among an elite group of global innovators that are leading healthcare transformation. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250918372780/en/ AMRA Medical Recognized as one of TIME Magazine’s ‘World’s Top HealthTech Companies’ The selection, which comes just one week after celebrating AMRA’s 15 years of progress and innovation within the body composition space, highlights AMRA’s long-standing commitment to becoming a global leader in health informatics. By delivering detailed, reproducible insights within fat distribution and muscle composition, AMRA’s MRI-based technology is helping clinicians, researchers, and healthcare organizations unlock new levels of understanding across the metabolic and musculoskeletal sectors. “Being recognized by
illumynt, a CNE Direct Company, Is Pleased to Announce the Promotion of Jörg Herbarth to Chief Executive Officer (CEO)18.9.2025 17:30:00 EEST | Press release
illumynt, a CNE Direct company, is pleased to announce the promotion of Jörg Herbarth to Chief Executive Officer (CEO). Jörg has been a key member of illumynt’s executive leadership team since joining in June 2022, most recently serving as Chief Operating Officer. In his new role as CEO, Jörg will spearhead illumynt’s mission to become the number one provider of AI- and data-centric IT Asset Disposition (ITAD) solutions worldwide. Paul Knight, illumynt’s current CEO, will transition to the role of Founder & Chairman. In this capacity, Paul will continue to support the executive team with strategic guidance, while Jörg assumes full leadership of day-to-day operations and global expansion initiatives. Mr. Knight had come out of retirement a year ago to undertake some new initiatives and advance the company's strategic direction. With some necessary changes having taken place- he is thrilled to facilitate this transition to a reduced role again. Under Jörg’s leadership, illumynt will cont
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