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DELBERT-LABORATORIES

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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/

contact@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.

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