PARIS– 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 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.
