Polish biopharma firm Mabion’s lead candidate is a biosimilar of Roche’s MabThera (rituximab) - a monoclonal antibody intended to treat lymphoma, leukemia and rheumatoid arthritis – known as MabionCD20.
Last week the firm obtained the consent of regulators in Croatia, Bosnia and Herzegovina, Serbia and Poland to perform clinical trials of the drug in patients with diffuse large B-cell lymphoma, and announced it would extend a service agreement with Zagreb, Croatia-based contract research organisation (CRO) Altiora to carry out the work.
“Altiora presented the most advantageous offer including comprehensive management of project,” Mabion’s CEO Maciej Wieczorek told Outsourcing-Pharma.com. “Based on previous cooperation, we have developed a clear trail of communication and procedures, and therefore we have entrusted execution of this task to proven partner.”
Furthermore, Altiora’s rapid pace of recruitment was a decisive factor in selecting the CRO, Wieczorek told us, adding patient recruitment is the biggest challenge in carrying out trials in the Central and Eastern Europe (CEE) region.
“[This is] because the sponsor of the study has no effect on the rate of patients for inclusion in the study. It is difficult to predict in advance the number of patients enrolled in the study by doctors who meet the inclusion criteria.”
The lymphoma study will involve approximately 140 patients and Mabion said it is close to receiving approval to conduct trials in Bulgaria, Romania, Moldova, Ukraine, Georgia and Hungary, which would also be carried out by Altiora.
If successful, Mabion intends to register MabionCD20 in all the global markets where Mabthera is sold. According to Roche’s annual report, sales of the monoclonal antibody in 2013 clocked in at 6.9bn Swiss Francs ($7.2bn). The US patent is set to expire in April 2015.