Clinigen to distribute 'Copiktra' in most of Europe

The AIM-traded firm said Copiktra was granted marketing authorisation by the European Medicines Agency in May as a monotherapy for the treatment of adults with relapsed or refractory chronic lymphocytic leukemia (CLL), in patients who had received at least two prior therapies, and for the treatment of follicular lymphoma (FL) that was refractory to at least two prior systemic therapies.

It said the goal of therapy for patients with such cancers was to improve overall survival and quality of life.

Copiktra is a dual inhibitor of PI3K-delta and gamma pathways, which are involved in the proliferation of malignant cells and are thought to play a role in the formation and maintenance of the supportive tumor microenvironment.

The ‘PRIMO’ phase 2 study was also seeking to evaluate Copiktra for patients with relapsed or refractory peripheral T-cell lymphoma.

Under the terms of the agreement Clinigen said it would market, supply and distribute Copiktra into 39 countries across Europe including Austria, Belgium, Croatia, Czech Republic, Denmark, Finland, France, Greece, Hungary, Ireland, Italy, the Netherlands, Poland, Portugal, Spain, Sweden and Switzerland.

Secura Bio would promote and distribute Copiktra directly in Germany and the United Kingdom.

“Clinigen is very pleased to be partnering with Secura Bio,” said chief operating officer and head of products Sam Herbert.

“This new and exclusive agreement will help address a significant unmet need for patients with B-cell blood cancers across Europe.

“This agreement underlines Clinigen's strength in partnering with pharmaceutical companies and leveraging our significant commercial knowledge and infrastructure to ensure the right medicine gets to the right patients at the right time.”

At the close on Wednesday, Clinigen Group was down 0.31% at 642p.