Clinigen to run managed access program for Onxeo’s belinostat in Europe

Doctor with patient
The Clinigen and Onxeo program for belinostat will initially be available in 13 countries in Europe.

French pharma Onxeo is teaming up with CRO Clinigen to bring blood cancer med belinostat to European patients in dire need through a managed access program.

Clinigen’s Idis Managed Access division will run the program, which offers the Onxeo med to patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) and who have exhausted other treatment options available in Europe.

The CRO’s support to physicians include screening, drug supply, customer service, and appropriate regulatory documents. The healthcare institutions will pay for the drugs distributed through the program, a Clinigen spokesperson told FierceCRO. The CRO will not assist Onxeo in collecting any real-world data on belinostat, the spokesperson said.

The program will be initially available in the U.K., Germany, France, Spain, Italy, Denmark, Sweden, Norway, Finland, Belgium, the Netherlands, Luxembourg, and Austria.

A subtype of non-Hodgkin’s lymphoma, PTCL accounts for about 10% to 15% of all NHL cases, and that’s about 12,000 cases each year globally, according to Onxeo's estimates.

After “orphan drug” and “fast track” designations from the FDA, belinostat, under the brand name Beleodaq, received accelerated approval in the U.S. in July 2014. But it still hasn’t been approved in Europe. Actually, there are no approved med in Europe for PTCL once it has progressed on first-line treatment. A managed access program legally allows physicians to request a potentially lifesaving med either not yet marketed in a country or still in clinical trial stages, for individual patients.

In 2015, Clinigen became a world leader in managed access of drugs through a £225 million (about $340 million then) acquisition of its rival Idis, which was at that time owned by private equity firm CPBE. The combined force has delivered over 220 managed access programs to thousands of patients, said Steve Glass, Clinigen’s chief commercial officer for North America and Europe, in a statement.

While the CRO’s Idis Managed Access division works with pharma companies to bring innovative medicines for unmet clinical need through particular programs, its Idis Global Access section offers support to healthcare professionals, mainly pharmacists, to provide medicines for individual patients.

“These medicines are not necessarily innovative medicines, but may not be available in their local markets due to several reasons, e.g., drug shortages, never commercially made available, withdrawn in that market,” said the company spokesperson, who also said occasional overlaps between the two services could occur.

Onxeo is also the product of a 2014 merger between two oncology-focused biopharma companies—Paris-based BioAlliance Pharma and Danish company and developer of belinostat, Topotarget, which licensed out the rights of the med in the U.S., India and potentially China to Spectrum Pharma in 2010.

A phase 3 trial is currently underway to evaluate the efficacy of belinostat in combination with chemo combo treatment CHOP against CHOP itself as first-line treatment for PTCL.