Clinigen and Onxeo initiate Managed Access programme for belinostat in Europe for patients with peripheral T-cell lymphoma (PTCL)

Paris, April 24, 2017 – 18 :30 CEST. Clinigen Group plc’s (AIM: CLIN, ‘Clinigen’ or the ‘Group’) Idis Managed Access (MA) division and Onxeo S.A (Euronext Paris, Nasdaq Copenhagen: ONXEO, ‘Onxeo’), have agreed to launch a Managed Access programme for belinostat (Beleodaq®) in Europe. Belinostat is for use in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).

PTCL is a form of blood cancer comprising of a group of rare and aggressive non-Hodgkin lymphomas (NHL), a malignant lymphoproliferative disorder. PTCL accounts for approximately 10%-15% of all NHL cases.

Belinostat is a histone deacetylase inhibitor (‘HDAC inhibitor’) used to treat refractory or relapsed PTCL. The product received accelerated approval* by the US Food and Drug Administration (‘FDA’) in July 2014 due to the unmet medical need in this rare disease. There are no approved treatments for PTCL in Europe.

The programme allows physicians to request belinostat for individual patients for whom alternative treatment options are not currently available. This enables patients on a named patient basis in Europe** to benefit from belinostat treatment ahead of a potential European approval.

Steve Glass, Chief Commercial Officer, North America and Europe, of Clinigen said:

“There is a huge unmet need for patients with aggressive blood cancers such as PTCL. As the trusted global leader in access to unlicensed medicines, Clinigen is working in partnership with Onxeo to help patients gain access to this important medicine. As Clinigen and Idis MA, we have delivered over 220 Managed Access programmes to thousands of patients. We help physicians access medicines when no other treatment options are available reducing unmet clinical need. This aligns with our mission of getting the right medicine to the right patient at the right time.”

Judith Greciet, Chief Executive Officer of Onxeo said:

“Consistent with our efforts to address the unmet needs of people diagnosed with relapsed or refractory PTCL, we are pleased to partner with Clinigen to establish this Named Patient programme. In selected European countries in which local health authorities permit the programme, the belinostat Managed Access programme will allow healthcare professionals to prescribe belinostat to specific patients.”

Healthcare professionals can obtain details about the belinostat Managed Access programme by calling a Clinigen representative at: +44 (0) 1283 44 347, or emailing customer.services@clinigengroup.com.

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