FDA approval of Beleodaq™ (belinostat)
• Accelerated Approval of Topotarget’s Beleodaq™ for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma
• Early Action follows Priority Review 5 weeks before PDUFA Date
• Trigger milestone payment of USD 25 million to Topotarget
• Beleodaq™ is expected to be available to patients in July 2014 and will be launched through Spectrum Pharmaceutical's existing oncology sales force
BioAlliance Pharma SA (Euronext Paris - BIO), an innovative Company specialized in the development of drugs in orphan oncology diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Topotarget Accelerated Approval of Beleodaq™ for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (R/R PTCL). This follows a Priority Review of the Beleodaq™ New Drug Application (NDA) and was an Early Approval action prior to the August 9, 2014 PDUFA (Prescription Drug User Fee Act) date.
Beleodaq™ was granted marketing authorization under the FDA’s accelerated approval program, which allows conditional approval of a medicine for a life-threatening disease based on early evidence suggesting clinical benefit. The approval is based on results from the BELIEF study, which enrolled 129 PTCL patients refractory to or who had failed at least one prior systemic therapy.
A milestone cash payment of USD 25 million from Spectrum Pharmaceuticals is triggered by the NDA approval. A double-digit royalties as well as sales milestones of the aggregated net sales will be received by the company.
“With the FDA’s Accelerated Approval of Beleodaq™, the teams of Topotarget have succeeded in developing a new efficacious treatment option for patients with PTCL. Such a key achievement is a very positive sign to begin Onxeo’s long and successful story and it reinforces the value of Onxeo “, comments Judith Greciet, CEO of BioAlliance Pharma.