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
June 3, 2014
BioAlliance Pharma SA, 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.
BioAlliance Pharma and Topotarget are merging to create Onxeo, following approval of shareholders of both companies end of June 2014.
Onxeo aims to become a leading orphan oncology company. With a portfolio of advanced programs targeting severe orphan oncology diseases for which there is an unmet medical need, Onxeo will offer increased market attractiveness, notably towards specialized international investors, using its scale and significant footprint as a biotechnology leader with a growing portfolio of high value-added products.
Topotarget (NASDAQ OMX: TOPO) is a Danish-based biopharmaceutical company headquartered in Copenhagen, Denmark, dedicated to clinical development and registration of oncology products. In collaboration with Spectrum Pharmaceuticals, Inc., Topotarget focuses on the development of its lead drug candidate, belinostat, which has shown positive results in the treatment of hematological malignancies and solid tumors, obtained by both mono- and combination therapy. For more information, please refer to www.topotarget.com.
About BioAlliance Pharma
Dedicated to cancer treatments with a focus on resistance targeting and orphan products, BioAlliance Pharma conceives and develops innovative products for orphan or rare diseases.
Created in 1997 and introduced to the Euronext Paris market in 2005, BioAlliance Pharma’s ambition is to become a leading player in these fields by coupling innovation to patient needs. The company’s teams have the key competencies required to identify, develop and register drugs in Europe and the USA.
BioAlliance Pharma has developed an advanced product portfolio:
Orphan Oncology products
Livatag® (Doxorubicin Transdrug™) (primary liver cancer): Phase III on going
Validive® (Clonidine Lauriad®) (mucositis): Phase II on going
AMEP®/Synfoldin (invasive melanoma): Clinical and Preclinical Phase
For more information, visit the BioAlliance Pharma web site at www.bioalliancepharma.com