Onxeo strengthens Beleodaq™ patent protection in the U.S. until 2027
Paris (France), Copenhagen (Denmark), August 28, 2014
Onxeo SA (Euronext Paris, NASDAQ OMX Copenhagen – ONXEO), an innovative company specialized in the development of drugs for orphan oncology diseases, today announced that the U.S. Patent Office will grant a new patent for Beleodaq™ (Belinostat U.S. commercial name) on September 16th 2014.
In addition to the existing patent, covering the chemical structure of Beleodaq
TM, this new patent also covers the formulation of the product, strengthening and expanding significantly its industrial property protection until October 2027 in the U.S.
Beleodaq™ also benefits from the commercial exclusivity related to its orphan status in the US.
Beleodaq™ has obtained Marketing Authorization from the Food and Drug Administration (FDA) for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (R/R PTCL) in early July 2014. PTCL accounts for around 10 to 15% of non-Hodgkin’s lymphoma and its global incidence is estimated at 12,000 cases each year.
“This new patent significantly increases the value of our product”,
commented Judith Greciet, CEO of Onxeo. “Indeed, it extends the period of market exclusivity, and it will foster the initiation of other promising indications’ development with our U.S. partner Spectrum Pharmaceuticals”. 2
Onxeo has the vision to become a global leader and pioneer in oncology, with a focus on orphan or rare cancers, through developing innovative therapeutic alternatives to “make the difference”. The Onxeo teams are determined to develop innovative medicines to provide patients with hope and significantly improve their lives.
Key products at advanced development stage are:
® (Doxorubicin Transdrug™): Phase III in hepatocellular carcinoma
® (Clonidine Lauriad®): Phase II in severe oral mucositis
Beleodaq® (belinostat): registered in the US in peripheral T-cell lymphoma
For more information, visit the website www.onxeo.com
Judith Greciet, CEO
+33 1 45 58 76 00
Nicolas Fellmann, CFO
+33 1 45 58 76 00
Caroline Carmagnol – Alize RP
+33 6 64 18 99 59
Michael Steen-Knudsen – Impact Communications
+45 25 17 18 15