PARIS & COPENHAGEN, Denmark--(BUSINESS WIRE)--Regulatory News:
Onxeo SA (Paris:ONXEO) (NASDAQ OMX:ONXEO) (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®, 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”.
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:
Livatag® (Doxorubicin Transdrug™): Phase III in hepatocellular carcinoma
Validive® (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
This communication expressly or implicitly contains certain forward-looking statements concerning Onxeo and its business. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of Onxeo to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Onxeo is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise. For a discussion of risks and uncertainties which could cause actual results, financial condition, performance or achievements of Onxeo to differ from those contained in the forward-looking statements, please refer to the Risk Factors ("Facteurs de Risque") section of the 2013 Reference Document filed with the AMF on April 7, 2014, which is available on the AMF website (http://www.amf-france.org) or on the company’s website (www.onxeo.com).