|[August 28, 2014]
Onxeo Strengthens Beleodaq® Patent Protection in the U.S. Until 2027
PARIS & COPENHAGEN, Denmark --(Business Wire)--
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 (News - Alert) 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
Validive® (Clonidine Lauriad®): Phase II in severe
Beleodaq® (belinostat): registered in the US in peripheral T-cell
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).
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