Onxeo Confirms Receipt of the $25M Milestone Payment on Beleodaq®


PARIS & COPENHAGEN, Denmark--(BUSINESS WIRE)-- Regulatory News :

Onxeo SA (Paris:ONXEO) (NASDAQ OMX:ONXEO) (Euronext Paris, NASDAQ OMX Copenhagen
- ONXEO), an innovative company specializing in the development of orphan
oncology drugs, announces that it has received from his US partner Spectrum
Pharmaceuticals the milestone payment of $25 million related to the approval of
Beleodaq® by the FDA.

Early July 2014, Beleodaq® was granted by the U.S. Food and Drug Administration
(FDA) conditional marketing authorization for the treatment of patients with
relapsed or refractory peripheral T-cell lymphoma (PTCL) under the FDA’s
accelerated approval program. Related to that, Onxeo US partner Spectrum
Pharmaceuticals has paid the $25 million milestone as planned by contract.

Following the New Drug Application approval, Spectrum Pharmaceuticals team has
initiated Beleodaq® promotion in August to key hematologists and has already
generated about $2 million in sales for the 3rd quarter 2014, bringing the first
royalty stream for Onxeo.

“Beleodaq® marketing authorization is a tremendous achievement from both teams,
who have worked very closely and successfully managed to get this NDA
significantly ahead of schedule”, comments Judith Greciet, CEO of Onxeo. “The
milestone payment represents of course a large addition to our cash situation
but also signs the fruitful collaboration between our two companies, both
heading for the same goal, making Beleodaq® a recognized product for its
clinical value as well as its significant sales potential.”

About Onxeo
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: Positive
preliminary top-line results
Beleodaq® (belinostat): registered in the US in peripheral T-cell lymphoma
For more information, visit the website www.onxeo.com

Disclaimer

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).
Contacts
Onxeo
Judith Greciet, CEO
j.greciet@onxeo.com
or
Nicolas Fellmann, CFO
n.fellmann@onxeo.com
+33 1 45 58 76 00
or
Alize RP
Caroline Carmagnol / Sophie Colin, +33 6 64 18 99 59 / +33 1 44 54 36 62
caroline@alizerp.com / scolin@alizerp.com

Attachments

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