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

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 3^rd 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).