ONXEO Consolidates Its Intellectual Property with the Grant of New Patent Protection of Validive® in Japan Until 2029

Regulatory News:

Onxeo S.A. (Paris:ONXEO) (NASDAQ OMX:ONXEO) (Euronext Paris, NASDAQ OMX Copenhagen: ONXEO), an innovative company specializing in the development of orphan oncology drugs, today announced the grant of Validive® patent by the Japanese Patent Office. Validive® is based on Onxeo mucoadhesive technology Lauriad® and is currently entering phase III in the prevention of severe oral mucositis in patients treated for a head and neck cancer.

The newly granted patent in Japan is based on the original application of clonidine in oral mucositis and protects Validive® until 2029.

After China, South Korea and Singapore, this grant from Japan authorities enlarges Validive®’s patent protection and strengthens significantly the value of this strategic orphan oncology asset for the Asian market.

Oral mucositis is a radio/chemotherapy related condition occurring very frequently in patients undergoing head and neck cancer treatment. With no curative or preventive treatment currently, oral mucositis represents a serious unmet medical need for the patients.

The incidence of head and neck cancer in Japan is estimated to 18 000 cases each year, an attractive market of about 100m$. The overall incidence in Asia (China + South-East region) is of 180 000 cases⁽¹⁾, about 25% of the global incidence.

End 2014, the clinical development of Validive® has achieved a major step with positive top-line results of its Phase II clinical trial comparing the efficacy and safety of Validive® versus placebo in the prevention of radio-chemotherapy induced severe oral mucositis in head and neck cancer patients. The results showed a significant decrease in the incidence of severe oral mucositis in the Validive® pooled arms versus placebo: overall incidence of severe oral mucositis was 45% in the Validive® groups, with a maximum absolute decrease of 16% compared to placebo. Occurrence of severe oral mucositis was delayed in the Validive® groups compared to placebo and higher doses of radiation were received by the Validive® treated patients before severe oral mucositis occurred. The study has also confirmed that Validive® was well tolerated .

"The new patent protection in Japan is key regarding product’s potential, as it increases commercial attractivity for Validive® in a region presenting a large market. In parallel of the efficacy and safety data demonstrated in the recently completed phase II trial, it reinforces Validive®‘s position as a promising key product in our orphan oncology portfolio”, comments Judith Greciet, CEO of Onxeo.

(1) Globocan 2012

About oral mucositis
Severe oral mucositis is a particularly invalidating pathology induced by radio/chemotherapy treatments and very frequent in patients with head and neck cancer. It may induce intense oral pain and eating disability requiring enteral or parenteral nutritional support. Thirty per cent of patients need to be hospitalized as a result and symptoms can force patients to stop treatment for an undefined period thus reducing treatment efficacy. Oral mucositis has currently no validated curative or preventive treatment.

About Validive®
Validive® (clonidine Lauriad®) is developed for the treatment of severe oral mucositis induced by radiotherapy or chemotherapy in patients suffering from head and neck cancer. This is a new therapeutic application of clonidine based on the mucoadhesive technology Lauriad®.
Clonidine stimulates the alpha-2 adrenergic receptors traditionally used to treat high blood pressure. It stimulates these receptors in the brain. This leads to a decrease in peripheral resistance and thus a lowering of blood pressure, as well as a reduction in heart rate and renal vascular resistance. However, clonidine also acts as an agonist of the alpha-2 adrenergic receptors on leucocytes and macrophages, thereby decreasing the expression of the pro-inflammatory genes and the release of cytokines IL6, IL1ß and TNFa. This effect leads to a reduction in the pro-inflammatory mechanisms. It also acts on the anti-inflammatory mechanisms by increasing the release of TGF ß.

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).