Onxeo S.A. (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

150318EN_Patent Validive