Date: 2015-03-18
Type of information: Granting of a patent
Product name: Validive®
Compound: clonidine Lauriad®
Therapeutic area: Cancer - Oncology - Rare diseases
Action mechanism:
- alpha2-adrenergic receptor agonist. Validive® is a therapeutic application of clonidine based on the mucoadhesive technology Lauriad®. Onxeo’s proprietary Lauriad® technology significantly increases the mucous and salivary concentrations of the active ingredient it contains, with decreased systemic absorption. As an agonist of the alpha-2 adrenergic receptors, Validive® exhibits anti-inflammatory properties, and was developed for the prevention and treatment of chemoradioation therapy-induced severe oral mucositis in patients with head and neck cancer. Preclinical studies and a Phase II trial have confirmed Validive’s mechanism of action and demonstrated that the therapy significantly reduces incidence of severe mucositis, improves oral mucositisrelated symptoms and decreases radiotherapy-related adverse events, and exhibits a favorable safety profile and strong adherence to treatment.
Company: Onxeo (France)
Disease: oral mucositis in patients treated for a head and neck cancer
Latest news:
Patents:
- • On June 18, 2015, Onxeo announced the allowance by the US Patent and Trademark Office (USPTO) of a patent covering its product Validive® until September 2029. This allowed US patent claims a new use of clonidine, the active principle of Validive®, in the treatment of oral mucositis. Moreover, this treatment with clonidine formulated in Onxeo’s mucoadhesive technology Lauriad® is also covered by the patent. After significant countries in Asia, this allowance from the USPTO strengthens significantly the patent protection of Validive® and its value.
- • On March 18, 2015, Onxeo 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. 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 .
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
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Is general: Yes
