April 18, 2013 | By Márcio Barra
The Portuguese pharmaceutical company Bial announced today the signing of an exclusive licensing deal with ONO Pharmaceutical, a Japanese company based in Osaka, to develop and commercialize in Japan the drug Opicapone, a new treatment for Parkinson disease.
In this deal, ONO will pay an upfront fee to Bial, with more installments paid as the drug development and commercialization moves along in Japan. The values signed in the deal were not disclosed.
BIAL’s CEO António Portela stated to Agência Lusa that this is “an historic, significant and very satisfying moment for the entire team”, adding that they “were able to create and develop a second medicine from our own investigation, reassuring our technical and scientific capabilities and giving us confidence about the sustainability of our R&D project”. Now that the drug is licensed for the Japanese Market, the company will now focus on “finding the right partners in the US and EU”, as attaining a foothold in the Japanese market will surely bring more credibility to Bial.
Opicapone is an adjunct therapy to levodopa preparations (levodopa/carbidopa or levodopa/benserazide), acting as a long acting COMT (Cathechol-O-Methyl Transferase) inhibitor. Patients under a levodopa regimen eventually start wearing off from the drug, as the duration of Levodopa’s effect diminishes. COMT inhibitors have been widely used to prolong the duration of levodopa effect and diminish the wearing off effect.
The drug is currently in Phase III of clinical trials and is and nearing regulatory submission. In clinical trials, Opicapone showed an “increase in the systemic exposure to levodopa and a long acting effect as a COMT inhibitor, in a single daily dose”
The existing COMT inhibitors in Japan requires multiple administrations per day due to short duration of action, so Opicapone’s single daily dosage might be a big plus for the experimental therapy in the market.
In declarations to DinheiroVivo.pt, António Portela declared that “being in Japan is extremely important”, since 22% of all worldwide sales of drugs for Parkinson’s disease occur in Japan.
The drug will only reach the Japanese market in a few years, as the Japanese market is a bit different that the rest of the world, owing to the unique responses that the Japanese population has to medicines. Thus, Japanese authorities require that Japanese companies who license foreign treatments to conduct the clinical development of the licensed drug in Japan.