Livatag was already patented until 2019 with a first patent family covering the pharmaceutical product’s composition. The second one covers the specific administration scheme of Livatag, strengthening and extending its patent protection until 2032. This new issuance from the Japanese patent office comes in addition to the one already delivered in Europe.
Moreover, Livatag benefits from additional market exclusivity related to its orphan status, for 10 years in Europe and 7 years in the U.S. from the date of market authorization.
"This new patent reinforces the already well-established industrial protection of Livatag and recognizes the innovation of its administration scheme. It also demonstrates our capacity to set up a strong IP around our strategic program ", declared Aude Michel, Head of Corporate Development of BioAlliance Pharma.
Primary liver cancer, also called hepatocellular carcinoma, is a particularly aggressive chemo-resistant cancer. It is the second leading cause of cancer-related deaths worldwide, few therapeutic alternatives are available and there is a significant unmet medical need.
While the disease is classified as an orphan disease in Europe and in the U.S., its incidence is very high in Asian countries, and especially in Japan where there are about 36.000 new cases per year.
Livatag is currently in a phase III trial in Europe and in the U.S. (ReLive trial), expected to be completed end of 2016.
"Japan represents a significant market for Livatag and is a key country to establish product’s footprint in Asia. The strengthened and extended patent protection in Japan enhances the value of this drug which is at an advanced stage of its clinical development and has significant sales potential", added Judith Greciet, CEO of BioAlliance Pharma.