August 28, 2019
Daix (France), August 28, 2019 – Inventiva (Euronext: IVA), a clinical-stage biopharmaceutical company developing oral small molecule therapies for the treatment of diseases in the areas of fibrosis, lysosomal storage disorders and oncology, today announced that the European Patent Office (EPO) granted on August 28, 2019 a new patent protecting the use of lanifibranor in 38 European countries in the treatment of several fibrotic diseases, including non-alcoholic steatohepatitis (NASH), until June 2035.
This new patent strengthens and extends the term of protection of lanifibranor in Europe, which was already established with the New Chemical Entity (NCE) patent expiring in August 2031 (this expiration date includes a possible five-year extension to compensate for regulatory delays linked to obtaining the marketing approval).
In addition to Europe, the use of lanifibranor in several fibrotic conditions, including NASH, is already protected in the United States. Inventiva has filed patent applications with similar claims in other key markets for the pharmaceutical industry, such as China and Japan, which are currently under review.
Pierre Broqua, Ph.D., Chief Scientific Officer and cofounder of Inventiva, commented: “The grant of this patent in Europe is excellent news, as it strengthens and extends the protection of lanifibranor in numerous fibrotic indications, including NASH, in one of our key markets. Together with the USPTO’s decisions in the United States, it represents a tremendous boost to the patent portfolio covering our lead drug candidate in regions and countries where the need for treatment of fibrotic diseases is very high. This positive momentum confirms our innovative R&D approach underpinning our strategy.”
Lanifibranor, its lead product, is an anti-fibrotic treatment acting on the three alpha, gamma and delta PPARs (peroxisome proliferator-activated receptors), which play key roles in controlling the fibrotic process. Its anti-fibrotic action targets two initial indications with substantial unmet medical need: NASH, a severe and increasingly prevalent liver disease already affecting over 30 million people in the United States, and systemic sclerosis, a disease with a very high mortality rate and for which there is no approved treatment to date.
Inventiva is also developing a second clinical program with odiparcil (IVA 336) for the treatment of patients with mucopolysaccaridosis type VI (or Maroteaux-Lamy syndrome), a rare and severe gene disease affecting children. Odiparcil has also the potential to address other MPS types, characterized by the accumulation of chondroitin or dermatan sulfate (MPS I or Hurler/Sheie syndrome, MPS II or Hunter syndrome, MPS IVa or Morquio syndrome and MPS VII or Sly syndrome). Inventiva is also developing a portfolio of early research projects in the field of oncology.
Inventiva benefits from partnerships with world-leading research entities such as the Institut Curie in the field of oncology. Two strategic partnerships have also been established with world-class major pharmaceutical companies AbbVie and Boehringer Ingelheim in the fields of autoimmune diseases (specifically in psoriasis) and fibrosis respectively. These partnerships provide milestone payments to Inventiva upon the achievement of pre-clinical, clinical, regulatory and commercial milestones, in addition to royalties on the products resulting from the partnerships.
Inventiva employs over 100 employees and owns R&D facilities near Dijon, acquired from the international pharmaceutical group Abbott. The Company owns, a proprietary chemical library of over 240,000 molecules as well as integrated biology, chemistry, ADME and pharmacology platforms.
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