Inventiva secures a new European patent strengthening and extending the protection of its lead product candidate lanifibranor The latest European patent granted by the European Patent Office protects the use of lanifibranor in several fibrotic diseases, including NASH, until June 2035 The patent bolsters the Company’s patent portfolio for lanifibranor, which already included a European NCE patent valid until 2026, with a potential extension to 2031 Applications for patents protecting the use of lanifibranor in NASH in other key countries, including China and Japan, are currently under review 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.” About lanifibranor Lanifibranor, Inventiva’s lead product candidate, is an orally-available small molecule that acts to induce anti-fibrotic, anti-inflammatory and beneficial metabolic changes in the body by activating all three peroxisome proliferator activated receptor (“PPAR”) isoforms, which are well characterized nuclear receptor proteins that regulate gene expression. Lanifibranor is a PPAR agonist that is designed to target all three PPAR isoforms in a moderately potent manner, with a well balanced activation of PPARα and PPARδ, and a partial activation of PPARγ. While there are other PPAR agonists that target only one or two PPAR isoforms for activation, lanifibranor is the only pan PPAR agonist in clinical development. Inventiva believes that lanifibranor’s moderate and balanced pan PPAR binding profile contributes to the favorable safety and tolerability profile that has been observed in clinical trials and pre clinical studies to date. Inventiva is currently evaluating lanifibranor in a Phase IIb clinical trial for the treatment of non-alcoholic steatohepatitis (“NASH”), a common and progressive chronic liver disease, for which there is currently no approved therapy. About Inventiva Inventiva is a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of diseases with significant unmet medical needs in the areas of fibrosis, lysosomal storage disorders and oncology. Leveraging its expertise and experience in the domain of compounds targeting nuclear receptors, transcription factors and epigenetic modulation, Inventiva is currently advancing two clinical candidates – lanifibranor and odiparcil – in non-alcoholic steatohepatitis (“NASH”) and mucopolysaccharidosis (“MPS”), respectively, as well as a deep pipeline of earlier stage programs. Lanifibranor, its lead product candidate, is being developed for the treatment of patients with NASH, a common and progressive chronic liver disease. Inventiva is currently evaluating lanifibranor in a Phase IIb clinical trial for the treatment of this disease for which there are currently no approved therapies. Inventiva is also developing odiparcil, a second clinical‑stage asset, for the treatment of patients with MPS, a group of rare genetic disorders. The Company is currently investigating odiparcil in a Phase IIa clinical trial for the treatment of patients with the MPS VI subtype. In parallel, Inventiva is in the process of selecting an oncology development candidate for its Hippo signalling pathway program. The Company has established two strategic partnerships with AbbVie and Boehringer Ingelheim in the areas of autoimmune diseases and idiopathic pulmonary fibrosis (“IPF”) respectively. AbbVie has started the clinical development phase of ABBV‑157, a drug candidate for the treatment of moderate to severe psoriasis resulting from its collaboration with Inventiva. Both collaborations entitle Inventiva to receive milestone payments upon the achievement of pre-clinical, clinical, regulatory and commercial milestones, in addition to royalties on any approved products resulting from the partnerships. The Company has a scientific team of approximately 70 people with deep expertise in the fields of biology, medicinal and computational chemistry, pharmacokinetics and pharmacology a well as in clinical development. It also owns an extensive library of approximately 240,000 pharmacologically relevant molecules, around 60% of which are proprietary, as well as a wholly‑owned research and development facility. Inventiva is a public company listed on compartment C of the regulated market of Euronext Paris (Euronext: IVA – ISIN: FR0013233012). www.inventivapharma.com Contacts Inventiva Frédéric Cren Chairman & CEO firstname.lastname@example.org +33 3 80 44 75 00 Brunswick Group Yannick Tetzlaff / Tristan Roquet Montegon Media relations email@example.com +33 1 53 96 83 83 LifeSci Advisors Monique Kosse Investor relations firstname.lastname@example.org +1 212 915 3820 Important Notice This press release contains forward-looking statements, forecasts and estimates with respect to the clinical development plans, business and regulatory strategy, and anticipated future performance of Inventiva and of the market in which it operates. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will” and “continue” and similar expressions. Such statements are not historical facts but rather are statements of future expectations and other forward-looking statements that are based on management’s beliefs. These statements reflect such views and assumptions prevailing as of the date of the statements and involve known and unknown risks and uncertainties that could cause future results, performance or future events to differ materially from those expressed or implied in such statements. Actual events are difficult to predict and may depend upon factors that are beyond Inventiva’s control. There can be no guarantees with respect to pipeline product candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. Therefore, actual results may turn out to be materially different from the anticipated future results, performance or achievements expressed or implied by such statements, forecasts and estimates. Given these uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of this press release. Readers are cautioned not to place undue reliance on any of these forward-looking statements. Please refer to the “Document de référence” filed with the Autorité des Marchés Financiers on April 12, 2019 under n° R.19-006 for additional information in relation to such factors, risks and uncertainties. Inventiva has no intention and is under no obligation to update or review the forward-looking statements referred to above. Consequently, Inventiva accepts no liability for any consequences arising from the use of any of the above statements.
Inventiva – PR – Lanifibranor – New patent Europe – EN – 28082019