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Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland) November 17, 2022 – GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with liver diseases characterized by high unmet medical needs, today announced the highlights from its Pipeline Day events reviewing the Company’s clinical progress and recent strategic updates.
A video replay of the Pipeline Day events which took place in Paris (on October 5, 2022) and New York (on October 19, 2022) is now available and can be accessed from the “Events & Presentations” page under the “Investors & Media” section of the GENFIT website.
Pipeline and R&D strategy
Over the last 12 months, GENFIT has successfully executed its strategic plan.
In December 2021, GENFIT signed a licensing and collaboration agreement with Ipsen for the elafibranor program, which consolidated GENFIT’s financial situation (€120M upfront payment, €28M equity investment with a significant premium, up to €360M milestones and tiered double-digit royalties up to 20%).
GENFIT also secured patient recruitment for the ELATIVE® Phase 3 trial in PBC, successfully completing this activity in June 2022 despite challenges faced with the COVID pandemic. Topline data are expected in the next few months.
GENFIT then strengthened, diversified and expanded our Research and Development pipeline with the goal to capitalize on our expertise in bringing early stage assets up to pre-commercialization stages in liver diseases. Its new R&D strategy now focuses exclusively on liver diseases with high unmet medical need and significant market potential, with the in-licensing of the rights for a novel asset initially developed by Genoscience Pharma in CCA in December 2021, followed by the acquisition of the Swiss-based clinical-stage biopharmaceutical company Versantis in September 2022, adding three additional assets positioned in ACLF, in HE and in UCD/OAD.
Pascal Prigent, Chief Executive Officer of GENFIT commented: ”GENFIT’s perspectives have dramatically evolved over the last two years. Although the outcome was not what we had hoped for, GENFIT has greatly benefited from its work in NASH. We have acquired great know-how in liver disease specific research, from target identification to proprietary models. We also developed expertise in clinical development and regulatory affairs in emerging diseases. We have built solid networks with experts, academic institutions, patient associations, etc. It is this accumulated experience and established infrastructure that we are able to leverage now. The clinical development of elafibranor in PBC is nearing completion with high level results expected in Q2 next year. We see the signature of the related strategic partnership with Ipsen at the end of 2021 as further reason to be optimistic about elafibranor’s commercial outlook. The deal with Ipsen also gave us the financial means to make significant progress on our pipeline over the past nine months, as we executed two other deals with Genoscience and Versantis, continuing to execute our strategic roadmap. During our Pipeline Day, we were excited to host a deep dive into the new programs recently integrated into our pipeline and hear from leading experts, who provided valuable insights into the unmet medical needs of patients, as well as potential market opportunities. These presentations also outlined what we believe has been a transformative year for GENFIT, as we work with increased momentum to diversify our pipeline with innovative therapeutic opportunities for rare liver diseases.”
Key Expert Speakers included:
Back Bay Life Science Advisors also shared the results of a market study conducted in 2021 in ACLF. This study was based on an extensive review of published literature as well as in-depth discussions with Key Opinion Leaders (KOLs) managing ACLF patients, with hospital pharmacists, hospital administrators, and managed care organizations (payers) in the US.
Pipeline Program Highlights
NTZ and VS-01-ACLF for acute on-chronic liver failure (ACLF)
VS-02-HE for hepatic encephalopathy (HE)
GNS561 for cholangiocarcinoma (CCA)
VS-01-UCD for urea cycle disorder (UCD)/organic acidemia disorder (OAD)
GENFIT is a late-stage biopharmaceutical company dedicated to improving the lives of patients with liver diseases characterized by high unmet medical needs. GENFIT is a pioneer in liver disease research and development with a rich history and strong scientific heritage spanning more than two decades. Thanks to its expertise in bringing early-stage assets with high potential to late development and pre-commercialization stages, today GENFIT boasts a growing and diversified pipeline of innovative therapeutic and diagnostic solutions.
Its R&D pipeline covers five therapeutic areas via six independent programs which explore the potential of differentiated mechanisms of action, across a variety of development stages (Phase 1, Phase 2, Phase 3). These diseases are acute on-chronic liver failure (ACLF), hepatic encephalopathy (HE), cholangiocarcinoma (CCA), urea cycle disorder (UCD)/organic acidemia disorder (OAD) and primary biliary cholangitis (PBC). Beyond therapeutics, GENFIT’s pipeline also includes a diagnostic franchise focused on NASH and ACLF.
GENFIT has facilities in Lille and Paris, France, Zurich, Switzerland, and Cambridge, MA, USA. GENFIT is a publicly traded company listed on the Nasdaq Global Select Market and on compartment B of Euronext’s regulated market in Paris (Nasdaq and Euronext: GNFT). In 2021, IPSEN became one of GENFIT’s largest shareholders and holds 8% of the company’s share capital. www.genfit.com
FORWARD LOOKING STATEMENTS
This press release contains certain forward-looking statements with respect to GENFIT, including those within the meaning of the Private Securities Litigation Reform Act of 1995, in relation to expected availability of ongoing or upcoming clinical data over the coming months and years, specifically data from the Phase 3 ELATIVE® clinical trial, launch of a Phase 1b/2 study of GNS561 in CCA, anticipated market potential in each of the disease areas that GENFIT is investigating, development costs and timelines for development of our pipeline. The use of certain words, including “consider”, “contemplate”, “think”, “aim”, “expect”, “understand”, “should”, “aspire”, “estimate”, “believe”, “wish”, “may”, “could”, “allow”, “seek”, “encourage” or “have confidence” or (as the case may be) the negative forms of such terms or any other variant of such terms or other terms similar to them in meaning is intended to identify forward-looking statements. Although the Company believes its projections are based on reasonable expectations and assumptions of the Company’s management, these forward-looking statements are subject to numerous known and unknown risks and uncertainties, which could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking statements. These risks and uncertainties include, among other things, the uncertainties inherent in research and development, including in relation to safety, biomarkers, progression of, and results from, its ongoing and planned clinical trials, review and approvals by regulatory authorities of its drug and diagnostic candidates, the impact of the COVID-19 pandemic, exchange rate fluctuations, potential synergies related to the acquisition of Versantis and our capacity to integrate Versantis and to develop its programs and our continued ability to raise capital to fund its development, as well as those risks and uncertainties discussed or identified in the Company’s public filings with the AMF, including those listed in Chapter 2 “Main Risks and Uncertainties” of the Company’s 2021 Universal Registration Document filed with the AMF on April 29 2022 under n° D.22-0400, which is available on the Company’s website (www.genfit.com) and on the website of the AMF (www.amf-france.org) and public filings and reports filed with the U.S. Securities and Exchange Commission (“SEC”) including the Company’s 2021 Annual Report on Form 20-F filed with the SEC on April 29, 2022 and the 2022 Half-Year Business and Financial Report. In addition, even if the Company’s results, performance, financial condition and liquidity, and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. These forward-looking statements speak only as of the date of publication of this document. Other than as required by applicable law, the Company does not undertake any obligation to update or revise any forward-looking information or statements, whether as a result of new information, future events or otherwise.
GENFIT | Investors
Tel: +33 3 2016 4000 | email@example.com
PRESS RELATIONS | Media
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1 Based on actual figures as well as preliminary market studies derived from different sources
2 Extrapolated from ‘Time trend in the healthcare burden and mortality of ACLF in the US’ – Hepatology 2016
3 Potnis et al., International Journal of Hepatology 2021
4 Stepanova et al., Clin Gast Hep 2012
5 Hepatic Encephalopathy Market Report by Coherent Market Insights
6 The purpose of IND-enabling studies is to secure approval to conduct the first-in-human clinical trials with a new drug (IND stands for Investigational New Drug)
7 IQVIA derived data
8 Olympus Research Global
9 Harding JJ, Awada A, Roth G, Decaens T, Merle P, Kotecki N, Dreyer C, Ansaldi C, Rachid M, Mezouar S, Menut A, Bestion EN, Paradis V, Halfon P, Abou-Alfa GK, Raymond E. First-In-Human Effects of PPT1 Inhibition Using the Oral Treatment with GNS561/Ezurpimtrostat in Patients with Primary and Secondary Liver Cancers. Liver Cancer. 2022 Feb 15;11(3):268-277. doi: 10.1159/000522418
10 Summar et al., 2013 | Martin-Hernandez et al., 2014 | Nettesheim et al., 2017
11 2021 assessment from longitudinal and real-world data reference publications (no projections nor modelling)