GENFIT: Gearing Up for 2019 with Organizational Changes
Lille (France), Cambridge (Massachusetts, United States), September 24, 2018 – GENFIT (Euronext: GNFT - ISIN: FR0004163111) today announces some key leadership changes to accompany GENFIT into the next stage of its development and its evolution from an R&D biotechnology company to a fully-integrated biopharmaceutical company.
Dean Hum, PhD, Chief Scientific Officer of GENFIT since 2000, has been appointed Deputy CEO. An 18-year veteran of the Company, he will continue to coordinate all R&D activities for GENFIT, but will also support Jean-François Mouney, Chairman and CEO, in leading the executive and leadership team in developing and implementing short-term and long term strategy. Dean will bring to this new role his demonstrated ability to address key corporate challenges, ranging from financial transactions to corporate strategy, and including human resources and operational management.
On the clinical front, Sophie Mégnien, MD, Chief Medical Officer, is stepping down from her current role. While GENFIT regrets her decision, the Company fully understands it and wishes Sophie best of luck in her professional and personal life. The Company is confident in the high quality clinical team in place, now led by Pascal Birman, MD, Deputy Chief Medical Officer, to ensure a seamless transition. Dr. Birman, who joined GENFIT about a year ago, brings nearly 30 years of clinical development and management experience. He began his career in medical practice, before moving to industry, where he first worked as International Project Leader, then Director Therapeutic Research in the UK, and as Director of International Clinical Operations for Europe & Asia. He later joined Ipsen as Global Project Leader Endocrinology in 2004, and over his 13 years at the company, held various leadership positions: Senior Director Medical Development Endocrinology; VP Therapeutic Area New Opportunity; VP Clinical Development Programs Global.
Dr Birman will spearhead the transformation of the clinical and medical department as GENFIT moves into this new stage in its development. In this respect, two new members have joined his team:
- Julie M. Dietrich, who is currently on-boarding as Vice President Clinical Operations US after over 10 years at Amgen and several years at Bristol-Myers Squibb;
- Nadezda Mitrovic, MD, who, as new Head of Pharmacovigilance, brings to the Company over 15 years of experience in clinical research and pharmacovigilance.
He will also be able to draw on the expertise of:
-Christine Roussarie (PharmD), who, after significant experience ranging from national regulatory agencies to biotechnology companies in the UK, Spain and France, has joined as new Head of Regulatory Affairs;
-David Magrez who joined GENFIT several months ago as Director of Biometrics from Roche where he was Head of Real Life Data Analysis Strategy, and supervises, in particular, the data management activities resulting from the Company’s preclinical and clinical studies; and
-Patrice Monain, who brings nearly 20 years of experience as Global Head, Generic Patents at Sanofi to further develop and strengthen the Company's Intellectual Property.
In the meantime, GENFIT’s Executive Committee welcomes a new member, Pascal Prigent, who joined the Company in May 2018 as Executive Vice President Marketing and Commercial Development. Pascal, who led the commercial strategy for a multi-billion dollar vaccine portfolio prior to joining GENFIT, is currently building a Marketing and Commercialization team. This team includes experts such as Dr. Myriam Zylberman who spent more than 20 years at Eli Lilly working primarily on market access and brings to GENFIT key expertise on payers aimed at preparing for an optimal launch of elafibranor once marketing authorization is received, which is expected in NASH in 2020. In addition, Pascal has been appointed Director of the Paris office.
GENFIT continues to recruit in all areas and has expanded its office space, both in its Paris office as well as building a brand new 1,000m2 wing at its French headquarters in Lille.
Jean-François Mouney commented: “With this strong team, GENFIT is well positioned to execute on its strategic objectives. Dean Hum, as Deputy CEO, and Pascal Birman, taking over from Sophie Megnien, bring the expertise and leadership skills to accompany the scaling-up of our activity. With the arrival of Pascal nearly a year ago, business continuity is definitely ensured.”
Dean Hum, Deputy CEO and Chief Scientific Officer of GENFIT added: “With upcoming data in both PBC and NASH, we’re on the verge of exciting times for GENFIT. We have achieved a lot already but what is coming next has the potential to bring the Company into a new era of development. Therefore it’s the right time to gear up.”
GENFIT is gearing-up for an eventful year end in 2018, with top line phase 2a data in PBC expected in December, paving the way for a larger trial aimed at validating elafibranor’s potential as a new therapeutic option in this rare disease as a logical next step. 2019 should be a truly pivotal year, with interim top line phase 3 data in NASH expected end of year with a goal towards marketing one of the very first drugs to treat this disease which currently remains without any approved treatment. And more is to come, with news about blood-based NASH diagnosis, pediatric NASH and hepatic fibrosis over the next months.
GENFIT is a biopharmaceutical company focused on discovering and developing drug candidates and diagnostic solutions targeting liver diseases, in particular those of metabolic origin, and hepatobiliary diseases. GENFIT’s concentrates its R&D efforts in areas of high unmet medical needs corresponding to a lack of approved treatments. GENFIT’s lead proprietary compound, elafibranor, is a drug candidate currently being evaluated in one of the most advanced Phase 3 studies worldwide (“RESOLVE-IT”) in nonalcoholic steatohepatitis (NASH), considered by regulatory authorities as a medical emergency because it is silent, with potentially severe consequences, and with a prevalence on the rise. It is also evaluated in a Phase 2 study in Primary Biliary Cholangitis (PBC), a rare liver disease. As part of its comprehensive approach to clinical management of NASH patients, GENFIT is conducting an ambitious discovery and development program aimed at providing patients and physicians with a blood-based test for the diagnosis of NASH, i.e. non- invasive and easy-to-access. With facilities in Lille and Paris, France, and Cambridge, MA (USA), the Company has approximately 130 employees. GENFIT is a public company listed in compartment B of Euronext’s regulated market in Paris (Euronext: GNFT - ISIN: FR0004163111). www.genfit.com
FORWARD LOOKING STATEMENT / DISCLAIMER
This press release contains certain forward-looking statements. Although the Company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous 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 related to biomarkers, progression of, and results of clinical data from, the RESOLVE-IT trial and the trial of elafibranor in PBC, review and approvals by regulatory authorities, such as the FDA or the EMA, regarding in particular, elafibranor in NASH and PBC, as well as other drug candidates in other indications and biomarkers candidates, the success of any inlicensing strategies, the Company’s continued ability to raise capital to fund its development, as well as those discussed or identified in the Company’s public filings with the AMF, including those listed in Section 4 “Main Risks and Uncertainties” of the Company’s 2017 Registration Document registered with the French Autorité des marchés financiers on April 27, 2018 under n° R.18-032, which are available on GENFIT’s website (www.genfit.com) and on the website of the AMF (www.amf- france.org) as updated by the 2018 Half Year Report available on GENFIT’s website in the “Investors” section. Other than as required by applicable law, the Company does not undertake any obligation to update or revise any forward-looking information or statements. This press release and the information contained herein do not constitute an offer to sell or a solicitation of an offer to buy or subscribe to shares in GENFIT in any country. This press release has been prepared in both French and English. In the event of any differences between the two texts, the French language version shall supersede.
GENFIT | Jean-François Mouney – Chairman & CEO | +333 2016 4000
PRESS RELATIONS | Bruno Arabian | Ulysse Communication | +336 8788 4726