Pharnext strengthens its management team with three key appointments to support ongoing development of PXT3003 toward approval and commercialization
PARIS, France, October 19, 2021, 8:30 a.m. CET - Pharnext SA (FR0011191287 - ALPHA) (the "Company"), an advanced late-stage clinical biopharmaceutical company pioneering new approaches to developing innovative drug combinations based on big genomics data and artificial intelligence using its PLEOTHERAPY(TM) platform, is pleased to announce the strengthening of its senior management team with the appointments of Raj Thota, as Chief Manufacturing Officer and Head of CMC, Abhijit Pangu as the Head of Regulatory Affairs and the promotion of Xavier Paoli to Chief Operating Officer.
Raj Thota brings over 28 years of experience in pharmaceutical development, CMC filings, tech transfer, scale-up, and commercialization to Pharnext and previously served as Vice President, General Manager, and site head at Frontida BioPharm. Throughout his career, Raj has successfully led the development, optimization and launch of numerous products, including Xtampza(R) ER Capsules, Vimovo(R) Tablets, Osmolex(R) CR Tablets and Entocort(R) ER Capsules, and many more complex & patentable clinical stage molecules. Raj received a M.S. in Pharmaceutical Technology from IIT BHU, India, and M.B.A. in general management from Xavier University USA. He also completed a Regulatory Affairs Certification (RAC) from Regulatory Affairs Professional Society and Lean Six Sigma Greenbelt Certification from Villanova University, USA.
With over 20 years of pharmaceutical industry experience, Abhijit Pangu specializes in navigating drug development with global regulatory authorities to serve patients with high unmet needs in gastroenterology, neurology, urology/reproductive health, and rare diseases. He has provided strategic and operational guidance as a Senior Consultant to global companies to develop and implement US regulatory strategies for a diverse pipeline of products from early stages of development through late stages, commercialization and life-cycle management. Previously Abhijit has held leadership positions at Orphazyme, Ferring, and multiple generic pharmaceutical companies. Abhijit is a pharmacist by training with a Master's degree in Pharmacy and holds a globally recognized Regulatory Affairs Certification (RAC).
Xavier Paoli has been promoted to Chief Operating Officer, effective immediately. Xavier joined the Company in 2014 as the Commercialization Strategy Director and then has held the Chief Commercial Officer position since 2017. Xavier has almost 20 years of experience in drug commercialization in the biotech sector. He has been involved in successfully launching several brands at regional and national level for diseases with high unmet need and notably for rare diseases. Leveraging its scientific background in genetics and immunology, Xavier previously held marketing positions in several well-known companies, including GlaxoSmithKline, UCB Pharma and Alexion Pharmaceuticals. Xavier holds a Master's degree in Immunology and Genetics from the University Denis Diderot (Paris VII), and in Marketing from HEC Business School (Paris).
David Horn Solomon, Chief Executive Officer of Pharnext said: "I would like to welcome Raj and Abhijit to Pharnext and to congratulate Xavier on his promotion. Raj's extensive experience in pharmaceutical development and Abhijit's past work in navigating drug development with global regulatory authorities will considerably augment the strength of our senior management team. We are also delighted to promote Xavier, who played an instrumental role in setting up prelaunch activities for PXT3003 in Charcot-Marie-Tooth type 1A disease ('CMT1A') and has built strong ties with key opinion leaders and patient advocacy groups. He was also involved in many key transversal projects over the years and is perfectly suited to his new role of COO.
"Their combined expertise will be highly valuable as we continue to drive growth and deliver the successful commercialization of our products, pending positive clinical trial results. Our pivotal Phase III clinical study of PXT3003 in CMT1A, the PREMIER trial, is currently ongoing in the US and Europe and remains our key focus."
Pharnext is an advanced clinical-stage biopharmaceutical company developing novel therapeutics for orphan and common neurodegenerative diseases that currently lack curative and/or disease-modifying treatments. Pharnext has two lead products in clinical development. PXT3003 completed an international Phase III trial with positive topline results for the treatment of Charcot-Marie-Tooth disease type 1A ('CMT1A') and benefits from orphan drug status in Europe and the United States. An international pivotal Phase III study of PXT3003 in CMT1A, the PREMIER trial, is currently ongoing. PXT864 has generated encouraging Phase II results in Alzheimer's disease and will be advanced through partnerships. Pharnext has developed a new drug discovery paradigm based on big genomics data and artificial intelligence: PLEOTHERAPY(TM). Pharnext identifies and develops synergic combinations of drugs called PLEODRUG(TM). More information can be found at www.pharnext.com.
Pharnext is listed on the Euronext Growth Stock Exchange in Paris (ISIN code: FR0011191287).
This press release contains certain forward-looking statements concerning Pharnext and its business, including in respect of timing of and prospects for clinical trials and regulatory submissions of the Company's product candidates as well as a potential financing transaction, the use of proceeds therefrom and cash runway. Such forward-looking statements are based on assumptions that Pharnext considers to be reasonable. However, there can be no assurance that the estimates contained in such forward-looking statements will be verified, which estimates are subject to numerous risks including the risks set forth in Pharnext's URD approved by the AMF on November 9, 2020 under number N° R. 20-029 as well as in its annual periodic management reports and press releases (copies of which are available on www.pharnext.com) and to the development of economic conditions, financial markets and the markets in which Pharnext operates. The forward-looking statements contained in this press release are also subject to risks not yet known to Pharnext or not currently considered material by Pharnext. The occurrence of all or part of such risks could cause actual results, financial conditions, performance or achievements of Pharnext to be materially different from such forward-looking statements. Pharnext disclaims any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.
This press release and the information that it contains do not constitute an offer to sell or subscribe for, or a solicitation of an offer to purchase or subscribe for, Pharnext shares in any country, including the United States. The Company's securities may not be offered or sold in the United States absent registration or an exemption from registration; any public offering of securities to be made in the United States will be made by means of a prospectus that may be obtained from the issuer that will contain detailed information about the Company and management, as well as financial statements.
Regulatory filing PDF file
1241550 19-Oct-2021 CET/CEST