GenSight Biologics is strengthening its management team to support the launch of LUMEVOQ® in Europe

  • Philip Muti Senior Vice President for Regulatory Affairs and Quality

  • Michelle Himmels Vice President, Global Pricing and Market Access

Paris, September 12, 2022– (work wire) – Regulatory news:

GenSight Biologics (Euronext: SIGHT, ISIN: FR0013183985, PEA-PME Eligible), a biopharma company focused on the development and commercialization of innovative gene therapies for neurodegenerative retinal diseases and central nervous system disorders, today announced two major designations. Philip Moti has been appointed Senior Vice President, Organization and Quality, to CEO Bernard Gilley and a member of the Executive Committee. Michelle Himmels has been appointed Vice President, Global Pricing and Market Access (PMA), reporting to Cecil Rodal, Senior Vice President, Commercial Operations. These appointments are effective immediately. Both are recognized experts in their field and will play an integral role in the development of GenSight Biologics activities and the commercial launch of LUMEVOQ® in Europe.

“I am delighted to welcome these two leading experts to our management team,” CEO and Co-Founder of GenSight Biologics . commented Bernard Gilly. He added, “Philip has extensive experience securing regulatory pathways and interacting with regulatory authorities around the world, while Michel’s experience will be useful for accessing LUMEVOQ, pricing and reimbursement for GenSight’s broader portfolio.”

Philip Muti has been appointed as Senior Vice President, Organization and Quality

Philip Muti will be responsible for ensuring consistency of activities in relation to regional and local regulatory authorities, and coordinating teams to prepare for LUMEVOQ’s pre-marketing inspections.® and ensuring regulatory compliance in the future marketing of LUMEVOQ®. He will report to Bernard Gilly as a member of the Executive Committee.

“It is with great pleasure that I join the leadership team to contribute to the delivery of first-in-class gene therapy solutions to patients with severe eye disorders and high unmet medical needs,” hung Philip Muti. “I look forward to this new adventure.”

Philip has a MD from Paris Descartes University and a PhD in Human Biology from Paris-Sud University. He completed a Postdoctoral Fellowship at Harvard Medical School and the Massachusetts General Hospital Cancer Center, and received his MBA from ESCP-EAP (Paris). got a certificate Pharmacy is responsible (Responsible Pharmacist) in France and elected a member of the French National Academy of Pharmacy. Philip is also a visiting professor at the University of Paris-Saclay.

He worked for many years in regulatory, quality and commercial roles at leading healthcare companies such as Sanofi (then as Pasteur-Mérieux), GSK (then Smith Kline-Beecham), Roche, Ipsen, Abbvie and Medday Pharmaceuticals. He also founded Celestial Consulting & Coaching in the biotechnology and pharmaceutical sector. Most recently, Philip joined GenSight after serving as CEO of Regulation and Quality at the biopharmaceutical company Genfit.

Michael Himmels has been appointed Vice President of the International Monetary Authority

Michael Himmels will be responsible for the development and implementation of the global pricing and market access strategy, ensuring patient access to GenSight treatments. He will report to Cecil Rodal, Senior Vice President, Commercial Operations.

Join GenSight with 20 years of strong senior leadership experience related to product marketing across multiple geographies in the pharmaceutical and biotechnology industries.

There is a great unmet need in the treatment of acute retinal diseases. GenSight Biologics has been committed to changing this situation for more than 10 years.” Michelle Himmels hung. “Based on science, collaboration, and dedication, I am convinced that we will ensure timely patient access to our cutting-edge treatments. I am honored to join this team.”

Michael has a master’s degree. in Pharmaceutical Sciences from Utrecht University in the Netherlands, holds an MSc. from the University of Toronto, Canada, and an MBA from Copenhagen Business School, Denmark.

He started his life sciences career at large to mid-sized pharmaceutical companies and has since consolidated his expertise in pricing and market reach in small biotechnology. He was a member of the EMEA (Europe, Middle East, and Africa) management team at AveXis preparing for the launch of the first gene therapy. Most recently, he served as Head of Global Market Access and Pricing at Genmab. In addition to being the author of more than 90 peer-reviewed scientific publications, Mitchell has led many early advice requests and has been the global or regional leader for numerous reports to national health technology assessment bodies, including the first trial to assess comparative effectiveness with EUnetHTA.

About GenSight Biology

GenSight Biologics SA is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative gene therapies for neurodegenerative retinal diseases and disorders of the central nervous system. The GenSight Biologics pipeline leverages two core technology platforms, mitochondrial targeting sequencing (MTS) and optogenetics, to help maintain or restore vision in patients with blinding retinal diseases. GenSight Biologics’ lead product filter, LUMEVOQ® (GS010; lenadogene nolparvovec), is an investigational compound and has not been registered in any country at this point; A marketing authorization application is currently under review by the EMA for the treatment of Leber hereditary optic neuropathy (LHON), a rare mitochondrial disease that primarily affects adolescents and young adults and leads to irreversible blindness. Using its gene therapy-based approach, GenSight Biologics’ candidate products are designed to be administered in a single treatment per eye by intravitreal injection to provide patients with sustainable functional visual recovery.

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