PARIS–(BUSINESS WIRE)–Regulatory News:
GenSight Biologics (Euronext: SIGHT, ISIN: FR0013183985, PEA-PME eligible), a biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, today announced that the Company’s country leads for three key European markets are in place. Laurence Rodriguez, Robert Schupp and Neil Dugdale have joined the Company as the country leads for France, Germany and the United Kingdom, respectively, marking an important milestone in local preparations to commercialize LUMEVOQ® in H1 2022.
LUMEVOQ®, the Company’s gene therapy for the treatment of Leber Hereditary Optic Neuropathy (LHON) caused by a mutated ND4 mitochondrial gene, is currently under review for marketing authorization in Europe. The European Medicines Agency decision is expected in H1 2022, with the company expecting to achieve UK approval in the same time frame. Early engagement with authorities and payers is critical in markets such as Germany and the UK, where commercial sales can be generated before the reimbursed price is finalized. The French ATU (“Temporary Authorization of Use”) process, granted to LUMEVOQ® by the ANSM, similarly allows revenues to be generated from product use while the health technology assessment is still underway.
“Our team is delighted to welcome such accomplished individuals, who all combine well-honed operational skills in launching rare disease treatments in our key markets with an abiding passion for making a difference in patients’ lives,” said Bernard Gilly, Chief Executive Officer of GenSight Biologics. “Their appointments underscore our determination to achieve rapid commercial success for LUMEVOQ.”
Laurence Rodriguez joins GenSight with over 30 years’ experience in the life sciences industry, including 13 years in the rare diseases business at Sanofi Genzyme, where she held a range of commercial roles such as Marketing Manager, Marketing and Sales Manager and Business Unit Director. As Head of the Rare Diseases & Rare Blood Disorders unit at Sanofi Genzyme, she oversaw the successful launch of a number of rare disease products developed or acquired by the company. She holds a Bachelor’s degree in Biochemistry and a Master’s degree from the Sciences Po, Paris, France, and completed an Organization Leadership Program at the Harvard Business School.
“I am delighted to join such a company as GenSight, which is focused on innovation and patients’ unmet needs,” said Ms. Rodriguez. “I look forward to driving the achievement of LUMEVOQ milestones as the Country Lead in France.”
Robert Schupp brings more than 30 years of commercial life sciences experience to GenSight, including success building the commercial organization and rare disease franchise at Celgene in Germany and establishing the ultra-rare disease franchise of Santhera in Germany, Austria and Switzerland. His five years in the General Manager role at Santhera enabled him to build a strong network among LHON stakeholders, marked by successfully achieving reimbursement for Raxone® in Germany. In addition to an M.S. in Biology from the University of Cologne and a Ph.D. in Biochemistry from the Technical University of Munich, he completed post-graduate studies in Business Administration (University of Cologne) and Market Access Management (European Business School).
“I am very excited to join the GenSight team and to help bring a true innovation in biomedical therapy to patients losing their sight due to a rare genetic disease,” said Dr. Schupp. “With the imminent approval of LUMEVOQ, I am eager to involve and get the support of all stakeholders to secure patients’ access to our promising gene therapy.”
Neil Dugdale joins GenSight after more than 25 years in a range of commercial leadership roles, most recently as the Vice President of the Northern Europe sub-region and General Manager of the UK and Ireland at Sobi (Swedish Orphan Biovitrum AB). He led the commercial launch of Sobi’s treatments for hemophilia in the UK and Ireland and the launch planning for primary hemophagocytic lymphohistiocytosis (HLH) and thrombocytopenia. He holds degrees from the University of Liverpool (B.Sc. [hons]) and the Chartered Institute of Marketing Diploma and recently completed studies in Digital Transformation at the University of Cambridge.
“I am pleased to join GenSight Biologics and honored to lead the UK business,” said Mr. Dugdale. “I am extremely excited to be working with the innovative gene therapy developed by GenSight and eager to bring great positive change to patients affected by LHON.”
About GenSight Biologics
GenSight Biologics S.A. is a clinical-stage biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders. GenSight Biologics’ pipeline leverages two core technology platforms, the Mitochondrial Targeting Sequence (MTS) and optogenetics, to help preserve or restore vision in patients suffering from blinding retinal diseases. GenSight Biologics’ lead product candidate, LUMEVOQ® (GS010; lenadogene nolparvovec), has been submitted for marketing approval in Europe for the treatment of Leber Hereditary Optic Neuropathy (LHON), a rare mitochondrial disease affecting primarily teens and young adults that leads to irreversible blindness. Using its gene therapy-based approach, GenSight Biologics’ product candidates are designed to be administered in a single treatment to each eye by intravitreal injection to offer patients a sustainable functional visual recovery.