Spark Therapeutics, a late-stage gene therapy company developing treatments for debilitating genetic diseases, announced today that it has named Rogerio Vivaldi, M.D., M.B.A., as its first chief commercial officer. Dr. Vivaldi, former head of rare diseases at Genzyme, a Sanofi company, and the former CEO of Minerva Neurosciences, previously served as a board member at Spark since April 2014. He joins as the company prepares to complete its Phase 3 clinical trial for SPK-RPE65, to address inherited retinal dystrophies caused by mutations in the RPE65 gene.

A recognized rare disease commercial leader and pioneer, Dr. Vivaldi has worked to advance patient-centered medicine through innovative technologies since 1992, when he was the first physician in Brazil to treat Gaucher disease using enzyme replacement therapy. He later joined Genzyme Corporation, and in a series of roles of increasing responsibility, Dr. Vivaldi led the successful approval and reimbursement of more than 15 orphan products across more than 20 countries throughout the world. Most recently, Dr. Vivaldi led Minerva Neurosciences in the development of a portfolio of innovative product candidates addressing neuropsychiatric diseases and the successful completion of an initial public offering earlier this year.

“We are honored that Rogerio has chosen to bring his substantial, global commercial leadership experience to Spark,” said Jeffrey D. Marrazzo, co-founder and CEO of Spark.  “He has been an invaluable member of our Board and we welcome his transition to the team as we prepare to complete development of SPK-RPE65.”

At Spark, Dr. Vivaldi will oversee the planned launch of the company’s lead product candidate, SPK-RPE65, with responsibility for global commercial, patient advocacy, market access, and medical affairs operations.

“I am elated to join Spark as we prepare to commercialize SPK-RPE65 and build an organization to support broad access for affected patients throughout the world,” Dr. Vivaldi added.  “Gene therapy represents a potential new treatment paradigm for people with rare diseases, and it is an honor to help advance this effort through our work at Spark.”

About Dr. Rogerio Vivaldi

Dr. Rogerio Vivaldi is the former CEO and president of Minerva Neurosciences, Inc., a public, clinical-stage biopharmaceutical company focused on the development and commercialization of a portfolio of product candidates to treat patients suffering from neuropsychiatric diseases. He previously held a variety of senior roles at Genzyme, ultimately leading the company’s rare disease business and earning a reputation as a passionate advocate for patients. Dr. Vivaldi led the successful approval and reimbursement of more than 15 orphan products across more than 20 countries throughout the world. Bringing his medical and professional expertise to Genzyme, Dr. Vivaldi served as senior vice president of Rare Diseases having responsibility for Genzyme’s rare diseases business and the renal and endocrinology group. He also served as senior vice president and general manager of the company’s Latin America group. Dr. Vivaldi began his career as a physician, spending 18 years in private practice specializing in diabetes and endocrinology, and was the first physician in Brazil to treat Gaucher disease using enzyme replacement therapy. He received his medical degree from Rio de Janeiro University (UNIRIO) – School of Medicine, and completed his residency in endocrinology at Rio de Janeiro State University (UERJ) as well as his fellowship at Mount Sinai Hospital Center in New York in the department of genetics, where he focused on Gaucher disease. He received his M.B.A. degree from COPPEAD, Rio de Janeiro Federal University.

About Spark Therapeutics     

Spark is a gene therapy leader seeking to transform the lives of patients suffering from debilitating genetic diseases by developing one-time, life-altering treatments. Spark’s initial focus is on treating orphan diseases where no, or only palliative therapies, exist. Spark’s most advanced product candidate, SPK-RPE65, is in a fully-enrolled pivotal Phase 3 clinical trial for the treatment of a rare blinding condition. Spark plans to leverage SPK-RPE65 to address a broad spectrum of blinding conditions, and also has established a pipeline of gene therapy candidates to treat hematologic and neurodegenerative disorders, including SPK-FIX, a program for the potential treatment of hemophilia B through a global collaboration with Pfizer, Inc. Spark’s integrated gene therapy platform builds on two decades of research, development and manufacturing at The Children’s Hospital of Philadelphia, including human trials conducted across diverse therapeutic areas and routes of administration. For more information on Spark Therapeutics and its clinical pipeline visit www.sparktx.com.

X