Jeffrey L. Cleland, PhD, Chief Executive Officer, said, "We are delighted to welcome Bert to Versartis. With George Bright, MD, heading our Clinical Development and Bert leading Medical Affairs, we believe we have one of the most experienced clinical teams in rhGH therapy in the world. As we continue the development of VRS-317 in GHD children and expand VRS-317 into GHD adults, Bert's extensive depth and knowledge of drug development in children and adults with GHD will add significant value to our clinical, regulatory and commercialization plans. His expertise in GHD both as a physician and as a senior executive with several international pharmaceutical companies makes him particularly well suited for this leadership position. Bert has had an outstanding career in the pharmaceutical and biotechnology industry and brings a wealth of talent and experience to Versartis."
Most recently, Dr. Bakker was Global Brand Medical Director, Global Medical Affairs at Novartis Oncology where he led and developed the global medical affairs strategy for the use of two somatostatin analogs in neuro-endocrine tumors and oversaw a number of early clinical development studies. Previously, at Ipsen, he was Vice President Medical Affairs and led all activities of the US Endocrine Medical Affairs group which scientifically supported the company's products. At Genentech, Dr. Bakker was a key contributor as Medical Director in the Clinical Development group, where he covered all four stages of drug development, from early clinical development to post marketing studies for products including human growth hormone, anti CD-20 and anti-VEGF. Prior to Genentech, he was Medical Director, Worldwide Medical, Endocrine Care at Pfizer, Inc. Earlier, Dr. Bakker also held positions at Pharmacia (later Pfizer AB) and Schwarz Pharma Benelux. He began his medical career as a pediatric endocrinologist and Assistant Professor at the Academic Medical Center, University of Amsterdam, the Netherlands. He received his MD from the Medical School at the University of Leiden, the Netherlands and his PhD in Medical Sciences, from the University of Amsterdam, the Netherlands. Dr. Bakker was a Pediatric Endocrinology Fellow at Stanford University and the University of Utrecht, the Netherlands, where he also completed his pediatric residency. He is widely published and while at Genentech was one of the lead authors of the National Cooperative Growth Study Registry. His most cited publication is on the first year growth results with daily growth hormone in pediatric growth hormone deficiency.
Unmet Need for New GHD Treatments
Currently, there are seven marketed rhGH products in the US for the treatment of GHD. However, a key limitation of these products is the burden of daily injections, which can compromise compliance and lead to suboptimal treatment outcomes. As such, Versartis believes that there is a significant unmet need for an improved therapeutic option for both pediatric and adult GHD patients. Versartis previously demonstrated in a Phase 1a trial in GHD adults the potential for monthly dosing in this patient population as published in Yuen et al, JCEM 2013. Additionally, as previously announced, Versartis will hold a conference call later today to discuss the six month VRS-317 Phase 1b/2a VERTICAL clinical trial results in naive pre-pubertal children with GHD. VRS-317 is being developed to provide up to once-monthly dosing and has the potential to improve patients' compliance to rhGH therapy and overall treatment outcomes.