Healthcare Industry News: Versartis
News Release - June 23, 2014
Versartis Appoints Endocrinologist Bert Bakker, MD, PhD, as Senior Vice President, Medical AffairsSeasoned Industry Executive to Lead Medical Affairs
MENLO PARK, Calif., June 23, 2014 -- (Healthcare Sales & Marketing Network) -- Versartis, Inc. (VSAR), an endocrine-focused biopharmaceutical company that is developing VRS-317, a novel, long-acting form of recombinant human growth hormone (rhGH) for the treatment of growth hormone deficiency (GHD), today announced it has added Bert Bakker, MD, PhD, a senior industry executive with expertise in pediatric and adult endocrinology, to its executive team as Senior Vice President, Medical Affairs.
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.
Versartis, Inc. is an endocrine-focused biopharmaceutical company initially developing VRS-317, a novel, long-acting form of recombinant human growth hormone, for the treatment of growth hormone deficiency (GHD). VRS-317 is intended to reduce the burden of daily injection therapy by requiring significantly fewer injections, potentially improving compliance and therefore treatment outcomes. The Company has recently completed a Phase 2a clinical trial evaluating weekly, semi-monthly and monthly dosing regimens of VRS-317 in children with GHD. Further information on Versartis can be found at www.Versartis.com.
Cautionary Note on Forward Looking Statements
This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. We may, in some cases, use terms such as "believes," "potential," "will" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: potential market opportunities in GHD and the development of VRS-317. These statements are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, risks and uncertainties related to: our success being heavily dependent on VRS-317; VRS-317 being a new chemical entity; serious adverse side effects, if they are associated with VRS-317; VRS-317 may not have favorable results in later clinical trials or receive regulatory approval; other long-acting rhGH products and product candidates have failed to generate commercial success or obtain regulatory approval; delays in enrollment of patients in our clinical trials could increase our costs and cause delay; VRS-317 may cause serious adverse side effects or have properties that delay or prevent regulatory approval or limit its commercial profile; manufacturing; if approved, risks associated with market acceptance, including pricing and reimbursement; our ability to enforce our intellectual property rights; the importance of our license of intellectual property from Amunix Operating, Inc. and our need for additional funds to support our operations. We discuss many of these risks in greater detail under the heading "Risk Factors" section contained in our Quarterly Report on Form 10-Q for the 3 months ended March 31, 2014, which is on file with the Securities and Exchange Commission (SEC). Forward-looking statements are not guarantees of future performance and our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.
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