Healthcare Industry News: Bayer HealthCare
News Release - April 22, 2019
Neurelis Announces Completion of Senior Management Team Buildout to Support the Anticipated Commercial Launch of VALTOCO(TM)Neurelis' lead product candidate for seizures, VALTOCO™ (diazepam nasal spray), currently under FDA review
Company's team members are all seasoned pharmaceutical industry executives with vast experience in CNS and epilepsy
SAN DIEGO, April 22, 2019 -- (Healthcare Sales & Marketing Network) -- Neurelis, Inc., a privately held specialty pharmaceutical company focused on licensing, developing, and commercializing product candidates for epilepsy and the broader central nervous system (CNS) market, announced today that the company has completed the buildout of its senior management team to support the anticipated launch of its lead product, VALTOCO™ (diazepam nasal spray).
Neurelis President and CEO Craig Chambliss stated: "Over the past two years, we have been incredibly fortunate to add these talented executives to our team at this pivotal time. Their combined track record of building and launching successful commercial, clinical, and development organizations is critical as we prepare for the planned U.S. launch of VALTOCO™ and build our growing CNS pipeline. The unparalleled level of expertise, specifically in the outpatient seizure emergency market, positions Neurelis to significantly benefit the epilepsy community in the very near term."
VALTOCO™ (diazepam nasal spray) is a proprietary formulation of diazepam incorporating the unique combination of a vitamin E–based solution with Intravail®, a proprietary permeation enhancer excipient. VALTOCO™ has been developed for the management of pediatric, adolescent, and adult patients (age 6 and above) who require intermittent use of diazepam to control bouts of increased seizure activity, also known as cluster or acute repetitive seizures. The science of Intravail® enables the non-invasive delivery of a broad range of protein, peptide, and non-peptide drugs. Intravail® can be utilized via the oral, buccal, dermal, and intranasal drug administration routes. Currently under U.S. Food and Drug Administration (FDA) review, Neurelis is preparing for the commercial launch of VALTOCO™.
Chambliss announced the following management additions to the Neurelis team:
George Stuart, Chief Financial Officer
George Stuart has 29 years of finance and accounting experience, the majority of which have been spent within the specialty pharmaceutical and biotechnology industry. He has experience as a finance executive with both private and public companies, providing finance-related consulting services to early-stage specialty pharmaceutical and biotech companies. Prior to his involvement with Neurelis in 2010, George spent 3 years as the Senior Vice President and Chief Financial Officer of Questcor Pharmaceuticals where he led the move of Questcor's listing from the American to the NASDAQ exchange. In 2001, he helped launch Xcel Pharmaceuticals, a CNS start-up focused on epilepsy, serving as Vice President and Chief Financial Officer until its acquisition by Valeant Pharmaceuticals in 2005. Prior to the founding of Xcel, George was the Director of Finance for Ligand Pharmaceuticals and began his career with Deloitte in 1986 where he last held the position of Senior Manager.
Chuck DeWildt, Chief Commercial Officer
Chuck DeWildt has served in leadership roles in Sales, Marketing, and Market Access in the pharmaceutical and biotechnology industry for more than 25 years. Chuck joined Neurelis initially as Sr. Vice President of Commercial and Market Access in early 2018 and has overseen the commercial buildout of Neurelis since joining. Chuck was promoted to Chief Commercial Officer in 2019. His specific experience includes work in the CNS, respiratory, and oncology markets. Chuck joined Neurelis from Teva Pharmaceuticals Industries Ltd, where he was Vice President of Market Access. He joined Teva in 2011 as part of the Cephalon acquisition where he was the Head of Market Access and Reimbursement. Chuck began his pharmaceutical career at DuPont and joined Cephalon in 1999.
Adrian Rabinowicz, M.D., Senior Vice President of Clinical Development & Medical Affairs
Dr. Adrian L. Rabinowicz joined Neurelis in 2018 and is a board-certified neurologist with over 20 years of experience in global pharmaceutical and biotechnology companies. Prior to joining Neurelis, he served as Chief Medical Officer at Sancilio & Company, where he led all development programs, operational activities, and interactions with regulatory authorities. Previously, Dr. Rabinowicz was Senior Vice President of Clinical Development and Medical Affairs at Acorda Therapeutics, and also spent over seven years with Bayer HealthCare Pharmaceuticals, holding various roles of increasing responsibility in different therapeutic areas. Dr. Rabinowicz received his medical degree from the Universidad Del Salvador, Buenos Aires, Argentina and completed his residency in neurology at the University of Buenos Aires and his fellowship in Epilepsy and Neurophysiology at the University of Southern California, Los Angeles. He served as both an Assistant Professor of Neurology and the Co-Director of the USC Comprehensive Epilepsy program. Dr. Rabinowicz has received several national and international awards for his research, is a Fellow of the American Academy of Neurology, and has published over 75 peer-reviewed papers and several book chapters.
Thomas Liquard, Senior Vice President, Corporate Development
Thomas Liquard brings more than 15 years of organizational, corporate development, and commercial development leadership experience in the life sciences industry to Neurelis. Prior to joining Neurelis in late 2017, Thomas served as CEO of Immuron Limited and was COO and then CEO of Alchemia Limited after spending seven years with Pfizer. At Pfizer, he held various commercial roles of increasing scope and responsibility including in New Product Planning, Portfolio Decision & Analysis, U.S. Established Brands and Emerging Markets. Thomas began his life sciences career as a Senior Consultant with the Frankel Group (now part of the Huron Group).
Steve Jenner, Vice President of Marketing & Operations
Steve Jenner has more than 20 years of experience in the pharmaceutical and biotechnology industry with specific experience in the neurology, pain, glaucoma, and dermatology markets. Steve joined the Neurelis team in early 2019. He has served in various leadership roles in Sales, Marketing, Operations, and Managed Markets. Steve joined Neurelis from Zogenix, where he most recently served as the Vice President of Commercial for the U.S. Market. At Zogenix, he was responsible for leading the commercialization of multiple product launches, acting as commercial point person for all business development initiatives, and for the initial buildout of the rare disease business unit for the U.S. Market. Prior to Zogenix, he served as the Senior Vice President of Client Services at MedAccess Communications, and held marketing and product management leadership positions with companies such as Valeant Pharmaceuticals International, Allergan Pharmaceuticals, and Elan Pharmaceuticals, Inc. (which was acquired by Alkermes Plc.).
VALTOCO™ nasal spray is a proprietary formulation of diazepam, delivered via a nasal spray formulation, developed for the management of pediatric, adolescent, and adult patients (age 6 and above) who require intermittent use of diazepam to control bouts of increased seizure activity, also known as cluster or acute repetitive seizures. In clinical trials, VALTOCO™ demonstrated high bioavailability, low variability from dose to dose, and was well tolerated with the most common adverse event being nasal discomfort (seen in 5% of patients in clinical trials). The FDA previously granted Neurelis both Orphan Drug and Fast Track designations for VALTOCO™. The New Drug Application for VALTOCO™ is supported by an extensive clinical and pre-clinical package, including studies in healthy volunteers and patients with epilepsy. In the patient studies, more than 2,000 seizures have been treated to date with VALTOCO™ nasal spray.
Neurelis, Inc. is a privately held San Diego–based specialty pharmaceutical company organized to license, develop, and commercialize product candidates for epilepsy and the broader CNS market. Neurelis is leveraging its expertise in the development and commercialization of CNS compounds and strong relationships with leading researchers and clinicians in these markets to advance unique product candidates, such as VALTOCO™, to address significant unmet medical needs. For more information on the company, please visit www.neurelis.com.
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