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Ironshore Pharmaceuticals, Inc. (“Ironshore”), a wholly owned subsidiary of Highland Therapeutics Inc. (“Highland”) and a leader in the commercialization of novel treatments for Attention Deficit Hyperactivity Disorder (ADHD), today announced the appointment of Dr. Lewis Warrington to the position of Vice President / Head of Medical Affairs.
Dr. Warrington joins Ironshore with 18 years of pharmaceutical industry experience having served in various leadership positions of increased responsibility with several global companies. Most recently, he served as the Medical Affairs Strategic Lead at Merck where he was responsible for managing the overall medical strategy for central nervous system (CNS) products in the United States.
“We are excited to have Lewis join Ironshore at a time we are preparing to bring our innovative medicine – JORNAY PM™ – to U.S. healthcare providers, ADHD patients and their caregivers,” said Scott Evangelista, Ironshore’s President and Chief Operating Officer. “His extensive experience in developing and managing medical strategy and supportive tactics for commercialized brands will be a tremendous asset for Ironshore.”
Commenting on his appointment, Dr. Warrington said, “I am thrilled to be joining Ironshore at such a pivotal moment in the Company’s history. I look forward to helping it advance its novel ADHD therapy that has the potential to address unmet treatment needs and improve families’ lives.”
Dr. Warrington is a dual board-certified psychiatrist (adult and child & adolescent psychiatry). Dr. Warrington’s extensive experience includes: Vice President and Head, Respiratory Medical Unit, and Vice President and Head, Psychiatry and Neurology Medical Unit at Novartis; Senior Medical Director and Therapeutic Area Head, US CNS products at Sanofi-Aventis; and Medical Director, US Geodon Team at Pfizer.
Dr. Warrington received his medical degree from East Carolina University School of Medicine and completed a fellowship in child and adolescent psychiatry at the University of Florida College of Medicine.
Approved by the U.S. Food and Drug Administration (FDA) in August 2018, JORNAY PM (methylphenidate) is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older. JORNAY PM is the only stimulant medication that is taken in the evening and has demonstrated improvement in the severity of ADHD symptoms in the early morning and throughout the day. JORNAY PM is the first drug utilizing the proprietary drug delivery platform, DELEXIS®. It is expected to be available commercially in the first half of this year.
WARNING: ABUSE AND DEPENDENCE
See full prescribing information for complete boxed warning.
See additional safety information below
ADHD is among the most common childhood psychiatric conditions with behavioral symptoms fluctuating throughout the day. It is usually first diagnosed in childhood and often lasts into adulthood. Children with ADHD may have trouble paying attention, controlling impulsive behaviors, or be overly active. Many home-based difficulties for children and adolescents with ADHD occur during the early morning routine (i.e. before the school day begins).
ABOUT JORNAY PM
JORNAY PM is a central nervous system (CNS) stimulant prescription medicine used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in people 6 years of age and older. JORNAY PM may help increase attention and decrease impulsiveness and hyperactivity in people 6 years of age and older with ADHD. It is not known if JORNAY PM is safe and effective in children under 6 years of age.
JORNAY PM is dosed once daily in the evening and should be initiated at 8:00 p.m. Timing of administration of JORNAY PM may be adjusted between 6:30 p.m. and 9:30 p.m. to optimize the tolerability and the efficacy the next morning and throughout the day. Please see additional dosing information in the full prescribing information for JORNAY PM at http://ironshorepharma.com/labeling.pdf.
IMPORTANT SAFETY INFORMATION
WARNING: ABUSE AND DEPENDENCE
CNS stimulants, including JORNAY PM, other methylphenidate-containing products, and amphetamines, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence while on therapy.
WARNINGS AND PRECAUTIONS
PREGNANCY AND LACTATION
Please see additional safety information in the full prescribing information for JORNAY PM at http://ironshorepharma.com/labeling.pdf.
This press release contains forward-looking information, which reflects Ironshore’s current expectations regarding future events. Forward-looking information is based on a number of assumptions and is subject to a number of risks and uncertainties, many of which are beyond Ironshore’s control that could cause actual results and events to differ materially from those that are disclosed in or implied by such forward-looking information. These forward-looking statements are made as of the date of this press release and, except as expressly required by applicable law, Ironshore assumes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Nelson F. Isabel, Chief Financial Officer
Ironshore Pharmaceuticals & Development, Inc.
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