Ironshore Pharmaceuticals Announces Appointment of Dr. Lewis Warrington as Vice President / Head of Medical Affairs

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, Ironshores 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 Companys 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. Warringtons 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.

  • 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

See additional safety information below

ABOUT ADHD

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.

CONTRAINDICATIONS

  • Known hypersensitivity to methylphenidate or other components of JORNAY PM. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with methylphenidate products.
  • Concurrent treatment with a monoamine oxidase inhibitor (MAOI), or use of an MAOI within the preceding 14 days because of the risk of hypertensive crisis.

WARNINGS AND PRECAUTIONS

  • Serious Cardiovascular Reactions: Sudden death, stroke, and myocardial infarction have been reported in adults treated with CNS stimulants at recommended doses. Sudden death has been reported in pediatric patients with structural cardiac abnormalities and other serious heart problems taking CNS stimulants at recommended doses for ADHD. Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart arrhythmias, coronary artery disease, and other serious cardiac problems.
  • Blood Pressure and Heart Rate Increases: CNS stimulants may cause an increase in blood pressure and heart rate. Monitor all patients for hypertension and tachycardia.
  • Psychiatric Adverse Reactions: CNS stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychiatric disorder and may induce a manic or mixed episode in patients with bipolar disorder. In patients with no prior history of psychotic illness or mania, CNS stimulants, at recommended doses, may cause psychotic or manic symptoms.
  • Priapism: Prolonged and painful erections, sometimes requiring intervention, have been reported with methylphenidate products in both pediatric and adult patients. Priapism has also appeared during a period of drug withdrawal. Immediate medical attention should be sought if signs or symptoms of prolonged penile erections or priapism are observed.
  • Peripheral Vasculopathy, including Raynauds Phenomenon: CNS stimulants used to treat ADHD are associated with peripheral vasculopathy, including Raynauds phenomenon. Careful observation for digital changes is necessary during treatment with ADHD stimulants.
  • Long-Term Suppression of Growth: CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients. Monitor height and weight at appropriate intervals in pediatric patients.

ADVERSE REACTIONS

  • Based on accumulated data from other methylphenidate products, the most common (>5% and twice the rate of placebo) adverse reactions for pediatric patients and adults are: appetite decreased, insomnia, nausea, vomiting, dyspepsia, abdominal pain, weight decreased, anxiety, dizziness, irritability, affect lability, tachycardia, and blood pressure increased.
  • Additional adverse reactions (‰¥5% and twice the rate of placebo) in pediatric patients 6 to 12 years treated with JORNAY PM: headache, psychomotor hyperactivity, and mood swings.

PREGNANCY AND LACTATION

  • CNS stimulant medications, such as JORNAY PM, can cause vasoconstriction and thereby decrease placental perfusion.
  • The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for JORNAY PM and any potential adverse effects on the breastfed infant from JORNAY PM or from the underlying maternal condition. Monitor breastfeeding infants for adverse reactions, such as agitation, insomnia, anorexia, and reduced weight gain.

Please see additional safety information in the full prescribing information for JORNAY PM at http://ironshorepharma.com/labeling.pdf.

Forward-Looking Statements

This press release contains forward-looking information, which reflects Ironshores 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 Ironshores 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.
(345) 749-8170