GRAND CAYMAN, Cayman Islands--(BUSINESS WIRE)-- Ironshore Therapeutics Inc., a privately held pharmaceutical company focused on the commercialization of JORNAY PM® (methylphenidate HCl) extended-release capsules (CII) for patients with ADHD, today announced the appointments of Lewis Warrington as Chief Medical Officer, Nelson F. Isabel as Chief Financial Officer, Nilay Patel as Chief Legal Officer and Tim Branz as Chief Information Officer. Additionally, Ironshore welcomes Micheal Westphall as Chief People Officer and Aron Chuc as Vice President, Market Access Strategy.

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“It is a pleasure to welcome Lewis, Nelson, Nilay and Tim into their new leadership roles and Micheal and Aron into the Ironshore family at this critical juncture for the company. As we continue to build and expand the organization and increase our efforts in support of the U.S. commercialization of JORNAY PM®, their respective talents complement the team already in place, helping to ensure we are able to meet the needs of an increasingly diverse group of patients, caregivers, and stakeholders,” said Stephanie Read, President and Chief Executive Officer. “As we look forward, we intend to build a robust pipeline of new products, in addition to evaluating new patient populations who may benefit from JORNAY PM through continued research and development efforts, furthering our mission to develop and commercialize first-in-class treatment options to improve the lives of patients and caregivers.

“We are also extremely proud and honored that JORNAY PM has been nominated for the 2022 Prix Galien USA Best Pharmaceutical Agent Award. Since 2007, this prestigious award has acknowledged the leading-edge of scientific advances in life sciences. It is truly an exciting time for Ironshore as an emerging pharmaceutical company. Our top-talent have taken JORNAY PM, from our Founder’s concept on a napkin, through all stages of development, launch, and successful commercialization of a first-in-class treatment option for ADHD patients and caregivers. Finally, we are grateful to our newest investors for the unique position that we find ourselves in: a rapidly growing, commercial-stage, award-nominated Company which remains privately held.”

Lewis Warrington, MD, Chief Medical Officer

Dr. Lewis Warrington assumes the role of global Chief Medical Officer with extensive experience in Psychiatry, having completed a General Adult Psychiatry residency at the University of Virginia and a Child and Adolescent Psychiatry fellowship at the University of Florida. He also completed a Postdoctoral Fellowship in Neuropsychopharmacology at the Mayo Clinic. Over a 20-year career in pharmaceutical medicine in roles of increasing responsibility, Lewis has worked in multiple disease state areas to include ADHD, Schizophrenia, Bipolar Disorder, Major Depression, and Insomnia with a pedigree spanning Merck, Novartis, Sanofi and Pfizer.

Nelson F. Isabel, Chief Financial Officer

Nelson F. Isabel assumes the role of Chief Financial Officer of Ironshore, with 18 years of experience as a pharmaceutical industry executive. Prior to joining the Company, Nelson spent seven years at Biovail Corporation (now Bausch Health), Canada’s largest publicly traded pharmaceutical company, where he served on its Finance Leadership Team and was responsible for all investor relations activities. Prior to Biovail, Nelson was an equity research analyst covering the North American healthcare industry with CIBC World Markets and with Desjardins Securities.

Nelson has a B.Sc. in Biology (Experimental Animal Physiology) and a Master of Business Administration from the Schulich School of Business in Toronto. He has been a CFA Charterholder since 2002.

Nilay Patel, Chief Legal Officer

Nilay Patel assumes the role of Chief Legal Officer with over 20 years in the pharmaceutical industry. Nilay has broad legal experience, from both private practice and as in-house counsel, supporting every stage of pharmaceutical development and commercialization, across several products and disease states.

Nilay holds a JD from Columbia Law School and a BS Biochemistry from NC State University. He is also a registered patent attorney.

Tim Branz, Chief Information Officer

Tim Branz commenced his career in technology via PWC during the merger of Price Waterhouse / Coopers & Lybrand in 1999. Starting in Global Technology Solutions division at the National Network Operations Center, he transitioned to Healthcare Revenue Cycle Management where he was able to grow within the business for more than 20 years writing and leading software development efforts of proprietary RCM systems, managing the transition to cloud computing, and spearheading the evolution of security, governance, risk management, and compliance programs, serving in his final position as CIO prior to joining Ironshore’s IT leadership team in 2021. Tim holds a Bachelor’s degree from Stetson University and a Master’s degree in Computer Information Systems from Nova Southeastern University.

Micheal Westphall, Chief People Officer

Micheal Westphall has accepted the role of Chief People Officer bringing 20 years of progressive Human Resources experience including managing organizational growth and change. Most recently, Micheal was an HR Consultant, leading client organizations through establishing a strategic HR function. Micheal spent four years as the Global Head of Rewards and HR Operations at AveXis/Novartis Gene Therapies where she built an efficient HR Rewards organization to support the growth of the company from start-up through their first product launch. Micheal has also held various HR leadership roles in private and public organizations including Alight Solutions, Aon, and Abbott Laboratories.

Micheal holds an MBA from the University of Wisconsin-Whitewater and bachelor’s degree from California State University-San Bernardino.

Aron Chuc, Vice President, Market Access Strategy

Aron Chuc has accepted the role of Vice President, Market Access Strategy bringing over 17 years of pharmaceutical/biotech experience ranging from start-ups to multinationals including market access, sales, sales leadership, payer marketing, analytic and managed markets. He has extensive experience in contracting strategy, business development and brand value proposition to Payors with in-depth knowledge in various therapeutic areas including Central Nervous Systems, Cardiovascular, Respiratory and Gastrointestinal. For the past five years, Aron has worked at Alnylam Pharmaceuticals as their Sr. Director of Pricing, Contracting and Market Access. Prior to this, he held commercial roles at Orexigen Therapeutics, Chiasma Pharmaceuticals, Aegerion Pharmaceuticals, Sunovion Pharmaceuticals, Eli Lilly, and Astra Zeneca.

Aron holds an MBA Finance & Accounting from Vanderbilt University and a BA and a BS in Economics and Business Administration from SUNY Stony Brook.

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.
• Concurrent treatment with a monoamine oxidase inhibitor (MAOI), or use of an MAOI within the preceding 14 days.

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 Raynaud’s Phenomenon: CNS stimulants used to treat ADHD are associated with peripheral vasculopathy, including Raynaud’s 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 visit http://ironshorepharma.com/labeling.pdf for additional important safety information and the Full Prescribing Information, including Boxed Warning, for JORNAY PM.

About Ironshore Therapeutics Inc.

Ironshore Therapeutics Inc. (formerly known as Highland Therapeutics Inc.) is a pharmaceutical company whose mission is to develop and commercialize first-in-class treatment options to improve the lives of patients and caregivers.

Forward-Looking Statements

This press release contains forward-looking information, which reflects the company’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 the company’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, the company assumes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

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