GEORGE TOWN, Grand Cayman--(BUSINESS WIRE)--Ironshore Pharmaceuticals Inc. (“Ironshore”), a wholly owned subsidiary of Highland Therapeutics Inc. (“Highland”), today announced the appointment of Scott Evangelista to the position of President & Chief Operating Officer (COO). Prior to joining Ironshore, Mr. Evangelista was President of Integrated Engagement Services at Quintiles (now IQVIA) where he was responsible for the Outsourced Commercial Businesses that supported companies in launching and growing their pharmaceutical brands.
Commenting on the appointment, Mr. David Lickrish, Highland’s Chairman & CEO stated, “Scott brings a unique perspective to the launch of new drugs gained from decades of experience providing front-line commercialization support to a variety of companies at various stages of growth. His unique skills and insight will help Ironshore be nimble and innovate in a rapidly evolving U.S. market as we prepare to launch our first drug. We believe JORNAY PM™ is an important treatment option for ADHD patients and the physicians who treat them, and we are thrilled to welcome Scott to the Senior Leadership Team at Ironshore to help support its launch in 2019.”
Approved 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 Ironshore’s proprietary drug delivery platform, DELEXIS®.
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
Commenting on his appointment, Mr. Evangelista said, “The opportunity to work with Ironshore to launch a game-changing treatment option, in a market that has not seen real innovation for over a decade, was impossible to pass up. Ironshore’s unwavering commitment to focusing on patient needs and meaningful clinical outcomes, has resulted in the development of an ADHD treatment unlike anything else. JORNAY PM represents everything that I love about combining ground-breaking drug delivery technology with a deep understanding of the clinical needs to make a meaningful difference in the lives of patients and their caregivers.”
Mr. Evangelista brings a wealth of commercial leadership and strategy expertise gained during a 26-year career in the life sciences industry. He has extensive experience across the spectrum of commercial operations including strategic management, sales, marketing, licensing, product growth, and clinical development. Prior to his employment at Quintiles, Mr. Evangelista was the National Commercial Life Sciences Practice Leader at Deloitte, a management consultancy firm. Mr. Evangelista also founded Swiftwater Group LLC, a specialty life sciences consulting firm that helped clients develop and implement successful life cycle plans and improve product performance at all stages — from designing effective launch programs to managing product extensions.
Mr. Evangelista holds a Bachelor of Science/Bachelor of Arts degree in Finance and a Master of Science/Master’s in Information Science degree from Boston University.
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.
- 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 has been reported in association with CNS stimulants at recommended doses in pediatric patients with structural cardiac abnormalities or other serious heart problems. In adults, sudden death, stroke, and myocardial infarction have been reported. Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart arrhythmias, or coronary artery disease.
- Blood Pressure and Heart Rate Increases: Monitor blood pressure and pulse. Consider the benefits and risks in patients for whom an increase in blood pressure or heart rate would be problematic.
- Psychiatric Adverse Reactions: Use of CNS stimulants may cause psychotic or manic symptoms in patients with no prior history, or exacerbation of symptoms in patients with pre-existing psychiatric illness. Evaluate for bipolar disorder prior to JORNAY PM use.
- Priapism: Cases of painful and prolonged penile erections and priapism have been reported with methylphenidate products. 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: Monitor height and weight at appropriate intervals in pediatric patients.
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.
Please see additional safety information in the Full Prescribing Information for Jornay PM at http://ironshorepharma.com/labeling.pdf.
About Ironshore Pharmaceuticals Inc.
Ironshore Pharmaceuticals Inc., a wholly owned subsidiary of Highland Therapeutics Inc., is a pharmaceutical company that is focused on the commercialization of innovative pharmaceutical brands in the U.S.
Highland Therapeutics Inc. is a client of MaRS Discovery District’s Health Venture Services group, which provides advisory services, connections to talent, customer & capital networks, and market intelligence to high-impact, Ontario-based life sciences ventures, helping them commercialize their ideas and build globally competitive companies.
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, Highland assumes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.