AP NEWS
Press release content from Business Wire. The AP news staff was not involved in its creation.
PRESS RELEASE: Paid content from Business Wire
Press release content from Business Wire. The AP news staff was not involved in its creation.

Ironshore to Present Data From a Pivotal Trial of JORNAY PM™ (methylphenidate HCl) CII at the 31st Annual International Conference on ADHD

November 4, 2019 GMT

RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--Nov 4, 2019--

Ironshore Pharmaceuticals Inc. (“Ironshore”), a wholly owned subsidiary of Highland Therapeutics Inc. and a leader in the commercialization of novel treatments for Attention-Deficit/Hyperactivity Disorder (“ADHD”), today announced that it will present data from a pivotal trial of JORNAY PM™ (methylphenidate HCl) extended-release capsules CII for the treatment of ADHD in patients 6 years and older and participate as a premier sponsor of the 31 st Annual International Conference on ADHD in Philadelphia, November 6-9, 2019. Attendees are encouraged to visit Ironshore representatives at Booths 210 & 309 to learn more about JORNAY PM.

JORNAY PM is the only stimulant medication that is dosed in the evening and has demonstrated improvement in the severity of ADHD symptoms in the early morning and throughout the day. JORNAY PM became commercially available in the United States in June 2019.

WARNING: ABUSE AND DEPENDENCE

See full prescribing information for complete boxed warning.

See additional important safety information below.

“Ironshore is proud to be a premier sponsor of the largest conference on ADHD,” said Dr. Randy Sallee, Ironshore’s Chief Medical Officer. “We look forward to convening with those on the frontline of ADHD, from clinicians and educators to parents and caregivers, and sharing data from one of the JORNAY PM pivotal trials which demonstrated improvement in ADHD symptoms in children during the early morning, late-afternoon and evening.”

The Annual International Conference on ADHD is the largest conference on ADHD and brings together various audiences affected by or involved in the treatment of ADHD, including clinicians, ADHD coaches, educators, advocates, parents and caregivers of children with ADHD and adults with ADHD. The conference is hosted by Children and Adults with Attention-Deficit/Hyperactivity Disorder (CHADD), Attention Deficit Disorder Association (ADDA) and ADHD Coaches Organization (ACO).

Ironshore-sponsored data at this year’s International Conference on ADHD are:

A Randomized, Double-Blind, Placebo-Controlled Study of HLD200, a Delayed-Release and Extended-Release Methylphenidate, in Children with ADHD: An Evaluation of Safety and Efficacy Throughout the Day and Across Settings
November 7, 2019; 5:30 pm – 6:30 pm EST, Philadelphia Marriott Downtown, Exhibit Hall – Franklin A, 4 th Floor
Michelle Po, PhD to present

To schedule an interview with an investigator or Ironshore executive, please contact Lora Grassilli at lgrassilli@klcpr.com.

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

Developed by Ironshore Pharmaceuticals & Development, Inc., 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

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

PREGNANCY AND LACTATION

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 Pharmaceuticals Inc.

Ironshore Pharmaceuticals Inc. commercializes innovative, patient-centric treatment options to improve the lives of patients and caregivers. Based in North Carolina, Ironshore Pharmaceuticals Inc. is responsible for the sales, marketing and distribution of pharmaceutical products within the US. Ironshore Pharmaceuticals Inc. is a wholly owned subsidiary of Highland Therapeutics Inc. based in Toronto, Canada.

About Ironshore Pharmaceuticals & Development, Inc.

Ironshore Pharmaceuticals & Development, Inc., based in Grand Cayman, develops novel therapeutics by leveraging the proprietary drug-delivery technology, DELEXIS®. Ironshore Pharmaceuticals & Development, Inc. is a wholly owned subsidiary of Highland Therapeutics Inc. based in Toronto, Canada.

# # #

Forward-Looking Statements

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.

View source version on businesswire.com:https://www.businesswire.com/news/home/20191104005201/en/

CONTACT: Nelson F. Isabel, Chief Financial Officer

Ironshore Pharmaceuticals & Development, Inc.

(345) 749-8170Media Contact

Lora Grassilli

Kovak-Likly Communications

(203) 762-8833,lgrassilli@klcpr.com

KEYWORD: NORTH CAROLINA UNITED STATES NORTH AMERICA

INDUSTRY KEYWORD: PHARMACEUTICAL HEALTH CLINICAL TRIALS MENTAL HEALTH

SOURCE: Ironshore Pharmaceuticals Inc.

Copyright Business Wire 2019.

PUB: 11/04/2019 08:00 AM/DISC: 11/04/2019 08:01 AM

http://www.businesswire.com/news/home/20191104005201/en