- Proceeds will be used to launch Jornay PM
- Jornay PM is a novel formulation of methylphenidate which is taken in the evening
- Trials demonstrated improvement in the severity of ADHD symptoms in the early morning and throughout the day
Ironshore Pharmaceuticals, announced on 8/23/18 the closing of the previously announced private placement of Senior Secured Notes (“Notes”). Ironshore issued $143 million in Notes, with Morgan Stanley & Co. LLC acting as sole placement agent for the offering.
Proceeds from the financing will be used to support the commercial launch of Jornay PM (methylphenidate) extended-release capsules CII, Ironshore’s FDA-approved medication for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older. Jornay PM is the only stimulant medication that is dosed once daily in the evening and was developed to help patients with ADHD obtain better control over the disruptive impairments they typically experience during the early morning routine and throughout the day.
“With this financing successfully closed, we are now fully engaged in pre-launch activities, including the recruitment of a seasoned management team to lead our commercialization efforts in the U.S.,” said David Lickrish, President and Chief Executive Officer. “Over the coming weeks, we intend to fill critical roles across several key functional areas of our U.S. organization, including a President and Chief Operating Officer, and leadership positions in Medical Affairs, Compliance and Market Access. We are eager to bring our innovative medicine – Jornay PM – to U.S. healthcare providers, ADHD patients and their caregivers in the first half of 2019.”
Ironshore announced that Jornay PM was approved by the FDA on 8/9/18. Jornay PM is a novel formulation of methylphenidate which 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®.
The effectiveness of JORNAY PM was established in two separate Pivotal Phase III, multicenter, randomized, double-blind, placebo-controlled studies conducted in a total of 278 pediatric patients aged 6 to 12 years with a diagnosis of ADHD per DSM-5 criteria.