Market Overview

Ironshore Pharmaceuticals Announces Agreement for $143 Million in Senior Secured Notes Financing


Pharmaceuticals & Development, Inc.
("Ironshore"), a wholly
owned subsidiary of Highland
Therapeutics Inc.
, today announced that it has entered into
agreements with purchasers to raise approximately US$143 million at a
purchase price of 98% by way of a private placement of Senior Secured
Notes. Morgan Stanley & Co. LLC is acting as sole placement agent for
the offering. The completion of the offering is subject to customary
conditions and it is anticipated that closing will occur on or about
August 22, 2018.

"With the FDA approval of JORNAY PM™ in hand, our primary focus has
shifted to ensuring an optimal commercial launch of this innovative drug
with its unique value proposition. JORNAY PM is the only stimulant
medication that is dosed once daily in the evening and was developed to
help patients with Attention Deficit Hyperactivity Disorder (ADHD)
obtain better control over the disruptive impairments they typically
experience during the early morning routine and throughout the day,"
said David Lickrish, President and Chief Executive Officer. "This
financing, in conjunction with the funds raised in 2017, will provide
the necessary resources for Ironshore to fully support the launch of a
blockbuster drug and fund the anticipated costs of all planned
commercialization and marketing initiatives with the launch of the drug
projected to occur in the first half of 2019."


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
  • Assess the risk of abuse prior to prescribing, and monitor for signs
    of abuse and dependence while on therapy

See additional safety information below

JORNAY PM (methylphenidate) extended-release capsules CII were approved
by the U.S. Food and Drug Administration (FDA) on August 8, 2018 for the
treatment of ADHD in patients 6 years and older.

Stimulant medications have been a cornerstone of ADHD treatment for
decades and more than 67.3 million prescriptions were written for these
products in the U.S. in the twelve months ended June 30, 20181.
The leading brand, Vyvanse2, reported U.S. net revenues of
US$2.0 billion over the same period. Ironshore has developed a product
for this market that represents a differentiated value proposition for
the treatment of ADHD. JORNAY PM is the only stimulant medication that
is dosed in the evening with demonstrated improvement in the severity of
ADHD symptoms in the early morning and throughout the day. Please see
additional dosing information in the full prescribing information at

Goodmans LLP is acting as Lead Counsel, King & Spalding LLP is acting as
U.S. counsel and Solomon Harris is acting as Cayman Islands counsel for
Ironshore in connection with the offering.


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



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


  • 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

1 As reported by IQVIA

2 Vyvanse is a registered trademark of Shire LLC

About Ironshore Pharmaceuticals & Development, Inc.

Ironshore Pharmaceuticals & Development, Inc., a wholly owned subsidiary
of Highland Therapeutics Inc., is a pharmaceutical company that is
leveraging its proprietary technology, DELEXIS®, to optimize the
delivery of previously approved drug products.

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. For more information, visit

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.

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