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Now Available – JORNAY PM™ (Methylphenidate HCl) CII, the First and Only ADHD Stimulant Dosed in the Evening

Novel Drug Delivery Technology Offers Hope to Families Struggling
Through Morning Routines

RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–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 JORNAY
PM™ (methylphenidate HCl) extended-release capsules CII
is now
available in the United States. JORNAY PM is a CNS stimulant approved by
the U.S. Food and Drug Administration (“FDA”) for the treatment of ADHD
in patients 6 years and older. JORNAY PM is the first and only ADHD
stimulant medication that is dosed in the evening and helps improve
symptoms from the time the patient wakes up the next morning and
continues to control symptoms throughout the day. The evening
administration of a stimulant medication is made possible by DELEXIS®,
Ironshore’s novel drug delivery platform. DELEXIS contains two
functional film coatings that act synergistically to achieve a unique
pharmacokinetic profile. The first layer delays the initial release of
drug for up to 10 hours while the second layer helps to control the rate
of release of the active pharmaceutical ingredient throughout the day.

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 important safety information below.

JORNAY PM was well tolerated in clinical trials with a safety profile
generally consistent with other methylphenidate products. Based on
accumulated data from other methylphenidate products, the most common
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
in pediatric patients 6 to 12 years treated with JORNAY PM: headache,
psychomotor hyperactivity, and mood swings. JORNAY PM is the first drug
utilizing Ironshore’s proprietary drug delivery platform, DELEXIS, and
is available in 20 mg, 40 mg, 60 mg, 80 mg, and 100 mg extended-release
capsules.

“The launch of our first commercial product for the treatment of ADHD
marks an important milestone in the Company’s history and demonstrates
our commitment to developing innovative, patient-centric treatment
options for patients with ADHD,” said David Lickrish, Chief Executive
Officer of Ironshore Pharmaceuticals & Development Inc. “We are
delighted to offer the ADHD community a novel medicine, developed over a
10-year period and supported by nine clinical studies, including two
pivotal trials, that works when patients wake up, but does not come at
the expense of coverage throughout the day.”

Commenting on the availability of JORNAY PM, Dr. Randy Sallee,
Ironshore’s Chief Medical Officer said, “ADHD can adversely impact a
patient’s ability to complete their morning routine, prepare for the
day, and get out of the house in the morning. As a Board Certified
psychiatrist, I believe the therapeutic profile of JORNAY PM, enabled by
advanced drug-delivery technology, has the potential to have a profound
impact on treatment paradigms in ADHD.”

Results from clinical studies demonstrated that children with ADHD
treated with JORNAY PM showed improved symptoms in the early morning
that lasted throughout the day. The drug also showed significant
improvements in standard tests that measure ADHD symptoms at home and
school throughout the day, as well as with new assessment tools that
measure difficulties in the early morning, late afternoon and evening.

“Patients with ADHD can have very challenging mornings,” said Dr. Ann
Childress, M.D, President, Center for Psychiatry and Behavioral
Medicine, Inc. in Las Vegas and Clinical Trial Investigator. “Several
families I work with have developed a number of creative, but often
disruptive strategies, like waking up extra early to take medicine in an
attempt to improve the early morning routine. I believe that JORNAY PM
represents a welcome addition to the therapeutic options available to
physicians that treat ADHD as well as for families who face
ADHD-associated difficulties, not only during the morning routine but
throughout the day.”

About Ironshore’s Phase III Clinical Studies

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. In addition to the
traditional scales that assess efficacy in ADHD clinical trials such as
the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) rating scale and
the ADHD Rating Scale (ADHD-RS-IV), Ironshore’s pivotal trials assessed
JORNAY PM’s efficacy in the early morning period using the morning
subscale of the Parent Rating of Evening and Morning Behavior-Revised
scale (PREMB-R AM) and the Before School Functioning Questionnaire
(BSFQ).

In Study 1, improvement in ADHD manifestations in a classroom setting
was demonstrated by the primary endpoint, an average of all post-dosed
SKAMP combined scores measured during a 12-hour period (8:00 AM to 8:00
PM), and improvement in ADHD manifestations in the early morning was
demonstrated by the secondary endpoint, PREMB-R AM.

In Study 2, improvement in ADHD manifestations throughout the day was
demonstrated by the primary endpoint, ADHD-RS-IV, and improvement in
ADHD manifestations before school was demonstrated by the secondary
endpoint, the BSFQ, which is intended to assess early morning before
school activities from the time the child awakens and some behaviors not
specific to early morning.

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

  • Known hypersensitivity to methylphenidate or other components of
    JORNAY PM. Hypersensitivity reactions such as angioedema and
    anaphylactic reactions have been reported in patients treated with
    methylphenidate products.
  • Concurrent treatment with a monoamine oxidase inhibitor (MAOI), or use
    of an MAOI within the preceding 14 days because of the risk of
    hypertensive crisis.

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 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 its 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.

Contacts

Nelson F. Isabel
Ironshore Pharmaceuticals & Development, Inc.
(345)
749-8170

Media Contact
Lora Grassilli
Kovak-Likly Communications
(203)
762-8833, [email protected]

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