BOSTON, Sept. 27, 2021 /PRNewswire/ -- Corium, Inc.
(Corium), a commercial-stage biopharmaceutical company leading the
development and commercialization of novel central nervous system
(CNS) therapies, today announces that it has closed on a
$235 million term loan agreement with
Hercules Capital, Inc. (NYSE: HTGC), a leader in specialty
financing for life science and technology companies. Corium
will receive an initial tranche of $100
million, and the remaining funds will be available in three
additional tranches upon the achievement of certain pre-defined
milestones.
Corium Secures $235 Million in Debt
Financing
Proceeds to be Used to Commercialize AZSTARYS™ and Advance
Pipeline
"This financing will provide funds to support continued U.S.
commercialization of AZSTARYS which is now available for the
treatment of ADHD for patients 6 years of age and over that was
approved by the FDA in March of this year, and the advancement of
our pipeline, including our investigational treatment for
Alzheimer's," says Perry J.
Sternberg, President and CEO of Corium. "I am
extremely proud of Hercules' confidence in Corium and its belief in
our growth potential."
"Hercules is pleased to enter into a strategic relationship with
Corium at this pivotal time in its evolution" says Michael Dutra, Managing Director at Hercules
Capital. "With an approved product now available that can help
address unmet medical needs, other potentially promising drugs in
development, and a successful contract development and
manufacturing operation business, Corium is executing on its
mission to provide clinicians with important new treatment options.
This substantial capital commitment from Hercules aims to help
Corium turn innovative technology into important commercial
products and reflects our dedication to provide customized
financing solutions to growth-stage life science companies."
J. Wood Capital Advisors LLC was the exclusive advisor
to Corium in the financing transaction.
Commercialization of AZSTARYS
AZSTARYS (serdexmethylphenidate [SDX] and dexmethylphenidate
[d-MPH]) (CII) was approved by the U.S. Food and Drug
Administration (FDA) in March 2021
for the treatment of Attention Deficit and Hyperactivity Disorder
(ADHD) in patients six years and older. AZSTARYS is the first
and only product containing SDX, a prodrug of d-MPH. AZSTARYS,
classified by the U.S. Drug Enforcement Administration as a
Schedule II controlled substance, includes a combination of 70
percent extended-release prodrug of d-MPH SDX (Schedule IV) and 30
percent immediate-release d-MPH (Schedule II). Its novel
formulation is designed to provide rapid and extended duration of
symptom control. AZSTARYS is available in three once-daily
strengths of SDX/d-MPH: 26.1/5.2mg, 39.2/7.8mg, and 52.3/10.4mg,
providing dosing flexibility to meet the needs of each
patient.
Indication and Important Safety Information for
AZSTARYS
AZSTARYS is a central nervous system (CNS) stimulant indicated
for the treatment of Attention Deficit Hyperactivity Disorder
(ADHD) in patients aged 6 years and older.
WARNING: AZSTARYS is a federally controlled substance (CII)
because it can be abused or lead to dependence. Keep
AZSTARYS in a safe place to prevent misuse and abuse. Selling
or giving away AZSTARYS may harm others and is against the
law.
Tell your healthcare provider if you or your child have ever
abused or been dependent on alcohol, prescription medicines, or
street drugs.
Who should not take AZSTARYS?
Do not take AZSTARYS if you or your child are:
- allergic to serdexmethylphenidate, methylphenidate, or any of
the ingredients in AZSTARYS.
- taking or have stopped taking within the past 14 days a
medicine used to treat depression called a monoamine oxidase
inhibitor (MAOI).
Serious problems can occur while taking AZSTARYS. Tell your
healthcare provider:
- if you or your child have heart problems, heart defects, high
blood pressure, or a family history of these problems. Sudden death
has occurred in people with heart problems or defects taking
stimulant medicines. Sudden death, stroke and heart attack have
happened in adults taking stimulant medicines. Your doctor should
check you or your child carefully for heart problems before
starting AZSTARYS. Since increases in blood pressure and heart rate
may occur, the doctor should regularly check these during
treatment. Call your healthcare provider right away or go to the
nearest hospital emergency room if you or your child have any signs
of heart problems such as chest pain, shortness of breath, or
fainting while taking AZSTARYS.
- if you or your child have mental (psychiatric) problems, or a
family history of suicide, bipolar illness, or depression. New or
worse behavior and thought problems or new or worse bipolar illness
may occur. New psychotic symptoms (such as seeing or hearing things
that are not real, believing things that are not true, being
suspicious) or new manic symptoms may occur. Call your
healthcare provider right away if there are any new or worsening
mental symptoms or problems during treatment.
- if you or your child develop painful and prolonged erections
(priapism), seek medical help right away. Priapism has occurred
with methylphenidate (AZSTARYS). Because priapism can cause
long-lasting damage, it should be checked by a healthcare
professional right away
- if you or your child have circulation problems in fingers and
toes (called peripheral vasculopathy, including Raynaud's
phenomenon). Fingers or toes may feel numb, cool, painful,
sensitive to temperature, and/or change color from pale, to blue,
to red. Call your healthcare provider right away if any signs of
unexplained wounds appear on fingers or toes while taking
AZSTARYS.
- if your child is having slowing of growth (height and weight);
Your child should have his or her height and weight checked often
while taking AZSTARYS.
- if you or your child are pregnant or plan to become pregnant.
It is not known if AZSTARYS may harm your unborn baby.
- if you or your child are breastfeeding or plan to breastfeed.
AZSTARYS passes into breast milk. Talk to your healthcare provider
about the best way to feed your baby if you take AZSTARYS.
What are possible side effects of AZSTARYS?
The most common side effects of AZSTARYS include:
•
decreased appetite
•
nausea
•
indigestion
• weight
loss
|
•
trouble sleeping
•
vomiting
•
stomach pain
•
anxiety
|
•
dizziness
|
•
irritability
|
• mood
swings
•
increased blood pressure
|
•
increased heart rate
|
These are not all the possible side effects of AZSTARYS. Call
your doctor for medical advice about side effects.
What is AZSTARYS?
AZSTARYS is a central nervous system (CNS) stimulant
prescription medicine for the treatment of Attention-Deficit
Hyperactivity Disorder (ADHD) in people 6 years of age and older.
AZSTARYS may help increase attention and decrease impulsiveness and
hyperactivity in people with ADHD.
For additional safety information, click here
for Prescribing Information and Medication
Guide and discuss with your doctor.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch, or
call 1-800-FDA-1088.
About Corium
Corium, Inc. is a commercial-stage biopharmaceutical company
that is leading the development and commercialization of novel
central nervous system CNS therapies that provide clinicians with
important new treatment options for patients, their families, and
their caregivers. Corium recently launched AZSTARYS, its ADHD
drug for persons six and older, in the U.S. AZSTARYS was approved
by the U.S. FDA in March 2021. In
November 2018, all of Corium's
outstanding stock was acquired by an affiliate of Gurnet Point
Capital. For further information, please visit
www.corium.com.
Corium's President and CEO, Perry J.
Sternberg, is a biotechnology and pharmaceutical industry
leader with more than 25 years of commercial experience across a
wide range of therapeutic areas, including ADHD in diverse
markets. Prior to joining Corium, Mr. Sternberg served a dual
role at Shire Plc (Shire) as the Head of U.S. Commercial for seven
therapeutic area business units, as well as the Chief Commercial
Officer/Head of the Neuroscience Division, before the acquisition
of Shire by Takeda Pharmaceutical Corporation Limited in early
2019.
About Gurnet Point Capital
Gurnet Point Capital is a unique healthcare fund founded by
Ernesto Bertarelli and led by
Chris Viehbacher, who, together,
have decades of expertise in an industry for which they share a
passion, both as Chief Executives and as investors. With an
initial allocation of $2 billion, GPC
is investing long-term capital and supporting entrepreneurs in
building a new generation of companies. Based in Cambridge, MA, its remit is global,
encompassing life sciences and medical technologies. The fund
invests across all stages of product development through to
commercialization and does so with an approach that is a hybrid of
venture and private equity investing strategies.
www.gurnetpointcapital.com
Contact:
Corium, Inc.
Heather Gartman
202-413-4226
Gartmanpr@gmail.com
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SOURCE Corium, Inc.