Corium, Inc., a commercial-stage biopharmaceutical company leading the development and commercialization of novel central nervous system therapies, announces that it has closed on a $235 million term loan agreement with Hercules Capital, Inc., a leader in specialty financing for life science and technology companies.
Proceeds to be Used to Commercialize AZSTARYS™ (serdexmethylphenidate [SDX] and dexmethylphenidate [d-MPH]) (CII) and Advance Pipeline
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.
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.
Company Codes: NYSE:HTGC
