“Hercules is pleased to enter into a strategic relationship with Corium at this pivotal moment in its evolution”, declares Michel Dutra, Managing Director of Hercules Capital. “With an approved product now available that can help meet unmet medical needs, other potentially promising drugs in development, and successful contract development and manufacturing operations, Corium is fulfilling its mission of providing important new treatment options for clinicians. This substantial capital Hercules’ commitment aims to help Corium transform innovative technology into meaningful commercial products and reflects our commitment to provide customized financing solutions to growing life science companies. ”
J. Wood Capital Advisors LLC was the exclusive advisor to Corium in the financing transaction.
Marketing of AZSTAYS
AZSTARYS (serdexmethylphenidate [SDX] and dexmethylphenidate [d-MPH]) (CII) was approved by the United States Food and Drug Administration (FDA) in March 2021 for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients six years of age and older. AZSTARYS is the first and only product containing SDX, a d-MPH prodrug. AZSTAYS, classified by the U.S. Drug Enforcement Administration as a Schedule II Controlled Substance, comprises a combination of 70 percent d-MPH sustained-release prodrug SDX (Schedule IV) and 30 percent d- MPH immediate release (Annex II). Its new formulation is designed to provide fast and extended duration of symptom control. AZSTARYS is available in three once-daily SDX / d-MPH strengths: 26.1 / 5.2 mg, 39.2 / 7.8 mg and 52.3 / 10.4 mg, providing dosing flexibility for meet the needs of each patient.
Important safety notice and information for AZSTAYS
AZSTAYS is a central nervous system (CNS) stimulant indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in patients 6 years of age and older.
WARNING: AZSTARYS is a federally controlled substance (CII) because it can be abused or lead to addiction. Keep AZSTARYS in a safe place to prevent misuse and abuse. Selling or giving away AZSTARS may harm others and is against the law.
Tell your health care provider if you or your child have ever abused or been dependent on alcohol, prescription drugs, or street drugs.
Who should not take AZSTARS?
Do not take AZSTARYS if you or your child are:
- allergic to serdexmethylphenidate, methylphenidate or any of the ingredients in AZSTARYS.
- you have taken or have stopped taking in the last 14 days a medicine used to treat depression called a monoamine oxidase inhibitor (MAOI).
Serious problems can occur when taking AZSTARYS. Tell your health care provider:
- if you or your child has heart problems, heart defects, high blood pressure or a family history of these problems. Sudden death has occurred in people with heart problems or heart defects taking stimulant drugs. Sudden deaths, strokes, and heart attacks have occurred in adults taking stimulant drugs. Your doctor should carefully check whether you or your child has any heart problems before starting AZSTARYS. Since increases in blood pressure and heart rate may occur, the doctor should monitor them regularly during treatment. Call your health care provider right away or go to the nearest hospital emergency room if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting during the treatment. treatment with AZSTARYS..
- if you or your child has mental (psychiatric) problems or a family history of suicide, bipolar illness or depression. New or worse behavior and thinking problems or new or worse bipolar disease 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 health care provider right away if there are any new or worsening symptoms or mental problems during treatment.
- if you or your child develop painful and prolonged erections (priapism), see a doctor immediately. Priapism has occurred with methylphenidate (AZSTARYS). Because priapism can cause lasting damage, it should be checked out immediately by a healthcare practitioner.
- if you or your child have circulation problems in the fingers and toes (called peripheral vasculopathy, including Raynaud’s phenomenon). Fingers or toes may be numb, cold, sore, temperature sensitive, and / or change color from pale to blue, then red. Call your health care provider right away if any signs of unexplained sores appear on your fingers or toes while you are taking AZSTARYS.
- if your child has stunted growth (height and weight); Your child should have their height and weight checked often while taking AZSTARYS.
- if you or your child is pregnant or planning to become pregnant. It is not known whether AZSTAYS can harm your unborn baby.
- if you or your child is breast-feeding or planning to breast-feed. AZSTARYS passes into breast milk. Talk to your healthcare professional about the best way to feed your baby if you are taking AZSTARYS.
What are the possible side effects of AZSTARYS?
The most common side effects of AZSTARYS include:
• decreased appetite
• sleeping troubles
• Stomach pain
• mood swings
• increased blood pressure
• increased heart rate
These are not all the possible side effects of AZSTARYS. Call your doctor for medical advice on side effects.
What is AZSTARS?
AZSTAYS is a central nervous system (CNS) stimulant prescription medication for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in people 6 years of age and older. AZSTAYS can help increase attention and decrease impulsivity and hyperactivity in people with ADHD.
We encourage you to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Corium, Inc. is a commercial-stage biopharmaceutical company 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 medication for people six years of age and older, in the United States. AZSTARYS was approved by the United States FDA in March 2021. In november 2018, all of the outstanding shares of Corium were acquired by a subsidiary of Gurnet Point Capital. For more information, please visit www.corium.com.
Chairman and CEO of Corium, Perry J. Sternberg, is a leader in the biotechnology and pharmaceutical industry with over 25 years of business experience in a wide range of therapeutic areas, including ADHD in various markets. Prior to joining Corium, Mr. Sternberg held a dual role at Shire Plc (Shire) as US Sales Manager for seven Therapeutics business units, as well as Sales Director / Head of Neuroscience Division, prior to 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 they share a passion for, both as CEOs and as investors. With an initial endowment of $ 2 billion, GPC invests long-term capital and supports entrepreneurs in building a new generation of businesses. Situated at Cambridge, MA, its mission is global, encompassing life sciences and medical technologies. The fund invests at all stages of product development through commercialization and does so with an approach that is a hybrid of venture capital and private equity investment strategies. www.gurnetpointcapital.com
SOURCE Corium, Inc.