BOSTON, Feb. 22, 2023 /PRNewswire/ -- Corium, LLC, a commercial-stage biopharmaceutical company leading the development and commercialization of novel central nervous system (CNS) therapies, announced today publication of the results from a 12-month, open-label, phase 3 safety study of AZSTARYS (serdexmethylphenidate [SDX] and dexmethylphenidate [d-MPH]), which is indicated for treatment of attention-deficit hyperactivity disorder (ADHD) in people ages six and older. Published in the peer-reviewed Journal of Child and Adolescent Psychopharmacology (JCAP), the results show that AZSTARYS provided sustained symptom improvement and was well-tolerated in children aged 6 to 12 who participated in the study. AZSTARYS was approved by the U.S. FDA in March 2021 and has recently been launched nationally by Corium.
BOSTON & CAMBRIDGE, Mass.-(BUSINESS WIRE)--Corium, LLC ("Corium"), a commercial-stage biopharmaceutical company leading the development and commercialization of novel neuroscience therapies, and Gurnet Point Capital ("Gurnet Point"), a private investment firm focused on the healthcare and life sciences sectors, today announced the acquisition of their manufacturing business and a $100 million equity investment by Webster Equity Partners ("Webster"), a healthcare-focused private equity firm that focuses on applying its expertise in the health care services sector to drive sustainability and long term value. The manufacturing business, named Corium Pharma Solutions, Inc. ("Corium Pharma Solutions"), transacted with an investment by Webster for more than $400 million in value.
Corium Launches ADLARITY® (donepezil transdermal system) for Patients with Alzheimer's Dementia
Boston, MA, September 29, 2022 — Corium, Inc., a fully-integrated biopharmaceutical company leading the development and commercialization of novel central nervous system (CNS) therapies, announced today that ADLARITY (donepezil transdermal system) is now available for prescription in the U.S. for the treatment of patients with mild, moderate, or severe dementia of the Alzheimer's type.
Boston, MA, September 21, 2022 — Corium, Inc., a fully integrated biopharmaceutical company leading the development and commercialization of novel central nervous system (CNS) therapies, announced publication of a poster, “Serdexmethylphenidate/Dexmethylphenidate Effects on Sleep in Children With Attention Deficit Hyperactivity Disorder,” at the Psych Congress 2022 in New Orleans. The poster presented an analysis of the twelve-month open label safety study in children ages 6-12 using AZSTARYS (serdexmethylphenidate [SDX] and dexmethylphenidate [d-MPH]), which is indicated for the treatment of attention-deficit hyperactivity disorder (ADHD) in patients six and older. The data showed that the children, after one month of taking AZSTARYS, had statistically significant improvement in their sleep as assessed by the Children's Sleep Habits Questionnaire (CSHQ). The improvement in sleep was sustained through 12 months of treatment with AZSTARYS.
Boston, MA, September 19, 2022 — Corium, Inc., a fully-integrated biopharmaceutical company leading the development and commercialization of novel central nervous system (CNS) therapies, announced publication of its phase 1 healthy volunteer study results for ADLARITY (donepezil transdermal system) in the peer-reviewed Journal of Alzheimer's Disease. The article, “Comparison of Steady-State Pharmacokinetics of Donepezil Transdermal Delivery System with Oral Donepezil,” reports that Corium's novel once-weekly Alzheimer's dementia treatment delivered drug exposure equivalent to oral donepezil while presenting lower gastrointestinal (GI) adverse events overall compared to oral donepezil. The article is currently available online and expected to be published in the hardcopy of the Journal of Alzheimer's Disease, Volume 90, Issue 1, on October 25, 2022.
Boston, MA, September 13, 2022 — Corium, Inc., a commercial-stage biopharmaceutical company leading the development and commercialization of novel central nervous system (CNS) therapies, announces the debut of positive data on September 18, 2022, at the upcoming Psych Congress 2022 in New Orleans about its two FDA-approved medicines, AZSTARYS (serdexmethylphenidate [SDX] and dexmethylphenidate [d-MPH]) for patients six and older with ADHD, and ADLARITY (donepezil transdermal system) for patients with mild, moderate, or severe dementia of the Alzheimer's type.
Boston, MA, August 1, 2022 — Corium, Inc., a commercial-stage biopharmaceutical company leading the development and commercialization of novel central nervous system (CNS) therapies, announced today that both strengths of its new once-weekly ADLARITY (donepezil transdermal system) maintain equivalent daily exposure of donepezil when compared to oral formulations of donepezil, along with a favorable overall gastrointestinal (GI) side effect profile, according to trial results reported in a poster (68981) at the Alzheimer's Association International Conference 2022 in San Diego.
Boston, MA, June 1, 2022 — Corium, Inc., a commercial-stage biopharmaceutical company leading the development and commercialization of novel central nervous system (CNS) therapies, announced that serdexmethylphenidate (SDX), the novel prodrug of dexmethylphenidate (d‑MPH), has significantly lower potential for abuse and fewer stimulant-like adverse events compared to d‑MPH. This peer-reviewed finding appears in the May 2022 publication of Current Medical Research & Opinion. AZSTARYS (serdexmethylphenidate and dexmethylphenidate) is the first and only medicine containing SDX and was approved by the U.S. FDA in March 2021 as a once-daily treatment for ADHD symptoms in patients aged 6 years and older.
Boston, MA, March 28, 2022 — Corium, Inc., a commercial-stage biopharmaceutical company leading the development and commercialization of novel central nervous system (CNS) therapies, announced that its poster, “Serdexmethylphenidate/d-Methylphenidate Capsules for Children With ADHD: Effects on SKAMP‑C Evaluated Over 13 Hours in a Randomized, Double-blind, Placebo-controlled Laboratory Classroom Study,” will be presented at the Academy of Managed Care Pharmacy (AMCP) on March 30, 2022, in Chicago, IL. Corium’s once‑daily oral capsule AZSTARYS (serdexmethylphenidate (SDX) and dexmethylphenidate (d‑MPH)), significantly improved both attention and behavior with a 30‑minute onset and up to 13 hours of duration in children ages 6 to 12 years diagnosed with attention deficit hyperactivity disorder (ADHD), compared to a placebo. An author will report the findings (poster # F21), from a post hoc analysis of a pivotal Phase 3 study, at the AMCP.
Boston, MA, March 14, 2022 — Corium, Inc., a commercial-stage biopharmaceutical company leading the development and commercialization of novel central nervous system (CNS) therapies, announced today the U.S. Food and Drug Administration (FDA) has approved Corium’s ADLARITY (donepezil transdermal system) as a treatment for patients with mild, moderate, or severe dementia of the Alzheimer’s type. ADLARITY is the first and only once-weekly patch to continuously deliver consistent doses of donepezil through the skin, resulting in a low likelihood of adverse gastrointestinal (GI) side effects associated with oral donepezil. ADLARITY is the first approved prescription drug product using Corium’s proprietary CORPLEX transdermal technology, which has been used for years in consumer products.
Boston, MA, January 12, 2022 – PeaceLove Foundation, a nonprofit focused on innovative programs that improve emotional wellbeing by leveraging creativity as a self-care tool, and Corium, Inc., a commercial-stage biopharmaceutical company leading the development and commercialization of novel central nervous system (CNS) therapies, announced an expansion of their existing partnership. Under the new Corium sponsorship, PeaceLove will deliver expressive arts-based Scribl workshops to members of the greater Boston and Grand Rapids, MI communities, where Corium has a presence, and they will also train additional individuals to deliver Scribl workshops at the community level. PeaceLove and Corium have prior existing partnerships, including one that provides Scribl workshops to support the emotional wellbeing of Corium employees.
Boston, MA, October 29, 2021 - Corium, Inc., a commercial-stage biopharmaceutical company leading the development and commercialization of novel central nervous system (CNS) therapies, announced publication of results from its Phase 3 pivotal efficacy study in the November 2021 Journal of Child and Adolescent Psychopharmacology. The study showed that Corium's first-in-class, once-daily oral capsule AZSTARYS (serdexmethylphenidate [SDX] and dexmethylphenidate [d-MPH]) significantly improved attention deficit hyperactivity disorder (ADHD) symptoms compared to placebo in children ages 6 to 12 years with a 30-minute onset, 13-hour duration of efficacy, and well-tolerated safety profile comparable to that observed with other stimulant medications. Data from this study will be presented at CHADD's Virtual International Conference on ADHD.
Boston, MA, October 14, 2021 - Corium, Inc., a commercial-stage biopharmaceutical company leading the development and commercialization of novel central nervous system (CNS) therapies, announced today its first-in-class once-daily oral capsule AZSTARYS (serdexmethylphenidate [SDX] and dexmethylphenidate [d-MPH]), which was approved by the U.S. Food and Drug Administration (FDA) in March 2021, significantly reduced attention deficit hyperactivity disorder (ADHD) symptoms in children ages 6 to 12 years during a phase 3 controlled classroom clinical trial. The results are being presented in a poster and a Meet the Presenter session on October 15, 2021, during the American Psychiatric Nurses Association (APNA) 35th Annual Conference, held virtually on October 13-16. AZSTARYS is the first and only medicine to add the innovative SDX prodrug with d-MPH.
Boston, MA, October 12, 2021 - Corium, Inc., a commercial-stage biopharmaceutical company leading the development and commercialization of novel central nervous system (CNS) therapies, announced today the U.S. Food and Drug Administration (FDA) set a Prescription Drug User Fee (PDUFA) target action date of March 11, 2022 for Corium's new drug application (NDA) for once-weekly ADLARITY (donepezil transdermal system), its lead investigational product and a patch formulation of donepezil for the treatment of patients with dementia due to mild, moderate, or severe Alzheimer's disease. If approved, ADLARITY would be Corium's second CNS product approved for the U.S. market in 12 months.
Corium Secures $235 Million in Debt Financing
Boston, September 27, 2021 (PR NEWSWIRE) - Corium, Inc., 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.
Boston, July 21, 2021 (PR NEWSWIRE) - Corium, Inc., a commercial-stage biopharmaceutical company leading the development and commercialization of novel central nervous system (CNS) therapies, announces that the innovative AZSTARYS™ (serdexmethylphenidate [SDX] and dexmethylphenidate [d-MPH]), is now available in the U.S. for the treatment of attention deficit hyperactivity disorder (ADHD) symptoms in patients aged 6 years and older.
Boston, MA, March 3, 2021 (PR NEWSWIRE) - Corium, Inc., a commercial-stage biopharmaceutical company leading the development and commercialization of novel central nervous system (CNS) therapies, announced today the U.S. Food and Drug Administration (FDA) approval of once-daily oral capsule AZSTARYS™ (serdexmethylphenidate [SDX] and dexmethylphenidate [d-MPH])…
MENLO PARK, Calif., January 27, 2020 (GLOBE NEWSWIRE) - Corium, Inc., a commercial-stage biopharmaceutical company leading the development of novel transdermal healthcare products that are intended to provide alternative treatment options for patients and their families, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the company's New Drug Application (NDA) for ADLARITY (donepezil transdermal system), its lead investigational agent for the treatment of dementia of the Alzheimer's type in patients with mild, moderate, and severe Alzheimer's disease. FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of July 30th, 2020.
Corium Appoints Perry Sternberg as Chief Executive Officer
MENLO PARK, Calif., April 2, 2019 (GLOBE NEWSWIRE) - Corium, Inc. announced today that its Board of Directors has named Perry Sternberg as Chief Executive Officer. Mr. Sternberg is a senior pharmaceutical executive with commercial experience across a wide range of therapeutic areas in diverse markets…
Gurnet Point Capital Announces Completion of Tender Offer
CAMBRIDGE, Mass., November 27, 2018 - Gurnet Point Capital (“Gurnet Point”), a private investment firm focused on the healthcare and life sciences sectors, announced today that it has completed the previously announced tender offer for all outstanding shares of common stock of Corium International, Inc. (Nasdaq: CORI) (“Corium”), a commercial-stage biopharmaceutical company focused on the development, manufacture and commercialization of specialty transdermal products….
Corium Announces Agreement for Gurnet Point Capital to Purchase All Outstanding Shares
Total Transaction Valued in Excess of $500 Million , Representing a 50% Premium Gurnet Point Capital to Expand Operations While Focusing on the Approval and Commercialization of Corium's Corplex Donepezil MENLO PARK, Calif. , Oct. 11, 2018 (GLOBE NEWSWIRE) — Corium International, Inc….
