Marinus Pharmaceuticals Bolsters Clinical and Regulatory Expertise

Print 03 December 2015

Accomplished Pharmaceutical Executives Join Management Team

RADNOR, Pa., Dec. 03, 2015 (GLOBE NEWSWIRE) -- Marinus Pharmaceuticals, Inc. (Nasdaq:MRNS), a biopharmaceutical company dedicated to the development of innovative therapeutics to treat epilepsy and neuropsychiatric disorders, announced the hiring of Jaakko Lappalainen, M.D., Ph.D., as Vice President of Clinical Development and Kimberly A. McCormick, PharmD, as Head of Regulatory Affairs. Dr. Lappalainen has 10 years of experience in the design, monitoring, interpretation and reporting of clinical trials at pharmaceutical research and development companies, including AstraZeneca. Dr. McCormick has more than 15 years of regulatory strategy and submissions experience at major pharmaceutical firms, including Shire and Pfizer. Both individuals will report to Marinus's Chief Medical Officer, Albena Patroneva, M.D.

Dr. Patroneva, commented, "We are delighted to have Drs. Lappalainen and McCormick join Marinus at such a pivotal time for our company. Dr. Lappalainen will be responsible for advancing our CNS-selective GABAA modulator, ganaxolone through clinical trials to commercialization and Dr. McCormick will oversee all efforts related to global regulatory oversight for ganaxolone. The additional expertise in executing quality clinical trials and interacting with the regulatory agencies will be invaluable as we continue to advance the late stage clinical development of ganaxolone, and expand our reach into the acute care setting with our IV formulation."

Dr. Lappalainen is a U.S. board certified psychiatrist with extensive experience in clinical practice and medical research. Most recently, he served as Executive Director, Drug Development Services at Premier Research CRO, where he oversaw the safety and medical monitoring of clinical trials and provided consultations on clinical trial design and drug development. Prior to Premier Research, Dr. Lappalainen held various clinical development positions at AstraZeneca. While at AstraZeneca, he served as the Global Lead Physician for the MOVANTIK™ (naloxegol) Phase 3 program in non-cancer pain and opioid induced constipation and the Lead Physician for the early clinical development of two GABAA sub-type selective molecules. Earlier in his career, Dr. Lappalainen served as an Assistant Professor, Clinical Director and Attending Physician at Yale University School of Medicine, Department of Psychiatry. 

Dr. McCormick is an experienced Senior Regulatory Affairs professional with more than 15 years of regulatory strategy and experience in leading the development and registration of products across many different regions and therapeutic areas, with a focus in Neuroscience. Most recently, she served as Senior Director, Global Regulatory Affairs, Lifitegrast and ADHD/Vyvanse New Uses for Shire Pharmaceuticals. Prior to Shire Pharmaceuticals, she held various positions at Pfizer over the span of 12 years, including Director, Global Regulatory Affairs; Global Product Development: Neuroscience.

About Marinus Pharmaceuticals

Marinus Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to the development of ganaxolone, which offers a new mechanism of action, proven efficacy, safety and convenient dosing, to improve the lives of patients suffering from epilepsy and neuropsychiatric disorders.  Ganaxolone is a CNS-selective GABAA modulator that acts on a well-characterized target in the brain known to have both anti-seizure and anti-anxiety effects. Ganaxolone is being developed in three different dose forms (IV, capsule, and liquid) intended to maximize therapeutic reach to adult and pediatric patient populations in both acute and chronic care settings.  Ganaxolone IV is planned to enter the clinic in 2016 and is being developed to treat status epilepticus. Ganaxolone IV is complemented by its oral dose forms, providing the potential for IV-to-oral continuation therapy for patients transitioning from acute care to outpatient settings.  Ganaxolone capsule is being evaluated in a Phase 3 multi-national clinical trial as adjunctive treatment of focal onset seizures in adults.  Ganaxolone capsule and liquid are being studied in orphan pediatric indications with comorbidities in seizures and behavior disorders — PCDH19 epilepsy and Fragile X Syndrome. For additional information, please visit the Company's website at www.marinuspharma.com.

Forward-Looking Statements

To the extent that statements contained in this press release are not descriptions of historical facts regarding Marinus, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.  Words such as "may", "will", "expect", "anticipate", "estimate", "intend", "believe", and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements.  Examples of forward looking statements contained in this press release include, among others, statements regarding our interpretation of preclinical and clinical studies, development plans for our product candidate, including the development of dose forms, the clinical trial testing schedule and milestones, the ability to complete enrollment in our clinical trials, interpretation of scientific basis for ganaxolone use, timing for availability and release of data, the safety, potential efficacy and therapeutic potential of our product candidate and our expectation regarding the sufficiency of our working capital. Forward-looking statements in this release involve substantial risks and uncertainties that could cause our clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements.  Such risks and uncertainties include, among others, the uncertainties inherent in the conduct of future clinical trials, the timing of the clinical trials, enrollment in clinical trials, availability of data from ongoing clinical trials, expectations for regulatory approvals, and other matters, including the development of formulations of ganaxolone, that could affect the availability or commercial potential of our drug candidates.  Marinus undertakes no obligation to update or revise any forward-looking statements.  For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the Company in general, see filings Marinus has made with the Securities and Exchange Commission.

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