Minerva Neurosciences, Inc.

Dedicated to transforming the lives of people affected by neuropsychiatric diseases through innovative science that addresses patients' unmet needs.

About Us

Dedicated to transforming lives



Minerva Neurosciences is a clinical-stage biopharmaceutical company focused on the development and commercialization of a portfolio of product candidates to treat neuropsychiatric diseases. Our goal is to transform the lives of patients with improved therapeutic options and a patient-centric focus. Leveraging extensive domain expertise, we have identified and acquired or in-licensed a portfolio of development-stage proprietary compounds with innovative mechanisms of action. As we work to advance our current product pipeline, we plan to explore additional indications, identify new product candidates from our existing intellectual property, and acquire rights to additional promising product candidates with significant therapeutic potential. The Minerva Neurosciences executive management team includes globally recognized specialists in neuropsychiatric disease and commercialization of products addressing significant unmet medical needs.

The Minerva Neurosciences strategy is based on four key principles: unwavering commitment to neuropsychiatric patients, their families and communities; scientific rigor; continually leveraging patient and caregiver insights to drive scientific advancement; and an unparalleled commitment to integrity in all of our business dealings. As we work to advance our pipeline of products through clinical development and regulatory review, we will also selectively explore collaborations with leading pharmaceutical companies.

Leadership

Management Team


Rogerio Vivaldi, MD, MBA

Rogerio Vivaldi, MD, MBA

President and Chief Executive Officer

Over the past 20 years, Dr. Vivaldi has been involved in commercializing more than 20 pharmaceutical products addressing a wide range of unmet medical needs. He most recently served as Senior Vice President and Head of the Rare Diseases Business Unit at Genzyme Corporation and was previously head of Genzyme's Renal and Endocrinology Unit. Prior to that, he led the establishment of Genzyme's business operations in Brazil and served as President of Genzyme Latin America. He received his medical degree from Medical School - Rio de Janeiro University (UNIRIO), and completed his residency in endocrinology at State University of Rio de Janeiro (UERJ). He completed his M.B.A. at Coppead, Federal University of Rio de Janeiro (UFRJ).

Remy Luthringer, PhD

Remy Luthringer, PhD

Executive Vice President and Head of Research & Development (R&D)

Dr. Remy Luthringer has been involved in the development of more than 150 active molecules for clinical trials in the central nervous system. Dr. Luthringer served as Chief Medical Officer for Index Ventures, with a focus on investments in healthcare infrastructure. He was also the head of the FORENAP Institute for Research in Neurosciences and Neuropsychiatry in France. Dr. Luthringer has extensive experience in clinical psychiatric practice and holds a PhD in neurosciences and clinical pharmacology.

Geoff Race, FCMA, MBA

Geoff Race, FCMA, MBA

Executive Vice President and Chief Financial Officer

Prior to being named as Minerva Neurosciences' CFO, Mr. Race served as a consultant for the development of MIN-101 and MIN-117. He has previously served as Chief Executive Officer of Funxional Therapeutics Ltd., the lead program of which (FX125L) was acquired by Boehringer Ingelheim in 2012. He also served as Chief Financial Officer at PanGenetics B.V. He is a Fellow of the Chartered Institute of Management Accountants and earned his MBA from Durham University Business School.

Joseph Reilly

Joseph Reilly

Vice President and Chief Operating Officer

Joe Reilly was most recently Vice President, Head of Commercial Strategy and Operations at Genzyme Corporation. In more than a decade at Genzyme, he also served as Vice President of Global Business Operations, Vice President of Commercial Operations and Vice President of Finance in the Rare Diseases Division. Joe holds a BS and MS in Finance from Boston College.

Fred Ahlholm

Fred Ahlholm

Vice President and Chief Accounting Officer

Fred Ahlholm was most recently Vice President of Finance and Chief Accounting Officer for Amarin Corporation plc, where he helped direct the growth of the company from a small clinical-stage drug developer into a commercial enterprise of more than 400 employees. Fred is a CPA and earned his BBA at the University of Notre Dame.

Mark Levine

Mark Levine

Vice President and General Counsel

Mark Levine has extensive expertise in corporate and securities law and has represented companies in a variety of industries including life sciences, biotechnology, cloud-based services, internet consulting and renewable energy. He has substantial experience counseling companies on general corporate law matters, complex commercial transactions, mergers and acquisitions, securities law, corporate governance and regulatory affairs. He holds a bachelor of arts degree from Binghamton University, SUNY, and a juris doctor from Washington University in St. Louis.

Board of Directors

Marc Beer

Chairman of the Board, Aegerion Pharmaceuticals

Rogerio Vivaldi, MD, MBA

President and CEO, Minerva Neurosciences

Jan Van Heek

Chair of Audit Committee, Amarin

Francesco De Rubertis, PhD

Director, Index Ventures

Michele Ollier, MD

Director, Index Ventures

Nico Vandervelpen

Chief Operating Officer, LRM

Investors

Minerva Neurosciences investors include global leaders in pharmaceutical and life sciences investment, including:

Science

Targeting a range of unmet needs in neuropsychiatry


Minerva Neurosciences is focused on the field of neuropsychiatry within the CNS disease pharmaceutical market. Neuropsychiatry is a medical subspecialty devoted to understanding cognitive, emotional, behavioral, and perceptual symptoms resulting from circuit-specific brain dysfunction and includes a range of serious diseases and conditions. The Minerva Neurosciences pipeline will initially target the treatment of schizophrenia, major depressive disorder (MDD), insomnia, and Parkinson's disease, each of which affects millions of people around the world. Currently available treatment options for these conditions are known to have significant limitations that can result in high rates of discontinuation of therapy and unsatisfactory efficacy and safety profiles. Family members also often face significant challenges associated with the burden of these and many other neuropsychiatric diseases. Minerva Neurosciences is pursuing the development of new therapeutic options based on its deep knowledge of the pathology of neuropsychiatric diseases, the pharmacology of its library of compounds, and its understanding of desired outcomes for unmet patient needs. We believe our product candidates each have novel mechanisms of action and represent differentiated treatment options with the potential to address unmet needs with significantly improved efficacy and safety.

Minerva's Pipeline

Minerva currently has a portfolio of best-in-class product candidates in the pipeline. Dr. Luthringer led the effort to license and develop two products now in the Minerva pipeline, MIN-101 and MIN-117, during his tenure at our legacy companies Cyrenaic Pharmaceuticals and Sonkei Pharmaceuticals, which were merged in 2013 to create Minerva Neurosciences. In 2014, Minerva Neurosciences further expanded the company's product candidate portfolio by acquiring all of the shares of Mind-NRG S.A., which hold exclusive rights to develop and commercialize MIN-301 (development program also led by Dr. Luthringer). Likewise during February 2014 and pending certain conditions, Minerva initiated a co-development licensing agreement with Janssen Pharmaceuticals N.V., a Johnson & Johnson company, to acquire EU development and commercialization rights on sales of MIN-202. Building on this platform, our focus on the science of neuropsychiatry positions us to continually identify new therapeutic options in our goal to build an extensive pipeline of therapies targeting many additional unmet needs for patients in the years ahead.

Pipeline of Next Generation Neuropsychiatry Pharmaceuticals

Program
Primary Indication
Novel MOA
Phase l
Phase ll
Rights
MIN - 101
Schizophrenia
5-HT2A / Sigma2
6 Phase I trials completed; Additional studies ongoing
Phase IIa complete
Phase IIb to be initiated in 2H14
Global (ex-Asia)
MIN - 117
Major Depressive Disorder (MDD)
5-HT1A / 5-HTT / Alpha-1a,b / Dopamine Transporter / 5-HT2A
100% Complete
tbd – subject to additional financing
Global (ex-Asia)
MIN - 202
Primary and Secondary Insomnia
Orexin-2 antagonist
Phase la Complete - Phase lb 2H13
Phase Ia complete
Phase Ib initiated 2H13
European Union
MIN - 301
Parkinson’s Disease
ErbB4 activator
tbd – subject to additional financing
Global

MIN-101 for the Treatment of Schizophrenia

Patients with schizophrenia can suffer from (1) positive symptoms, such as delusions, hallucinations, thought disorders, and agitation, (2) negative symptoms, such as mood flatness and lack of pleasure in daily life, (3) cognitive symptoms, such as the decreased ability to understand information and make decisions, difficulty focusing, and decreased working memory function, and (4) sleep disorders. Minerva's lead product candidate, MIN-101, is an innovative molecule behaving as an antagonist on 5-HT2A and sigma-2 receptors. It is in development for the treatment of patients affected by schizophrenia and, in particular, those suffering from negative symptoms of the disease.

Most currently approved therapies for schizophrenia show efficacy primarily in the management of positive symptoms. As a result, patients with predominantly negative symptoms, representing 48% of the overall patient population, are often underserved. Side effects of current pharmaceutical treatment options include sedation, uncontrollable muscle movements, weight gain, cognitive impairment, and sleep disorders. The side effect profile and lack of efficacy on negative and cognitive symptoms contribute to discontinuation rates for current therapies of 60%-80% over the course of 18 months. Due to its particular pharmacologic profile, MIN-101 has the potential to address negative and cognitive symptoms and improve sleep while addressing overall symptoms of schizophrenia for patients in treatment as well as for treatment-naive patients, all with an improved side effect profile compared to the current standard of care. Research results thus far suggest that MIN-101 could have sleep promoting effects, as treatment showed a non-significant but favorable trend toward improvement in sleep initiation parameters.

In a Phase IIA, placebo-controlled trial, clinically significant improvement of negative symptoms was observed after three months of drug administration. The next Phase IIB trial planned with MIN-101 will explore the effect of several doses of MIN-101 in schizophrenic patients with predominantly negative symptoms. Minerva Neurosciences holds the exclusive license for this molecule from Mitsubishi Tanabe Pharmaceutical Company (MTPC). Pursuant to the license agreement, the company may make, sell, and import products related to the MIN-101 compound globally, excluding most of Asia.

MIN-117 for the Treatment of Major Depressive Disorder (MDD)

M117 is an innovative molecule behaving as an antagonist on 5-HT1A and 5-HTT receptors and both serotonin and dopamine reuptake. It is in development for the treatment of MDD, a mood disorder in which feelings of sadness, loss, anger, or frustration interfere with a person's ability to carry out and enjoy once-pleasurable activities. There are currently approximately 30 million cases of MDD in the United States and the five major European markets of France, Germany, Italy, Spain, and the United Kingdom. MDD is also one of the leading causes of occupational disability. While pharmacologic therapies are the mainstay of treatment for depression, less than half of patients receiving first-line drug treatment for MDD enter into remission. Of those who do achieve remission, approximately 30%-50% will later relapse while taking medication. In addition, current therapies are linked with several side effects, including sleep problems, upset stomach, headache, anxiety or restlessness, cognitive impairments, weight gain, and sexual dysfunction. Further, due to their mechanisms of action, some current treatment options take up to four weeks to have a noticeable effect, which can expose patients to a period of vulnerability and risk.

Existing preclinical and clinical pharmacology data indicate that therapeutic effects such as sleep modification and potential onset of mood improvements can occur without many of the side effects associated with currently approved therapies. Two Phase I clinical trials have confirmed the safety and tolerability profile of MIN-117 and the potential for once-a-day administration. Further, the effects on sleep of MIN-117 in the Phase I clinical trials indicate a potential onset of action in MDD patients within just a few days. Minerva holds the exclusive license for this molecule from MTPC and, pursuant to the license agreement, the company may make, sell, and import products related to the MIN-117 compound globally, excluding most of Asia.

MIN-202* for the Treatment of Insomnia

MIN-202 is an innovative molecule acting as a selective orexin-2 receptor antagonist for the treatment of primary and secondary insomnia. The major drawbacks of current insomnia medications are that immediate-onset therapies taken at bedtime can interfere with natural sleep onset and deep sleep patterns. As a result, patients can experience residual effects the following day, such as daytime sedation, slowed or distorted reaction-time, and cognitive impairment. We believe MIN-202 is an advanced compound that targeted the action of wakefulness-promoting neurons, which is likely to result in better safety and tolerability and preservation of physiologic and restorative sleep. We are currently working with Janssen to advance clinical research for MIN-202, including dosing studies in healthy subjects, safety and tolerability studies related to repeat dosing, and studies to confirm that orexin pathways are involved in stress, indicating that MIN-202 may be positioned as adjunctive therapy to antidepressants.

*In collaboration with Janssen Pharmaceutica N.V., Johnson & Johnson Innovation, and the Janssen Neuroscience therapeutic area.

MIN-301 for the Treatment of Parkinson's Disease

MIN-301 is a recombinant form of the neuregulin-1β1 peptide and is currently in preclinical development for the treatment of Parkinson's disease. There were an estimated 800,000 cases of Parkinson's disease in the United States in 2012, and it was identified as the 14th leading cause of death in 2011. Current treatments for Parkinson's disease have been shown to improve symptoms for many patients, but they have not been proven to delay the onset of disease, slow or prevent disease progression, or reverse its effects. Research involving multiple preclinical models mimicking Parkinson's disease symptoms has been carried out with MIN-301. The results obtained thus far show that the peptide has the potential to restore motor function distorted in Parkinson's patients, with a positive effect on cognition. In February 2014, Minerva Neurosciences acquired Mind-NRG S.A., which owns the rights globally to the MIN-301 peptide.

Investors and Media

The Minerva Neurosciences team is focused on its commitment to deliver long-term value to investors through solid business planning and execution.
Visit Site

Contact

Minerva Neurosciences, Inc.

245 First Street, Suite 1800
Cambridge, MA 02142
617.444.8446
For general inquiries, please contact:
info@minervaneurosciences.com

For media inquiries, please contact:
Bill Berry
Berry & Company Public Relations
212.253.8881
bberry@berrypr.com

For investor inquiries, please contact:
Renee Leck
Stern Investor Relations
212.362.1200
renee@sternir.com



© Copyright 2014 Minerva Neurosciences Inc., All Rights Reserved
Privacy Policy | Terms of Use