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2016-02-01

Minerva Neurosciences, Inc.: Minerva Neurosciences Announces Top Line Data From MIN-202 Phase I Clinical Study in Japanese Patients

Treatment With Selective Orexin-2 Receptor Antagonist Observed to be Well
Tolerated

WALTHAM, Mass., Feb. 01, 2016 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc.
(NASDAQ:NERV), a clinical-stage biopharmaceutical company focused on the
development of therapies for central nervous system (CNS) disorders, today
announced top line results from a Phase I clinical trial conducted in Japan
with MIN-202 (JNJ-42847922), a selective orexin-2 receptor antagonist under
joint development with Janssen Pharmaceutica NV.

It was observed that single dose morning administration of MIN-202 was well
tolerated at all three dose levels tested, 5 milligrams (mg), 20 mg and 40
mg. The observed plasma pharmacokinetic features were comparable to those
observed in previous studies carried out in healthy non-Asian study
participants. No clinically relevant safety concerns were observed based on
the assessment of multiple safety endpoints. Somnolence was the most
frequently reported adverse event at the two higher doses, an expected
finding as this compound is being developed as a treatment for patients
suffering from insomnia disorder and as adjunctive treatment to concomitant
antidepressant drug therapy in major depressive disorder (MDD).

"These findings are an important step in the global development of MIN-202,"
said Dr. Remy Luthringer, president and chief executive officer of Minerva.
"They add to the expanding database of study participants treated with this
compound worldwide and support further clinical testing in an important part
of the world."

This trial was a single center, double blind, placebo-controlled randomized
single ascending dose study to investigate the safety, tolerability and
pharmacokinetics of MIN-202 in 24 healthy Japanese adult male study
participants.

Minerva entered into a co-development and license agreement with Janssen in
February, 2014 covering MIN-202 and any other orexin-2 compounds. Under this
agreement, Minerva has an exclusive license to these compounds in the
European Union, Switzerland, Liechtenstein, Iceland and Norway. Janssen has
exclusive rights to these compounds worldwide outside of these territories.

About Minerva Neurosciences

Minerva Neurosciences, Inc. is a clinical-stage biopharmaceutical company
focused on the development and commercialization of a portfolio of products
to treat CNS diseases. Minerva's proprietary compounds include: MIN-101, in
Phase 2B development for schizophrenia; MIN-202 (JNJ-42847922), in Phase 2A
and Phase 1B development for insomnia and adjunctive treatment of MDD,
respectively; MIN-117, in Phase 2A development for MDD; and MIN-301, in
pre-clinical development for Parkinson's disease. Minerva's common stock is
listed on the NASDAQ Global Market under the symbol "NERV." For more
information, please visit www.minervaneurosciences.com.

Forward-Looking Safe Harbor Statement

This press release contains forward-looking statements which are subject to
the safe harbor provisions of the Private Securities Litigation Reform Act of
1995, as amended. Forward-looking statements are statements that are not
historical facts, reflect management's expectations as of the date of this
press release, and involve certain risks and uncertainties. Forward-looking
statements include statements herein with respect to the timing and results
of future clinical milestones regarding MIN-202; the timing of future
clinical trials and results of clinical trials regarding MIN-202; the
clinical and therapeutic potential of MIN-202; our ability to successfully
develop and commercialize MIN-202; the sufficiency of our current cash
position to fund our operations; and management's ability to successfully
achieve its goals. These forward-looking statements are only predictions and
may differ materially from actual results due to a variety of factors
including, without limitation, whether final data from the Phase 2A MIN-202
trial will be consistent with the preliminary results, whether MIN-202 will
advance further in the clinical trials process and whether and when, if at
all, it will receive final approval from the U.S. Food and Drug
Administration or equivalent foreign regulatory agencies and for which
indications; whether MIN-202 will be successfully marketed if approved;
whether our therapeutic product discovery and development efforts will be
successful for MIN-202; our ability to achieve the results contemplated by
our co-development agreements; management's ability to successfully achieve
its goals; our ability to raise additional capital to fund our operations on
terms acceptable to us; and general economic conditions. These and other
potential risks and uncertainties that could cause actual results to differ
from the results predicted are more fully detailed under the caption "Risk
Factors" in our filings with the Securities and Exchange Commission,
including our Quarterly Report
on Form 10-Q for the quarter ended September 30, 2015, filed with the
Securities and Exchange Commission on November 5, 2015. Copies of reports
filed with the SEC are posted on our website at
www.minervaneurosciences.com. The forward-looking statements in this press
release are based on
information available to us as of the date hereof, and we disclaim any
obligation to update any forward-looking statements, except as required by
law.
William B. Boni

VP, Investor Relations/
Corp. Communications
Minerva Neurosciences, Inc.
(617) 600-7376

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This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Minerva Neurosciences, Inc. via Globenewswire

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