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2016-03-11

Minerva Neurosciences Announces Positive Top Line Results From Phase Ib Clinical Trial in Major Depressive Disorder With MIN-202

Minerva Neurosciences, Inc.
Press release

Minerva Neurosciences Announces Positive Top Line Results From Phase Ib
Clinical Trial in Major Depressive Disorder With MIN-202

Treatment with selective orexin-2 receptor antagonist observed to be well
tolerated and to improve symptoms of depression, independent from its effect on
sleep

WALTHAM, Mass., March 11, 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 positive top line results from a Phase Ib clinical trial in major
depressive disorder (MDD) with MIN-202 (JNJ-42847922), a selective orexin-2
receptor antagonist under joint development with Janssen Pharmaceutica NV.

“Treatment with MIN-202 was observed to result in consistent improvements in
the symptoms of depression in MDD patients in this trial,” said Dr. Remy
Luthringer, president and chief executive officer of Minerva. “The results
pave the way to initiate a Phase IIb trial in patients suffering from MDD.
These improvements support the potential of MIN-202 to have a direct effect on
mood independent from its effect on sleep. We previously observed that MIN-202
had a significant effect on sleep in our Phase IIa trial in patients suffering
from insomnia disorder.”

The Phase 1b trial was a randomized, multi-center, double-blind, parallel
group, diphenhydramine- and placebo-controlled study to evaluate the effect of
MIN-202 in MDD outpatients 18-65 years of age. Forty-eight participants were
enrolled in three groups that received doses of 20 milligrams (mg) of MIN-202
daily, 25 mg of diphenhydramine daily (used as a positive control to induce
sedation) or placebo over four weeks.

MIN-202 was observed to be well tolerated by study participants over a
one-month treatment duration, with no new emerging safety signals and no
serious adverse events.

Consistently greater improvements in depressive symptomatology were observed in
patients randomized to receive MIN-202 compared to those randomized to receive
placebo (PLA) or diphenhydramine (DPH), as measured by clinician administered
rating scales, including the Hamilton Depression Rating Scale (HDRS17). Core
symptoms of depression (as measured by the HAM-D6) were observed to be
significantly improved in the MIN-202 arm when compared with the PLA arm.

The primary endpoint was safety and tolerability, and secondary endpoints
included assessments of depressive symptomatology, cognition and sleep. The
trial was conducted at seven clinical sites in Europe. Only top line results
with respect to safety, tolerability and efficacy on depressive symptomatology
are reported in this press release. Complete results are planned for
peer-reviewed presentation in the future.

MIN-202 is also under development to treat primary insomnia disorder. Recently
announced top line data from a Phase IIa trial in this indication included
statistically significant improvements in sleep efficiency (SE) as measured by
objective polysomnography, the primary endpoint of the trial, observed in study
patients treated with MIN-202, with an acceptable safety and tolerability
profile, compared to patients treated with placebo.

Minerva entered into a co-development and license agreement with Janssen in
February 2014 covering MIN-202 and 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
IIb development for schizophrenia; MIN-202 (JNJ-42847922), in Phase IIa and
Phase Ib development for insomnia and adjunctive treatment of MDD,
respectively; MIN-117, in Phase IIa 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 Ib 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. BoniVP, Investor Relations/Corp. CommunicationsMinerva
Neurosciences, Inc.(617) 600-7376

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