Minerva Neurosciences Announces European Commission Approval of Amendment of MIN-202 Agreement With Janssen
(Thomson Reuters ONE) -
Proceeds from amended agreement, combined with finances raised from recent
public stock offering and current financial resources, significantly extend
Minerva cash runway
Combined proceeds are expected to support anticipated data readouts from five
planned clinical trials with three product candidates
WALTHAM, Mass., Aug. 25, 2017 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc.
(NASDAQ:NERV), a clinical-stage biopharmaceutical company focused on the
development of therapies to treat central nervous system (CNS) disorders, today
announced that the European Commission has approved an amendment to its co-
development and license agreement with Janssen Pharmaceutica NV (Janssen)
related to MIN-202 (JNJ 42827922), a selective orexin-2 receptor antagonist, and
the related repurchase of all Minerva shares owned by Johnson & Johnson
Innovation - JJDC, Inc. (an affiliate of Janssen).
The effectiveness of this agreement, entered into in June 2017, was contingent
upon approval of its terms by the European Commission and upon the closing of
the acquisition of Actelion Ltd. by affiliates of Janssen. Each of these
conditions has now been met, and the amendment is expected to take effect on
August 29, 2017.
Under the amended agreement, Minerva gains global strategic control of the
development of MIN-202 to treat insomnia, and Janssen foregoes its right to
royalties on MIN-202 insomnia sales in Minerva territories. Minerva retains its
rights to MIN-202 as adjunctive therapy for major depressive disorder (MDD),
which include an exclusive license in the European Union, Switzerland,
Liechtenstein, Iceland and Norway, with royalties payable by Minerva to Janssen,
and royalties on sales payable by Janssen to Minerva elsewhere worldwide.
Payments to Minerva by Janssen under this new agreement include an upfront
payment of $30 million, $20 million at the start of a Phase 3 insomnia trial for
MIN-202 and $20 million when 50% of the patients are enrolled in this trial.
Janssen has waived the remaining payments due from Minerva for Phase 2
development of MIN-202, which total approximately $13 million. Minerva has
assumed all financial responsibility for Phase 3 development costs for MIN-202
in insomnia. All Minerva stock previously owned by Johnson & Johnson Innovation
- JJDC, Inc., totaling approximately 3.9 million shares and representing
approximately 9% of total Minerva shares outstanding, will be repurchased by
Minerva at par value of $.0001 per share or approximately $389 in total.
As previously announced, Minerva's cash, cash equivalents and marketable
securities as of June 30, 2017 were approximately $77.6 million. The Company
completed a public offering on July 5, 2017 that resulted in net proceeds of
approximately $41.5 million. Combined with the $30 million upfront payment and
the waiving of $13 million in payments for Phase 2 development of MIN-202 under
the amended agreement with Janssen, these total proceeds and savings are
expected to support anticipated data readouts from five clinical trials
projected to take place by the end of 2019. These include the Company's planned
pivotal Phase 3 trial with MIN-101 in schizophrenia, three Phase 2b trials with
MIN-202 in insomnia and MDD and a Phase 2b trial with MIN-117 in MDD. Additional
clinical activity planned during that period includes a Phase 1 trial with MIN-
301, which is in pre-clinical development.
About MIN-202 (JNJ 42827922)
MIN-202 is a selective orexin 2 receptor antagonist under development for the
treatment of insomnia and as adjunctive therapy for MDD. In the brain, the
orexin system is involved in the control of several key functions, including
metabolism and wakefulness. MIN-202 seeks to inhibit the activity of the neurons
that promote wakefulness by selectively blocking the orexin 2 receptor. Rather
than making an individual sleepier, blocking the orexin 2 receptor reduces the
level of the neurotransmitters that signal the brain to maintain vigilance and
wakefulness.
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
clinical development for schizophrenia; MIN-117, in clinical development for
major depressive disorder (MDD); MIN-202 (JNJ-42847922), in clinical development
for insomnia and 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 with MIN-101, MIN-202, MIN-117 and MIN-301; the timing and outcomes
of future interactions with U.S. and foreign regulatory bodies; our agreements
with Janssen related to MIN-202; our ability to successfully develop and
commercialize MIN-101, MIN-202, MIN-117 and MIN-301; 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 based on
our current expectations and may differ materially from actual results due to a
variety of factors including, without limitation: whether MIN-101, MIN-202, MIN-
117 and MIN-301 will advance further in the clinical trials process and whether
and when, if at all, they will receive final approval from the U.S. Food and
Drug Administration or equivalent foreign regulatory agencies and for which
indications; whether the results of future clinical trials of MIN-101, MIN-202,
MIN-117 and MIN-301, if any, will be consistent with the results of past
clinical trials; whether MIN-101, MIN-202, MIN-117 and MIN-301 will be
successfully marketed if approved; whether any of our therapeutic product
discovery and development efforts will be successful; 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 June 30, 2017, filed with the Securities and Exchange Commission on August
3, 2017. 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.
Contact:
William B. Boni
VP, Investor Relations/
Corp. Communications
Minerva Neurosciences, Inc.
(617) 600-7376
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq 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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Datum: 25.08.2017 - 14:30 Uhr
Sprache: Deutsch
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