Catalent and Minerva Neurosciences Enter Commercial Supply Agreement for Schizophrenia Drug Roluperidone
September 24 2019 - 9:00AM
Minerva Neurosciences, Inc. (NASDAQ: NERV), a clinical-stage
biopharmaceutical company focused on the development of innovative
therapies to treat central nervous system (CNS) disorders, and
Catalent, the leading global provider of advanced delivery
technologies, development, and manufacturing solutions for drugs,
biologics, gene therapies, and consumer health products, today
announced that they have entered into a long-term commercial supply
agreement for Roluperidone (MIN-101), an investigational compound
under development by Minerva for the treatment of negative symptoms
of schizophrenia. Under the terms of the agreement, Catalent
will manufacture and package the finished dose form of the drug at
its facility in Schorndorf, Germany.
Negative symptoms can persist chronically
throughout the lifetime of patients with schizophrenia and
contribute to poor quality of life and functional outcomes.
No treatment is approved to treat these symptoms in the United
States. Minerva is currently conducting a pivotal Phase 3
clinical trial with roluperidone at sites in Europe and the U.S.
and could potentially be the first to market.
“Launching any new drug with a partner marks the
culmination of many years of hard work and having to overcome
challenges, and is a milestone for a project,” commented Aris
Gennadios, Ph.D., President, Catalent Softgel & Oral
Technologies. He added, “Catalent has a proven track record in
developing new treatments and bringing them to market quickly,
efficiently, and in the most patient-friendly dose form; and we are
pleased to partner with Minerva on this important potential
therapy.”
“We are pleased to be working closely with our
partner, Catalent, under a long-term supply agreement for a
compound with the potential to treat negative symptoms, one of the
leading unmet needs in schizophrenia,” said Rick Russell, President
of Minerva Neurosciences.
To date, Catalent has worked with Minerva to
undertake the tech transfer from pilot to commercial-scale
production. This included analytical methods transfer and
validation, process optimization, stability studies, and
registration batch manufacturing; as well as packaging studies, and
assessing the influence of formulation factors on the product’s
critical quality attributes as required by Quality by Design (QbD)
process.
About Catalent
Catalent is the leading global provider of advanced delivery
technologies, development, and manufacturing solutions for drugs,
biologics, gene therapies, and consumer health products. With over
85 years serving the industry, Catalent has proven expertise in
bringing more customer products to market faster, enhancing product
performance and ensuring reliable global clinical and commercial
product supply. Catalent employs nearly 13,000 people, including
approximately 2,400 scientists, at more than 35 facilities across
five continents, and in fiscal year 2019 generated over $2.5
billion in annual revenue. Catalent is headquartered in Somerset,
New Jersey. For more information, visit
www.catalent.com. More products. Better treatments.
Reliably supplied.™
About Minerva Neurosciences
Minerva Neurosciences, Inc. is a clinical-stage
biopharmaceutical company focused on the development and
commercialization of a portfolio of product candidates to treat CNS
diseases. Minerva’s proprietary compounds include:
roluperidone (MIN-101), in clinical development for schizophrenia;
seltorexant (MIN-202 or JNJ-42847922), in clinical development for
insomnia and major depressive disorder (MDD); MIN-117, in clinical
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 scope of
future clinical trials and results of clinical trials with
roluperidone; the clinical and therapeutic potential of this
compound; the timing and outcomes of future interactions with U.S.
and foreign regulatory bodies; our ability to successfully develop
and commercialize our therapeutic products; 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 roluperidone 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 any of our therapeutic products will be
successfully marketed if approved; whether any of our therapeutic
product discovery and development efforts will be successful;
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, 2019, filed with the Securities and
Exchange Commission on August 5, 2019. 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. BoniVP, Investor Relations/Corp.
CommunicationsMinerva Neurosciences, Inc.(617) 600-7376
For Catalent:
Chris Halling+44 (0) 7580 041073Chris.halling@catalent.com
Richard Kerns+44 (0) 161 728 5880richard@nepr.agency
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