Marinus Pharmaceuticals Comments on Patent Challenge by Ovid Therapeutics Inc. and Provides Update on Marinus’ Post Grant Review
27 Março 2024 - 9:41AM
Business Wire
Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS), a pharmaceutical
company dedicated to developing and commercializing innovative
therapeutics to treat seizure disorders, today affirmed its
commitment to defending its patent portfolio amidst an Inter Partes
Review (IPR) challenge of U.S. Patent 11,110,100 from Ovid
Therapeutics, Inc. filed on March 26, 2024. This challenge relates
to a Marinus patent for the use of ganaxolone in treating status
epilepticus (SE) and refractory status epilepticus (RSE). Marinus
has multiple patents relating to ganaxolone for the treatment of SE
and RSE.
“Over the past two decades, Marinus has invested more than $100
million into our ganaxolone development programs in SE,” stated Dr.
Scott Braunstein, Chairman and CEO of Marinus. “That investment has
yielded a strong patent portfolio, fortified by robust clinical
data on the pharmacology and effective dosing of ganaxolone, and
underscores our commitment to improving the lives of patients and
families affected by seizure disorders. We believe this Ovid
challenge is without merit and is an unfortunate distraction to the
important work we do at Marinus. As a company grounded in
scientific research, we will vigorously defend our patents which
support our mission of delivering innovative new treatment options
to patients with significant unmet needs.”
Between 2021 and 2023, Marinus was granted two method of use
patents (U.S. 11,110,100 B2 and U.S. 11,679,117 B2) by the USPTO
for intravenous (IV) ganaxolone in the treatment of SE. These
patents cover the clinical dosing regimen for SE patients,
including those with RSE and super refractory status epilepticus.
In Marinus’ Phase 2 trial in RSE, treatment with ganaxolone
demonstrated rapid cessation of SE and led to the insight that a
minimum plasma concentration of ganaxolone that was maintained over
a duration of at least eight hours produced sustained resolution of
SE even as the rate of infusion was decreased. This effect was not
demonstrated with shorter durations at the target concentration or
with lower plasma levels. These findings are described in the
Marinus ‘100 Patent and are the basis of the dosing regimen being
used in Marinus’ Phase 3 trial in RSE, the first randomized,
controlled registration trial that has been conducted in this
indication.
Marinus’ first provisional patent application for ganaxolone in
SE was filed in February 2015. In August 2016, Ovid filed a
provisional patent application on the use of ganaxolone in
epileptic disorders, despite having no ganaxolone development
programs.
In March 2023, Marinus initiated a Patent Trial and Appeal Board
(PTAB) post-grant review (PGR) challenging Ovid’s SE patent for
ganaxolone (U.S. 11,395,817 B2) to invalidate the patent prior to
Marinus’ potential commercial launch of ganaxolone in SE. Marinus’
petition for PGR argues that the claims of the Ovid ‘817 Patent are
invalid and should not have been issued by the USPTO on multiple
grounds, including that the claims were anticipated by Marinus’
existing patent application filed in February 2015, and that the
claims were obvious over the prior art.
In response to Marinus’ request for PGR, Ovid abandoned 23 of
the 31 claims in its patent. The Patent Office subsequently
instituted the PGR on the remaining claims. Marinus believes Ovid’s
swift action in relinquishing the majority of their claims
underscores the merits of the PGR challenge. In instituting the
PGR, the PTAB stated that it was more likely than not that Marinus
would be able to invalidate the remaining eight claims of the Ovid
‘817 Patent. The PGR process is ongoing, and a final decision is
expected by the middle of 2024. Marinus most recent filing in the
PGR can be found here.
Marinus emphasizes its long-standing commitment to developing
innovative therapies for patients with rare genetic epilepsies and
refractory seizure disorders and remains focused on its mission to
bring ganaxolone to patients in need.
About Marinus Pharmaceuticals Marinus is a
commercial-stage pharmaceutical company dedicated to the
development of innovative therapeutics for seizure disorders. The
Company first introduced FDA-approved prescription medication
ZTALMY® (ganaxolone) oral suspension CV in the U.S. in 2022 and
continues to invest in the potential of ganaxolone in IV and oral
formulations to maximize therapeutic reach for adult and pediatric
patients in acute and chronic care settings. For more information
about Marinus visit www.marinuspharma.com.
Forward-Looking Statements To the extent that statements
contained in this press release are not descriptions of historical
facts regarding Marinus, they are forward-looking statements
reflecting the current beliefs and expectations of management made
pursuant to the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995. Words such as "may", "will",
"expect", "anticipate", "estimate", "intend", "believe", and
similar expressions (as well as other words or expressions
referencing future events, conditions or circumstances) are
intended to identify forward-looking statements. Examples of
forward-looking statements contained in this press release include,
among others, statements regarding the Marinus’ patent portfolio
and the related IPR filed by Ovid and the PGR filed by Marinus; and
other statements regarding the company's future operations,
financial performance, financial position, prospects, objectives
and other future events.
Forward-looking statements in this press release involve
substantial risks and uncertainties that could cause our clinical
development programs, future results, performance or achievements
to differ significantly from those expressed or implied by the
forward-looking statements. Such risks and uncertainties include,
among others, our ability to prevail in the IPR and PGR, the
company’s ability to continue as a going concern; unexpected market
acceptance, payor coverage or future prescriptions and revenue
generated by ZTALMY; unexpected actions by the FDA or other
regulatory agencies with respect to our products; competitive
conditions and unexpected adverse events or patient outcomes from
being treated with ZTALMY, uncertainties and delays relating to the
design, enrollment, completion, and results of clinical trials;
unanticipated costs and expenses; the company’s cash and cash
equivalents may not be sufficient to support our operating plan for
as long as anticipated; our ability to comply with the FDA’s
requirement for additional post-marketing studies in the required
time frames; the timing of regulatory filings for our other product
candidates; clinical trial results may not support regulatory
approval or further development in a specified indication or at
all; actions or advice of the FDA or EMA may affect the design,
initiation, timing, continuation and/or progress of clinical trials
or result in the need for additional clinical trials; the size and
growth potential of the markets for the company’s product
candidates, and the company’s ability to service those markets; our
ability to develop new formulations of ganaxolone or prodrugs; our
ability to obtain, maintain, protect and defend intellectual
property for our product candidates; the potential negative impact
of third party patents on our or our collaborators’ ability to
commercialize ganaxolone; delays, interruptions or failures in the
manufacture and supply of our product candidate; the company’s
expectations, projections and estimates regarding expenses, future
revenue, capital requirements, and the availability of and the need
for additional financing; the company’s ability to obtain
additional funding to support its clinical development and
commercial programs; the potential for our ex-US partners to breach
their obligations under their respective agreements with us or
terminate such agreements in accordance with their respective
terms; the risk that drug product quality requirements may not
support continued clinical investigation of our product candidates
and result in delays or termination of such clinical studies and
product approvals; and the availability or potential availability
of alternative products or treatments for conditions targeted by us
that could affect the availability or commercial potential of our
product candidate. This list is not exhaustive and these and other
risks are described in our periodic reports, including the annual
report on Form 10-K, quarterly reports on Form 10-Q and current
reports on Form 8-K, filed with or furnished to the Securities and
Exchange Commission and available at www.sec.gov. Any
forward-looking statements that we make in this press release speak
only as of the date of this press release. We assume no obligation
to update forward-looking statements whether as a result of new
information, future events or otherwise, after the date of this
press release.
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version on businesswire.com: https://www.businesswire.com/news/home/20240327247358/en/
Investors Jim DeNike Senior
Director, Investor Relations Marinus Pharmaceuticals, Inc.
jdenike@marinuspharma.com
Media Molly Cameron
Director, Corporate Communications & Investor Relations Marinus
Pharmaceuticals, Inc. mcameron@marinuspharma.com
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