Marinus Pharmaceuticals Announces New Method of Use Patent Granted for IV Ganaxolone by USPTO in Status Epilepticus
21 Junho 2023 - 5:01PM
Business Wire
Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS), a pharmaceutical
company dedicated to the development of innovative therapeutics to
treat seizure disorders, today announced that the United States
Patent and Trademark Office (USPTO) has granted a new method of use
patent for intravenous (IV) ganaxolone in the treatment of status
epilepticus (SE), expiring in 2040.
The USPTO issued U.S. Patent No. 11,679,117, covering the
clinical dosing regimen administering ganaxolone for SE patients,
including those with refractory and super refractory status
epilepticus. This is Marinus’ second method of use patent granted
for IV ganaxolone in SE, broadening the dosing regimen and further
strengthening the Company’s intellectual property position.
“The issue of this patent, along with other recent allowances
granted by the USPTO, is an important milestone in protecting the
commercial potential of ganaxolone,” said Scott Braunstein, M.D.,
Chairman and Chief Executive Officer of Marinus. “This achievement
allows for broad investment in our IV franchise and demonstrates
our unwavering dedication to preserving the innovative strength of
our portfolio.”
Corresponding patent applications are expected to be filed in
several other key global markets and additional novel applications
are pending for IV ganaxolone in SE in the U.S.
About Marinus Pharmaceuticals
Marinus is a commercial-stage pharmaceutical company dedicated
to the development of innovative therapeutics for seizure
disorders. The Company’s commercial product, ZTALMY® (ganaxolone)
oral suspension CV, has been approved by the U.S. FDA for the
treatment of seizures associated with CDKL5 deficiency disorder in
patients two years of age and older. The potential of ganaxolone is
also being studied in other rare seizure disorders, including in
Phase 3 trials in tuberous sclerosis complex and refractory status
epilepticus. Ganaxolone is a neuroactive steroid GABAA receptor
modulator that acts on a well-characterized target in the brain
known to have anti-seizure effects. It is being developed in IV and
oral formulations to maximize therapeutic reach for adult and
pediatric patients in acute and chronic care settings. For more
information 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, our commercial and clinical
strategy, development plans and timelines, our patent prosecution
plans 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, 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 its
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; the company’s expectations, projections and
estimates regarding expenses, future revenue, capital requirements,
and the availability of and the need for additional financing;
delays, interruptions or failures in the manufacture and supply of
our product candidates; the company’s ability to obtain additional
funding to support its clinical development and commercial
programs; the company’s ability to protect its intellectual
property; and the effect of the COVID-19 pandemic on our business,
the medical community, regulators and the global economy. This list
is not exhaustive and these and other risks are described in our
periodic reports, including our annual reports 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230621023451/en/
Company: Molly Cameron Director, Corporate Communications
& Investor Relations Marinus Pharmaceuticals, Inc.
mcameron@marinuspharma.com
Marinus Pharmaceuticals (NASDAQ:MRNS)
Gráfico Histórico do Ativo
De Abr 2024 até Mai 2024
Marinus Pharmaceuticals (NASDAQ:MRNS)
Gráfico Histórico do Ativo
De Mai 2023 até Mai 2024