Marinus Pharmaceuticals Further Strengthens Intellectual Property Estate with Method of Treatment Patent for ZTALMY® Titration Regimens
16 October 2024 - 7:00AM
Business Wire
New U.S. patent issued for ZTALMY® (ganaxolone)
oral titration regimens cover the treatment of a range of epilepsy
disorders, expiring September 2042
Marinus continues to grow its IP portfolio to
protect its scientific innovation
Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS), a pharmaceutical
company dedicated to the development of innovative therapeutics to
treat seizure disorders, today announced it has added to its
intellectual property (IP) estate with a new patent issued by the
United States Patent and Trademark Office (USPTO) for ZTALMY®
(ganaxolone) oral titration regimens covering the treatment of a
range of epilepsy disorders, including CDKL5 deficiency disorder,
tuberous sclerosis complex (TSC) and Lennox-Gastaut syndrome (LGS).
The U.S. patent No. 12,115,169 expires in September 2042.
“The new patent granted to Marinus further strengthens the IP
protection of ZTALMY and supports our development and
commercialization plans for ganaxolone in TSC and other areas of
high unmet need, such as LGS,” said Scott Braunstein, M.D.,
Chairman and Chief Executive Officer of Marinus. “Our patent
portfolio is the result of decades of research and scientific
innovation, fortified by robust data on the pharmacology and
effective clinical dosing of ganaxolone. We are pleased that the
USPTO recognized that the claimed titration regimens are markedly
different from prior titration regimens. We believe that this
revised ganaxolone titration schedule has the potential to have a
meaningful impact on tolerability, compliance, and lead to improved
patient outcomes in a range of epilepsy disorders.”
About Marinus Pharmaceuticals
Marinus is a commercial-stage pharmaceutical company dedicated
to the development of innovative therapeutics for seizure
disorders. The Company’s product, ZTALMY® (ganaxolone) oral
suspension CV, is an FDA-approved prescription medication
introduced in the U.S. in 2022. For more information, please visit
www.marinuspharma.com and follow us on Facebook, LinkedIn and
X.
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 expectation that the new
intellectual property for ganaxolone that covers the titration
regimen will support development of additional indications for use
of ZTALMY and has the potential to have a meaningful impact on
tolerability, compliance, and lead to improved patient outcomes in
a range of epilepsy disorders, as well as other statements
regarding our strategy, development plans and timelines 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, the company’s ability to protect its intellectual
property; unexpected actions by the FDA or other regulatory
agencies with respect to our product candidates or 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; the timing of regulatory
filings for our 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; delays, interruptions or failures in the manufacture
and supply of our product candidates; and the company’s ability to
obtain additional funding to support its clinical development and
commercial programs. 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20241015820494/en/
Investors Sonya Weigle Chief People
and Investor Relations Officer Marinus Pharmaceuticals, Inc.
sweigle@marinuspharma.com
Media Molly Cameron Director,
Corporate Communications & Investor Relations Marinus
Pharmaceuticals, Inc. mcameron@marinuspharma.com
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