Catalyst Pharmaceuticals Receives Two New U.S. Patent Allowances For FIRDAPSE®
02 Novembro 2023 - 11:37AM
Catalyst Pharmaceuticals, Inc. ("Catalyst" or "Company")
(Nasdaq: CPRX), a commercial-stage biopharmaceutical company
focused on in-licensing, developing, and commercializing novel
medicines for patients living with rare diseases, today
announced that the Company has received notification by the United
States Patent and Trademark Office ("USPTO") that two additional
patents covering FIRDAPSE® (amifampridine) Tablets 10 mg, were
allowed and will be granted within the next two months. These new
patents are for claims associated with the unique and novel,
previously unknown, bioavailability of FIRDAPSE under fasting and
fed conditions of dosing. FIRDAPSE is the only approved treatment
available in the U.S. for Lambert-Eaton myasthenic syndrome.
"We are very pleased to receive these patent
notifications from the USPTO. This milestone reaffirms our
unwavering dedication to advancing our core objectives, which are
crucial in strengthening and maintaining the ongoing commercial
success of our flagship product, FIRDAPSE," stated Patrick J.
McEnany, Chairman and Chief Executive Officer of Catalyst. "Aligned
with our portfolio strategy, we remain committed to advancing our
core objectives to reinforce and safeguard the sustained commercial
viability of FIRDAPSE, which currently benefits from patent
exclusivity protection in the United States until 2037."
"These patent allowances strengthen our
cumulative understanding of the uniqueness of FIRDAPSE and bolster
its strong intellectual property estate offering enhanced patent
protection," stated Dr. Steven Miller, Chief Operating Officer and
Chief Scientific Officer of Catalyst. "These two new patents, with
expiry dates out to mid-2032, cover claims related to the product's
novel and unique bioavailability when administered under fasting
and fed dosing conditions, further strengthening our NAT2 family of
patents. We expect these patents to be granted within two months.
Preparations are already in motion to include these additional
FIRDAPSE patents in the FDA Orange Book post-grant, bringing the
total listed patent count to eight."
About FIRDAPSE®FIRDAPSE® (amifampridine)
Tablets 10 mg is an oral, nonspecific, voltage-dependent, potassium
(K+) channel blocker that causes depolarization of the presynaptic
membrane and slows or inhibits repolarization. This action results
in the opening of slow voltage-dependent calcium (Ca2+) channels,
allowing for a subsequent influx of Ca2+. In turn, it induces the
exocytosis of synaptic vesicles containing Acetylcholine (ACh) to
release more ACh into the synaptic cleft, enhancing neuromuscular
transmission and providing for improved muscle function.
About Catalyst
PharmaceuticalsWith exceptional patient focus, Catalyst is
committed to developing and commercializing innovative
first-in-class medicines that address rare neurological and
epileptic diseases. Catalyst's flagship U.S. commercial
product is FIRDAPSE® (amifampridine) Tablets 10 mg, approved
for the treatment of Lambert-Eaton myasthenic syndrome ("LEMS") for
adults and for children ages six to seventeen. In January
2023, Catalyst acquired the U.S. commercial rights to
FYCOMPA® (perampanel) CIII, a prescription medicine approved
in people with epilepsy aged four and older alone or with other
medicines to treat partial-onset seizures with or without
secondarily generalized seizures and with other medicines to treat
primary generalized tonic-clonic seizures for people with epilepsy
aged 12 and older. Further, Canada's national healthcare
regulatory agency, Health Canada, has approved the use of
FIRDAPSE for the treatment of adult patients
in Canada with LEMS. Finally, on July 18, 2023,
Catalyst acquired an exclusive license for North
America for AGAMREE® (vamorolone) oral suspension 40 mg/mL, a
novel corticosteroid treatment for Duchenne Muscular
Dystrophy. AGAMREE® previously received FDA Orphan Drug and
Fast Track designations and was recently approved for
commercialization in the U.S. on October 26, 2023.
For more information about Catalyst
Pharmaceuticals, Inc., visit the Company's website
at www.catalystpharma.com. For Full Prescribing and Safety
Information for FIRDAPSE®, visit www.firdapse.com. For Full
Prescribing Information, including Boxed WARNING for FYCOMPA®,
please visit www.fycompa.com. For Full Prescribing Information
for AGAMREE®, please visit www.agamree.com.
Forward-Looking StatementsThis
press release contains forward-looking statements. Forward-looking
statements involve known and unknown risks and uncertainties, which
may cause Catalyst's actual results in future periods to differ
materially from forecasted results. A number of factors, including
(i) whether these new patents will withstand challenge by generic
drug companies, (ii) whether Catalyst can successfully protect
FIRDAPSE® from generic competitors until the expiration of its
patent estate, and (iii) those factors described in Catalyst's
Annual Report on Form 10-K for the fiscal year 2022 and its other
filings with the U.S. Securities and Exchange
Commission ("SEC"), could adversely affect Catalyst. Copies of
Catalyst's filings with the SEC are available from
the SEC, may be found on Catalyst's website, or may be
obtained upon request from Catalyst. Catalyst does not undertake
any obligation to update the information contained herein, which
speaks only as of this date.
Source: Catalyst Pharmaceuticals
Investor Relations Contact:
Mary Coleman, Catalyst Pharmaceuticals
(305) 420-3200
mcoleman@catalystpharma.com
Media Contact:
David Schull, Russo Partners
(858) 717-2310
david.schull@russopartnersllc.com
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