Catalyst Pharmaceuticals Announces FIRDAPSE® New Drug Application Submitted in Japan by Partner DyDo Pharma
December 18 2023 - 6:30AM
Catalyst Pharmaceuticals, Inc. (“Catalyst”) (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 its collaboration partner,
DyDo Pharma, Inc. ("DyDo"), reported that it has submitted a New
Drug Application (“NDA”) to Japan's Pharmaceuticals and
Medical Devices Agency (“PMDA”) seeking marketing approval for
FIRDAPSE® (amifampridine) Tablets 10 mg (generic name:
amifampridine phosphate), for the treatment of Lambert Eaton
myasthenic syndrome ("LEMS") in Japan. The submission is based on
preliminary favorable analysis results of interim data after six
months into the safety phase of the registration study to evaluate
the efficacy and safety of FIRDAPSE for the treatment of LEMS. The
review period is expected to be approximately a minimum of nine
months from the submission date.
“The NDA submission to the PMDA by our partner
DyDo represents a pivotal milestone in our mission to broaden
FIRDAPSE’s access as a treatment for LEMS patients in Japan,”
stated Patrick J. McEnany, Catalyst’s Chairman and CEO. “Given the
absence of therapies available in Japan for this rare neuromuscular
disorder, we believe that if approved, FIRDAPSE holds the potential
to be a novel treatment option for Japanese individuals grappling
with this condition. As we continue to collaborate with our partner
during the review process, the submission also triggers an
expansion of our territorial rights for the product and a milestone
payment to Catalyst. We look forward to initiating our plans to
expand the reach for FIRDAPSE into other global regions seeking a
novel therapy for the treatment of LEMS.”
In June 2021, Catalyst entered into a license
agreement with DyDo for the development and commercialization of
FIRDAPSE in Japan. Under the terms of the agreement, Catalyst is
eligible to receive a regulatory milestone payment from DyDo upon
submission of the NDA to the PMDA. Under the Company’s license
agreement with SERB S.A., upon acceptance of the NDA submission to
the PMDA in Japan, Catalyst’s territorial rights to develop and
market the product will automatically extend to other key markets
in Asia, Central, and South America. The Company is currently
initiating plans to seek opportunities to expand the product’s
global footprint through strategic partnerships, with a current
focus on the Asia Pacific and Latin American regions.
About FIRDAPSE® (amifampridine)
Tablets 10 mgFIRDAPSE® (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. Amifampridine phosphate
was granted orphan drug designation by the Ministry of
Health, Labour, and Welfare in Japan, and
FIRDAPSE has previously been approved for use in the United
States for adults and for children ages six to seventeen and in
Europe and Canada for the treatment of adults with LEMS.
About DyDo PharmaDyDo Pharma is
the rare disease pharmaceutical wholly owned subsidiary of DyDo
Group Holdings. DyDo Group Holdings, Inc. operates through the
following segments: Domestic Beverage Business, International
Beverage Business, Pharmaceutical-related Business, Food Business,
and Other Businesses. The Domestic Beverage Business accounts for
more than 70% of total sales, and beverages are sold through
vending machines that are widely prevalent in Japan. The
company was founded on January 27, 1975, and is
headquartered in Osaka, Japan.
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
DyDo Pharma's clinical trial in Japan will be successful,
(ii) whether FIRDAPSE® will ever be approved for
commercialization in Japan, and (iii) those factors described
in Catalyst's Annual Report on Form 10-K for 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,
Inc.
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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