Catalyst Pharmaceuticals Announces Issuance of U.S. Patent for Firdapse®
October 06 2020 - 11:15AM
Catalyst Pharmaceuticals, Inc. (Catalyst) (Nasdaq: CPRX), a
commercial-stage biopharmaceutical company focused on developing
and commercializing innovative therapies for people with rare
debilitating, chronic neuromuscular and neurological diseases,
today announced that the United States Patent and Trademark Office
(USPTO) has issued a new U.S. patent to Catalyst Pharmaceuticals
for Firdapse® (amifampridine), U.S. Patent No. 10,793,893, Methods
of Administering 3,4-Diaminopyridine, expiring April 7, 2034.
"We are pleased that our patent for Firdapse®
(amifampridine) has issued and believe that it will create
significant barriers to therapeutically equivalent generic
competition from entering the market for approximately nine years
beyond orphan drug exclusivity," said Patrick J. McEnany, Chairman
and Chief Executive Officer of Catalyst. Mr. McEnany added, "We
remain committed to serving the neuromuscular community by
continuing to investigate Firdapse® for other rare
neurodegenerative diseases. We also look forward to results from
various investigator-sponsored trials that, if positive, will
strengthen the value proposition for the use of Firdapse®.”
“This patent is directed to innovative methods
of administering amifampridine to slow metabolizers of
amifampridine,” commented Steven Miller, Ph.D., Chief Operating
Officer and Chief Scientific Officer of Catalyst. Dr. Miller added,
“Within the next few days, we intend to submit a request to the FDA
that this patent be listed in Approved Drug Products with
Therapeutic Equivalence Evaluations (commonly known as the FDA’s
Orange Book), which is published by the United States Food and Drug
Administration.”
Amifampridine is extensively metabolized by
N-Acetyl Transferase, type 2 (or NAT2) and the rate of this
metabolism can be quite variable in patients. The patent is
directed to the use of suitable doses of amifampridine to treat
patients, regardless of the therapeutic indication, that are slow
metabolizers of amifampridine. Any drug product containing
amifampridine with a label that states the patented dosing regimens
and doses in the Dosing and Administration section prior to
4/7/2034 could possibly infringe this patent. Generic drug product
labels would necessarily have to do this, and Catalyst would take
appropriate action to protect its intellectual property.
About Firdapse®
Firdapse® (amifampridine) 10 mg tablets 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 Pharmaceuticals
Catalyst Pharmaceuticals is a commercial-stage
biopharmaceutical company focused on developing and commercializing
innovative therapies for people with rare debilitating, chronic
neuromuscular and neurological diseases, including Lambert-Eaton
myasthenic syndrome (LEMS), anti-MuSK antibody positive myasthenia
gravis (MuSK-MG) and spinal muscular atrophy (SMA) Type 3.
Catalyst's new drug application for Firdapse® (amifampridine) 10 mg
tablets for the treatment of adults with LEMS was approved in
November 2018 by the U.S. Food & Drug
Administration ("FDA"), and Firdapse is now commercially
available in the United States. Further, Canada’s national
healthcare regulatory agency, Health Canada, recently approved the
use of Firdapse® (amifampridine) for the treatment of patients in
Canada with LEMS.
Firdapse is currently being evaluated in
clinical trials for the treatment of MuSK-MG and SMA Type 3 and has
received Orphan Drug Designation from the FDA for
myasthenia gravis.
Forward-Looking Statements
This 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) the scope of protection from
competition provided by the patent, and (ii) those factors
described in Catalyst's Annual Report on Form 10-K for fiscal year
2019 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.
Investor Contact
Brian Korb
Solebury Trout
(646) 378-2923
bkorb@troutgroup.com
Company Contact
Patrick J. McEnany
Catalyst Pharmaceuticals
Chief Executive Officer
(305) 420-3200
pmcenany@catalystpharma.com
Media Contact
David Schull
Russo Partners
(212) 845-4271
david.schull@russopartnersllc.com
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