Catalyst Pharmaceuticals Announces Notice of Allowance of a U.S. Patent Application for "Methods of Administering 3,4-Diamino...
August 11 2020 - 6:00AM
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 Notice of Allowance for U.S. Patent
Application Serial Number 14/128,672. The allowed
application, "Methods of Administering 3,4-Diaminopyridine", claims
a method of treating a human patient diagnosed with a 3,4-DAP
sensitive disease by administering 3,4-DAP (or salts thereof) to
slow acetylating patients having certain mutations in each allele
of the NAT2 gene.
A Notice of Allowance is issued after the USPTO
determines that the prosecution on the merits of a patent has been
completed. The patent can then be granted from an application
upon payment of the patent issue fee. Catalyst expects the
patent to issue in the next few months. Once issued, the
patent would be expected to expire no earlier than June 29,
2032. The expiration of this patent could also be extended
based on delays in patent prosecution, if any. This
extension, if any, will be calculated after the patent has been
issued. The Notice of Allowance and the allowed claims for
this application are posted on the USPTO public PAIR website.
“The receipt of this Notice of Allowance from
the USPTO represents an important milestone in expanding our
Firdapse® intellectual property portfolio and adds to Catalyst’s
options for further developing the Firdapse® franchise,” said Dr.
Steven Miller, Chief Operating Officer and Chief Scientific
Officer. Dr. Miller continued, “Notably, we believe that the
comprehensive nature of the allowed claims in the resulting patent
will provide Catalyst with additional protection through at least
June of 2032. This will permit us to continue, and possibly
expand, our research efforts for other indications, as well as
improved formulations for Firdapse®.”
Upon issuance of this patent, Catalyst will seek
to list this patent in the FDA's "Orange Book" (the FDA's list of
all approved drugs in the United States). When a patent is
listed in the FDA's Orange Book for an approved drug, no generic
equivalent of the drug may be approved by the FDA unless the
generic drug applicant can prove that they do not infringe the
listed patent or until the applicant successfully challenges the
validity of the listed patent.
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. Prior to its approval,
Firdapse® for LEMS had received breakthrough therapy designation
and orphan drug designation from the FDA.
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) when the patent will officially be
issued, (ii) when the patent, once officially issued, will expire,
(iii) the scope of protection from competition provided by the
patent, and (iv) 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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