Catalyst Pharmaceuticals Files Federal Lawsuit Against U.S. Food and Drug Administration
June 12 2019 - 8:47AM
Catalyst Pharmaceuticals, Inc. (Catalyst) (Nasdaq:CPRX), today
announced it has filed a suit against the U.S. Food and Drug
Administration (FDA) and several related parties challenging the
recent approval of a new drug application and related drug labeling
for Jacobus Pharmaceutical Company’s drug Ruzurgi™ for the
treatment of Lambert-Eaton Myasthenic Syndrome (LEMS) in pediatric
patients. The complaint was filed today in the United States
District Court for the Southern District of Florida.
The complaint alleges that the defendants’
approval of Ruzurgi violated multiple provisions of FDA regulations
regarding labeling, resulting in misbranding in violation of the
Federal Food, Drug, and Cosmetic Act (FDCA); violated Catalyst’s
statutory rights to Orphan Drug Exclusivity and to New Chemical
Entity Exclusivity under the FDCA; and was in multiple other
respects arbitrary, capricious, and contrary to law, in violation
of the Administrative Procedure Act. Among other remedies, the suit
seeks an order vacating the FDA's approval of Ruzurgi.
“New chemical entities (drugs) are required to
go through the full drug approval process which requires
demonstration of safety and efficacy,” said Patrick J. McEnany,
Chairman and Chief Executive Officer of Catalyst Pharmaceuticals,
Inc. “We believe the FDA has misapplied its regulations,
contradicting decades of precedent and has undercut Catalyst’s
orphan drug exclusivity. We are compelled to bring this action, to
preserve the specialized regulatory framework provided by the
Orphan Drug legislation, and the prospect of future rare disease
drug development for all rare disease patients in need of an
approved treatment.”
About Catalyst
Pharmaceuticals
Catalyst Pharmaceuticals is a biopharmaceutical
company focused on developing and commercializing innovative
therapies for people with rare debilitating, chronic neuromuscular
and neurological diseases, including LEMS, anti-MuSK antibody
positive myasthenia gravis (MuSK-MG), congenital myasthenic
syndromes (CMS), 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 recently approved
by the U.S. Food & Drug Administration, 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, CMS, and SMA Type 3
and has received Orphan Drug Designation from the FDA for CMS and
myasthenia gravis. Firdapse (amifampridine) 10 mg tablets is the
first and only approved drug in Europe for the symptomatic
treatment in adults with LEMS.
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) whether Catalyst's suit to vacate
the FDA's approval of Ruzurgi, among other relief, will be
successful, (ii) the impact of the approval of Ruzurgi on
Catalyst's future results of operations and business, and (iii)
those factors described in Catalyst's Annual Report on Form 10-K
for the fiscal year 2018 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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