Catalyst Pharmaceuticals Announces Ruling on Lawsuit against the FDA and Intent to Appeal
September 29 2020 - 4:40PM
Catalyst Pharmaceuticals, Inc. (Catalyst) (Nasdaq: CPRX), today
reported that the federal judge handling Catalyst's case against
the FDA has adopted the previously reported Report and
Recommendation of the Magistrate Judge, granted summary judgment in
favor of the FDA and Jacobus, and dismissed Catalyst's case.
Catalyst is currently reviewing the District Judge's decision,
which it believes to be erroneous, and intends to appeal the result
to the Eleventh Circuit Court of Appeals.
In the order, the District Judge found that
Catalyst’s interpretation of the Orphan Drug Act “is not
necessarily wrong, but it is not the only reasonable way to
interpret the plain language of the statute.” The District
Judge found that the relevant statutory language was ambiguous and
adopted FDA’s interpretation rather than Catalyst’s. The
District Judge also rejected Catalyst’s argument that the approved
labeling for Ruzurgi® is false and misleading. As a result of
the District Judge's decision, Ruzurgi® remains approved for the
treatment of pediatric LEMS patients in the United
States.
Patrick J. McEnany, the Company's Chairman and
CEO, stated: "We are of course disappointed with Judge Bloom’s
decision to accept the Magistrate’s Report and Recommendation in
our lawsuit challenging the FDA’s decision to approve Ruzurgi® for
the treatment of pediatric patients with Lambert-Eaton Myasthenic
Syndrome (LEMS). This decision in no way affects our Catalyst
PathwaysTM patient services programs, market access for Firdapse®
or our ongoing marketing efforts for Firdapse® to adult LEMS
patients, which represent about 99% of the LEMS patient
community."
Mr. McEnany continued: "Judge Bloom’s decision
also does not alter the fact that Jacobus Pharmaceuticals is not
permitted to market Ruzurgi® to adult LEMS patients in the United
States, and Catalyst intends to continue to aggressively take all
steps necessary to protect Firdapse®’s exclusivity under the Orphan
Drug Act."
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 adult
patients with LEMS in Canada.
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) whether Catalyst can successfully
overturn the decision of the District Judge in the 11th Circuit
Court of Appeals, (ii) whether Catalyst can continue to
successfully market its product despite the lower price charged by
Jacobus for its amifampridine drug, and (iii) those factors
described in Catalyst's Annual Report on Form 10-K for the fiscal
year 2019 and Catalyst's 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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