Catalyst Pharmaceuticals Announces 11th Circuit Court of Appeals Denial of Jacobus Pharmaceutical Company Inc.'s Petition for Rehearing
Catalyst Pharmaceuticals (Nasdaq: CPRX) announced that the 11th Circuit Court of Appeals denied Jacobus Pharmaceutical's petition for rehearing regarding the FDA's approval of Ruzurgi® for pediatric LEMS patients. This ruling supports Catalyst's position and anticipates a forthcoming mandate for summary judgment in their favor. CEO Patrick J. McEnany emphasized the company's commitment to patient care, ensuring uninterrupted access to amifampridine, whether through commercial or compassionate use programs. Catalyst aims to provide the necessary support to patients transitioning to FIRDAPSE.
- Court ruling denies Jacobus Pharmaceutical's petition, affirming FDA approval of Ruzurgi®.
- Catalyst anticipates a favorable summary judgment soon.
- Company demonstrates strong commitment to patient access and support.
- Potential for Jacobus to appeal the ruling to the U.S. Supreme Court.
- Timing uncertainties related to the mandate issuance and subsequent district court actions.
CORAL GABLES, Fla., Jan. 10, 2022 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. (Catalyst) (Nasdaq: CPRX), a commercial-stage, patient-centric biopharmaceutical company focused on in-licensing, developing, and commercializing novel high-quality medicines for patients living with rare diseases, today reported that the 11th Circuit Court of Appeals has denied Jacobus Pharmaceutical Company Inc.'s petition for rehearing of the 11th Circuit's prior ruling to overturn the U.S. Food and Drug Administration (FDA) approval of Ruzurgi® for pediatric patients with Lambert-Eaton myasthenic syndrome (LEMS) based on the orphan drug exclusivity of FIRDAPSE®. Catalyst expects that the mandate to the District Court with instructions to enter summary judgment for Catalyst will be issued in the near future.
Patrick J. McEnany, Catalyst's Chairman and CEO stated: "Catalyst's priority has always been, and will continue to be, to put patients' needs first, and we are well prepared to address their questions and do everything we can to ensure that ALL LEMS patients continue with uninterrupted access to amifampridine for treating their LEMS condition, whether through commercial access or compassionate use access for those who qualify. Our patient-focused Catalyst Pathways® team stands ready to provide information to patients currently being treated with Ruzurgi on how best to transition to FIRDAPSE."
Information for Prescribers and Patients is available at 1-833-422-8259 and www.yourcatalystpathways.com.
About Catalyst Pharmaceuticals
Catalyst Pharmaceuticals is a commercial-stage, patient-centric biopharmaceutical company focused on in-licensing, developing, and commercializing novel high-quality medicines for patients living with rare diseases. With exceptional patient focus, Catalyst is committed to developing a robust pipeline of cutting-edge, first- or best-in-class medicines for other rare diseases. Catalyst's New Drug Application for FIRDAPSE® (amifampridine) Tablets 10 mg for the treatment of adults with Lambert-Eaton myasthenic syndrome ("LEMS") was approved in 2018 by the U.S. Food & Drug Administration ("FDA"), and FIRDAPSE is commercially available in the United States as a treatment for adults with LEMS. 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.
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 Jacobus will appeal the ruling of the 11th Circuit to the U.S. Supreme Court, (ii) the timing as to when the mandate will issue, and the timing, following the issuance of the mandate, when the District Court will enter summary judgment in favor of Catalyst in its lawsuit against the FDA, and (iii) those factors described in Catalyst's Annual Report on Form 10-K for the fiscal year 2020 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.
Source: Catalyst Pharmaceuticals Inc.
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