Catalyst Pharmaceuticals Provides Update on Impact of COVID-19 Pandemic on its Business Activities
- Safety of personnel, patients and healthcare providers remains our top priority
- Drug supply remains well-stocked with patients having access to uninterrupted supply of Firdapse® (amifampridine) 10mg
- Catalyst partners with First Responders Children’s Foundation to support COVID-19 EMERGENCY RESPONSE FUND
“We are committed to protecting the safety and well-being of our personnel, the entire LEMS community, healthcare providers, patients in clinical trials, and clinical trial site employees, and this will remain our priority throughout these challenging times,” said
Protecting Catalyst Team and Communities
Catalyst is following the guidance from the
Catalyst announced today a corporate partnership with First Responders Children’s Foundation to support the
Firdapse Manufacturing and Supply
Our Firdapse supply chain remains robust and ready for any contingencies that arise due to the COVID-19 outbreak, and thus far we have observed no disruptions in the production of Firdapse. We reiterate that we are committed to providing patients with the ability to obtain an uninterrupted supply of Firdapse. As we reported on our fourth quarter and year end conference call a few weeks ago, we have an adequate supply of Firdapse to address patients’ needs through December and are pleased to report that we have just completed a manufacturing campaign that will provide an additional six months of inventory beyond December. Like Catalyst, our
Catalyst ended 2019 in a strong financial position. The Company reported that it had
Clinical Development Timelines
At this time, we continue to believe that we will report top-line results from our Phase 3 trial for MuSK-MG in the current quarter, but the worldwide travel restrictions and social distancing requirements of the COVID-19 pandemic have put a strain on clinical trial staff and their availability for study close-out activities. Catalyst is continuing to monitor sites through remote means in accordance with guidance recently provided by the FDA and is working with sites remotely on data entry and data checking, to the extent that sites will allow and study coordinators are able. Catalyst is fortunate that enrollment had been completed, and the trial was nearly finished, before the advent of the COVID-19 health emergency. However, many activities at trial sites need to occur before our study can be unblinded. Assuming this trial is successful, we hope to submit an sNDA for Firdapse for MuSK-MG by the end of this year. We expect that we will be able to provide more current information on our clinical programs during our first quarter earnings call that is scheduled for next month.
In addition, we had planned to report top-line results from our SMA Type 3 proof-of-concept trial in the current quarter. However, the Serbian government has recently imposed temporary new regulations for clinical trials requiring all clinical activities not needed for patient safety to be halted. Although fully recruited, screened, and ready to start, our SMA trial subjects in
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.
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 impact of the effects of the COVID-19 pandemic on Catalyst's 2020 net product revenues and on the timeline for reporting the top-line results from Catalyst's MuSK-MG trial and SMA Type 3 proof-of-concept study, and (ii) 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.
Brian KorbSolebury Trout (646) 378-2923 firstname.lastname@example.org Company Contact Patrick J. McEnany Catalyst PharmaceuticalsChief Executive Officer (305) 420-3200 email@example.com Media Contact David Schull Russo Partners(212) 845-4271 firstname.lastname@example.org
Source: Catalyst Pharmaceuticals, Inc.