- U.S. launch scheduled for early in the first quarter of 2019
- Catalyst is well-capitalized and sees no current need for capital infusion
CORAL GABLES, Fla., Dec. 03, 2018 (GLOBE NEWSWIRE) — Catalyst Pharmaceuticals, Inc. (Catalyst) (Nasdaq: CPRX), a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating, chronic neuromuscular and neurological diseases today announced that the company will host a conference call and webcast on December 13, 2018 at 8:30 AM ET to discuss its commercialization plan for Firdapse®, including the cost of therapy. Firdapse will be available early in the first quarter of 2019.
“We look forward to providing the details of the commercial launch plan for Firdapse for the treatment of LEMS, as well as our plan for achieving our stated objective of affordable access to Firdapse for all,” said Patrick J. McEnany, Chairman and Chief Executive Officer of Catalyst Pharmaceuticals. “We are well-capitalized to support the launch of Firdapse, and as we have stated in our recent public filings we have sufficient cash to execute our business plan through at least 2019.”
Investors who wish to participate in the conference call may do so by dialing (877) 407-8912 for domestic and Canadian callers or (201) 689-8059 for international callers. Those interested in listening to the conference call live via the internet may do so by visiting the Investors page of the company’s website at www.catalystpharma.com and clicking on the webcast link on the Investors home page.
A webcast replay will be available on the Catalyst website following the call by visiting the Investor page of the company’s website at www.catalystpharma.com.
About Firdapse® (amifampridine)
Firdapse® (amifampridine) 10 mg tablets is an oral, nonspecific, voltage-dependent, potassium (K+) channel blocker that causes depolarization of the presynaptic membrane and slows or inhibits repolarization. This action results in the opening of slow voltage-dependent calcium (Ca2+) channels, allowing for a subsequent influx of Ca2+. In turn, it induces the exocytosis of synaptic vesicles containing Acetylcholine (ACh) to release more ACh into the synaptic cleft, enhancing neuromuscular transmission, and providing for improved muscle function. Firdapse is approved in the U.S. and the European Union for use by patients with LEMS.
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, congenital myasthenic syndromes (CMS), MuSK antibody positive myasthenia gravis (MuSK-MG), and spinal muscular atrophy (SMA) type 3. Amifampridine phosphate has received Orphan Drug Designation from the United States FDA for CMS and myasthenia gravis. Firdapse (amifampridine) 10 mg tablets is the first and only approved drug in Europe for symptomatic treatment in adults with LEMS.
Catalyst is also developing a generic version of vigabatrin.
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 will be successful in commercializing Firdapse (ii) whether, even if Catalyst is successful in commercializing Firdapse, Catalyst will become profitable, (iii) whether Firdapse will ever be approved for the treatment of CMS, MuSK-MG, SMA type 3, or any other disease, and (iv) those other factors described in Catalyst’s Annual Report on Form 10-K for the fiscal year 2017 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.
CONTACT: 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