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CORAL GABLES, Fla., May 10, 2017 -- Catalyst Pharmaceuticals, Inc. (Nasdaq:CPRX), a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating neuromuscular and neurological diseases, today announced that an abstract highlighting the results of an investigator-sponsored Phase 2b study of Firdapse® (amifampridine phosphate) in the treatment of MuSK antibody positive myasthenia gravis (MuSK-MG) has been accepted for a scientific poster presentation at the 13th International Conference on Myasthenia Gravis and Related Disorders to be held on May 15-17, 2017 in New York.
“The current pilot study with MuSK-MG patients showed measurable evidence of benefit in all the assessed outcome measures, despite the small sample size. We feel these results are a strong signal that amifampridine phosphate can be a safe, effective treatment for the difficult to manage symptoms of MuSK-MG. An expanded trial will seek to confirm the results presented in Dr. Mantegazza’s abstract,” said Gary Ingenito, M.D., Ph.D., Catalyst’s Chief Medical Officer.
This study was conducted by a team of researchers led by Renato Mantegazza, MD and Silvia Bonanno, M.D., Department of Neuroimmunology and Neuromuscular Diseases, Fondazione Istituto Neurologico “Carlo Besta” in Milan, Italy, a major referral center for MuSK-MG patients.
The poster presentation details are as follows:
Title: “MuSK MG Patients Showed a Positive Response to Amifampridine Phosphate in a Randomized, Placebo-Controlled, Crossover Study”
Poster Session: Day 1 Poster Session at Marriott Downtown, 85 West St., New York, NY 10280
Session Date/Time: May 15, 2017 from 6:00 to 8:30 PM
Authors: Silvia Bonanno, M.D., Barbara Pasanisi, M.D., Carlo Antozzi, M.D., Lorenzo Maggi, M.D., Francesca Andreetta, Ph.D., Ornella Simoncini, MSc., and Renato Mantegazza, M.D.
About Catalyst Pharmaceuticals
Catalyst Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating neuromuscular and neurological diseases, including Lambert-Eaton myasthenic syndrome (LEMS), congenital myasthenic syndromes (CMS), MuSK antibody positive myasthenia gravis and infantile spasms. Firdapse® has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the treatment of LEMS and Orphan Drug Designation for LEMS, CMS and myasthenia gravis. Firdapse is the first and only approved drug in Europe for symptomatic treatment in adults with LEMS.
Catalyst is also developing CPP-115 to treat refractory infantile spasms, and possibly refractory Tourette's Disorder. CPP-115 has been granted U.S. Orphan Drug Designation for the treatment of infantile spasms by the FDA and has been granted E.U. Orphan Medicinal Product Designation for the treatment of West syndrome by the European Commission. In addition, Catalyst is developing a generic version of Sabril® (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 whether Catalyst can successfully design and complete a registration trial evaluating Firdapse for the treatment of MuSK-MG that is acceptable to the FDA, whether any such trial for the treatment of MuSK-MG that is acceptable to the FDA will be successful, whether Catalyst can obtain the funding required to conduct such a trial, and those factors described in Catalyst's Annual Report on Form 10-K for the fiscal year 2016 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 The Trout Group LLC (646) 378-2923 [email protected] Media Contacts David Schull Russo Partners (212) 845-4271 [email protected] Company Contact Patrick J. McEnany Catalyst Pharmaceuticals Chief Executive Officer (305) 529-2522 [email protected]
