Catalyst Pharmaceuticals Announces Launch of Expanded Access Program Website and Participation at the American Association of Neuromuscular & Electrodiagnostic Medicine Conference
CORAL GABLES, Fla., Sept. 14, 2016 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. (Nasdaq:CPRX), a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating diseases, today announced the launch of a new website for its expanded access program (EAP) and its planned participation at the 63rd American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) conference which will be held on September 14-17, 2016 at the Hilton New Orleans Riverside in New Orleans.
This week Catalyst officially launched its new Expanded Access Program website at www.muscleweakness-eap.com. Catalyst's EAP continues to enroll new patients and provide Firdapse® (amifampridine phosphate) at no charge to eligible patients with Lambert-Eaton Myasthenic Syndrome (LEMS) and Congenital Myasthenic Syndromes (CMS). Expanded Access Programs are not required by regulatory agencies, but are a mechanism supported by them for getting investigational treatment to patients who have a life threatening or severely debilitating disease and who cannot be satisfactorily treated with an alternative therapy approved by the FDA. This new website is
designed to make it even easier and transparent for patients to learn about Catalyst's Expanded Access Program and the possibility of getting access to Firdapse at no cost if they are eligible.
"As part of our ongoing commitment to patients, Catalyst is fully dedicated to our Expanded Access Program and focused on making Firdapse more accessible to the patients who need it," said Patrick J. McEnany, Chief Executive Officer of Catalyst Pharmaceuticals. "We hope this new website enables more patients with LEMS and CMS to understand our program and learn more about this experimental treatment option for these debilitating diseases."
Catalyst will have a booth in the exhibition hall (Booth #212) of the AANEM conference.
Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) is a nonprofit membership association dedicated to the advancement of neuromuscular (NM), musculoskeletal, and electrodiagnostic (EDX) medicine. For more information, please visit: http://www.aanem.org/
About Catalyst Pharmaceuticals
Catalyst Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating diseases, including Lambert-Eaton myasthenic syndrome (LEMS), congenital myasthenic syndromes (CMS), infantile spasms, and Tourette's Disorder. Firdapse® for the treatment of LEMS has
received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) 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 infantile spasms, epilepsy and other neurological conditions associated with reduced GABAergic signaling, like post-traumatic stress disorder and 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 by the European Commission for the treatment of West Syndrome. In addition, Catalyst is developing a generic version of Sabril® (vigabatrin).
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 the receipt of breakthrough therapy designation for Firdapse will expedite the development and review of Firdapse by the FDA or the likelihood that the product will be found to be safe and effective, what study design for a second trial evaluation of Firdapse for the treatment of LEMS will be acceptable to the FDA, the timing of such trial, and whether it will be successful, whether Catalyst's assumptions in its updated business plan will be accurate and the
impact of unanticipated events or delays in projected activities on Catalyst's cash requirements and on Catalyst's ability to get to an accepted NDA submission for Firdapse without the need for additional funding, what clinical trials and studies will be required before Catalyst can resubmit an NDA for Firdapse for the treatment of CMS and whether any such required clinical trials and studies will be successful, whether the investigator-sponsored study evaluating Firdapse for the treatment of MuSK-MG will be successful, whether any NDA for Firdapse resubmitted to the FDA will ever be accepted for filing, the timing of any such NDA filing or acceptance, whether, if an NDA for Firdapse is accepted for filing, such NDA will be given a priority review by the FDA, whether Firdapse will ever be approved for commercialization, whether Catalyst will be the first company to receive
approval for amifampridine (3,4-DAP), giving it 7-year marketing exclusivity for its product, whether CPP-115 will be determined to be safe for humans, what additional testing will be required before CPP-115 is "Phase 2 ready", whether CPP-115 will be determined to be effective for the treatment of infantile spasms, post-traumatic stress disorder, Tourette's Disorder or any other indications, whether Catalyst can successfully design and complete a bioequivalence study of its version of vigabatrin compared to Sabril that is acceptable to the FDA, whether any such bioequivalence study the design of which is acceptable to the FDA will be successful, whether any ANDA that Catalyst submits for a generic version of Sabril will be accepted for filing, whether any ANDA for Sabril accepted for filing by the FDA will be approved (and the timing of any such approval), whether any of Catalyst's
product candidates will ever be approved for commercialization or successfully commercialized, and those other factors described in Catalyst's Annual Report on Form 10-K for the fiscal year 2015 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.
The Trout Group LLC
Patrick J. McEnany
Chief Executive Officer
Matt Middleman, M.D.
Source: Catalyst Pharmaceuticals, Inc.
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